Fill - Free fillable Institutional Review Board PDF form

Institutional Review Board

Policies and Procedures

Spring 2020

Institutional Review Board Policies and Procedures 1

Table of Contents

Introduction

Procedures

Institutional Authority

Guiding Principles

Human Subject Research Criteria

Types of Research

IRB Composition

Training Requirements

Conflicts of Interest

Record Keeping

Meetings

Procedure for the Types of Review

Board Actions

IRB Decision Appeal

Update Review

Cooperative Activities

Types of IRB Review

Exempt Status Determination

Expedited Review

Full Board Review

Recruitment, Informed Consent and Compliance

Recruitment Participants

Informed Consent Process

Informed Consent Form

Confidentiality/Anonymity

Retention of Signed Forms

Deception Studies

Waivers of Informed Consent

Application Process

Before You Apply

Application Submission Process

Review Process

Continuing Review, Final Reports and Study Closure

Compliance and Incident Reporting

Appendices

IBR Decision Charts

Quick-Start Guide for Principal Investigators

Sample Informed Consent Letters

Application

Institutional Review Board Policies and Procedures 2

Introduction

Bunker Hill Community College (BHCC) has assembled and identified an Institutional Review

Board (IRB) to review research proposals that include a proposed use of human subjects.

Protection of human participants is of the utmost importance for practical and ethical reasons.

BHCC has created this document to help faculty, staff, students and administrators design and

implement research projects that protect the rights and welfare of human subjects and support

the institution's research mission. Much of what is discussed in this document can be found on

the website of the Department of Health and Human Services (DHHS) Office of Human

Research Protections (OHRP) or http://www.hhs.gov/ohrp. We have attempted to summarize

the basic DHHS policy for the protection of human research participants as specified in the

Code of Federal Regulations (CFR) Title 45, Part 46, Subpart A (also known as the Common Rule,

45 CFR 46).

The role of the IRB is to:

• Review proposed research projects that involve the use of human subjects;

• Ensure risks to subjects are minimized and risks to subjects are reasonable in relation to

anticipated benefits;

• Ensure selection of subjects is equitable.

1. Risks to subjects are minimized: (i) By using procedures which are consistent with sound

research design and which do not unnecessarily expose subjects to risk, and (ii)

whenever appropriate, by using procedures already being performed on the subjects for

diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,

and the importance of the knowledge that may reasonably be expected to result. In

evaluating risks and benefits, the IRB should consider only those risks and benefits that

may result from the research (as distinguished from risks and benefits of therapies

subjects would receive even if not participating in the research). The IRB should not

consider possible long-range effects of applying knowledge gained in the research (for

example, the possible effects of the research on public policy) as among those research

risks that fall within the purview of its responsibility.

3. Selection of subjects is equitable. In making this assessment the IRB should take into

account the purposes of the research and the setting in which the research will be

conducted and should be particularly cognizant of the special problems of research

involving vulnerable populations, such as children, prisoners, pregnant women, mentally

disabled persons, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective subject or the subject's legally

authorized representative, in accordance with, and to the extent required by §46.116.

Institutional Review Board Policies and Procedures 3

5. Informed consent will be appropriately documented, in accordance with and to the

extent required by §46.117.

6. When appropriate, the research plan makes adequate provision for monitoring the data

collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and

to maintain the confidentiality of data.

a. When some or all of the subjects are likely to be vulnerable to coercion or undue

influence, such as children, prisoners, pregnant women, mentally disabled

persons or economically or educationally disadvantaged persons, additional

safeguards have been included in the study to protect the rights and welfare of

these subjects.

nker Hill Community College (BHCC) would like to thank Middlesex Community College, MA, (MCC)

for permission to use the MCC IRB Policies and Procedures as a template for our document.

Procedures

BHCC is responsible for the protection of human subjects for any research activities conducted

by, or under the supervision of, its faculty, staff or students, regardless of funding source and

the location of the project. The IRB reviews research protocols involving human subjects and

evaluates and protects against risk for those subjects. BHCC and the Principal Investigators (PI)

are responsible for ensuring that high ethical standards are maintained for all research

involving human subjects.

The BHCC IRB reviews human subject research proposals to ensure that the rights and welfare

of human subjects used in research studies by BHCC personnel or by external researchers are

protected; that risks have been considered and minimized; that the potential for benefit has

been identified and maximized; that all human subjects only volunteer to participate in

research after being provided with legally effective informed consent; and that any research is

conducted in an ethical manner and in compliance with established standards. Those

individuals seeking to conduct such research may not solicit subject participation or begin data

collection until they have obtained clearance by the Bunker Hill Community College Institutional

Review Board.

The IRB does not assume the role of evaluating the soundness of the proposed research study,

the merits of the research design, nor the potential contribution of the research to the scholarly

literature. Rather, the IRB is charged with evaluating each project’s compliance with ethical

standards in regard to issues such as informed consent, confidentiality and any risk to the

participants.

Only human subject research (defined as a systematic investigation, including research

development, testing and evaluation, designed to develop or contribute to generalizable

Institutional Review Board Policies and Procedures 4

knowledge [45 CFR part 46 s. 102d]) is subject to IRB review. Normal educational practices such

as educational tests when the subjects are not identified and classroom activities that are solely

for instructional purposes do not require review by the IRB. If the instructor of a class or a

student wishes to present or publish information gathered from human subjects in a context

beyond the class for which it was gathered, the activity is considered to be research and must

be reviewed by the Institutional Review Board. Any researcher who is in doubt about the above

policy is encouraged to contact the IRB Chair with questions or submit their proposal to the IRB.

These policies and procedures will be reviewed and updated as necessary. Any changes to

applicable federal regulations will be implemented immediately, announced, and will supersede

these procedures. PI’s are responsible for following the latest version of this document and

using the most recent forms that accompany it.

Institutional Authority

Research at BHCC is conducted in accordance with the approved Federal Wide Assurance (FWA

No. IORG0009428) on file with the U.S. Department of Health and Human Services (DHHS) Office

for Human Research Protections (OHRP) in which the BHCC IRB #1 is designated as the IRB of

record. The FWA is an assurance that BHCC will comply with the federal regulations for the

protection of human subjects in research. It is a commitment from the BHCC President that the

institution will have written IRB procedures, provide review of nonexempt research covered by

the FWA, obtain and document informed consent unless otherwise waived in accordance with

the regulations, ensure that all collaborating institutions operate under an approved FWA, have

formal written agreements of compliance from all nonaffiliated investigators, and the IRB will

be provided with sufficient resources to fulfill these responsibilities. All sponsored human

subject research must be reviewed by the IRB.

This procedures document establishes and empowers the Bunker Hill Community College

(BHCC) Human Subjects Protection Committee. The IRB reviews all projects and programs

involving human subjects in accordance with these policies and procedures, applicable federal

regulations, laws of the Commonwealth of Massachusetts and sponsor policies and guidelines.

Individuals seeking to conduct research may not solicit subject participation or begin data

collection until they have obtained clearance by the BHCC IRB. The IRB meets regularly to

review research protocols. The IRB is authorized to review, approve, require modifications in or

disapprove research activities using human subjects conducted by or through the College. It is

important to the institution that the BHCC IRB has a high level of respect from the research

community in order to better fulfill its charge and develop trust between all parties concerned.

The IRB Senior Officer is appointed by the President to have responsibility for oversight of

human subject research. Research that has been approved by the IRB may be subject to further

appropriate review and approval or disapproval by the President, designee or IRB Senior

Officer. However, the President, designee or IRB Senior Officer may not approve the non-

exempt research if it has not been approved by the IRB.

BHCC’s institutional policy conveys the authority to the IRB to the following:

Institutional Review Board Policies and Procedures 5

• Provide advice and counsel to personnel engaged in activities involving human subjects.

• Review all research studies involving human participants before their involvement may

begin.

• Require revisions in research studies and consent documents as a condition of approval.

• Approve new research studies and the continuation of previously approved studies.

• Disapprove the initiation of new research studies, if necessary

• Monitor the activities of approved studies. This includes a continuing review at least

once per year. Monitoring may also involve, if necessary, verifying compliance with

approved studies and informed consent procedures. Verification may include observing

the informed consent process as practiced by any investigator or authorized person in

any approved protocol especially in cases where the consentee is from a vulnerable

population.

• Develop mechanisms for prompt reporting to the IRB of unanticipated problems

occurring in approved studies, or in other studies related in context to the approved

studies.

• Suspend or terminate a previously approved study, if necessary.

• Restrict aspects of a research study for the purpose of participant protections, if

necessary.

• Access, and to make copies of, records related to any research approved by the IRB (or

another body under an IRB Authorization Agreement), regardless of the location of

those records, for any reason. Where feasible, appropriate notice will be given of the

need to review, copy or duplicate records while being sensitive to causing the least

inconvenience or disruption of ongoing research.

Guiding Principles

The basic principles that govern the BHCC IRB are contained in Ethical Principles and Guidelines

for the Protection of Human Subjects of Research (“The Belmont Report”), and The National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April

18, 1979 (see http://www.hhs.gov/ohrp/humansubjects/index.html).

