Prisoner Subject Worksheet (45 CFR 46 Subpart C)(To be completed by the PI)
Protocol No.______PI______
Study Title:______
√ / Categories of Research: Please designate the category that describes the involvement of prisoners in this research proposal.Research conducted or supported by DHHS may involve prisoners as subjects if the institution responsible certifies to the Secretary that the IRB has approved the research under §46.305
___ / 1. The research is minimal risk and no more than an inconvenience to subjects AND the research is a study of the possible causes, effects, and processes of incarceration and of criminal behavior. (45 CFR 36.306(a)(2)(i))
___ / 2. The research is minimal risk and no more than an inconvenience to subjects AND the research is a study of prisons as institutional structures or of prisoners as incarcerated persons (45 CFR 46.306(a)(2)(ii))
___ / 3.The research is a study on conditions particularly affecting prisoners as a class (ie. Research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) (45 CFR 46.306(a)(2)(iii)). May proceed only after approval by the Secretary (through OHRP)
Requires consult by the Secretary and publication in the FEDERAL REGISTER
___ / 4. The research is a study on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health and well being of the subject. (45 CFR 46.306 (a)(2)(iv)).
a. Will the study require assignment of prisoners to control groups?
______Yes ______No
b. If Yes, will the control group benefit from the research?
______Yes ______No
May proceed only after approval by the Secretary (through OHRP)
Requires consult by the Secretary and publication in the FEDERAL REGISTER
___ / The study does not involve research under categories 1-4 above. (45 CFR 46.306 (b)). If yes, the research is not permissible under federal Regulations. This research may not be conducted.
1. Is this research supported by DHHS? (Upon IRB approval of the research, the IRB will send a certified letter to the OHRP, for final approval. The OHRP must approve all DHHS research involving prisoners)
_____Yes _____No
2. Does the research present no more than minimal risk and no more than inconvenience to the subjects?
_____Yes ______No
Explain:
3. Are there any possible advantages accruing to the prisoner through his/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) that are of such a magnitude that his or her ability to weigh the risk of the research against the value of such advantages in the limited choice environment of the prison is impaired?
______Yes ______No
Explain:
4. Are the procedures for the selection of subjects within the prison fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners?
______Yes______No
Explain:
5. If control groups will be used, will the control subjects be randomly selected?
_____Yes ______No ______N/A
Explain:
6. Are the risks commensurate with risks that would be accepted by non-prisoner volunteers?
______Yes______No
Explain:
7. Is the information presented in language understandable to the subject population?
______Yes ____No
Explain:
8. State how you will assure that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole?
Explain:
9. Is each prisoner clearly informed in advance that participation in the research will have no effect on his or her parole? (This must be stated in the consent form)
______Yes ____No
Explain:
10. When the research requires follow-up beyond the period of incarceration, have provisions been made for locating the individual?
_____Yes ______No ______N/A
Explain:
11. Are participants informed of how follow up will take place if such is required?
_____Yes______No
Explain:
______
Principal Investigator’s Signature Date