MANUAL: Administrative Policy & Procedure Manual SJMHS Locations: St. Joseph Mercy Ann Arbor, St. Joseph Mercy Chelsea, St. Joseph Mercy Livingston, St. Mary Mercy Livonia POLICY: Persons meeting the federal definition of a prisoner may be enrolled or remain in research provided that the protocol-specific justifications for the criteria have been met with a confirmation from the IRB, the Institutional Official, and the DHHS Secretary, when applicable. Definitions Prisoner: Under the federal research regulations at 45 CFR 46, subpart C, the term "prisoner" refers to any individual involuntarily confined or detained in a penal institution, prison, or facility. The term is intended to encompass individuals: sentenced to such an institution under a criminal or civil statute, detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a prison (i.e., court-ordered to a psychiatric facility, confined to the home with an ankle alert bracket, etc.) and individuals detained pending arraignment, trial, or sentencing. Any individual who meets this definition is considered a prisoner under the DHHS regulations. This is the case even when an individual becomes incarcerated after they are enrolled. Contact the Research Compliance Department for further clarification of this definition. Minimal risk: Minimal risk for prisoners is defined by the regulations as 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)]. Note that this definition departs from the definition of minimal risk for the rest of 45 CFR 46. Additionally, the regulations state that the IRB must find that the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers [45 CFR 46.305(a)(3)]. I. Prisoners in research A. Principle of justice Page 1 of9
The Belmont Report calls for research to only burden groups who are already burdened (vulnerable populations), after other populations have been exhausted or where the participation of the burdened group in the research is germane to their situation. Therefore, research involving participants who are prisoner should only be approved when it cannot reasonably be conducted without their participation. Their participation in research should never be justified based simply on their availability, compromised position or the convenience for the researcher. When reviewing research involving participants who are prisoners, the IRB should consider whether the population targeted for recruitment represents the population compatible with the aims of the study. The principal of justice in the Belmont report demands both that the outcome of the research not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. B. Regulations 1. Under the Common Rule definition (45 CFR 46, subpart Q, persons meeting the definition of a prisoner may be enrolled in research that meets the special regulatory criteria. 2. Under the FDA regulations, there are no specific provisions for research involving prisoners, but the FDA states that the IRB should be cognizant of the special problems of research involving vulnerable populations, including prisoners. 3. Be advised that under Michigan law. Department of Corrections, Public Acts 1984, R 791.733, Inmate Participation in Research, Rule 33: "A facility [of the Dept. of Corrections] shall establish and maintain written policy and practice that prohibit the use of inmates for medical, pharmaceutical, or cosmetic experiments. This rule does not preclude individual treatment of an inmate based on the need for a specific medical procedure that is not generally available." The Dept. of Corrections must review and approve any research prior to its being conducted and with the review and approval of an IRB. II. Steps to take when a participant unexpectedly becomes a prisoner When an investigator learns that a participant already enrolled in the research study has become a prisoner: 1. Confirm that the participant meets the federal definition of a prisoner. 2. Notify the Research Compliance Department and the IRB promptly via an Internal Adverse Event/Unexpected Problem form. 3. The Investigator must immediately stop all research activities with the participant who became a prisoner and stop obtaining identifiable information, unless it is in the participant's best interest and safety to continue in research (see below). Page 2 of9
SAINT -U^ JOSEPHW MERCY A M«mb«i of um r H*oim 4. There are 3 options for a course of action once a participant becomes a prisoner: a) Retain participant and have IRB review the research for subpart C. b) Withdraw participant from the study, if this is safe to do. c) Stop all research activities with the participant and then resume activities after the participant has concluded his/her prisoner status, if this is safe to do. Consultation with the Research Compliance Department is advised to help sort through the available options for the participant. The following steps will be taken to determine which course of action is best for the participant: 5. Withdrawal Option: Terminate the enrollment of the prisoner-participant by withdrawing him or her, if this is safe to do. 6. Stop and resume option: The prisoner-participant will temporarily be a prisoner and no research activities will take place with the prisoner-participant during the time frame that the participant is a prisoner.. Keep the prisoner-participant enrolled, but stop all research activities with the person and then resume the research activities after the person no longer meets the federal definition of a prisoner. For example, a study involves taking a questionnaire every 6 months and the participant will not be due to take the questionnaire until after they are no longer a prisoner; where no research activities will take place during the prisoner status period. 7. Retain the participant and continue study participation and submit to the IRB option: Submit the study to the IRB for review under 45 CFR 46 Subpart C, The IRB review follows the same process for new studies and continuing studies that seek to enroll or retain a prisoner. The Investigator will need to obtain the prison's permission and submit a Request for Revision form that address each of the regulatory criteria for enrolling prisoners to the IRB. 8. Participant's best interest to remain in the study: The Principal Investigator must consult with and advise the IRB Chair of the risks associated with terminating participation of the person when it is in the prisoner-participant's best interest for health or safety reasons to remain in the study. The IRB or IRB Chair should consider the risks, prior to terminating participation for the prisonerparticipant. a) If the Chair concurs, then the prisoner-participant may continue in the research study while the Investigator simultaneously pursues IRB approval for conducting research with prisoners. The Investigator will need to obtain the prison's permission and submit an amendment to the IRB. Page 3 of9
