Homewood Institutional Review Board
Research Protocol Review
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YES or NO responses, type unlimited text in the COMMENTS field. If completed manually, you are limited
to the available space for comments in the printed form.
Protocol No.
Principal Investigator:
Title of Project:
Reviewer(s):
Please answer all questions below. If you have any questions, please contact the HIRB office.
A. Research Design
1. Is the hypothesis clearly stated?
Yes
No
2. Does the study contribute to generalizable knowledge?
3. Is it worth exposing participants to risk?
Yes
Yes
No
No
Comments:
B. Risk/Benefit Analysis
1. What is the level of risk?
Minimal Risk (A risk is minimal where the probability and magnitude of harm or discomfort anticipated in
the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examination or tests.)
Greater than Minimal Risk (requires Full Board review)
High Risk
2. Identify any risks that may apply (check all that apply) -- explain more fully under Comments:
Physical Harms (pain, discomfort, injury or loss of function; direct result of procedure or side effect;
permanent or transitory)
Psychological Harms (emotional distress; Psychological trauma; Invasion of privacy)
Social Harms (breach of confidentiality)
Economic (employment status, financial standing)
Other:
3. Does the research design minimize risks? (Are precautions, safeguards or alternatives in place to minimize
risks?)
Yes
No
4. Are the risks reasonable in relation to anticipated benefits?
5. Is there a benefit to participants?
6. Is there a benefit to society?
Yes
Yes
Yes
No
No
No
Comments:
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C. Selection of Participants
1. Are the participants appropriate to the research?
Yes
No
2. Is there an equitable selection of participants? (gender, age, race)
Yes
No*
(*) If selection of participants is not equitable,
was there adequate justification for studying a certain population?
Yes
No
N/A
Comments:
D. Informed Consent
1. Whether documented or oral, the informed consent process is Adequate
needs revision.
(Informed consent is not a single event or just a form to be signed. It is an educational process that
takes place between the investigator and the prospective participant.)
2. Whether documented or oral, all the basic elements* of informed consent (and additional elements as
appropriate) are:
included in the consent text or language
insufficient/ needs revision (explain in Comments)
(*) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116
 If
Written consent - Is the consent document written at a level that will be understood by these participants?
Yes
No
 If
Oral Consent –
- Is the Request for Use of Oral Consent adequately justified?
Yes
No
missing request
- Should a consent short form be provided to participant? (information presented to the participant when a
signed consent document is not used - must be signed by a witness)
Yes*
No
missing
*If provided, is the short form disclosure adequate?
Yes
No
 If
Waiver or Alteration of consent requirements is requested - Does the research meet the criteria for a waiver or alteration?
Yes
No
Comments:
E. Children
1. If children are participants in the research, Parental Permission (consent) must be obtained –
- is the Permission form (or text) adequate?
Yes
No
must provide
2. If a child is capable, the investigator should obtain the child’s ‘Assent’ to participate in the research in addition to
Parental Permission, either orally or documented.
- The Assent process - The Assent language -
is adequate
needs revision
omitted from protocol
is appropriate to the age or comprehension of the child
needs revision
Comments:
F. Compensation for Participation
1. Is the compensation provided to the participants appropriate/ reasonable based upon the complexities and
inconveniences of the study and the particular participant population?)
Yes
No
N/A
Comments:
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G. Privacy and Confidentiality
1. Will personally-identifiable research data be protected to the extent possible from access or use?
2. If access to medical records is requested,
is a medical records release from the participants required?
3. Should a Certificate of Confidentiality be obtained?
(Will information about an illegal behavior be obtained?)
Yes
Yes
No
Yes
No
N/A
No
Comments:
H. Additional Protections
1. Should additional safeguards be included to protect the rights and welfare of participants who are likely to be
vulnerable to coercion or undue influence? (Pregnant Women, Prisoners, Children, Decisionally-Impaired
Individuals)
Yes
No
N/A
2. Are recruitment procedures designed to assure that informed consent is freely given?
3. Are advertisements to be used to recruit participants?
Yes*
No
N/A
*If Yes, is the advertisement non-coercive (free of undue influence)?
Yes
No
Yes
No
N/A
N/A
Comments:
I. International Research
1. If the research is conducted outside the U.S.,
should investigators obtain local permissions?
Yes
No
n/a
2. Is the consent process conducted in English
local language?
If non-English, is a translated consent form/script provided?
Yes
No
n/a
3. Should an expert in conducting local research be consulted about potential risks to participants?
Yes
Comments:
Reviewer Recommendation
The research is:
Approved
Approve pending revision – see additional comments
Disapprove - !! see additional comments
To be reviewed by the Full Board
The review period is:
One year
Less than one year, the recommended interval is (specify):
Following the enrollment of a specified # of participants (specify #):
Other
Additional Comments:
________________________________________
Reviewer’s Signature
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Date
New10/21/09
No