The following principles apply to all research, regardless of funding, that involves human

subjects at Bunker Hill Community College to ensure that adequate safeguards are provided:

1. Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort will

also be considered in approving proposed research.

2. Risks to subjects must be reasonable in relation to anticipated benefits, if any, to

subjects, and the importance of the knowledge that may reasonably be expected to

result.

3. Adequate provision(s) must be made for all facilities, procedures and professional

attention necessary for the protection of the individual as a research subject. Faculty are

responsible for all undergraduate student research from application to completion.

4. Adequate provisions should be made for recruiting a subject population that is

representative of the population base in terms of gender and minority representation

unless otherwise justified scientifically.

Institutional Review Board Policies and Procedures 6

5. Research involving human subjects must be supervised by qualified persons, including

qualified clinicians for all study-related healthcare decisions.

6. Participation of a human subject in research must be voluntary with the right of the

subject to withdraw at any time. Information provided to gain subject consent must be

adequate, appropriate and presented in lay language appropriate to the subject

population.

7. All research programs involving human subjects must be reviewed by and must receive

approval of a formally constituted review prior to their initiation or prior to initiating

any changes to the protocol. Continuing research programs are subject to periodic

review to be carried out no less than once a year.

Human Subject Research Criteria

BHCC will be considered to be engaged in human subject research when research is conducted

by or under the direction of any employee or agent of this institution using any property or

facility of the College, or when the research involves the use of the College's non-public

information to identify or contact human research subjects or prospective subjects. OHRP

considers institutions to be engaged in human subject research when employees or agents

intervene for research purposes with any human subjects of the research by:

• manipulating the environment;

• interacting with human subjects for research purposes;

• performing invasive or noninvasive procedures; and/or

• obtaining the informed consent of human subjects.

OHRP does not consider institutions to be engaged in human subject research when employees

or agents:

• inform prospective subjects about availability of the research;

• provide prospective subjects with information about the research but do not obtain

subjects’ consent for the research or act as representatives of the investigators;

• provide prospective subjects with information about contacting investigators for

information or enrollment; and/or

• seek or obtain the prospective subjects’ permission for investigators to contact them.

OHRP’s Guidance on Engagement of Institutions in Human Subjects Research provides

additional information on this topic at: http://www.hhs.gov/ohrp/policy/engage08.html

Employees and students are responsible for ensuring their proposed research is guided by the

ethical principles in the Belmont Report and thus determining whether their research activities

require Institutional Review Board (IRB) approval and, if so, seeking such approval. If the

employee or student has any doubt concerning the classification of the research activities s/he

is encouraged to contact the IRB Chair.

Institutional Review Board Policies and Procedures 7

Types of Research

Research is a systematic investigation, including research development, testing and evaluation,

designed to develop or contribute to generalizable knowledge (usually intended for publication

or public dissemination). Research is usually described in a formal protocol that sets forth an

objective and a set of procedures to reach that objective. Program evaluations, assessments,

institutional effectiveness and student learning that are used for internal purposes only are not

considered to be research. Classroom research projects conducted for the primary purpose of a

learning experience in the methods and procedures of research usually do not meet the federal

definition of research. Consult the IRB Chair for more information.

A research protocol is a written description and scientific rationale for a proposed research

activity. The protocol is submitted to the IRB and includes a discussion of the human subject

protection issues that are relevant to the study. At a minimum, the protocol should address:

• the methods;

• benefits and risks to subjects;

• experimental procedures;

• anticipated number of subjects;

• proposed consent document and consent process to be used

• recruitment plan; and

• appropriate additional safeguards if potentially vulnerable subjects are to be enrolled.

The most common type of research conducted at Bunker Hill Community College is socio-

behavioral research, which may include survey, ethnographic or experimental research where

risks to the subjects are usually minimal and generally related to the release of information

gathered, rather than direct interaction with the physical body. While all researchers must

complete the training requirements for human research subjects, socio-behavioral research

that involves surveys are usually considered low risk, non-invasive and are usually designated as

expedited or exempt status by the IRB. When reviewing behavioral and social sciences research,

the IRB ensures that investigators have made every attempt to minimize risk and possible harm

to participants, whether social, psychological or physical. Potential risks to participating in

behavioral and social science research could be, but are not limited to, breach of

confidentiality; invasion of privacy; embarrassment; and risk to reputation, employability, and

insurability.

IRB Composition

IRB members are appointed for a three-year renewable term on a rotating basis. The IRB is

composed of at least five voting members. All appointments are made by the President and

reported to OHRP. A quorum is needed to record all official actions. One more member than

half the membership, including a nonscientist, must be present to meet the quorum

requirement. Alternates and non-voting members may also be appointed, with alternates

authorized to vote at convened meetings only in the absence of the member for whom they are

the designated alternate. Although an alternate may be designated for more than one IRB

member, each alternate may represent only one regular member at a convened meeting.

Institutional Review Board Policies and Procedures 8

The IRB is composed of members with varying backgrounds and expertise in special areas to

provide complete and adequate review of the research. Committee members are required to

complete training and should possess not only broad specific competence sufficient to

comprehend the nature of the research, but also other competencies necessary for judgments

as to acceptability of the research in terms of BHCC regulations, relevant law, ethical standards

and standards of professional practice. Consultants may be used to review proposals for which

additional expertise is needed at the researcher’s expense.

Federal regulations require that an IRB includes both men and women, at least one member

whose primary concerns are in science areas, one whose primary concerns are nonscientific

areas and at least one community member who is not otherwise affiliated (either directly or

through immediate family) with Bunker Hill Community College. Members with a

behavioral/social science or biomedical research discipline should be considered a scientist,

while members whose expertise would incline them to view research activities from a

standpoint outside of a biomedical or behavioral scientific discipline should be considered a

nonscientist. Degrees in education are considered nonscientific. No person shall be excluded

from serving on the IRB based on sex, race, color or national origin.

Research roles and responsibilities include the following:

IRB Signatory Official

The Signatory Official is an individual who has the authority to make a commitment on behalf of

the institution that the appropriate regulatory requirements will be met. This individual is

responsible for preparing regulatory documents for review and has the authority to sign the

Federal Wide Assurance submitted to OHRP. The IRB Signatory Official at BHCC is the Vice

President of Academic and Student Affairs and reports to the President.

IRB Chair

The IRB Chair is the individual assigned with the administrative responsibility for oversight of

the human protection programs. On the FWA this role is referred to as the Human Protections

Administrator. The Chair must maintain knowledge to serve as a regulatory resource on human

subject protection and to ensure that proposals are in compliance with federal regulations and

guidelines. The IRB Chair shall have an understanding of ethical issues, state law, institutional

policies, and federal human subject research protection issues and regulations. The Chair must

be willing to commit the time required and possess administrative and organizational skills

involved in conducting committee meetings. The Chair is responsible for assuring the protection

of human subject research participants and serving in a leadership role to encourage respect

and compliance for the IRB process.

The duties of the Chair may include:

• reviewing protocols submitted for exempt or expedited review;

• assigning studies to IRB reviewers;

• soliciting feedback from at least two reviewers for research receiving expedited review;

Institutional Review Board Policies and Procedures 9

• scheduling IRB meetings, arranging meeting location(s), creating agendas, distributing

materials for review, taking meeting minutes, documenting meeting actions,

communicating actions to PIs in a timely manner and entering and tracking all related

documentation in a database;

• summarizing IRB review recommendations for dissemination to PIs;

• reviewing and signing letters generated from board actions;

• approving minor amendments and determining which amendments go to the convened

IRB;

• responding to concerns or complaints from research participants, research staff, or

investigators and determining when they should be referred to the convened IRB;

• assisting with ongoing development of IRB Policies and Procedures

• Reviewing and approving protocol exemption requests or appointing a designee to do

so;

• suspending or terminating research protocols if necessary; and

• coordinating, reviewing, and managing all documents for the IRB to ensure that a)

research protocols are reviewed appropriately and in a timely manner, b) records and

files are maintained, c) information is communicated to the appropriate parties and d)

CCCC is in compliance with federal human research regulations and other applicable

federal guidelines.

IRB Vice Chair

The IRB Vice Chair is a voting member of the IRB and presides over all convened IRB meetings in

the absence of the Chair. The Vice Chair is appointed by the Chair and has authority to sign all

IRB action items in the absence of the Chair. The above duties may be assigned to the Vice

Chair in the Chair’s absence or if a conflict of interest arises. The Vice Chair is an active,

respected member of the IRB who is well informed of the regulations relevant to the use of

human participants in research.

Board Members

Members are appointed for a period of three years and may be re-appointed. The term of

appointment may be terminated by notice of the Committee member to the Chair or by notice

from the Chair. If a member is unable to attend meetings for an extended period, as a

consequence of unavoidable conflicting activities, the IRB Chair must be informed so that a

replacement may be appointed. Additionally, members may be removed from the IRB before

their term is completed for reasons of poor attendance for which there is not reasonable

justification, or for other manifestations of unwillingness or incapability to serve the

committee adequately. In either event, the Chair will appoint a replacement. Tenure on the

IRB may be extended by mutual agreement between the member and the Chair.

Members are required to meet training requirements, perform the assigned duties for the

board or notify the Chair of their inability to do so, be available to attend regularly scheduled

meetings, acquire and maintain a working knowledge of federal human subject protection

through the education and training requirements and review protocols and come to meetings

Institutional Review Board Policies and Procedures 10

prepared to discuss them. Board members also review and recommend approval of IRB Policies

and Procedures.

Alternate members may be appointed to serve at-large or to take the place of a regular

appointed member. If both the alternate and the regular member(s) attend the same meeting,

only one may vote and the minutes must reflect who is in attendance as a voting member.

Liability coverage for IRB members is provided through the Bunker Hill Community College

liability insurance, whether or not the IRB member is an employee of Bunker Hill Community

College.

Principal Investigators

Principal investigators (PI’s) are responsible for consulting with appropriate IRB staff to

determine whether research requires IRB review and approval, regardless of whether it is

funded research or not. PIs who intend to gather data as part of evaluations, assessments,

service, reporting, classroom assignments, educational inquiry or practice AND intend to use

the data as research data for the purpose of publishing or sharing with a research community

or the public at large must obtain IRB approval from the BHCC IRB PRIOR to conducting the

activity.

If review is required, PI’s must ensure that an application and protocol are submitted to the IRB.

PI’s must comply with IRB decisions, conditions, and requirements and obtain informed consent

to ensure that no human subject will be involved in the research without consent. PIs are

responsible for retaining consent documents, providing progress reports on the research,

submitting annual review reports on IRB forms and adverse event reports, reporting any

amendments for changes in research and submitting a final report at the conclusion of each

project.

PI’s are also responsible for being aware of any new research publications in the peer-reviewed

scientific literature that may impact their ongoing human subject research.

PI’s and their personnel involved in conducting human subject research must agree to maintain

in strict confidence the names, characteristics, data gathered from research instruments,

incidental comments and other information on all subjects and subjects’ data they encounter

so as not to conflict with state and federal laws and regulations. PIs and their personnel must

understand that “confidentiality” means they may not discuss nor divulge in any manner a

subject’s name or any identifying information or characteristics, scores, ratings, comments or

information about a subject with anyone who is not an authorized member of the research

team.

Student Researchers

Student researchers who are conducting human subject research as part of their degree work

must be knowledgeable of human subject research, including ethics, and must meet the

mandatory training requirement. Classroom or course projects that are developed for the sole

Institutional Review Board Policies and Procedures 11

purpose of education for individual students and involves data gathering from human subjects

as part of evaluations, assessments, service, reporting, classroom assignments, educational

inquiry or practice must either seek IRB approval for their project or abrogate their rights to

publish or present data as research. If students choose to share these observations with others

in ways that do not fit the definition of research (contributing to generalizable knowledge),

their actions should be governed by the ethical standards of their discipline. Data gathered may

only be shared with the course instructor or faculty advisor, or in the case of an

internship/practicum, the collaborating party.

Student investigators who intend to gather data as part of evaluations, assessments, service,

reporting, classroom assignments, educational inquiry or practice AND intend to use the data

as research data for the purpose of publishing or sharing with a research community or the

public at large must obtain IRB approval PRIOR to conducting the activity.

Training Requirements

Institutional policy requires that all of the following individuals must complete the minimum

institutional requirement for training to demonstrate knowledge of human subject research,

including ethics:

• IRB members

• Principal investigators

• Members of the research team

• Student researchers

In order to demonstrate the guidelines and ethical principles for human subject research are

understood, research projects may not begin until the training for all members of the research

team is complete. A certificate of completion from the appropriate online training is required

before any appointment to the board or application is approved. The IRB Chair will maintain a

log of training completion dates. Certification must be renewed every three years.

To complete this requirement, BHCC offers the National Institutes of Health (NIH) training at

http://phrp.nihtraining.com/users/login.php. This is a free web-based training program. Other

training programs may be reviewed and approved by the IRB Chair.

Conflicts of Interest

Conflict of interest, defined as a set of conditions in which judgment concerning a primary

interest may be biased by a secondary interest, is inherent to the conduct of research. In any

given situation, conflict of interest must be managed through a system of identification,

disclosure, containment, reduction and elimination.

A conflict of interest may include an affiliation with an organization, company, venture or other

body with whom the person has a direct financial interest; this includes any financial benefit,

directly or through relatives by blood or marriage, in the subject matter or materials of a

research proposal. While the focus is often on financial conflicts, which are quantifiable, non-

Institutional Review Board Policies and Procedures 12

financial interests exist as well. Non-financial interests may conflict with the protection of

research participants and should also be disclosed and managed when present.

Management of IRB conflicts of interest will include (1) no IRB members will participate in the

review of or vote on any research study in which the member has a conflict of interest, except

to provide information requested by the IRB; (2) excusing members from the final deliberation

to prevent them from voting on studies in which they have declared a potential conflict of

interest; and (3) proactive education to increase awareness of existing policies and the

potential for conflicts of interest.

The IRB requires that PIs provide written information regarding any potential conflict of interest

relevant to research studies submitted for IRB review. Investigators will disclose whether they

have a vested interest in any commercial enterprise associated with any aspect of the protocol,

and, if yes, to fully explain and identify the safeguards taken to prevent investigator bias in

subject recruitment and/or the consent process.

To ensure that conflict of interest does not compromise the rights and welfare of human

participants of research, the IRB will determine: (1) if methods used for management of

financial interests of parties involved in the research adequately protect the rights and welfare

of human participants; (2) whether other actions are necessary to minimize risks to

participants; and (3) the kind, amount and level of detailed information to be provided to

research participants regarding a conflict of interest.

IRB Members

It is the responsibility of each IRB member to identify and avoid any situations in which he or

she, either personally or by virtue of his/her position, might have a conflict of interest, or may

be perceived by others as having a conflict of interest. If assigned as a reviewer for a matter

with which the IRB member feels that he or she may have a conflict of interest, the IRB member

must notify the IRB Chair so the matter may be reassigned to another reviewer. In order not to

delay the review process, it is essential that potential reviewers peruse upon receipt the

matters for which they are assigned to determine whether they may have a conflict.

A member with a conflict of interest will be required to recuse him/herself and leave the room

during final deliberation and voting for any research in which the member has a potential

conflict of interest. Such members are excluded from the quorum count for the study being

considered. The minutes will reflect by name all individuals not participating due to a conflict of

interest and their absence from the room and re-entry.

Because often they are the most knowledgeable about the topic being investigated, IRB

members are permitted to vote on studies submitted by members of their own department or

division, only if the IRB member has no other potential conflicting interest, such as

responsibility for the design, oversight or supervision of the study. Members who believe they

have been involved in attempts by investigators or others to influence the review of a particular

Institutional Review Board Policies and Procedures 13

study will bring the matter to the attention of the IRB Chair. The member may be advised to

recuse him/herself or abstain from the final deliberation and vote if a perceived conflict of

interest exists.

Possible conflicts of interest for IRBs may originate at two levels and may include:

Individual Level

• Member is PI or researcher on a study under review

• Member or staff holds significant financial interest in research sponsor

• Loyalty to colleagues submitting for review

• Member is too closely tied to area of research under review

• Possible impact of decisions on member’s own work (e.g. policy changes)

• Personal agenda

• Non-IRB role

Institutional Level

• Pressure or desire to protect the Institution

• Promotion of research vs. protection of human participants

• Potential liability

• Institutional or community values

• Pressure for rapid reviews

• Institutional equity or ownership

Institutional Officials

As academic institutions have increasingly entered into financial and collaborative research

arrangements with private industry, institutional conflicts of interest have become a topic of

growing concern and increasing public scrutiny. To avoid potential conflicts of interest,

executive leaders such as the President, Executive Vice President and Vice Presidents shall not

serve as IRB board members unless a compelling situation exists.

Record Keeping

The IRB Chair prepares and maintains adequate documentation of IRB activities, including the

following:

• All records for protocol reviews, including research applications, approved informed

consent documents, annual/continuing review reports, modifications, statements of

significant new findings provided to subjects, general project information provided to

subjects (e.g., fact sheets, brochures) and final reports submitted by investigators

• Detailed minutes of IRB meetings, showing all information required by HHS regulations

in 45 CFR 46.115(a)(2)

• Members present (any consultants/ guests/others shown separately)

• Results of discussions on debated issues and record of IRB decisions

• Record of voting (showing votes for, against and abstentions)

Institutional Review Board Policies and Procedures 14

• Copies of all correspondence between IRB and the investigators related to research

applications. Significant emails or other electronic communication should be printed

and kept on file at the Chair’s discretion

• Adverse reactions or incident reports and documentation that the IRB has reviewed

such reports

• List of IRB members that includes all of the information required by HHS regulations in

46.103(b)(3), including: name, earned degrees, representative capacity, indications of

experience such as board certifications, licenses, etc., sufficient to describe each

member's chief anticipated contributions to IRB deliberations; and any employment or

other relationship between each member and the institution; for example: full-time

employee, part-time employee, member of governing panel or board

• Federal assurance documents

• Written procedures of the IRB, including an assurance that the institution complies with

the federal policy for the protection of human subjects as described in 45 CFR

46.103(b)(4) and 46.103(b)(5)

• Training certifications

The above documents should be kept on file for at least three (3) years.