A M«mb»f Of TflrtHyr HfrOllh b) Otherwise, all further research involving the prisoner-participant must be stopped until the IRB has reviewed the research and determined whether the research is suitable for the involvement of prisoners under the Federal regulatory criteria. 9. Criteria are not met: If after IRB review some the requirements of Subpart C cannot be met: a) If it is in the best interests of the participant for health or safety reasons to remain in the study, then the IRB should keep the participant enrolled and inform OHRP (if the study is funded or sponsored by OHRP) of the decision along with the justification. The Secretary of DHHS will review the situation and inform the IRB of its final determination. b) Otherwise, then the participant must be removed from the study. Other options should be explored, as relevant, such as continuing the intervention under an alternate mechanism such as compassionate use, off label use, etc. 10. Criteria are Met: If the requirements are met, including IRB approval, review by the Institutional Official, as well as certifying to and receiving approval from the Secretary of DHHS (if the research is funded or regulated by OHRP; see below), then research may resume with the prisoner-participant. III. IRB review when prisoners are the intended participant population The Federal regulations contain special protections for research involving prisoners who, due to their confinement, may have a limited ability to make voluntary and un-coerced decisions about whether or not to participate in research (45 CFR 46, sub part C). A. Review Method Full board (convened) -Research that involves prisoners must receive full board IRB review unless it meets the criteria for expedited prisoner research (below), to ensure that adequate protections and safeguards are in place. Page 4 of 9 Expedited Review -For research that does not involve interaction with prisoners (e.g. existing data, record review) review by expedited procedure is permissible: 1. Research that does not involve interaction with prisoners may be reviewed by the expedited procedure if a determination is made that the research involves no greater than minimal risk (see special definition above) for the prison population being studied and if it meets the requirements for expedited review. 2. Review by a prisoner representative is not required for research reviewed by the expedited method. However, the prisoner representative may review the research as a reviewer.
A M«mb*r ef Trinity HMtth 3. Review of modifications and continuing review must use the same procedures as initial review. Exemption -Research that involves prisoners, including existing data, may not be exempt from the federal regulations. B. Justification for the use of Prisoners The IRB will take a conservative approach when considering research that includes this vulnerable population. The principal investigator must provide written justification within the research protocol for including this population, address how the prisoner -participants protections will be upheld, risks will be mitigated, and how adequate safeguards to minimize coercion, undue influence, and protect the participants' rights are addressed. Research involving participants who are prisoners that is greater than minimal risk to these participants (see special Definitions, should address whether studies have previously been tested on animals (other than humans) and on participants that are not considered vulnerable or already burdened. C. Regulatory criteria and requirements that must be met 1. Prisoner representative IRB member: In order to consider research involving participants that meet the OHRP definition of a prisoner, IRBs must (45 CFR 46.304): a) Have a majority of its members not associated with the prison(s) involved in the research (exclusive of prisoner members). b) Adequately represent the interests and special concerns of prisoners by including a prisoner or a prisoner advocate in the IRB membership (voting member) with appropriate background and experience to serve in that capacity and to represent the prisoners, unless the research has already been reviewed by an IRB that included a prisoner advocate. This representative must perform primary or secondary review of the research, whether this is at initial, continuing, amendments, or review of a closure of the study, focusing on the requirements in Subpart C or equivalent protections. Page 5 of9
HEAITH SYSTEM A M«m&»r oi Trinity H*oifh Page 6 of 9 Additionally: a) The prisoner representative must be present at a convened meeting when the research involving prisoners is reviewed. If the prisoner representative is not present, research involving prisoners cannot be reviewed or approved. b) The prisoner representative may be listed as an alternative member who becomes a voting member when needed. c) The prisoner representative may attend the meeting by phone, video-conference, or webinar, as long as the representative is able to participate in the meeting as if they were present in person at the meeting. 2. Permissible categories: Prisoners may only participate in one of the following categories of research (45 CFR 46.306): a) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk (see Definitions section) and no more than inconvenience to the participants; b) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk (see special definition above) and no more than inconvenience to the participants; c) Research on conditions particularly affecting prisoners as a group, provided that the study may proceed only after the Secretary of DHHS has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the federal Register, of his/her intent to approve such research; (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, etc.) or d) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the participant. 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 of DHHS has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research. e) The DHHS Secretarial Waiver for certain epidemiological research conducted or supported by DHHS: The research's sole purpose: (i) to describe the prevalence or incidence of a disease by identifying all cases, or
