Research Involving Prisoners

"Prisoner" is defined as any person involuntarily confined or detained in a penal institution. The term also includes persons detained in other facilities (e.g., group homes, work release centers) by statute or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as persons detained pending arraignment, trial, or sentencing.

If a subject in an ongoing research study subsequently becomes a prisoner, the researcher must report this to the IRB immediately so that the IRB can review the protocol again with a prisoner representative present, to adequately assess the special conditions that the prisoner will face with respect to continued participation in the study while incarcerated.

The IRB will only approve research involving prisoners if the following findings are made:

1. For DHHS-supported research, the research under review represents one of the categories of research permissible under-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 such advantages in the limited choice environment of the prison 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 to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
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 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.

1st - Research Must Meet Specified Criteria

The specified criteria is listed under the above section, "Permitted Research Involving Prisoners."

2nd - Research Must Represent One of the Following Categories

The following categories are pulled from 45 CFR 46.306(a)(2)

1. 45 CFR 46.306(a)(2)(i) - Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
2. 45 CFR 46.306(a)(2)(ii) - Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
3. 45 CFR 46.306(a)(2)(iii) - Research on conditions particularly affecting prisoners as a class (for example, 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 addiction, and sexual assaults) provided that the study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research.
4. 45 CFR 46.306(a)(2)(iv) - Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research.

3rd - Two Actions Must Occur

1. The institution engaged in the research must certify to the Secretary (through OHRP) through a certification letter that the IRB designated under its assurance of compliance has reviewed and approved the research under 45 CFR 46.305; and
2. The Secretary (through OHRP) must determine that the proposed research falls within the categories of research permissible under 45 CFR 46.306(a)(2).

HHS conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution on behalf of the Secretary under 45 CFR 46.306(a)(2).

The definition of minimal risk for prisoners is different than for the rest of the population.

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.

The IRB must submit a Certification Letter to OHRP following review of DHHS-supported research involving prisoners. The purpose of this letter is to certify to the Secretary that the IRB approved the research under 45 CFR 46.305.

The Certification Letter to OHRP will be constructed by the IRB and must include:

• Name and address of the institution;
• Specifically identified research protocol in question;
• Copy of the IRB application and all relevant materials reviewed and approved by the Board;
• Any relevant HHS grant application of protocol;
• IRB specific findings of 45 CFR 46.305

Prisoner research certification letters should be mailed to:

Attention: OHRP Prisoner Research Contact Person
Office for Human Research Protections
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852