Records related to research shall be retained for at least three (3) years after completion of the

research, and the records shall be accessible for inspection and copying by authorized

representatives of the Department of Health and Human Services and other federal regulatory

agencies at reasonable times and in a reasonable manner.

Principal investigators must keep all records, including evidence of informed consent, for at

least three (3) years after completion of the research. Informed consent forms must be

accessible for inspection and copying by the BHCC IRB and authorized representatives of OHRP

upon request.

The IRB Chair assigns a protocol number to incoming applications, records the number and

includes the number in all official documentation.

The primary concern of the IRB is the protection of the rights and welfare of human subjects in

research. The efforts of the IRB are directed at (1) identification of the risk, (2) evaluation of the

risk, (3) evaluation of procedures to minimize risk, and (4) evaluation of the informed consent

document which explains the risks to the subjects. Only the IRB has the authority to approve

research that involves human subjects.

Meetings

Meeting schedules are set to accommodate, as best as possible, the availability of all the

members. Schedules are set by semester to accommodate faculty and to allow for the

maximum number of board members to be available and present. The frequency of meetings is

typically monthly during the semester and the duration is approximately two hours. The place

Institutional Review Board Policies and Procedures 15

and time of meeting, agenda, and study material to be reviewed are distributed to IRB

members at least seven (7) days prior to the meeting.

Members may participate in meetings via phone and are included in the quorum. Meetings

requiring a vote of the full board may not be held via email; discussion and deliberation must

occur in real time. Meetings that do not require the full board, including discussion of expedited

review proposals, may be conducted via email as necessary.

Meetings during the summer months are scheduled based on need. Meetings by telephone or

electronic communication are authorized if a meeting, but not a vote, is necessary and an in-

person meeting cannot be scheduled.

Principal Investigators, including those who are also IRB members, may offer information and

answer questions about their protocols at a convened meeting, but may not participate in the

review or voting (even if this means being unable to continue the meeting because of quorum

requirements).

Although convened meetings of the IRB are open to the public, materials submitted for review,

discussions of protocols, and individual votes are considered confidential and should not be

discussed outside of the meeting context. If during an IRB meeting the Chair moves the meeting

to executive session then any visitors will be asked to leave the room until the executive session

has ended.

Procedures for Types of Review

There are three types of IRB review: Exempt, Expedited and Full Review.

Exempt and expedited applications are reviewed upon submission to the IRB Chair throughout

the year. Every effort is made to complete exempt and expedited reviews in a timely fashion,

but the amount of time may vary depending on the clarity and completeness of the application,

reviewers’ schedules and whether there are concerns that will need to be addressed by the IRB.

The IRB Chair may return applications that are incomplete or require clarification.

The IRB Chair is responsible for exempt status determinations and may consult with others as

appropriate. The IRB Chair or designee, not the investigator, shall make the determination as to

whether a project is or is not exempt. For research to qualify for exempt status determination,

it must meet federal criteria for this category. The IRB Chair will notify the IRB of all decisions.

Expedited reviews will be assigned by the IRB Chair to two designated IRB members. The two

designated IRB members will review the expedited application and provide written feedback

using the IRB Reviewer Approval form.

For full review applications, a primary and secondary reviewer will be assigned to lead the

discussion of that protocol at the full board meeting. The full IRB will review application

Institutional Review Board Policies and Procedures 16

information and have access to additional study documentation upon request. If external

reviewers are necessary, they must be subject to the same conflict of interest policies as IRB

members. Every attempt will be made to complete the review process in a timely manner.

Applications for full review that are submitted at least two weeks in advance of a scheduled IRB

meeting should be able to be addressed at that meeting. Any necessary revisions to the

application or the Informed Consent document will be addressed after the meeting. Incomplete

applications or full review proposals requiring revisions may take longer for final approval,

especially if the submission date is on or close to a scheduled IRB meeting.

The IRB Chair will notify the PI of all IRB decisions in writing. No research may be initiated until

approval is issued by the IRB chair.

Protocol changes or amendments must be submitted to the IRB for expedited review and

approval. See below for full descriptions of the categories that qualify for exempt and

expedited review and a sample timeline for project submission, review and approval.

All grant-funded projects coming to Institutional Review Board must have their original grant

proposal reviewed by the IRB chair in addition to the IRB application.

IRB members are required to keep all information related to research applications confidential.

This means that information reviewed by the members, which may be sensitive in nature,

should not be discussed outside of the review process or discussed in a place where the

discussion might be overheard.

Board Actions

The IRB may vote to approve, approve with modifications, defer or disapprove a research

protocol. For applications requiring full board review, these actions require a vote of the

majority of the members present at a meeting with a quorum present. If the vote is not

unanimous, the minority opinion(s) must be recorded in or attached to the minutes.

An IRB member may abstain from voting for any reason, without explanation. PIs are informed

in writing of all IRB decisions. Decisions may include:

Approved

Approval of the application will be based on a majority vote and the following:

• completeness of the application packet and supporting documents;

• the extent to which the human subject rights are protected;

• justification that the potential benefits to the subject or the importance of the

knowledge to be gained outweighs any potential risks that may be present;

• the adequacy of institutional facilities and other resources necessary for completion of

the study and protection of subjects’ rights;

• the adequacy of procedures for securing informed consent from the subject;

Institutional Review Board Policies and Procedures 17

• the adequacy of measures for minimizing of risk and the protection of the health, safety,

comfort and legal rights of the subject; and

• the adequacy of measures for protecting the privacy of subjects and maintaining

confidentiality of data.

When a protocol has been approved, the Chair will issue a letter that indicates the IRB’s action,

signs and dates it and distributes one copy of the form to the principal investigator and one to

the IRB files. Along with the notification of approval, PIs are informed that any subsequent

changes in projects must be reviewed and approved by the IRB before they are initiated and

that unanticipated problems must be reported.

Dissenting votes must be recorded with reason(s) noted.

Approval with modifications

Action taken if the IRB requires minor additional information and/or modifications. Necessary

revisions are agreed upon and communicated to the PI. When the revisions are made by the PI,

either the IRB Chair or the designated representative is authorized to provide approval for the

study to begin. This action will be documented in the IRB records.

Defer

Action taken if substantial modification is required or if insufficient information is provided to

evaluate the application adequately. To receive approval for a deferred protocol, it must again

be submitted for an IRB review. The PI is notified by the Chair of the IRB and the additional

information necessary for completion of the review is requested. In the case of a deferred

protocol, the PI may be invited to attend an IRB meeting to present/clarify the protocol for the

board.

Disapprove

Action taken if a majority considers that the decision would not be changed by modifications to

the protocol. If the protocol is disapproved, the PI will be informed in writing of the reasons for

disapproval. The PI may revise and resubmit his/her protocol for another review.

Non-binding recommendations

The IRB may also offer non-binding recommendations with its action to approve or defer a

protocol.

Dismissed/Withdrawn

Applications that are dismissed or withdrawn will be discarded and noted accordingly.

The IRB is authorized to modify, suspend, or terminate approval of research that has been

associated with unexpected serious harm to subjects, or is not being conducted in accordance

with 45 CFR 46 or the decisions, conditions, and requirements set forth by the IRB. PIs must

respond in writing to IRB stipulations and recommendations on new protocols and continuing

Institutional Review Board Policies and Procedures 18

reviews within 90 days or the application will be terminated. Notification will be sent one

month in advance of termination.

IRB Decision Appeal

The PI may appeal the decision of the IRB when a protocol has been disapproved or approved

subject to restrictions and mutual agreement cannot be reached as to an acceptable

alternative. By Federal regulations, institutional officials may not approve research that has not

been approved by the IRB. A PI may approach the IRB to appeal or reconsider a decision

regarding a human subject research activity. A final decision regarding the appeal will be made

by a vote of the IRB. PIs do not, however, have the option to seek the reversal of an IRB

decision by submitting the same protocol to another NIH IRB or the Signatory Official.

Update and Review

IRB policies and procedures will be reviewed annually to assure compliance with changes in

regulatory requirements, to provide additional information or improve clarification of

information already contained within the document.

Cooperative Activities

Cooperative activities relating to human subjects are those which involve Bunker Hill

Community College and another institution. Normally, the research must be reviewed and

approved by the IRBs at both institutions before it can be initiated. However, the IRB of one

institution may rely on the IRB of the other institution under the following conditions:

• Both institutions have Federal Wide Assurances (FWAs) approved by OHRP;

• Both institutions have entered into an Authorization Agreement (or equivalent

document) that stipulates the responsibilities of both parties; and

• The appropriate section of the FWA of the deferring institution designates the IRB of the

approving institution.

In the absence of these conditions, the PI must secure the approval of the IRB at each

institution engaged in the research and submit documentation of such approvals to the other

IRBs. The IRB Chair will verify (via the OHRP website) that the other institutions have approved

FWAs.

Types of IRB Review

There are three types of IRB review: Exempt Status Determination, Expedited Review or Full

Board Review. Depending on the level of risk of the research protocol and the participant

population, IRBs may conduct either full board review or expedited review.

Exempt Status Determination

Only the IRB has the authority to make the Exempt Status Determination. Certain low-risk

research in which no personal identifiers are collected is exempt from the requirements in the

Federal regulations concerning IRB review and approval. Under Federal regulations [45 CFR

Institutional Review Board Policies and Procedures 19

46.101 (b)], certain categories of activity are considered research but may be declared exempt

from review by the IRB. This determination must be made by the IRB prior to the research being

conducted. If a study falls into one of the exempt categories, researchers still have ethical

responsibilities to protect participants' rights.

The six federally-approved categories of exemption under 45 CFR 46.101(b) are:

1. Research conducted in established or commonly accepted educational settings,

involving normal educational practices, such as (i) research on regular and special

education instructional strategies, or (ii) research on the effectiveness of or the

comparison among instructional techniques, curricula, or classroom management

methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,

achievement), survey procedures, interview procedures or observation of public

behavior, unless: (i) information obtained is recorded in such a manner that human

subjects can be identified, directly or through identifiers linked to the subjects; and (ii)

any disclosure of the human subjects' responses outside the research could reasonably

place the subjects at risk of criminal or civil liability or be damaging to the subjects'

financial standing, employability or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude,

achievement), survey procedures, interview procedure, or observation of public

behavior that is not exempt under paragraph 2 of this section, if: (i) the human subjects

are elected or appointed public officials or candidates for public office; or (ii) Federal

statute(s) require(s) without exception that the confidentiality of the personally

identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records,

pathological specimens or diagnostic specimens, if these sources are publicly available

or if the information is recorded by the investigator in such a manner that subjects

cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval

of Department or Agency heads, and which are designed to study, evaluate, or

otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining

benefits or services under those programs; (iii) possible changes in or alternatives to

those programs or procedures; or (iv) possible changes in methods or levels of payment

for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome

foods without additives are consumed or (ii) if a food is consumed that contains a food

ingredient at or below the level and for a use found to be safe, or agricultural chemical

Institutional Review Board Policies and Procedures 20

or environmental contaminant at or below the level found to be safe, by the Food and

Drug Administration or approved by the Environmental Protection Agency or the Food

Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Review

Under federal regulations certain types of research may qualify for an expedited review [under

45 CFR 46.110]. For certain kinds of research involving no more than minimal risk, and for minor

changes in approved research, the IRB Chair or a designated voting member or group of voting

members review the proposed research rather than the entire IRB. An expedited reviewer

cannot disapprove research; rather the application must go to the full board for review to

disapprove.

While personal identifiers may be collected, the type of data collection does not assume the

level of risk. For example, it cannot be assumed that research poses minimal risk because it

involves only interview or survey data collection. Sensitive questions may lead to distress that

exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to

participants, their relatives and others.

Research conducted under the expedited category should present no more than minimal risk to

human subjects. It could also involve minor changes in previously approved research. The PI

should designate on the application form which of the following categories that best applies to

qualify the research for expedited review.

The list of categories of research that may be reviewed by the IRB through an expedited review

process includes but is not limited to the following:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

a. Research on drugs for which an investigational new drug application (21 CFR Part

312) is not required. (Note: Research on marketed drugs that significantly increases

the risks or decreases the acceptability of the risks associated with the use of the

product is not eligible for expedited review.)

b. Research on medical devices for which (i) an investigational device exemption

application (21 CFR Part 812) is not required; or (ii) the medical device is

cleared/approved for marketing and the medical device is being used in accordance

with its cleared/approved labeling.

2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as

follows:

a. from healthy, nonpregnant adults who weigh at least 110 pounds. For these

subjects, the amounts drawn may not exceed 550 ml in an 8 week period and

collection may not occur more frequently than 2 times per week; or

b. from other adults and children, considering the age, weight, and health of the

subjects, the collection procedure, the amount of blood to be collected and the

Institutional Review Board Policies and Procedures 21

frequency with which it will be collected. For these subjects, the amount drawn may

not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may

not occur more frequently than 2 times per week.

3. Prospective collection of biological specimens for research purposes by noninvasive

means. Examples:

a) hair and nail clippings in a nondisfiguring manner

b) deciduous teeth at time of exfoliation or if routine patient care indicates a need

for extraction

c) permanent teeth if routine patient care indicates a need for extraction

d) excreta and external secretions (including sweat)

e) uncannulated saliva collected either in an unstimulated fashion or stimulated by

chewing gumbase or wax or by applying a dilute citric solution to the tongue

f) placenta removed at delivery

g) amniotic fluid obtained at the time of rupture of the membrane prior to or

during labor

h) supra- and subgingival dental plaque and calculus, provided the collection

procedure is not more invasive than routine prophylactic scaling of the teeth and

the process is accomplished in accordance with accepted prophylactic

techniques

i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth

washings

j) sputum collected after saline mist nebulization

4. Collection of data through noninvasive procedures (not involving general anesthesia or

sedation) routinely employed in clinical practice, excluding procedures involving x-rays

or microwaves. Where medical devices are employed, they must be cleared/approved

for marketing. (Studies intended to evaluate the safety and effectiveness of the medical

device are not generally eligible for expedited review, including studies of cleared

medical devices for new indications.) Examples:

a) physical sensors that are applied either to the surface of the body or at a

distance and do not involve input of significant amounts of energy into the

subject or an invasion of the subjects privacy

b) weighing or testing sensory acuity

c) magnetic resonance imaging

d) electrocardiography, electroencephalography, thermography, detection of

naturally occurring radioactivity, electroretinography, ultrasound, diagnostic

infrared imaging, doppler blood flow, and echocardiography

e) moderate exercise, muscular strength testing, body composition assessment,

and flexibility testing where appropriate given the age, weight, and health of the

individual

Institutional Review Board Policies and Procedures 22

5. Research involving materials (data, documents, records, or specimens) that have been

collected, or will be collected solely for nonresearch purposes (such as medical

treatment or diagnosis). (NOTE: Some research in this category may be exempt from

federal regulations for the protection of human subjects. This listing refers only to

research that is not exempt.)

6. Collection of data from voice, video, digital, or image recordings made for research

purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to,

research on perception, cognition, motivation, identity, language, communication,

cultural beliefs or practices, and social behavior) or research employing survey,

interview, oral history, focus group, program evaluation, human factors evaluation, or

quality assurance methodologies. (NOTE: Some research in this category may be exempt

from federal regulations for the protection of human subjects. This listing refers only to

research that is not exempt.)

8. Continuing review of research previously approved by the convened IRB as follows:

a. where (1) the research is permanently closed to the enrollment of new subjects;

(2) all subjects have completed all research-related interventions; and (3) the

research remains active only for long-term follow-up of subjects; or

b. where the remaining research activities are limited to data analysis; or

c. where no subjects have been enrolled and no additional risks have been

identified.

Full Board Review

For any research that does not meet either the criteria for Exempt Status Determination or

Expedited Review, the PI must complete an application for Full Board Review. When full board

review is necessary, the IRB application is presented and discussed at a meeting at which a

quorum of IRB members is present. For the research to be approved, it must receive the

approval of a majority of those voting members present. (Note that, in effect, an abstention

counts as a negative vote.) Any IRB members with a conflict of interest should recuse

themselves before voting. The PI may be invited to the IRB meeting to discuss the research

application. The PI may not be present for the vote.

Recruitment, Informed Consent and Compliance

Federal regulations require that investigators obtain legally effective informed consent of the

subject or the subject’s legally authorized representative. The informed consent process is

intended to educate potential subjects about the research project, outline their involvement

and request their voluntary participation. It is intended to be an active process of sharing

information and providing critical communication about the research study between the PI and

the prospective subject. A verbal explanation of the project, with discussion and questions, is

important in augmenting the written consent form. The informed consent document is a guide

Institutional Review Board Policies and Procedures 23

to this process and is the written record that the subject entered the study voluntarily and with

full understanding of the research project. The informed consent document serves as a

reminder to the participant of what they have agreed to do or are considering.

Recruitment of Participants

Advertising to recruit study participants should be conducted to ensure that participation is

voluntary. The IRB reviews all recruitment documents and the methods and materials that PIs

propose to use to recruit subjects. The recruitment information is submitted with the

application to the IRB for review, regardless of the type of review. Direct advertising includes

methods such as newspaper, radio, television, bulletin boards, posters and flyers intended for

prospective subjects. The materials are reviewed by the IRB to assure that the recruitment

method is not unduly coercive. This is especially important for studies that may include subjects

who are likely to be vulnerable to undue influence. Procedures should be clearly outlined so

that the IRB is assured that the information collected is handled appropriately and if sensitive

information is gathered, the PI should outline the steps that will be taken to protect the

subjects’ confidentiality. PIs must recruit college students by public announcement and not by

personal solicitation. If a PI intends to recruit participants in any other way, justification must

be presented to the IRB and approval must be granted.