A M«mb»f Ol UMif Htolfh (ii) to study potential risk factor associations for a disease. All requirements of subpart C apply. SJMHS must review the research under subpart C, certify to OHRP, and receive OHRP authorization prior to initiating any research involving prisoners. 3. Required criteria and requirements: To approve research involving prisoners the IRB must document protocol-specific justifications that the criteria are met, below (45 CFR 46.305). Note: If a participant unexpectedly becomes a prisoner, the IRB may decide that some of the criteria would not be applicable and this should be noted: a) The permissible category that the research fits into (as listed above); b) Any possible advantages accruing to the prisoner through his or her participation in the research, when compared with the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the penal institution, 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 penal institution is impaired; c) The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers; d) Procedures for selecting participants within the penal institution 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 participants must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project; e) The information and consent is presented in language that is understandable to the prisoner population. Consent must be voluntary and presented without coercion. f) Adequate assurance exist that parole boards will not take into account a prisoner's participation in the research when making decisions regarding parole. Each prisoner must be clearly informed in advance that participation in the research will have no effect on his or her parole; and g) 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, while taking into account the varying lengths of individual prisoner's sentences, and for informing participants of this fact. If the IRB approves the study contingent on the Institutional Official's approval, the study will next reviewed by the Institutional Official. Page 7 of9
H EALTH SYSTEM A M«fflb*f Of TfirtHy Htolth stjoeshealth. org D. Review by the Institutional Official Next, the Institutional Official must review the IRB's review and determination of the study, if the study was approved, to ensure that he/she concurs with the IRB's decision and that the review was conducted in keeping with this policy and the applicable federal regulations. The Institutional Official may disapprove the research, request modifications, or approve the research. E. Certifying to the Secretary of DHHS Once a study has gained approval from both the IRB and the Intuitional Official and if the research is supported by or subject to the oversight of OHRP, then the Secretary of DHHS' approval is required prior to the research beginning. Otherwise, the research study may begin (or research may resume with the prisoner-participant). Under 45 CFR 46.305(c), the institution responsible for conducting research involving prisoners that is supported by DHHS must certify to the Secretary (through OHRP) that the IRB has made the seven findings required under 45 CFR 46.305(a). The Research Compliance Department will send a certification letter to OHRP which will certify that the 7 findings were made for the specific research study and any relevant DHHS grant application or protocol. OHRP requires [45 CFR 46.115(b)], that a copy of the research proposal be submitted so that OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one. The term "research proposal" includes the IRB-approved protocol, any relevant HHS grant application or proposal, any IRB application forms required by the IRB, and any other information requested or required by the IRB to be considered during initial IRB review. DHHS conducted or supported research involving prisoners may not precede until OHRP issues its approval in writing to SJMHS, on behalf of the Secretary under 45 CFR 46.306(a)(2). The IRB will provide written correspondence to the Investigator regarding when the study may begin or information regarding the Secretary's disapproval of the research. IV. Other applicable regulations A. Minors who are Prisoners Research that includes a participant that is both a prisoner and a minor require that the additional protections of 45 CFR 46 subpart C and/or 21 CFR 50 Subpart D for children Page 8 of9
A MtmUi Ct Trinity Health apply. For example, a young adolescent detained in a juvenile detention facility would be considered a prisoner. See SJMHS IRB policy: Vulnerable Populations- Children B. Waiver of Consent Prohibited for Emergency Research Under 45 CFR 46.101(i) a waiver of the regulatory requirement for obtaining and documenting informed consent for emergency research is described. This waiver does not apply to research involving prisoners. V. Documentation and Correspondence Each time a study that involves prisoners is reviewed by the IRB, the IRB meeting minutes will reflect: 1. That an IRB member who is a prisoner or a prisoner advocate with appropriate background and experience to serve in that capacity and to represent the prisoners attended the IRB meeting where the research was reviewed, including the review of initial, continuing, amendments, adverse events, and closure of the study. 2. The IRB's protocol-specific justifications for the required criteria and requirements under HHS regulations at 45 CFR 46.305(a), as well as the justification for the use of prisoners in a research study, will appear in the IRB meeting minutes and in the correspondence to the Investigator. The Investigator will be notified by the IRB when the study has been approved by each applicable authority, including the IRB, and when the study may begin. If changes are requested or if the study is not approved, the Investigator will also be provided with written correspondence from the IRB. Approved by: Institutional Official Effective Date Page 9 of 9