Fillable Research/Project Review and Approval Form: Parts A and (Thomas Edison State University)

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Research/Project Review and Approval Form: Parts A and (Thomas Edison State University)

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This form serves as both a decision making tool and application for IRB approval of
research projects involving human subjects.
Research/Project Review and
Approval Form: Parts A and B
RESEARCH/PROJECT INFORMATION
Principal Investigator Name: _____________________________________________________________________________________
Street: ____________________________________________________________________________________________________
City: _______________________________________________________________ State: ______ Zip/Postal Code: ___________
Phone Number: ___________________________ Email Address: ____________________________________________________
Research/Project Title: _______________________________________________________________________________________
Research/Project Duration: from ____________________________________ to ________________________________________
A research/project is a systematic investigation designed to develop or contribute to generalizable knowledge, through dissemination by publication
or presentation. Human subjects are living people about or from whom an investigator conducting a research/project obtains data through
interaction or identifiable private information. The Principal Investigator is the person conducting the research/project who is responsible for
assuring that all research/project procedures are followed correctly. The Principal investigator is under the auspices of the University, such as a
staff member at the University or State Library. When systematic data about human subjects are collected, especially for the purpose of
dissemination, an IRB review and approval process must be followed according to federal regulation 45 CFR
(ohsr.od.nih.gov/guidelines/45cfr46.html).
1) Types of IRB Review: Depending on the level of risk of the research/project protocol and the participant population, IRBs may conduct either
full board review or expedited review.
a) Expedited Review
i) For certain kinds of research/project involving no more than minimal risk and for minor changes in previously approved
research/projects, the IRB Chair and a designated voting member or group of voting members review the proposed
research/project rather than the entire IRB.
ii) It cannot be assumed that research/project 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. The IRB determines the designation of Expedited Review.
iii) See the following web site for a list of procedures which may be approved through expedited review:
www.hhs.gov/ohrp/policy/expedited98.html
b) Full Board Review
i) When full board review is necessary, the research/project proposal is presented and discussed at a meeting at which a
quorum of IRB members is present.
ii) For the research/project to be approved, it must receive the approval of a majority of those voting members present.
iii) IRB members may participate by means of electronic and/or telephonic communication and need not be present physically.
c) Research/project Exemptions from IRB Review
i) Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research/project but may be
declared exempt from review by the IRB. This determination must be made by the IRB prior to the research/project being
conducted.
ii) Certain low-risk research/projects are exempt from the requirements in the Federal regulations concerning IRB review
and approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect
participants' rights.
The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution.
TYPES OF IRB REVIEW
Research/Project Review and
Approval Form Part A: Decision
Making Tool
Does the research/project fall under the category of
human subjects research?
Directions: Provide a research/project summary and complete the questionnaire, in order to help you determine if your research/project requires
an application submission to the IRB. When you have completed Part A submit this form to the appropriate IRB member. The IRB website has a list
o
f IRB member, and the unit of the University and State Library that they service.
Summary of Research/Project: Submit a one page summary (or abstract) of your research/project with the following form. Include the following
information in the summary: who are the participants, what you will do, when the research/project will occur, where it will occur, and what you
hope to determine by completing the research/project.
Questionnaire: Complete the following questionnaire to determine if the proposed research/project could be considered human subjects research.
Human subjects are called participants in a research/project study.
1) Will the participants in the research/project be identifiable through records, responses, or personal information to anyone else but the researcher?
YES NO
2) Could participants’ reputations, financial standing, or legal standing be at risk if their responses were identified? YES NO
3) Does the research/project ask questions about or explore sensitive aspects of participants’ lives, such as illegal conduct, drug and alcohol use,
mental health issues, abuse, or sexual issues? YES NO
4) Does the research/project involve the taking of any images or audio of the participants, via any means, camera, audio, cell phone, etc.?
YES NO
5) Does the research/project target any of the following types of participants, who are considered vulnerable populations?
Children who are under the age of 18 Physically challenged Economically disadvantaged
Legally incompetent adults Pregnant women Terminally ill
Cognitively or mentally impaired individuals Traumatized or comatose Prisoners
6) Does the research/project involve any of the following activities?
Administration of drugs Taking tissue samples Drawing blood
Administration of alcohol Use of medical devices Giving injections
Administration of nutritional supplements Invasive procedures
7) Is any of the data to be collected online with identifiable email addresses or electronic signatures? YES NO