It is not uncommon for incentives to be offered to subjects for participation in research (e.g.,

payment, gift cards, extra credit, etc.). This is not considered a benefit but a recruitment

incentive. Incentives, if used, must be clearly explained in the informed consent document. An

explanation of procedures for early withdrawal must be included. Incentives should be set to

encourage participation in the research but not an amount that could be considered coercive.

The amount and schedule of all incentives should be presented in the informed consent

document.

Informed Consent Process

1. Inform the prospective subject that there is a study in which s/he might wish to participate

2. Provide the prospective subject a consent form to review

3. Explain the potential risks and/or benefits of participating in the research study

4. Ask the prospective subject whether s/he has any questions

5. Collect a signed informed consent document, if required, and retain original for a minimum

of three years after the close of the study.

6. Provide a duplicate copy of the informed consent document for the participant to keep.

7. Forms must be available for the IRB to review upon request.

Informed Consent Form

When an individual participates in a research project, the individual is entitled to certain

information. This information includes a full and frank disclosure of all the facts, probabilities,

options, and opinions which a reasonable person might be expected to consider before giving

his/her consent.

Institutional Review Board Policies and Procedures 24

Since each research project is different, there is no generic informed consent form. However,

the following provides a description of required sections and the specific information that is

required in each section. In developing a consent form for a specific research project, please

note the following points:

1. The informed consent document must provide full and complete information about the

project and be organized carefully so that the specific elements of informed consent,

described below, are covered thoroughly:

a. study purpose and statement that the study involves research;

b. description of procedures, including duration and types of activities;

c. statement of any risks and benefits;

d. statement of data confidentiality;

e. statement that participation is voluntary and a person may withdraw from the

study at any time without penalty or consequences;

f. description of incentives, if any;

g. contact information of the researcher, faculty advisor (if appropriate) and the

BHCC IRB;

h. verification that participant is 18 years of age or older; and

i. date and signature lines for the participant or legally authorized representative.

2. The informed consent document must be written in language that is understandable

without using jargon or technical language. Writing it at a sixth- to eighth-grade reading

level is suggested.

3. The language should be written in the second person. The final Statement(s) of Consent,

however, should be written in the first person.

4. The degree of detail, and the length of the consent form, should reflect the level of risk

that the project entails for the subject.

5. If a study involves minors or participants with impaired decision-making ability, consent

must be provided by the legally authorized representative and assent of the participants

in addition to informed consent.

6. Separate forms may be required for different subject groups (e.g., parents, minors, non-

English speakers), different types of activities and different kinds of information

(photographs, audiotapes, videotapes).

Confidentiality/Anonymity

Every effort must be made to ensure confidentiality of data. Security of storage, limitation of

access, and coding constitute the best measure to minimize risk of inadvertent disclosure to

unauthorized parties. Measures to prevent this problem should be described in applications for

studies in which the data collected are sensitive. The IRB recommends the following language

Institutional Review Board Policies and Procedures 25

be included in the informed consent form related to privacy and confidentiality: “Every effort

will be made to protect your privacy and confidentiality, but there may be a slight risk of

disclosure from participating in any research study.”

Retention of Signed Forms

Signed consent forms must be stored so as to be available upon IRB request. Consent forms

must be stored securely in locked files or a locked office by the PI, but procedures must be

developed to ensure that the consent forms are kept in a secure location and can be retrieved

expeditiously when necessary upon request by regulatory authorities or BHCC IRB

administrative personnel.

Deception Studies

In studies that propose to mislead or deceive the subjects during data collection, the IRB has

even more responsibility to protect the rights of the subjects. The IRB may set limits for such

procedures and recommend alternate procedures to achieve research objectives that involve

deception.

Special considerations and consent documents are required when disclosure of the purpose

and/or methodology could bias the outcome of the study. In situations where participants will

be deceived, some information may be omitted and participants are told (on the signed form)

that disclosure of the purpose and/or methodology could bias the outcome of the study and

that they will be debriefed at the conclusion of the activity.

Waivers of Informed Consent

Waiving the consent procedure may be used if the research is considered minimal risk or

justification is provided to document the request for the waiver.

The IRB may approve a consent procedure which does not include, or which alters, some or all

of the elements of informed consent as stated, or waives the requirement to obtain informed

consent as outlined in 45CFR 46.116 (d) provided the IRB finds and documents the

• research involves no more than minimal risk to the participants;

• waiver or alteration will not adversely affect the rights and welfare of the participant;

and

• research could not reasonably be carried out without the waiver or alteration.

Application Process

Before you Apply

As soon as you decide to pursue a research project, contact the IRB Chair or a member of the

IRB to discuss your project. Gathering information about human subject protections and the IRB

process will allow you to better prepare your project timeline. Your aim should be to

understand the level of risk your project entails and the steps involved in submitting an IRB

application. The IRB website www.bhcc.edu/irb provides information on the application

Institutional Review Board Policies and Procedures 26

process, forms and frequently asked questions. The IRB Chair and members of the IRB are

available to review draft applications and answer questions along every step of the process. All

training must be completed before submitting an IRB application.

Application Submission Process

Applications and all supporting documentation must be submitted to the IRB Chair

electronically as MS Word documents. Original signatures must be included on the PI Signature

and Assurance page and may be scanned and sent electronically or mailed to the IRB Chair.

Applications will be checked for completeness and assigned a protocol number. The IRB Chair

verifies the appropriate level of review (full, expedited or exempt from further IRB oversight).

All research involving human subjects that is conducted by those acting as an agent of Bunker

Hill Community College, regardless of where the research is to be conducted or the designated

review category must be submitted to the IRB for review regardless of funding, if any.

Review Process

IRB members are assigned responsibility for expedited reviews on a rotating basis. Complex

research applications may require certain types of expertise for adequate review. In these

situations, applications will be assigned specifically to those IRB members with the appropriate

expertise needed. Assignment of a review allows for IRB members to anticipate when they

need to make themselves available to review applications and ensure proper turn-around time.

The IRB Chair is authorized to determine research that meets exempt status requirements.

Projects reviewed and approved under exempt status do not require submission of any other

forms for IRB review unless a change to the research results in a change of the exempt status

determination. If a research protocol changes, it is the responsibility of the PI to consult with

the IRB Chair.

Once an application has been reviewed, the IRB Chair will notify the PI in writing of the IRB’s

decision. For approved protocols, the written notification should include the date of the

approval, the date (anniversary of the approval date) of continuing review or a final report.

Continuing Review, Final Reports and Study Closure

Continuing review

Projects that extend greater than one year are required to be reviewed at least annually. PIs

must file a continuing review form with the IRB. The purpose of the continued review is to meet

regulatory requirements, update the informed consent form and provide a summary to the IRB

of the research activities that have occurred over the past year. Minor changes to the research

protocol may be submitted under the continuing review process. Major changes must be

submitted through the amendment process.

Institutional Review Board Policies and Procedures 27

PIs wishing to retain identifiable information must file for continuing review before the

anniversary date of their initial approval. The IRB recommends that the PI include a plan for the

use of data so identifiable information is kept for only a limited time. Data that has identifiers

removed may be maintained indefinitely in this manner as there is no risk to linking the data to

the subjects who originally participated in the research.

Continuing review information should summarize:

• Number of subjects that participated in the study

• Unanticipated problems

• Withdrawal of subjects

• Complaints about the research

• Recent literature that may be relevant to the research

• Copy of current informed consent form

• New proposed consent documents

If the research is no more than minimal risk, the expedited review process may be used for

continuing review.

PIs are sent a notice from the IRB approximately 30 days before the anniversary date of their

approval. If a PI fails to provide continuing review information to the IRB, the research must

stop, unless the IRB determines that it is in the best interest of the individual subjects to

continue participating in the research. Enrollments of new subjects cannot occur after the

expiration of IRB approval. If continuing review of a research protocol does not occur prior to

the end of the approval period, approval automatically expires.

Final Report

A final report is required to close out a project upon completion or by the expiration date of the

IRB approval. The IRB Chair will notify PIs approximately 30 days in advance of the expiration

date, requesting that either the PI close out the project by submitting a final report or a

continuing review form. It is the PI’s responsibility to complete continuing review and final

reports in a timely manner. If no continuing review or final report is received within 30 calendar

days following the expiration date, the IRB Chair will mark the file “expired” and close the

project. No research involving human subjects or their identifiable data will be allowed to

continue.

