CERTIFICATION FOR IRB PROFESSIONALS
EXAM SCRIPT COMPREHENSIVE STUDY
GUIDE
●● what is the assurance of compliance?
Answer: An assurance of compliance is a written document submitted by
an institution (not an Institutional Review Board) that is engaged in non-
exempt human subjects research conducted or supported by HHS.
Through the assurance of compliance, an institution commits to HHS
that it will comply with the requirements set forth in the regulations for
the protection of human subjects at 45 CFR part 46.
●● How often must an institution renew its FWA in order to maintain an
active FWA?
Answer: The Institution must renew its FWA every 5 years, even if no
changes have occurred, in order to maintain an active FWA.
Any renewal or update that is submitted to, and accepted by, OHRP
begins a new 5-year effective period.
●● How long does an institution have to update its FWA if there is a
change to the legal name of the institution, the human protections
administrator, or signatory official
Answer: within 90 days
,The Institution must update its FWA within 90 days after changes occur
regarding the legal name of the Institution, the Human Protections
Administrator, or the Signatory Official.
●● OHRP requires that any institution filing for an FWA, must indicate
that it will be guided by a statement of principles governing the
institution in the discharge of its responsibilities for protecting the rights
and welfare of human subjects of research conducted at or sponsored by
the institution.
According to OHRP guidance, the statement of principles may include
what...
Answer: This statement of principles may include:
(a) an appropriate existing code, declaration (such as the World Medical
Association's Declaration of Helsinki), or statement of ethical principles
(such as the Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research of the U.S. National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research), or
(b) a statement formulated by the institution itself.
●● When do the terms of an FWA apply?
,Answer: These terms apply whenever the Institution becomes engaged
in human subjects research conducted or supported* by any U.S. federal
department or agency that has adopted the Common Rule, unless the
research is otherwise exempt from the requirements of the Common
Rule or a U.S. federal department or agency conducting or supporting
the research determines that the research shall be conducted under a
separate assurance. (For guidance on the meaning of "engaged,"
For the purposes of the FWA, federally-supported means the U.S.
Government providing any funding or other support.]
see OHRP's guidance at http://www.hhs.gov/ohrp/regulations-and-
policy/guidance/guidance-on-engagement-of-institutions/index.html.)[*
●● An institution submitted an FWA must indicate that is has established
written procedures for:
what 3 things?
Answer: (a)Reporting: 1. UPIRTSO 2. Serious or continuing non-
compliance 3. Suspension or termination of IRB approval
(b) Determining which projects require review more often than annually
and which projects need verification from sources other than the
investigator that no material changes have occurred since previous IRB
review
, (c )ensuring prompt reporting to the IRB of proposed changes in
research activity - changes cannot be implemented before IRB review
and approval except when necessary to eliminate apparent immediate
hazards to subjects
●● The FWA submission must attest to the fact that there is institutional
support for the IRB. What does this mean?
Answer: The institution will ensure that each IRB upon which it relies
for the review of research to which the FWA applies has meeting space
and sufficient staff to support the IRB's review and recordkeeping duties.
●● Do international institutions have a separate FWA form or terms of
assurance?
Answer: ? No, there is a single version of the FWA and the Terms of
Assurance for US and non US institutions.
●● An institution may extend its FWA to cover a collaborating
individual investigator under certain conditions using the sample
Individual Investigator Agreement or a comparable agreement developed
by the institution
true or false
Answer: true
EXAM SCRIPT COMPREHENSIVE STUDY
GUIDE
●● what is the assurance of compliance?
Answer: An assurance of compliance is a written document submitted by
an institution (not an Institutional Review Board) that is engaged in non-
exempt human subjects research conducted or supported by HHS.
Through the assurance of compliance, an institution commits to HHS
that it will comply with the requirements set forth in the regulations for
the protection of human subjects at 45 CFR part 46.
●● How often must an institution renew its FWA in order to maintain an
active FWA?
Answer: The Institution must renew its FWA every 5 years, even if no
changes have occurred, in order to maintain an active FWA.
Any renewal or update that is submitted to, and accepted by, OHRP
begins a new 5-year effective period.
●● How long does an institution have to update its FWA if there is a
change to the legal name of the institution, the human protections
administrator, or signatory official
Answer: within 90 days
,The Institution must update its FWA within 90 days after changes occur
regarding the legal name of the Institution, the Human Protections
Administrator, or the Signatory Official.
●● OHRP requires that any institution filing for an FWA, must indicate
that it will be guided by a statement of principles governing the
institution in the discharge of its responsibilities for protecting the rights
and welfare of human subjects of research conducted at or sponsored by
the institution.
According to OHRP guidance, the statement of principles may include
what...
Answer: This statement of principles may include:
(a) an appropriate existing code, declaration (such as the World Medical
Association's Declaration of Helsinki), or statement of ethical principles
(such as the Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research of the U.S. National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research), or
(b) a statement formulated by the institution itself.
●● When do the terms of an FWA apply?
,Answer: These terms apply whenever the Institution becomes engaged
in human subjects research conducted or supported* by any U.S. federal
department or agency that has adopted the Common Rule, unless the
research is otherwise exempt from the requirements of the Common
Rule or a U.S. federal department or agency conducting or supporting
the research determines that the research shall be conducted under a
separate assurance. (For guidance on the meaning of "engaged,"
For the purposes of the FWA, federally-supported means the U.S.
Government providing any funding or other support.]
see OHRP's guidance at http://www.hhs.gov/ohrp/regulations-and-
policy/guidance/guidance-on-engagement-of-institutions/index.html.)[*
●● An institution submitted an FWA must indicate that is has established
written procedures for:
what 3 things?
Answer: (a)Reporting: 1. UPIRTSO 2. Serious or continuing non-
compliance 3. Suspension or termination of IRB approval
(b) Determining which projects require review more often than annually
and which projects need verification from sources other than the
investigator that no material changes have occurred since previous IRB
review
, (c )ensuring prompt reporting to the IRB of proposed changes in
research activity - changes cannot be implemented before IRB review
and approval except when necessary to eliminate apparent immediate
hazards to subjects
●● The FWA submission must attest to the fact that there is institutional
support for the IRB. What does this mean?
Answer: The institution will ensure that each IRB upon which it relies
for the review of research to which the FWA applies has meeting space
and sufficient staff to support the IRB's review and recordkeeping duties.
●● Do international institutions have a separate FWA form or terms of
assurance?
Answer: ? No, there is a single version of the FWA and the Terms of
Assurance for US and non US institutions.
●● An institution may extend its FWA to cover a collaborating
individual investigator under certain conditions using the sample
Individual Investigator Agreement or a comparable agreement developed
by the institution
true or false
Answer: true
