Institutional Review Board Members
(to be revised and submitted to OPRR as changes occur)

NAME OF INSTITUTION PROVIDING ASSURANCE:

OPRR ASSURANCE NUMBER: __________________
NAME OF INSTITUTION PROVIDING IRB REVIEW
(IF DIFFERENT FROM ABOVE):1

 OPRR ASSURANCE NUMBER (IF ANY): ___________________

NAME (voting members only)2,3
LAST,   FIRST

HIGHEST
DEGREES
EARNED

PRIMARY SCIENTIFIC OR NONSCIENTIFIC SPECIALTY

AFFILIATION WITH INSTITUTION(S)4 ABOVE (YES/NO; IF YES, SPECIFY)

ATTESTATION OF IRB CHAIRPERSON
*      

FOR ALL RESEARCH CONDUCTED UNDER THIS ASSURANCE, THE IRB CHAIRPERSON HEREBY ATTESTS THAT, EXCEPT WHERE SPECIFICALLY WAIVED OR ALTERED BY THE IRB UNDER 45 CFR 46.116(c), 46.116(d), or 46.117(c), THE IRB WILL UPHOLD THE REQUIREMENTS OF 45 CFR 46 FOR WRITTEN INFORMED CONSENT, IN NONEXCULPATORY LANGUAGE UNDERSTANDABLE TO THE SUBJECT (OR THE SUBJECT'S LEGALLY AUTHORIZED REPRESENTATIVE), INCLUDING THE FOLLOWING BASIC ELEMENTS PER 45 CFR 46.116(a/b):

(1) IDENTIFICATION AS RESEARCH; PURPOSES, DURATION, AND PROCEDURES; PROCEDURES WHICH ARE EXPERIMENTAL;
(2) REASONABLY FORESEEABLE RISKS OR DISCOMFORTS;
(3) EXPECTED BENEFITS TO THE SUBJECT OR OTHERS;
(4) ALTERNATIVE PROCEDURES OR TREATMENTS;
(5) EXTENT OF CONFIDENTIALITY TO BE MAINTAINED;
(6) WHETHER COMPENSATION OR MEDICAL TREATMENT ARE AVAILABLE IF INJURY OCCURS (IF MORE THAN MINIMAL RISK);
(7) WHOM TO CONTACT FOR ANSWERS TO QUESTIONS ABOUT THE RESEARCH, SUBJECT'S RIGHTS, AND RESEARCH-RELATED INJURY;
(8) PARTICIPATION IS VOLUNTARY; REFUSAL TO PARTICIPATE WILL INVOLVE NO PENALTY OR LOSS OF BENEFITS TO WHICH SUBJECT IS ENTITLED; SUBJECT MAY DISCONTINUE AT ANY TIME WITHOUT PENALTY OR LOSS OF BENEFITS TO WHICH SUBJECT IS ENTITLED;
(9) WHEN APPROPRIATE, ADDITIONAL ELEMENTS PER 45 CFR 46.116(b).

AS IRB CHAIRPERSON, I HEREBY SO ATTEST.

SIGNATURE: ________________________

DATE:

PHONE:                               E-MAIL:

ADDRESS:
       
       
       
       
       
       
       
       
       
       
       
       
       
       
       
       
       
       
 *DENOTES CHAIRPERSON
**DENOTES ALTERNATES (IF ANY, DENOTE MEMBER FOR WHOM ALTERNATE WILL SERVE)

(1) WHERE REVIEW IS CONDUCTED BY ANOTHER INSTITUTION'S IRB, THE IRB MUST ENSURE ADEQUATE KNOWLEDGE OF LOCAL CONDITIONS, INCLUDING COMMUNITY ATTITUDES, RELEVANT CULTURAL SENSITIVITIES, INSTITUTIONAL POLICIES/COMMITMENTS, APPLICABLE LAW, AND STANDARDS OF PROFESSIONAL CONDUCT/PRACTICE.

(2) NO IRB MEMBER MAY PARTICIPATE IN THE REVIEW OF ANY PROJECT IN WHICH THE MEMBER HAS A CONFLICTING INTEREST.

(3) IRBs MUST BE CONSTITUTED SO AS TO ENSURE APPROPRIATE REVIEW AND ADDITIONAL SAFEGUARDS FOR RESEARCH INVOLVING VULNERABLE CATEGORIES OF SUBJECTS.

(4) AFFILIATION MAY TAKE THE FORM OF EMPLOYMENT, MEMBER OF GOVERNING BOARD, STOCKHOLDER, OR PAID/UNPAID CONSULTANT (FOR PURPOSES OTHER THAN IRB FUNCTIONS).

(5) SEE OPRR TIPS FOR INFORMED CONSENT AT: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm
 
 
 
 


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Updated June 23, 2000