Protocol for a Research Project Submitted for Review to the
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
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:
Faculty Advisor: (if applicable):
Is this project a continuation of a previously approved project? ΟYes Ο No
Project Period:
Funding Source:
IRB Proposal Submission
In a brief abstract, please provide the following information using the headings
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.
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
Instruments: Describe measures, instruments, or tools to be used. Attach copies
of all data collection instruments. Attach verification of authors 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
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
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
IRB Proposal Submission
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:
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
IRB Proposal Submission
IRB #:
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.
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 ________________________
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.