The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
Home Before we begin Let's begin History of H.S. Protection Confidentiality of Secondary Youth Data Responsibility for Protecting Human Subjects Administration of the IRB
Research Juvenile Justice Site Map
Protecting Human Subjects from Harm
Human Subjects Research
Ethical Principles of the Belmont Report
The Institutional Review Board (IRB)
Protecting Human Subjects from Harm
The Consent Process
Privacy Protections
Related Laws


Human subjects must be protected from the risk of physical, psychological, social, economic, and legal harms.

Juvenile justice professionals must ensure that risks to youth are minimized even when certain risks are unavoidable.

Risks associated with research are often considered within the context of medical research. Compared to the potential dangers associated with research that exposes human subjects to experimental drugs and medical procedures, the potential risks to human subjects in juvenile justice research may seem insignificant to some researchers. Although juvenile justice research rarely exposes youth to the potential of physical harm, youth can be at risk for other types of harm.

The scenario below describes a proposed research study of juvenile sex offenders. What factors must the IRB consider when reviewing the investigator’s research proposal? The information that follows should help you with your decision.

Dr. Rogers is a psychiatrist and professor at a university medical school. He has submitted a research proposal for review to the university medical school IRB. Dr. Rogers is applying for a federally sponsored research grant. The subjects of the proposed research are first time, less serious, one-victim, adjudicated juvenile sex offenders who do not pose a threat to the community and who are ordered by the judge to participate in a 12-Step group treatment program for sex offenders. If funded, the research effort will provide these youth with individualized clinic-based and home-based counseling, interventions in addition to the existing 12-Step group treatment program.

The focus of human subject protection regulations is to ensure that the probability of harm, or risk, to research subjects as a result of their participation should be justified by the anticipated benefits to the subjects or to society. When the probability and magnitude of harm or discomfort anticipated in a study is not greater than risks ordinarily encountered in daily life, the research condition poses minimal risk to participants.

When developing research proposals and planning the research protocol, juvenile justice researchers must consider any potential risks to youth involved in the research as well as the anticipated benefits. The subjective assessment of potential risks and benefits is referred to as a risk/benefit analysis. Using the information from the analysis, researchers are responsible for making an ethical judgment about asking youth to accept any potential risks associated with the study. Federal regulations [28 CFR Part 46.111 (b)] on research involving vulnerable populations such as children, prisoners, and individuals with questionable mental capacity require additional safeguards to protect the rights and welfare of these subjects.

Typically, juvenile justice research involves sensitive information about youth. Procedures for collecting, maintaining, or releasing data can pose risks to youth and their families. Irresponsible and unethical disclosure of youth and family information to unauthorized persons can result in psychological, social, economic, and legal harms. Unfortunately, these potential non-physical risks are often too quickly dismissed or overlooked or, worse, not recognized. It is the responsibility of juvenile justice professionals to protect juveniles who are the subjects of research from harms, such as:
  • Anxiety and Apprehension
  • Embarrassment
  • Social Stigmas
  • Loss of Respect in the Community
  • Loss of Neighbors, Friends, and Family
  • Fear of Retaliation from Peers
  • Arrest and Prosecution
Researchers who gather information from and about juveniles must guard the privacy of youth and keep the information about them confidential. Within the context of juvenile justice research, privacy refers to youth and their willingness to share information about themselves with others. Private information is information about the behaviors of youth; behaviors that youth assume have not been witnessed by the researcher or other individuals. When juveniles willingly share private information with the researcher, they may rightfully expect this private information will not be made public or shared with family members, peers, or with school and legal authorities.

In human subjects research, private information is individually identifiable because the researcher can readily identify the research participant or associate the subject with specific information. Concerns about privacy are often associated with the methods that researchers utilize to obtain behavioral, emotional, intellectual, or physical information about research participants. An invasion of one’s privacy implies collecting private information about an individual without his or her permission.

