The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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Message:

Research that involves human subjects must conform to the Common Rule.

Implication:
Juvenile justice professionals must recognize their obligation when youth and/or their families are the human subjects of research studies.

Human subjects involved in juvenile justice research must be protected from undue or unnecessary risks. These risks can be physical, psychological, social, economic, and/or legal. Researchers who use Federal funding to conduct research involving human subjects must adhere to the Federal regulations that ensure human subject protection. These regulations are known as the Common Rule. The Common Rule for the Department of Justice (Title 28 Part 46) protects human research subjects and establishes the essential rules that all juvenile justice professionals must follow when conducting Federally funded research activities. Federal regulations address protection of privacy and the assurance of confidentiality along with detailed procedures for establishing and operating an Institutional Review Board (IRB).

The Common Rule defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Research can be in the form of experiments, observational studies, surveys, tests, or the study of existing data. When youth are the focus of research, they are known as human subjects. A human subject is defined by the Common Rule as “a living individual about whom an investigator conducts research.” The investigator obtains data through:

· intervention or interaction with the individual; or
· access to identifiable private information.

Researchers who contribute to the knowledge base of juvenile delinquency rely on interventions, direct observations, and interactions with youthful offenders and, perhaps more often, on information gathered from the files and records of these youth. In many studies, the investigator has no direct contact with youth but, rather, obtains relevant data from existing juvenile offender records. Whether data are collected directly from youth or from existing paper or electronic files, both research methods focus on the “living individual.”

The essence of human subjects research is the “study of people.”
Juvenile Justice Researchers should refer to the diagram below to determine applicability of 28 CFR 46 to their research effort.


Adapted from: http://www.ojp.usdoj.gov/funding/pdfs/decision_tree.pdf

Additional decision trees that address IRB requirements of 28 CFR are available at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c2

Specific topic guidance for human subjects research is available at http://www.hhs.gov/ohrp/policy/index.html#topics


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