/ Addendum PResearch Involving Prisoners
Jacksonville – IRB-03
Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”.

Study Title:

You have indicated that you wish to include prisoners in this project. Prisoners may only be involved in research if all of the following conditions are met:

DEFINITIONS:

Prisoner means any individual involuntarily confined or detained in a penal institution, including 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, and individuals detained pending arraignment, trial, or sentencing. [45 CFR §46.303(d)]

The term prisoner is intended to encompass 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, and individuals detained pending arraignment, trial, or sentencing. This includes situations where a human participant becomes a prisoner after the research has commenced.

Minimal risk means that 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.

1. Explain why it is important to enroll prisoners in this project:

2. Describe the additional safeguards that are included in the study to (a) protect the rights and welfare of prisoners, and (b) to minimize any coercion or undue influence that could affect prisoners ability to voluntarily decide whether or not to participate in the research. For example: obtaining independent assessments by a non-study physician, using flyers to recruit rather than directly approaching prisoners, employing a consent monitor and/or consent advocate, prorating or calibrating payments to minimize influence, etc).

3. Is this protocol sponsored by DHHS (Department of Health and Human Services), including NIH (National Health Institute) and NCI (National Cancer Institute)?

No. Do not answer any further questions.

Yes. Research that is sponsored by DHHS or other offices within DHHS has strict requirements governing the inclusion of prisoners in the research. You must comply with all of the following requirements before you can include prisoners in sponsored research. Answer all remaining questions on this form.

Inclusion of Prisoners in Federally Funded Research

4. Does participating in the research offer the prisoner any possible advantages that are of sufficient magnitude to affect his or her ability to decide whether or not to participate in the research? Compare the advantages of the study to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison. Assess if this will affect the prisoner’s ability to objectively weigh the risks of the research against the value of the advantages in the limited choice environment of the prison.

Yes. Prisoners cannot be included in the project.

No. Justify:

5. Are the risks involved in the research commensurate with the risks that would be accepted by non-prisoner volunteers?

No – risks to prisoners may be greater than what nonprisoner volunteers would agree to. Prisoners cannot be included in the project.

Yes. Explain:

6. Are the procedures used to selectsubjects within the prison fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners? Control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project unless the principal investigator provides to the Board justification in writing for following some other procedures,

No. Prisoners cannot be included in the project.

Yes. Explain:

7. Is the information about the research presented in language which is understandable to the subject population?

No. Prisoners cannot be included in the project.

Yes. Explain:

8. Is there adequate assurance that parole boards will not take into account a prisoner's participation in the research when making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole?

No. Prisoners cannot be included in the project.

Yes. Explain:

9. Is there any need to provide follow-up exams or care to participants after the end of their participation?

No. Go to Question 9.

Yes. (a) Describe what provisions are in place to provide these exams or care, taking into account the varying lengths of individual prisoners' sentences:

(b)Describe how participants are informed of follow-up examinations and care:.

10. Which of the following categories do you believe justifies your inclusion of prisoners? CHECK ONE.

Note 1: Your inclusion of prisoners under any category must be reviewed and approved by the Secretary of DHHS.

Note 2: You may attach documentation that provides a justification for the category you select in place of typing a detailed answer in the field provided. If you elect to do this please indicate in the justification field to “See attached documentation”, provide the title or description of the attachment, and include the attachment immediately after this addendum for easy reference by the reviewer.

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 and no more than inconvenience to the subjects. Justify:

b. Study 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. Justify:

c. 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) provided that the study may proceed only after the DHHS Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the FEDERAL REGISTER, of his intent to approve such research.Justify:

d. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. 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 DHHS Secretary 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. Justify:

Addendum P: PrisonersPage 1 of 2

IRB Version: 11/24/2009

PI Version: