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Are there additional regulatory considerations for research involving prisoners?
Yes, in addition to the requirements of subpart A, subpart C of the HHS regulations at 45 CFR part 46 identifies more requirements for research involving prisoners.
How do the regulations define “prisoner”?
“Prisoner” means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing (45 CFR 46.303(c)).
When is an institution “engaged” in research involving prisoners?
In general, an institution is considered engaged in a particular human subjects research proposal involving prisoners when its employees or agents, for the purposes of the research proposal, obtain:...
(1) data about the prisoner subjects through intervention or interaction with them; or
(2) identifiable private information about the prisoner subjects.
Some examples of activities that would make an institution engaged in human subjects research involving prisoners are:
(1) seeking the informed consent of prisoners to be subjects in research;
(2) using, studying or analyzing, for research purposes, identifiable private information about prisoners, or identifiable specimens obtained from prisoners; and
(3) surveying prisoners for a research study.
In addition, institutions generally become engaged in research involving prisoners if they are the primary awardee of HHS funds to conduct such research, even where all activities involving prisoner subjects are carried out by agents or employees of another institution.
Do the exemptions apply to research involving prisoners?
No, none of the exemption categories in the HHS regulations for research involving human subjects at 45 CFR 46.101(b) apply to research involving prisoners (45 CFR 46.101(i).
What are the categories for permissible research involving prisoners?
Research involving prisoners is permissible only if the research involves one or more of four permissible categories, or if the research meets the criteria described in an HHS Secretarial waiver that applies to certain epidemiological research (68 FR 36929, June 20, 2003):
The first two categories are (i) the study of the possible causes, effects, and processes of incarceration, and of criminal behavior, and (ii) the study of prisons as institutional structures or of prisoners as incarcerated persons. Research in these two categories is permissible only if the study presents no more than minimal risk, and no more than inconvenience to the subjects (45 CFR 46.306(a)(2)).
The third category (iii) is research on conditions particularly affecting prisoners as a class; the regulations list as examples vaccine trials and other research on hepatitis, which is much more prevalent in prisons than elsewhere, and research on social and psychological problems such as alcoholism, drug addition, and sexual assaults. Research in this category may proceed only after the HHS Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and has published notice in the Federal Register of his or her intent to approve the research (45 CFR 46.306(a)(2)).
The fourth category (iv) is research on practices, either innovative or accepted, which have the intent and reasonable probability of improving the health or well-being of the
subject. In this category, if the IRB-approved proposal is a study in which some prisoners will be assigned to a control group and these prisoners may not benefit from their participation in research, such research may proceed only after the HHS Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and has published notice in the Federal Register of his or her intent to approve the research (45 CFR 46.306(a)(2)). OHRP interprets control groups which may not benefit from research to include a control group receiving standard of care that the prisoners would otherwise receive, services as usual, or a placebo.
What conditions must be met for an IRB to approve research involving prisoners?
Along with the requirements of subpart A, an IRB must make the following seven additional findings required by the regulations in order to review and approve research involving prisoners:
1. The research under review represents one of the categories of research permissible under 45 CFR 46.306(a)(2);
2. Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of receiving such advantages in the limited-choice prison environment is impaired;
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. Unless the principal investigator provides the IRB with written justification for following some other procedures, control subjects must be selected randomly from the group of available prisoners that meet the characteristics needed for that particular research proposal;
5. The information is presented in language that 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 IRB 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 46.305(a)).
OHRP notes that in order to make some of these seven findings and meet the requirements of subpart A of 45 CFR part 46, the IRB must be familiar with the specific conditions in the local prison(s) or jail site(s) that are pertinent to subject protections, before approving the proposal for the local site (45 CFR 46.107(a)).
What are the IRB composition requirements for review of research involving prisoners?
In addition to satisfying the requirements of 45 CFR 46.107, when an IRB reviews a proposal involving prisoners as subjects, the composition of the IRB must satisfy the following regulatory requirements at 45 CFR 46.304(a) and (b):
1. A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB.
2. At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research proposal is reviewed by more than one IRB, only one IRB need satisfy this requirement.
3. The IRB must meet these composition requirements for all types of review by the convened IRB, including initial review, continuing review, and review of amendments.
How do the regulations define “minimal risk” for research involving prisoners?
For research involving prisoners, the regulations at subpart C of 45 CFR part 46 define “minimal risk” as follows: Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons (45 CFR 46.303(d)). The wording of the subpart C definition differs in several ways from the definition of “minimal risk” in subpart A of 45 CFR part 46, which applies generally to research involving human subjects. The differences are:
1. The subpart C definition refers to “physical or psychological harm” rather than “harm or discomfort” as in subpart A.
2. The subpart C definition compares the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life, or in “routine medical, dental, or psychological examinations,” rather than in daily life or “routine physical or psychological examinations or tests” as in subpart A.
3. The subpart C definition identifies ”healthy persons” as the comparison group against which the risks of the research should be measured, rather than leaving the comparison group unspecified, as in subpart A. OHRP interprets the term “healthy persons” in this definition as referring to healthy persons who are not prisoners.
Can informed consent be waived or altered in research involving prisoners?
Yes, so long as the appropriately constituted IRB reviews the research and makes the appropriate findings regarding the waiver or alteration of informed consent requirements, research involving prisoners may be approved with a waiver or alteration of informed consent. However, even if informed consent is waived or altered, subpart C of 45 CFR part 46 still requires that the subjects be clearly informed in advance that participation in the research will have no effect on their parole, if such notification is relevant. (45 CFR 46.305(a)(6)).
Note that prisoners cannot be involved in emergency research where the requirement for informed consent has been waived by the Secretary under the authority of 45 CFR 46.101(i).
What happens if a human subject becomes a prisoner during the course of a research study?
If a human subject involved in ongoing research becomes a prisoner during the course of the study, and the relevant research proposal was not reviewed and approved by the IRB in accordance with the requirements for research involving prisoners under subpart C of 45 CFR part 46, the investigator must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must be suspended immediately, except as noted below. Upon receipt of the investigator's report that a previously enrolled research subject has become a prisoner, if the investigator wishes to have the prisoner subject continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C, and the institution(s) engaged in the research involving the prisoner subject must send a certification to OHRP and wait for a letter of authorization in reply.
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