Definitions Specific to Subpart C (CFR 46.303)
Prisoner - any individual involuntarily confined or detained in a penal institution encompassing:
- 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
- Individuals detained pending arraignment, trial or sentencing
Minimal Risk - “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*”
*This definition is different from the definition of minimal risk found in CFR 46.102.
Acceptable research involving prisoners:
- 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
- Study of prisons as institutional structures or of prisoners as incarcerated people provided that the study presents no more than minimal risk and no more than inconvenience to the subjects
- 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 addition, and sexual assaults
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or wellbeing of the subject.
All research with prisoners must be reviewed by a designated prisoner advocate member of the IRB. A prisoner advocate is someone with the appropriate background and experience to represent the best interests of the prisoners who might be recruited as subjects in research.
Research planned on non-prison populations can be continued if a subject becomes incarcerated, if the following conditions are met:
- The IRB is notified within 72 business hours of the investigator becoming aware that a subject is incarcerated. Notification by email, followed by a signed hard copy is acceptable. Data collection must cease; the investigator may request that data collection continue and provide justification that it is in the best interest of the prisoner for the research to continue. (This will primarily be confined to interventional research). If granted, then data collection may continue during the period while the amendment is processed. This request should be made to the IRB.
- An amendment is filed that includes an additional consent form with the necessary language to reflect the altered conditions (see below).
- Board review of the amendment is a full board review with the specially constituted board.
- No data collection may occur until the full board has approved the project.
Because prisoner research requires a prisoner advocate, a minimum of two months should be allowed for research review. Please contact UCAIHS when submitting a new or amended proposal so that the representative can be scheduled into a meeting as soon as possible.
The UCAIHS will notify the principal investigator of soonest review date possible.
Source Documents (click on for link):
An addendum consent form must be generated to include the following:
“The following information applies to your continued participation in the above referenced research study given involuntarily detention, confinement or incarceration (in a jail, prison or alternative facility) and is in addition to the information provided to you in your signed informed consent document:
Confidentiality of personal information about you – including your medical records (if applicable) and personal research data gathered in connection with this study- will be maintained in a manner consistent with federal and state laws and regulations.
You should know that research data (or medical information, if applicable) about you may be reviewed or copied by the sponsor of the research or by New York University. Personal information about you might be shared with or copied by authorized officials of the Federal Food and Drug Administration, the Department of Health and Human Services (if applicable), and the _____________________ [insert name of facility where subject is involuntarily detained or name of correctional system in the case of involuntary detainment as an alternative to a prison setting].
In addition, you should be aware that confidentiality regarding your status as a prisoner cannot be guaranteed.
Your participation in this research project will have no effect on consideration of sentencing, length of sentence, or parole.
Providing prisoners with incentives is not permitted by [INSERT INSTITUTION NAME] Use if appropriate. Therefore, for this portion of the study you will not receive the incentive promised when you originally agreed to be a research subject. If you are still a research subject after you are released from prison, then you will once again receive incentives.
STUDY VISIT CHANGES:
In your original consent form we described all study visits occurring at____________. Based upon your status as a prisoner, study visits will now be conducted at ______________. [Outline any applicable changes to study visits such as changes in location, arrangements for transportation, or changes to the visit schedule.
[Note to Investigators: YOU MUST ENSURE THAT ALL CHANGES DESCRIBED HEREIN ARE APPROVED BY THE IRB AS PROTOCOL MODIFICATIONS!]
I have been provided with an opportunity to read this addendum to consent carefully. All of the questions that Ii wish to raise concerning this study have been answered.
By signing this consent form, I have not waived any of the legal rights or benefits, to which I otherwise would be entitled. My signature indicates that I freely consent to participate in this research study.
[INCLUDE LEGALLY AUTHORIZED REPRESENTATIVE LINES IF APPLICABLE]