While privacy refers to persons, confidentiality refers to data or information about the person and the agreements made about procedures that restrict information sharing with other individuals. A breach of confidentiality can occur when private information is mismanaged or protections are not in place to assure adequate protection from disclosure of information. Individually identifiable private information collected as part of a research study must remain confidential regardless of whether any potential harm can or cannot be identified. Under certain conditions, an invasion of privacy or breach of confidentiality can present a risk of serious harm to research participants. Information about sexual activity or drug and alcohol practices of youth, if disclosed by the researcher, can jeopardize the physical safety of youth or lead to their prosecution for unlawful behavior. Under Federal law and some state laws, researchers can obtain in advance a Certificate of Confidentiality that will provide protection against a subpoena for research data. In instances where the identities or data on research participants are sought by law enforcement agencies, sometimes under subpoena, the threat of punishment to the uncooperative researcher is eliminated.

The risks associated with juvenile justice research, even when unavoidable, can be minimized. While the likelihood of non-physical harms is more difficult to determine, necessary protections and safeguards to reduce their probability should be incorporated into the protocol when the research is being planned. These safeguards can include, but are not limited to:
  • Utilizing data collection and storage procedures that ensure confidentiality of youth information.
  • Providing potential participants with relevant information that enables them to comprehend what is involved in the study and to make a decision of whether or not to participate.The Consent Process.
  • Developing necessary procedures to assist participants who may experience negative outcomes (such as anxiety and embarrassment) from participating in the research study.
  • Carrying out a thorough risk/benefit analysis.
The IRB reviewing the research proposed by Dr. Rogers must carefully assess the risks and benefits of the study. The Board's discussion will include the factors outlined below and perhaps others that are not apparent from the short description of the research study described earlier in this section.

Identify the risks associated with the research.
No physical risks are expected.
Psychological harms in the form of guilt or embarrassment may result; however, Dr. Rogers anticipates these risks to be temporary and minimal.
No psychological, social, or economic harms are anticipated relative to invasion of privacy and confidentiality of records; youth data collection, analysis, and storage processes have built-in safeguards. Privacy Protections
The IRB will determine the level of risk remembering that the Common Rule regulations for research involving children requires additional safeguards to protect their rights and welfare.

Review the research design to determine if risks are minimized.
The IRB has detailed information about Dr. Roger’s credentials and clinical expertise and experience as well as the qualifications of the co-investigator and graduate students.
Data monitoring schedules are provided that detail collection, analysis, and storage.
Dr. Rogers provided the IRB with details of the safeguards designed to detect, prevent, and treat all potential harmful effects of study participation.

Assess anticipated benefits.
Dr. Rogers provided the IRB with details of the anticipated benefits to research subjects and to society; therapeutic benefits to youth, increased knowledge and understanding about youth sex offenders along with the relative importance of this information, and the probable decrease in community safety issues relative to the offense.

Determine that risks are reasonable in relation to anticipated benefits.
The IRB must make an ethical judgment based on the available information about risks and benefits of the proposed research study. Dr. Rogers submitted to the IRB the theoretical framework for the study and the results of a preliminary investigation with a similar population of youth. This information, along with specific youth benefits and expected knowledge gain, will be applied to the risk/benefit decision of the IRB.

Ensure disclosure of risks and benefits.
The IRB must assure that parents and youth are provided with an accurate description of potential risks and anticipated benefits and Federal guidelines for informed consent are upheld.

Monitor data and maintain privacy and confidentiality.
The IRB must determine the adequacy of provisions to protect youth privacy and to maintain confidentiality of youth data. Likewise, safeguards must be applied throughout the study that meet Common Rule regulations and special provisions for children.

Determine intervals of periodic review.
Based on the level of risk, the IRB will determine the appropriate interval to reevaluate the research study; continuing review may occur no less than one time per year. During the research study, unexpected results may occur or new knowledge may be gained; the IRB may need to reassess the risk/benefit ratio. With regards to new risk and benefit information, the IRB may require that the research design be altered or the project halted. On the other hand, initial precautions or safeguards may be relaxed. When changes in the risk/benefit ratio occur, the IRB must also determine whether new information should be provided to youth and parents; consent to participate is an on-going process.

Harm to human subjects is not limited to physical injury. Research participants are also at risk of psychological, social, economic, and legal harm.

OJJDP Home | NCJJ Home | National Juvenile Court Data Archive | Site Map