The Investigator Manual should be consulted by study teams and staff as well as HRP- 415 Prisoner Checklist to ensure the study team has provided sufficient information in the protocol to justify enrollment of prisoners. Prisoner research must comply, as applicable, with seven additional requirements as outlined by 45 CFR 46.305(a) (note that some criteria below will not be applicable when the research involves only secondary data analysis or record reviews):

1. The research under review must represent one of the categories of research permissible under 45 CFR 46.306(a)(2). 
2. The advantages associated with study participation must not be considered coercive.
3. The risks involved in the research must be commensurate with risks that would be accepted by non-prisoner volunteers. 
4. Procedures for the selection of subjects within the prison must be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. 
5. The information must be presented in language which is understandable to the subject population.
6. There must be adequate assurance that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner must be clearly informed in advance that participation in the research will have no effect on his or her parole.
7. If the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision must be made for such examination or cares, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact. continuity in accessing health care. 

Research involving prisoners is permissible only if the research involves one or more of four permissible categories under 45 CFR 46.306, 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):

• Generally, the research reviewed by the IRB that involves prisoners is permissible under the first two categories: (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)).
• Used less often, research involving prisoners can also be permissible under the third category (iii): research on conditions particularly affecting prisoners as a class; or the fourth category (iv): research on practices, either innovative or accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.
• Rarely used, the HHS Secretarial waiver for certain epidemiological research conducted or supported by HHS functions as a fifth category of permissible research. This category allows DHHS to conduct or support certain important and necessary epidemiologic research on prisoners that presents no more than minimal risk and no more than inconvenience to the prisoner-subjects. The criteria for this category are that the research must have as its sole purpose (i) to describe the prevalence or incidence of a disease by identifying all cases, or (ii) to study potential risk factor associations for a disease. The institution still must review the research under subpart C and certify to OHRP that an appropriately constituted IRB has reviewed the proposal and made all other required findings under HHS regulations at 45 CFR 46.305(a) and receive OHRP authorization prior to initiating any research involving prisoners. All of the other requirements of subpart C apply to research in this category.

Categories (i) – (iv) above require certification to OHRP IF the research is conducted or supported by DHHS. See the Certification section below for additional information. If the research is not conducted or supported by DHHS, certification to OHRP is not required. The fifth category, certain epidemiological research, will always require certification to OHRP as that is research that will always be conducted or supported by DHHS.

For category (iii) above, if the research is conducted or supported by DHHS, the research is only permissible after consultation with the HHS Secretary and a published notice in the Federal Register. For category (iv) above, if the research is conducted or supported by DHHS, HHS Secretary consultation and a published notice in the Federal Register is ONLY needed when prisoners are in the control group and may not benefit. Consult with IRB Leadership if the research being reviewed is conducted or supported by DHHS and falls within one or both categories. If the research is not conducted or supported by DHHS, the research is permissible under these two categories without HHS Secretary consultation and publication in the Federal Register.

When reviewing research involving interaction with prisoners, at least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement. 

Full reviews

• For convened board reviews, the prisoner representative must be the primary or secondary reviewer. 

Expedited Reviews

• Research involving existing data or records review (no interaction with prisoners) may be expedited, if appropriate. Generally, a study that involves interaction with prisoners should not be expedited.
  • For research that does not involve interaction with prisoners, the prisoner representative is not required to be a reviewer of the study. However, IRB analysts may still consult with the prisoner representative, if warranted.

Expedited continuing reviews

• If the study involves interaction with subjects (e.g., surveys), the prisoner representative must be the designated reviewer. 
  • NOTE: Designated Reviewer means that they are the assigned reviewer, not just a consultant.  In these cases, select “Designated Reviewer” in the Send to IRB Member activity form.
• If the study has progressed to the point of data analysis or long term follow up (with no interaction with prisoners), review by the prisoner representative is not required.

Expedited changes of protocol

• The prisoner representative must be the Designated Reviewer of the change, unless the modification(s) reviewed under expedited procedures does not involve interaction with prisoners (e.g., a change in funding or a change to procedures involving participants in the study who are not prisoners).
  
  If the change requires review by a prisoner representative, IRB analysts will use the Send to IRB member activity to send the study to the prisoner representative for their review. 

Following IRB review and conditional approval (Approved with Administrative Hold)* of DHHS-supported research involving prisoners, the IRB must certify to the Secretary (through OHRP) that the IRB has made the findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible categories of research under 45 CFR 46.306(a)(2). The certification process can be found here: How to Submit Subpart C Certification Request to OHRP. 

Once certification is received from OHRP (UW-Madison HRPP Quality and Compliance Office will forward certification to staff reviewer), the certification should be sent to the study team so they can resubmit the application with the certification uploaded to the Administrative Hold response. Final approval can then be granted.

*Final approval of the study can’t be granted until certification from OHRP is received.

To send a subpart C certification request to OHRP, the institution must submit this form: https://oashsps.my.site.com/ohrpwebforms/s/prisoner-web-form   in conjunction with a copy of the research proposal. The term “research proposal” includes:

• the IRB-approved protocol, including consent forms (if applicable);
  any IRB application forms required by the IRB; and
  any other information requested or required by the IRB to be considered during IRB review

Note: If an IRB considers the grant application during its review of the study, only submit portions of the grant application relevant to subpart C review.

How to fill out the form

Administrative Information Section:

Name of Institution: University of Wisconsin – Madison
Address of Institution: 500 Lincoln Drive, Madison, WI 53706
Contact First Name: Nadine
Contact Last Name: Connor
Contact Title: Institutional Official
Contact Phone: 608-262-1703
Contact Email: compliance@research.wisc.edu 
Award Number: Enter the Agency/Sponsor Reference Number from the funding entry in ARROW
Funding Agency: Choose the applicable funding agency(ies) funding the study
Granting Institution's Program Officer: The staff reviewer will need to ask the study team to provide this information. 
OHRP Assurance #: 00005399
IRB Registration # for Reviewing IRB: Indicate either 00000366 if the HS IRB reviewed OR 00003739 if MRR IRB reviewed.

Study Information Section:

Study Title: Indicate title listed in IRB application.
Name of Principal Investigator: Also indicate the degree of PI (e.g., Bucky Badger, Ph.D)
Brief Summary of Protocol: Summarize the research design and procedures of the study.
Date(s) of IRB meeting(s) in which protocol was considered, including the dates of initial IRB review and subpart C review: If the study is being expedited, no dates will be entered. You can indicate “The study was reviewed via expedited procedures.”
Permissible Categories of Research Section: Choose which category the research is permissible under. 

Certifications Section:

Both boxes must be checked before submitting the form. NOTE: Before submitting the form, a PDF of the form must be made for record-keeping purposes. This can be done by printing the webpage and choosing the printing “destination” to be “Save to PDF.” The file name of the PDF should be the Principal Investigator’s last name followed by the IRB application ID (e.g. Badger 2023-0000). The PDF should then be placed on Box in HRPP Non-Public Documents -> OHRP Prisoner Certification Requests. Once all the information is filled out,both boxes are checked, and a PDF of the form has been made/saved, click “Submit.”

View/Upload Files Section:

The option to upload files will become available after submitting. After files are uploaded, press Finish to confirm the completion of the form. 

After submission/completion of the form, please email compliance@research.wisc.edu to to inform them that a certification request has been submitted and any correspondence from OHRP related to the certification can be forwarded to you.

If a participant becomes a prisoner at any time during the conduct of the study, regardless of study funding, the study team must report this to the IRB as a reportable event. See Reportable Events Involving Prisoners.