Compliance and Incident Reporting

Research conducted at Bunker Hill Community College is expected to follow Bunker Hill

Community College Policies and Procedures and adhere to federal regulations regarding the

protection of human subjects, regardless of who is conducting the research. Failure to do so

may result in noncompliance, which may result in disciplinary actions or sanctions such as

suspension or termination of IRB approval of specific or all research protocols, institutional or

individual action by the federal Office of Human Research Protections (OHRP),

recommendations for individual disciplinary action for failing to secure IRB approval before

commencing human subject research will be reported to the Signatory Official, suspension or

Institutional Review Board Policies and Procedures 28

termination of project support, loss of indemnification from liability by the institution for

adverse events if a PI fails to follow approved procedures.

Noncompliance is defined as research that is not conducted in accordance with institutional

policy or federal regulatory requirements for human subject protection. Protocol deviations

and variances from the protocol do not fall within these definitions until they are considered

serious or continuous. Serious or continuing practices are those that appear to cause injury

(physical, psychological, emotional, etc.) or any other unanticipated problems involving risks to

participants and/or others or constitute serious/continuous noncompliance with IRB

determinations or federal regulations.

IRB actions on a noncompliance event are final and not subject to appeal. Copies of all letters of

warning from the IRB Chair to PIs must be sent to the Signatory Official. Copies of all responses

to program audits related to IRB compliance submitted to outside agencies must be reviewed

by the Signatory Official prior to submission.

Institutional Review Board Policies and Procedures 29

Appendices

1. IRB Decision Charts

2. Quick Start Guide for Principal Investigators

3. Informed Consent Information

4. Application

Institutional Review Board Policies and Procedures 30

IRB Decision Charts

The Office for Human Research Protections (OHRP) provides graphic aids as a guide for

institutional review boards (IRBs), investigators, and others who decide if an activity is research

involving human subjects that must be reviewed by an IRB under the requirements of the U.S.

Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The charts

address decisions on the following:

• whether an activity is research that must be reviewed by an IRB;

• whether the review may be performed by expedited procedures; and

• whether informed consent or its documentation may be waived.

Please note:

The charts are intended to assist IRBs, institutions, and investigators in their decision-making

process and should not be used as substitutes for consulting the regulations.

The Charts can be found at:

https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html

Institutional Review Board Policies and Procedures 31

Quick Start Guide for Principal Investigators

The Bunker Hill Community College (BHCC) Institutional Review Board (IRB) reviews research

protocols involving human subjects to evaluate and identify risks to those subjects. Research is

a systematic investigation, including research development, testing, and evaluation, designed

to develop or contribute to generalizable knowledge (intended for publication or public

dissemination). BHCC and the Principal Investigators (PI) are responsible for ensuring that high

ethical standards are maintained for all research involving human subjects. Individuals seeking

to conduct human subject research may not solicit subject participation or begin data collection

until they have obtained clearance by the Bunker Hill Community College Institutional Review

Board.

Principal Investigators should review the BHCC IRB Policies and Procedures before submitting

an application. This Quick Start Guide is intended as a reference for PIs and does not substitute

the requirements outlined in the BHCC IRB Policies and Procedures.

• Determine if your project is considered human subjects research. Consult the OHRP

Decision Charts in the BHCC IRB Policies and Procedures and/or consult with the IRB

Chair or a member of the IRB to determine if your project is considered research under

the federal guidelines.

• If your project is considered human subjects research, consult with the IRB Chair to

determine the level of review needed.

• Work with the IRB Cahir to ensure access to relevant forms, BHCC IRB Policies and

Procedures, and meeting dates and Frequently Asked Questions.

• Complete the online human subject protections training. Here is the link to the

training https://phrp.nihtraining.com/users/login.php Include a copy of the training

certificate with your IRB application.

• Review the sample informed consent forms and the Elements of Informed Consent in

the BHCC IRB Policies and Procedures. The IRB Chair and members of the IRB are

available to assist you in the development of informed consent documents.

• If you have questions, share a draft of your application with the IRB Chair prior to

submission.

• Submit your application electronically to the IRB Chair at irb@bhcc.edu.

Institutional Review Board Policies and Procedures 32

Informed Consent Information

Unless otherwise authorized by the IRB, researchers are responsible to obtain informed consent

of participants. This is to ensure that only those human subjects who have consented to

participate are involved in the research. It is recommended that research be limited to

individuals who are 18 years or older.

The informed consent must include the following (sequential order recommended) and in

language that the participants can understand:

a. study purpose and statement that the study involves research;

b. description of procedures, including duration and types of activities;

c. statement of any risks and benefits;

d. statement of data confidentiality;

e. statement that participation is voluntary and a person may withdraw from the study at

any time without penalty or consequences;

f. description of incentives, if any;

g. contact information of the researcher, faculty advisor (if appropriate) & BHCC IRB ;

h. verification that participant is 18 years of age or older; and

i. date and signature line for the participant or legally authorized representative.

The informed consent document must be written in language that is understandable without

using jargon or technical language. Writing it at a sixth- to eighth-grade reading level is

suggested. The language should be written in the second person. The final Statement(s) of

Consent, however, should be written in the first person. The degree of detail, and the length of

the consent form, should reflect the level of risk that the project entails for the subject. If a

study involves minors or participants with impaired decision-making ability, consent must be

provided by the legally authorized representative and assent of the participants in addition to

informed consent.

Separate forms may be required for different subject groups (e.g., parents, minors, non-English

speakers), different types of activities and different kinds of information (photographs,

audiotapes, videotapes). The signature of a participant or the participant’s representative who

may provide legally effective informed consent is required for signed informed consent.

In some cases requests for waivers for informed consent, or documentation of consent, may be

considered depending upon the research protocol.

Institutional Review Board Policies and Procedures 33

Adverse events and unanticipated incidents that occur during the research should be reported

immediately to the IRB Chair. The report should provide the IRB Chair with a reasonably

detailed analysis of the incident and allow the PI to assess the situation and determine whether

the protocol requires modification to minimize risk, whether the informed consent should be

revised, or if subjects should be contacted to re-consent to participate in the research study.

Incident reports should include:

• description of the event in sufficient detail as to allow an informed review of the

occurrence;

• explanation as to why the event is unexpected and related to the research study;

• description of changes to the protocol to minimize further risk or a rationale if no

changes are required;

• description of changes to the informed consent or a rationale if no changes are

required;

• description of the plan to re-consent current participants or a rationale if no re-

consent is required; and

• risk/benefit analysis update – explain why the overall risk/benefit relationship of the

research is still acceptable in light of the information of the incident.

Institutional Review Board Policies and Procedures 34

Sample Informed Consent Letters

Sample informed consent form for face-to-face interviews

Consent form for: Integrating Faculty to Enhance Student Success

Introduction and Contact Information:

You are being asked to participate in a research project that is exploring strategies

for integrating faculty who teach developmental level courses. The researcher is

[xxx], currently a fellow in the Community College Leadership Academy. Please

read this form and feel free to ask questions. If you have further questions later,

[xxx] will discuss them with you. You can reach [xxx] at [email address].

Description of the Project:

The purpose of the study is to ascertain current level of integration and support

of faculty teaching developmental courses. A literature review of best practices

will be completed, along with a survey of adjuncts currently teaching

developmental courses at Bunker Hill Community College as well as evaluation of

data related to faculty and interviews with eight BHCC staff who work directly

with adjunct faculty teaching these courses.

The one-on-one interviews will be conducted by [xxx], and will take

approximately 30 minutes to complete. During the interview, you will be asked:

• what are the current practices for providing information, support and

supervision for adjunct faculty with whom you work;

• how satisfied you are with these current practices and why; and

• what you feel might further support adjunct faculty.

The interviews will not be recorded. [ xxx] will take notes; you may ask to

review xx notes and interpretations of your interview for accuracy.

Risks and Discomforts:

This research is of minimal risk. You may discuss any distress or other issues

related to your participation with the researcher. Your name will not be used in

any written reports of this study. While this study does not directly benefit

participants, your participation may help other community college faculty in the

future.

Confidentiality:

[xxx] will not ask you for any personal information that is not directly associated

with the purpose of this study. The information gathered for this project will not

Institutional Review Board Policies and Procedures 35

be published or presented in a way that would lead to your identity. Only[ xxx]

will have access to the notes taken during the interview, and these notes will be

destroyed by July 1, 2010.

Voluntary Participation:

Your participation in this study is entirely voluntary. If you decide to take part in

this study, you may terminate participation at any time without consequence.

You may decline to answer any of the interview questions without consequence.

If you wish to terminate participation, please contact [xxx].

Rights:

You have the right to ask questions about this research before you sign this

form and at any time during the study. You can reach the researcher [xxx] at

[email]. If you have any questions or concerns about your rights as a research

participant, please contact the Bunker Hill Community College Institutional

Review Board (IRB) which oversees research involving human subjects at

irb@bhcc.edu.

Signatures:

I HAVE READ THE CONSENT FORM. MY QUESTIONS HAVE BEEN ANSWERED. MY

SIGNATURE ON THIS FORM MEANS THAT I CONSENT TO PARTICIPATE IN THIS

STUDY. I ALSO CERTIFY THAT I AM 18 YEARS OF AGE OR OLDER.

