Question

Yes

No

Other

7.

Medical research–therapeutic studies of diseases for which there is an established standard of care (e.g., new asthma medications)

14

26

1/case by case

1/yes–noa

8.

Biomedical studies of a nontherapeutic nature, including studies that involve exposure to a biological or chemical agent to assess the effects on and reactions of humans (e.g., effects of cosmetic or cleaning agents on skin)

3

38

1/not likely

9.

If you answered “no” to any of the questions above, is it the case that some of these types of research are explicitly prohibited by your DOC policy or by legislation?

Answer the following questions only if at least one of the types of research described above is permitted in your DOC.

To ensure the safety of research subjects, in many research settings any study that involves human beings as research participants must be evaluated and approved by an institutional review board (IRB) before the study can commence. Please answer each of the questions below regarding IRB nvolvement in research at your organization.

31

8

3/NA

10.

Does your DOC require IRB approval before research can commence?

29

10

3/NA

11a.

Does your DOC have its own IRB within the organization?

13

26

3/NA

11b.

If you answered yes to Question 11a, are there prisoner representatives on the DOC’s IRB?

5

13

24/NA

12.

Does your DOC have an adverse events reporting process or procedure?

18

20

4/NA

NOTE: DOC, Department of Corrections; IRB, institutional review board; NA, not applicable; GED, General Education Development (tests); PTSD, post-traumatic stress disorder.

aVermont stated that the DOC is part of an umbrella Agency of Human Services (AHS). The AHS operates an IRB for review of all research, including DOC-related studies. No research involving minimal or greater risk to participants may proceed without IRB approval.

bOnly with IRB approval.



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