8) Will any identifying information that may link the data to individual participants be included in your research/project records?
YES NO
9) Does the research/project involve the study of existing databases where the individual participant data is identifiable? YES NO
10) Are participants voluntarily participating, and are they free to withdraw at any time? YES NO
A yes answer to any of the above questions except question #10 places the research/project in the category of human subject research. If a yes is
answered to any of the above questions except question #10, proceed to Part B:Application for IRB Approval.
IRB Member submitted to: __________________________________________________________ Date Reviewed: _______________
The research/project is determined to be: Research Not Research
IRB member signature: ________________________________________________________________________________________
Communicated to Principal Investigator: Method of communication and date: (IRB member to attach communication)
__________________________________________________________________________________________________________
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DIRECTIONS
Research/Project Review and
Approval Form: Part B
Application for IRB Approval
IRB member to forward electronic copy to IRB when form is completed.
The following items must be supplied and submitted to the IRB member identified on the University web site. All information is to be included.
Questions can be directed to the IRB member or IRB Chair, contact information is identified on the web site.
1. Research/Project Title
2. Contact Information for Principal Investigator
a. Contact information for Additional Investigators/team members
b. Report of Human Participant Protection Education for PI and Research/Project Team members
3. Funding Status
4. Research/Project Time Line (Estimates are acceptable)
a. Start of data collection
b. End of data collection
c. Period of data analysis
d. End of study
5. Participants in the study: Provide a description of the participants in the study; include age, sex, ethnicity, race, and other identifying
characteristics. Provide rationale for the use of vulnerable populations. Describe any precautions that would be taken to minimize risk
to participants. Describe procedures for obtaining consent/assent. If consent is not to be obtained, provide a rationale.
a. Attach consent form if applicable
6. Location of the study:
a. Name, address, description
b. Attach letter of agreement from appropriate facility personnel
7. Research/Project Proposal (attach): The proposal should include the following information, in the order indicated, from your
research/project.
a. Specific Aims of the Study
b. Sample characteristics:
i. Statement regarding the processes that you will use to recruit participants
ii. Describe sample demographics and sampling plan
c. Methods of Data Collection and Analysis
i. Be sure to include a description of any quantitative and/or qualitative techniques.
ii. Attach any questionnaires, surveys, tests, tools or research/project instruments
d. Statement of potential risks to participants that are inherent in this research/project protocol.
i. For example, identify possible sources of: breaches of confidentiality, treatment complications, psychological distress
e. Statement regarding precautions and safeguards that are incorporated into the design to minimize potential risks.
f. Statement of potential benefits to the participants.
g. Statement regarding precautions and safeguards that are incorporated into the design to maximize potential benefits.
h. A step-by-step description of the procedures that will be used in this research/project.
Signature of the Principal Investigator:
The undersigned accepts responsibility for this study, including adherence to DHHS, FDA
(www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) and Thomas Edison State University policies regarding the rights and welfare of
individuals who serve as participants in this study.
____________________________________________________ Date___________________________
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IRB USE ONLY
Research/Project Review and
Approval Form: Part B
Application for IRB Approval
IRB Use Only: for Approvals
Date of Review form submitted: _____________________________ Date of Application submitted: _____________________________
Type of Research/Project (www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)
Exempt Expedited Full board review
IRB member signature approval for exempt or expedited research: ________________________________________________________
IRB chair signature for research/project for full board approval: ___________________________________________________________
IRB Use Only: for Approvals with Modifications
Date of Review form submitted: _____________________________ Date of Application submitted: _____________________________
Type of research/project (www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)
Exempt Expedited Full board review
IRB member signature approval for exempt or expedited research/project with following modifications: _______________________________
Modifications to be listed here:
IRB chair signature for research/project for full board approval: ____________________________________________________________
IRB Use Only: for Denial of Application
Date of Review form submitted: _____________________________ Date of Application submitted: _____________________________
IRB member signature for denial of Application: ______________________________________________________________________
Rationale:
Denials go to full board review: ___________________________________________________________________________________
Date of full board review: _______________________________________________________________________________________
Disposition:
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ResearchProject Review and Approval Form: Parts A and (Thomas Edison State University)

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Completed 21 July 2020

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