Signature of participant Date

Printed name of participant

Signature of researcher Date

Printed name of researcher

Institutional Review Board Policies and Procedures 36

Sample statement for exempt survey research conducted online, without

identifiers, and not requiring documentation of informed consent

This online survey is part of a research study being conducted at Bunker Hill

Community College in Boston, MA. The survey in its entirety should take less than

15 minutes to complete.

The purpose of this study is threefold: 1) to investigate [xxx]; 2) to develop an

understanding of [xxx] and 3) to identify which services may contribute to [xxx].

While it is generally agreed that xx services result in [xxx], the current economic

climate, coupled with increasing mandates for student success, requires

community colleges to make deliberate and considered choices about what

resources can be directed toward student services. The results of this survey will

provide important information about [xxx].

Participation in this survey is anonymous. Your answers will go to a secure

location without your name or any identifying information about you. Your

responses cannot be linked to you, your specific school and results will only be

reported in aggregate.

Completing the online survey will indicate that you’ve consented to participate. If you choose

notto participate in this study simply close the survey browser window. You are free to exit out

of the survey at any time you choose, and you should feel free not to respond to any questions

with which you are uncomfortable.

Thank you very much for your consideration. If you have any questions you

may contact the researcher at [xxx] or the Bunker Hill Community College IRB

Chair at irb@bhcc.edu

Institutional Review Board Policies and Procedures 37

Application

Bunker Hill Community College

Institutional Review Board

Submit documents electronically to irb@bhcc.edu

___/____/____

_______________

Date Submitted

File Number

FULL BOARD or EXPEDITED APPLICATION REVIEW FORM

Type of Review Requested: ☐FULL BOARD ☐EXPEDITED

If unsure, please contact the IRB Chair at irb@bhcc.edu

Project Information:

Title of Research Project

Status of Project:

☐New Project

☐Periodic Review of Continuing

☐Project Revision to previously approved project

Project Personnel:

Principal Investigator/Project Director Dept. Phone Ext. Email address

Co-investigator/Student Investigator Dept. Phone Ext. Email address

Institutional Review Board Policies and Procedures 38

Anticipated Funding Source:

Projected Duration of Research in months:

Projected Starting Date:

Other organizations and/or agencies, if any, involved in the study: ________________

Participants covered under another IRB:

If Bunker Hill Community College is being requested to rely on the IRB of another institution

with an approved Federal Wide Assurance (FWA), please attach the Authorization Agreement

form and related documentation.

☐N/A

☐IRB Collaborating Institution Agreement form is attached with appropriate signatures.

List other institutions and locations

For Expedited Review only.

The Federally approved categories for Expedited Research found in

45 CFR 46.110 are listed below. Check one of the nine boxes below to identify the appropriate

category. Expedited review is for certain types of research that involve no more than minimal

risk and meet one of the categories below or for minor changes in approved research. See

BHCC IRB Charter and Standard Operating Procedures pages 7-9 for full detailed descriptions.

□ Collection of blood samples by typical methods and within allowable amounts

□ Noninvasive collection of biological specimens (hair and nail clippings, deciduous teeth,

placenta, dental plaque, excretion such as sweat or saliva, etc.)

Institutional Review Board Policies and Procedures 39

□ Study of existing data, documents, records, or specimens or data analysis of previously

approved research

□ Research on individual or group behavior using survey, interview, focus group, etc. (studies

of perception, cognition, game theory, or test development) where the PI does not

manipulate subjects’ behavior and research involves no more stress than in daily life

□ Collection of data from voice, video digital, or image recordings for research purposes (e.g.

investigations of speech defects)

□ Continuing review of previously approved research with no subject enrolled and no

additional risk identified

□ Research on investigational new drug/device exempt drugs or devices

□ Research involving materials (data/records/specimens) collected for non research

(treatment or diagnosis)

□ Collection of data from subjects 18 years of age or older using noninvasive procedures (e.g.

by MRI, EEG, moderate exercise, etc.)

For both Expedited and Full Board Review

Study Summary

Summarize the proposed research using language understandable to committee members

whose primary concerns are nonscientific. Do not attach full proposals to meet the

requirements for this section! The summary must be inserted here and include (1) a statement

of the purpose, study objective(s) and goal(s) background, significance, research design, and

methods, (2) a brief description of the procedures(s) involving human subjects; (3) a brief

description of any questionnaires, tests or other instruments to be used; how they will be used,

and a copy of such instruments.

Institutional Review Board Policies and Procedures 40

Selection of Participants

Anticipated number of participants to be enrolled (number of subjects needed to get adequate

data set): __________

Describe how study participants will be identified, recruited, and screened for eligibility.

Will recruitment advertising materials (e.g. flyers, newspaper advertisements, posters) be

used?

☐Yes ☐No

If yes, please submit these materials to the IRB with this application.

Are the subjects being offered any incentives such as academic credit, monetary compensation,

or thing of value, including the chance to participate in a lottery for a prize? ☐Yes ☐ No

If yes, please justify.

__________________________________________________________

Does this project involve Bunker Hill Community College students? ☐Yes ☐No

Human Subjects from the following populations will be involved in this study:

☐Subjects under 18 years of age ☐Non English Speakers

☐Prisoners ☐None of the above

Institutional Review Board Policies and Procedures 41

Check all the relevant activities that will apply to your subjects:

☐Analyze data previously recorded ☐Record physiological measures

☐Contact by mail, email, or telephone ☐Test physiological measures

☐Meet face-to-face ☐Record “spontaneous” behavior

☐Interview ☐Manipulate “subjects” behavior

☐Medical Record Review Manipulate psychological treatment/conditions

☐Surveys (Questionnaires/interviews) Manipulate physiological treatment/conditions

☐Other, explain:

___________________________________________________________________

Risk Information

Describe any potential risks or discomfort that could result to human subjects as a result of this

research.

How will you try to minimize these risks or discomfort?

Are there alternative methods to acquire the information that could avoid the risks?

☐Yes ☐No

If yes, explain:

Could the information be obtained from animals or other laboratory models?

☐Yes☐No

If yes, explain why these alternatives were not chosen

Institutional Review Board Policies and Procedures 42

Confidentiality of data

Will you be recording any private information that identifies the subjects?

☐Yes ☐No

If yes, describe the methods to be used to ensure the confidentiality of data obtained, including

plans for publication, disposition or destruction of data, etc.

Consent

What steps will be taken to assure that each subject’s participation is voluntary?

Attach a completed copy of all consent forms to be signed by the subjects and/or any

statements to be read to the subjects.

Waiver Requests

Do you intend to apply for any Waivers of the Informed Consent Requirements?

☐Yes ☐No

If yes, contact the IRB Chair.

Institutional Review Board Policies and Procedures 43

PRINCIPAL INVESTIGATOR ASSURANCE AND SIGNATURE PAGE

Each item must be read and each box must be checked. Then, submit the original by

intercampus mail with PI signature.

☐ I agree to personally conduct or supervise the described investigation(s).

☐ I understand that Bunker Hill Community College students will be recruited by public announcement and not

by personal solicitation.

☐ I understand that any medical procedures or treatments of human subjects will be performed by or under the

supervision of a person who is licensed or certified to perform that particular procedure.

☐ Once the project has begun, I will communicate any problems connected with the use of human subjects to

the IRB Chair.

☐ I agree to maintain adequate and accurate records in accordance with the regulations and to make those

records available for inspection in accordance with the regulations. (Records including informed consent

documents will be kept on file for a period of three years from the project completion date.)

☐ I (and all associated investigators) have completed the required human subject research training and

certificates are on file or have been sent to the BHCC IRB Chair.

☐ I certify that the protocol and method of obtaining informed consent as approved by the Bunker Hill

Community College Institutional Review Board will be followed during the period covered by this research

project. Any future changes to the research project will be submitted to the IRB for written review and

approval prior to implementation.

☐ I am responsible for submitting the materials for continuing review a minimum of once per year.

☐ I agree to insure that all associates, colleagues, and employees assisting in the conduct of the study(s) are

informed about their obligations in meeting the above commitments and confidentiality requirements.

☐ I understand that the research may not begin until this signature page has been received by the IRB and I have

received the official notice of approval from the IRB.

Principal Investigator/

Project Director Signature

Co-Investigator/

Student Signature (if appropriate)

Date and Printed Name of PI

Date and Printed Name of Co-Investigator

Signature of IRB Committee Chair:

Date:

IRB Chair-Check one Box:

☐

Approved

☐

Approved with Modifications

☐

Tabled

☐

Disapproved

Download
Save PDF to desktop

Email
Email completed PDF

Send for Signing
Email for others to sign

Print
Print document

NAME

Institutional Review Board

View Audit Log
Print With Audit Log
Duplicate Document

Fill Online, Printable, Fillable, Blank Institutional Review Board Form

Related forms

Fillable Institutional Review Board

Fill Online, Printable, Fillable, Blank Institutional Review Board Form

Related forms

First 20 documents completely FREE!