CIP EVALUATION TEST QUESTIONS AND ANSWERS
SET A+
✔✔Jesse Gelsinger - ✔✔1999 18-year-old Jesse Gelsinger participated in a gene
therapy trial to treat his rare metabolic condition, which had previously been controlled
with medication and diet. Shortly after treatment on study, Jesse experienced multi-
organ failure and subsequently died. Serious concerns were raised afterward about
conflict of interest, data safety monitoring and informed consent.
✔✔Identifiable Private Information - ✔✔45 CFR 46.102(f)(2) Information about behavior
that occurs in a context in which an individual can reasonable expect that no
observation is taking place, and information which as been provided for specific
purposes by an individual and which the individual can reasonably expect will not be
made public (e.g., a medical record).
✔✔Exempt Categories - ✔✔Research that does not require IRB review because
involvement of human subjects is limited to six types of activities/settings:
1) Research conducted in established or commonly accepted educational settings,
involving normal educational practices;
2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior;
3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior if the human subjects are elected or appointed public officials or candidates for
public office;
4) Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects;
5) Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate, or
otherwise examine:
,(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services
under those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for benefits or
services under those programs;
6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
foods without additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical
or environmental contaminant at or below the level found to be safe, by the Fo
✔✔Local Context - ✔✔45 CFR 46.107 IRBs must be knowledgeable about the local
research context:
*The IRB must be sufficiently qualified through the experience and expertise and
diversity of its members, including race, gender, cultural background, and sensitivity to
such issues as community attitudes to promote respect for its advice and counsel.
*The IRB must be able to evaluate research in terms of institutional commitments and
regulations, applicable law, and standards or professional conduct and practice.
✔✔Subpart D - Research Involving Children - ✔✔Additional protections for research
involving children include:
*45 CFR 46.402(d) Children are defined as persons who have not attained legal age for
consent in the jurisdiction in which the research will be conducted.
*45 CFR 46.404-408 There are 4 permissable categories of research involving children:
1. not >min risk with assent according to age/ability, permission from one parent;
2. >min risk but with prospect of direct benefit to participant with assent according to
age/ability, permission from one parent;
3. >min risk no direct benefit, but likely to yield generalizable knowledge about the
subject's disorder or condition, with assent according to age/ability, and permission from
both parents (unless one parent is deceased, unknown, incompetent, or not reasonably
available, or when only one parent has legal responsibility for the care and custody of
the child); and
4. not otherwise approvable but presents an opportunity to understand/ prevent/alleviate
a serious problem affecting the health or welfare of children), with assent according to
age/ability, and permission from both parents (with the same caveats noted previously).
In addition, the DHHS Secretary must consult with a panel of experts in pertinent
disciplines (for example: science, medicine, education, ethics, law) and provide an
opportunity for public review and comment, then determine that the research either:
* satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
* agree that the research presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting the health or
welfare of children; twill be conducted in accordance with sound ethical principles; and
adequate provisions are made for soliciting the assent and permission.
*45 CFR 46.409 Children who are wards of the stat
✔✔Subpart C - Research Involving Prisoners - ✔✔Additional protections for research
involving prisoners include:
, *45 CFR 46.303(c) Prisoner is defined as any individual who is involuntarily confined or
detained in a penal institution.
*45 CFR 46.304(b) At least one member of the IRB must be a prisoner or a prisoner
representative when reviewing research involving prisoners.
*45 CFR 46.305 IRBs must certify to DHHS that research involving prisoners:
(1) meets one of the categories of research permissible under 46.306;
(2) Any possible advantages accruing to the prisoner through his or her participation in
the research are not coercive;
(3) The risks involved in the research are commensurate with risks that would be
accepted by nonprisoner volunteers;
(4) Procedures for the selection of subjects within the prison are fair to all prisoners and
immune from arbitrary intervention by prison authorities or prisoners;
(5) The information is presented in language which is understandable to the subject
population;
(6) Adequate assurance exists that parole boards will not take into account a prisoner's
participation in the research in making decisions regarding parole, and each prisoner is
clearly informed in advance that participation in the research will have no effect on his
or her parole; and
(7) Where the Board finds there may be a need for follow-up examination or care of
participants after the end of their participation, adequate provision has been made for
such examination or care, taking into account the varying lengths of individual prisoners'
sentences, and for informing participants of this fact.
*45 CFR 46.306 Biomedical or behavioral research conducted or supported by DHHS
may involve prisoners as subjects only if the proposed research involves solely the
following:
(i) Study of the possible causes, effects, and processes of incarceration, and of criminal
behavio
✔✔Certificates of Confidentiality (COC) - ✔✔Public Health Act Section 301(d) Gives the
HHS Secretary authority to issue COCs which protect the privacy of subjects in health
research projects against compulsory legal process. NIH issues the COCs.
Effectiveness is retroactive once granted. Some regulations can supersede COCs (e.g.,
domestic abuse, child abuse). COCs only afford protections for information that is
recorded solely in research records (cannot protect clinical records against forced
disclosure).
