Since October 1, 2000 the Public Health Service has required specific training on the protection of human research participants for all investigators and key personnel listed on grant applications and contract proposal for either new or non-competing awards for research involving human participants. To ensure this compliance the Human Investigation Committee (HIC) requires all investigators and key personnel participating in human participant research to complete six required modules. These modules include basic information on conducting research with human participants, the nature of the Wayne State University (WSU) Federal Wide Assurance (FWA), the history and ethical foundations of biomedical research, the role of the four Institutional Review Boards (IRB) and the principal investigator, the requirements for obtaining continuing approval of research projects, reporting requirements for investigators, informed consent process and completion of WSU mandated forms.

The University has and is in the process of developing addition modules that may or may not be required of individuals conducting certain types of research. These additional modules will include such topics as

(1) conducting research with children,
(2) conducting research in prisoners and individuals confined to alternative facilities,
(3) conducting collaborative research with investigators from other academic institutions, and
(4) conducting international research.

While these additional modules will not be required of everybody, they will be required of individuals who are working with a specific venerable population or conducting unique types of research. These additional modules will be required by one of the WSU IRBs when appropriate as part of their approval of a specific research protocol.

The first optional module that is available on the Responsible Conduct in Research Online Training Program (http://rcr.wayne.edu/) involves the additional federal, state, and institutional requirements that are involved when an investigator would like to conduct research with prisoners or individuals who are admitted by the court to facilities that is an alternative to prison.

The definition of a prisoner is a person who is being held in a jail, prison, or treatment facility or who has been convicted or are awaiting arraignment, trial, or sentencing. This includes those who are in hospitals, alcohol, and drug treatment facilities under court order. The definition applies to minors as well as to adults. These regulations apply when the person is a prisoner prior to the research project as well as if the status changes during the research project.

The federal regulations and institutional policies allow prisoners to be involved in four categories of research:

Category 1:

Studies 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

· examples of this kind of research might involve demographic studies of rates of incarceration or records-based studies of recidivism.

Category 2:

Studies 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

· examples of this kind of research might involve confidential surveys of prisoners regarding food service or educational opportunities.

Category 3:

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

Category 4:

Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well being of the participant.

· Examples of this kind of research might include studies on alternative sentencing or clinical trials of cancer therapies that do not involve assignment to placebo.

Prisoners may not be enrolled in a research project involving a placebo unless the standard of care for the disease or condition is “no treatment” and the procedures for using the placebo are the same as the “no treatment” option.

Prisoners may not be enrolled in research protocols exempted from IRB review.

Because the prison or penal institution responsible for the care of the prisoner must participate in the implementation of the research projects, the principal investigator is responsible for obtaining the initial approval of the prison or penal institution before the research protocol is submitted to an WSU IRB. Once initial approval of the prison or penal institution administrative unit has been obtained and the protocol has been approved for the enrollment of prisoners in the research project by one of the WSU IRBs, the WSU Office of the Vice President for Research shall enter into a formal agreement with the prison or penal institution concerning their responsibilities in participating in a research project conducted by personnel of WSU or a WSU-affiliated health care institution.

The regulatory protections are applicable to all prisoner-participants, regardless of their status at the time of enrollment in a study. OHRP does not require immediate suspension of research activities when a participant becomes a prisoner. Rather, OHRP recommends that:

· Investigators inform the IRB immediately upon learning that a participant has entered prison and

· The IRB review the protocol “at the earliest opportunity” to determine whether continued participation in the research is appropriate under the regulations.

· Follow appropriate regulations to get approval or remove study participant

The word prisoner can be misunderstood. The federal regulations at 45 CFR 46 Subpart C and institutional policies apply when a participant has been convicted and placed in a mandated confinement or are awaiting arraignment, trial, or sentencing for a criminal act. The confinement by the judicial system may include placement in a half way house, juvenile detention centers, hospitals, rehabilitation facilities or jails.

For more information on research with prisoner participants, please take the educational training module. If you have further questions you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu