Fill - Free fillable Protocol for a Research Project Submitted for Review (Hampton University) PDF form

Protocol for a Research Project Submitted for Review to the

HAMPTON UNIVERSITY

Institutional Review Board

All research involving human subjects must be reviewed by the Hampton University

IRB. Submit the IRB proposal following the guidelines of this proposal submission

form. Please label the sections as indicated below. A proposal that does not follow these

guidelines or is incomplete will be returned. Submit one electronic copy in PDF format

of the full thesis or project/grant proposal and one of the following: IRB Approval Form

with approval signatures, IRB Application Form and Informed Consent Form and other

pertinent attachment(s):

Dr. Abiodun Adibi, Chair, Hampton University IRB

irbchair@hamptonu.edu

Applications are reviewed monthly. Submit IRB applications no later than one month

in advance of a scheduled IRB meeting. Please check with the IRB chair for the schedule

of IRB meetings. You are strongly advised to contact Dr. Adibi before submission of IRB

documents to determine what level of review will be required.

Dr. Abiodun Adibi, Chair, Hampton University IRB

Department of Biological Sciences, 203 DuPont Hall Telephone: 757-727-5017

All questions on the IRB application must be answered. Approvals by another

federally approved IRB may be accepted. Copies of approvals and an abstract of the

study must be filed with the Hampton University IRB for review for all proposals

approved by an external IRB.

Project Title:

Principal Investigator:

Department:

School:

Address:

Telephone:

E-mail:

Faculty Advisor: (if applicable):

Address:

Telephone:

E-mail:

Is this project a continuation of a previously approved project? ΟYes Ο No

Project Period:

Funding Source:

IRB Proposal Submission

8/2015

In a brief abstract, please provide the following information using the headings

given.

Introduction: Include rationale; statement of purpose, aims or objectives; research

questions or hypothesis as appropriate. Citations from the literature should be included in

support of your proposal.

Methods:

Study Design: Give brief overview of the design. Cite references pertaining to

the proposed research methods as needed. If there is an intervention, include a

section clearly describing the intervention involved. Are there any alternatives to

the proposed (i.e. “experimental”) procedure? If so, what are they?

Setting: Describe location where study will be conducted, including how you will

plan to gain access to subjects in the setting and procedures for obtaining

permission for the study. Attach any supportive documentation (i.e. letter of

agreement form host agency).

Participants: Include criteria to be used in selecting participants, including any

inclusion or exclusion criteria (e.g. age, gender, and ethnicity). Give anticipated

number of subjects. Discuss criteria related to health status, if relevant. Provide

any other additional information that may help to determine potential risk to

participants.

Instruments: Describe measures, instruments, or tools to be used. Attach copies

of all data collection instruments. Attach verification of author’s permission

to utilize copyrighted material.

Procedures: Describe how participants will be recruited and selected. Attach

any advertisements, flyers, consent forms, and verbal or written information

given to potential subjects.

What will the participants be asked to do in the study?

How will you obtain informed consent from participants and parents (if

applicable)?

Discuss any inducements, such as money or gifts, used for participation. If

payments are given, discuss the amount and method of disbursement.

IRB Proposal Submission

8/2015

Are any aspects of the subject kept secret from the participants? Ο No ΟYes

(Please describe)

Is any deception used in the study? Ο No ΟYes (Please describe)

Are participants misled about any aspect of the study? Ο No ΟYes (Please describe)

Will participants be recorded on video or audio taped? Ο No ΟYes

Will participants be recorded without their knowledge? Ο No ΟYes

Risk/Benefit: Discuss the potential risks of the study. This may include possible physical

injury, complications or side effects, emotional distress or violation of privacy.

Where potential risks exists, what will you do to protect participants from these

hazards? Discuss how risks will be minimized or consequences handled.

How will you protect the confidentiality of your participants? (Check one.):

Ο Identifying names or numbers will not be collected. (Data are anonymous.)

Ο Codes will be used on data; the list linking codes to personal identifiers will be

kept secure. (Data are confidential.)

Ο Other. Please describe:

Will participants be debriefed? Ο No ΟYes (Include your debriefing statement.)

What benefits can reasonably be expected from the study? Discuss direct benefits to

the individual, if any, as well as to a particular community or society at large.

What is the potential impact of the study for the subject, the institution, and the

field?

IRB Proposal Submission

8/2015

Remember to include copies of data collection instruments, information letters,

advertisements, consent forms and letters of permission from agencies involved in

the research with your electronic submission.

Signature of Principal Investigator:

________________________________________________ Date: ________________

Email these materials in a PDF format to:

irbchair@hamptonu.edu

If you have any questions, please contact the Chair of the IRB:

Dr. Abiodun Adibi

203 DuPont Hall

Department of Biological Sciences

Telephone: (757) 727-5017

Email: irbchair@hamptonu.edu

IRB Proposal Submission

8/2015

HAMPTON UNIVERSITY

HAMPTON, VIRGINIA 23668

IRB #:

INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL FORM

Title of Proposed Research: ___________________________________________________________________________

Project/Thesis/Course: _______________________________________________________________________________

Investigator(s): _____________________________________________________________________________________

Department/Area: ___________________________________________________________________________________

__________________________________________________________________________________________________

_______________________________ _________________________________

Signature (Investigator) Date Signature (Instructor or Advisor) Date

_______________________________

Signature (Department Chair) Date

_______________________________

Signature (Dean/Area Administrator) Date

The investigator has certified that the potential risk is outweighed by the expected benefits and

adequate steps have been taken to assure the protection of human subjects.

IRB Action: Approved _____ Disapproved ________

_________________________________

Dr. Abiodun Adibi, Ph.D.

Chairperson

Date of IRB Action: ____________________________

A written review on the involvement of human subjects in this research is required at the times given below. No changes

can be made in this research activity without prior written approval by IRB. All unanticipated risks to human subjects

should be reported immediately to the Chairperson of the IRB.

Frequency of Required Review Annual _______ Other ________________________

Comments:

CONSENT FORM CHECK LIST

HAMPTON UNIVERSITY INSTITUTIONAL REVIEW BOARD

The consent form must include ALL of the following items, IF APPLICABLE, and in the following order in

language that is readable/understandable (eight grade reading level or lower) to the subject’s legally authorized

representative. Failure to do so may result in IRB approval delays. NOTE: The form should be in the third person

(i.e. the “you” form).

 Study involves research and the purpose of the research

 The time it will take the subject to participate in the study

 Procedures to be followed and which procedures are experimental

 Reasonably foreseeable risks or discomforts

 Benefits to the subject or others

 Alternative procedures of treatment

 How the subject’s confidentially will be maintained

 Confidentiality of records which identify the subject

 If more than minimal risk: availability of medical treatment in the case of research related injury, including

who will pay for the treatment and whether other financial compensation is available-also, if there is a

potential for emotional/psychological risk, you must be able to provide proper counseling and indicate who

will provide the counseling

 Whom to contact for answers to pertinent questions about the research and the research subject’s rights, and

whom to contact in the event of a research related injury

 Participation is voluntary; refusal will involve no penalty or loss of benefits to which the subject is

otherwise entitled

 Subject may discontinue at any time without penalty or loss of benefits to which they are otherwise entitled

 Risks to the subject (or the fetus or embryo) if the subject is or may become pregnant

 Participation may be terminated by the investigator without regard to the subject’s consent; procedure(s)

for termination

 Cost of participation to the subject

 Compensation to the subject

 Significant findings will be provided to the subject upon request

 Approximate number of subjects in the study

 Right to have a copy of the consent form

*The consent form should also indicate contact person(s) (the PI) with their phone numbers in case the subject has

questions about the study and the chair of the IRB with their phone number in case the subject has questions about

their legal rights.

***There should also be a statement that “The Consent Form is valid only if it has been signed or stamped by

the chair (Name, phone number) of the Hampton University IRB”.

*There should be a line for the subject to write his/her name and another to sign and date.

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