✔✔8 Criteria for IRB Approval - ✔✔1. Minimize risk to subjects
2. Assess the risk/benefit ratio (potential benefits must outweight the risks)
3. Ensure equitable selection of subjects
4. Evaluate the informed consent process
5. Review/edit the informed consent documents
6. Review privacy and confidentiality provisions
7. Data and safety monitoring plan
8. Vulnerable populations
SET A+
✔✔Jesse Gelsinger - ✔✔1999 18-year-old Jesse Gelsinger participated in a gene
therapy trial to treat his rare metabolic condition, which had previously been controlled
with medication and diet. Shortly after treatment on study, Jesse experienced multi-
organ failure and subsequently died. Serious concerns were raised afterward about
conflict of interest, data safety monitoring and informed consent.
✔✔Identifiable Private Information - ✔✔45 CFR 46.102(f)(2) Information about behavior
that occurs in a context in which an individual can reasonable expect that no
observation is taking place, and information which as been provided for specific
purposes by an individual and which the individual can reasonably expect will not be
made public (e.g., a medical record).
✔✔Exempt Categories - ✔✔Research that does not require IRB review because
involvement of human subjects is limited to six types of activities/settings:
1) Research conducted in established or commonly accepted educational settings,
involving normal educational practices;
2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior;
3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior if the human subjects are elected or appointed public officials or candidates for
public office;
4) Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects;
5) Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate, or
otherwise examine:
,(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services
under those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for benefits or
services under those programs;
6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
foods without additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical
or environmental contaminant at or below the level found to be safe, by the Fo
✔✔Local Context - ✔✔45 CFR 46.107 IRBs must be knowledgeable about the local
research context:
*The IRB must be sufficiently qualified through the experience and expertise and
diversity of its members, including race, gender, cultural background, and sensitivity to
such issues as community attitudes to promote respect for its advice and counsel.
*The IRB must be able to evaluate research in terms of institutional commitments and
regulations, applicable law, and standards or professional conduct and practice.
✔✔Subpart D - Research Involving Children - ✔✔Additional protections for research
involving children include:
*45 CFR 46.402(d) Children are defined as persons who have not attained legal age for
consent in the jurisdiction in which the research will be conducted.
*45 CFR 46.404-408 There are 4 permissable categories of research involving children:
1. not >min risk with assent according to age/ability, permission from one parent;
2. >min risk but with prospect of direct benefit to participant with assent according to
age/ability, permission from one parent;
3. >min risk no direct benefit, but likely to yield generalizable knowledge about the
subject's disorder or condition, with assent according to age/ability, and permission from
both parents (unless one parent is deceased, unknown, incompetent, or not reasonably
available, or when only one parent has legal responsibility for the care and custody of
the child); and
4. not otherwise approvable but presents an opportunity to understand/ prevent/alleviate
a serious problem affecting the health or welfare of children), with assent according to
age/ability, and permission from both parents (with the same caveats noted previously).
In addition, the DHHS Secretary must consult with a panel of experts in pertinent
disciplines (for example: science, medicine, education, ethics, law) and provide an
opportunity for public review and comment, then determine that the research either:
* satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
* agree that the research presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting the health or
welfare of children; twill be conducted in accordance with sound ethical principles; and
adequate provisions are made for soliciting the assent and permission.
*45 CFR 46.409 Children who are wards of the stat
✔✔Subpart C - Research Involving Prisoners - ✔✔Additional protections for research
involving prisoners include:
, *45 CFR 46.303(c) Prisoner is defined as any individual who is involuntarily confined or
detained in a penal institution.
*45 CFR 46.304(b) At least one member of the IRB must be a prisoner or a prisoner
representative when reviewing research involving prisoners.
*45 CFR 46.305 IRBs must certify to DHHS that research involving prisoners:
(1) meets one of the categories of research permissible under 46.306;
(2) Any possible advantages accruing to the prisoner through his or her participation in
the research are not coercive;
(3) The risks involved in the research are commensurate with risks that would be
accepted by nonprisoner volunteers;
(4) Procedures for the selection of subjects within the prison are fair to all prisoners and
immune from arbitrary intervention by prison authorities or prisoners;
(5) The information is presented in language which is understandable to the subject
population;
(6) Adequate assurance exists that parole boards will not take into account a prisoner's
participation in the research in making decisions regarding parole, and each prisoner is
clearly informed in advance that participation in the research will have no effect on his
or her parole; and
(7) Where the Board finds there may be a need for follow-up examination or care of
participants after the end of their participation, adequate provision has been made for
such examination or care, taking into account the varying lengths of individual prisoners'
sentences, and for informing participants of this fact.
*45 CFR 46.306 Biomedical or behavioral research conducted or supported by DHHS
may involve prisoners as subjects only if the proposed research involves solely the
following:
(i) Study of the possible causes, effects, and processes of incarceration, and of criminal
behavio
✔✔Certificates of Confidentiality (COC) - ✔✔Public Health Act Section 301(d) Gives the
HHS Secretary authority to issue COCs which protect the privacy of subjects in health
research projects against compulsory legal process. NIH issues the COCs.
Effectiveness is retroactive once granted. Some regulations can supersede COCs (e.g.,
domestic abuse, child abuse). COCs only afford protections for information that is
recorded solely in research records (cannot protect clinical records against forced
disclosure).
✔✔8 Criteria for IRB Approval - ✔✔1. Minimize risk to subjects
2. Assess the risk/benefit ratio (potential benefits must outweight the risks)
3. Ensure equitable selection of subjects
4. Evaluate the informed consent process
5. Review/edit the informed consent documents
6. Review privacy and confidentiality provisions
7. Data and safety monitoring plan
8. Vulnerable populations
