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.
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.
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
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
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:
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.
- Anxiety and Apprehension
- Social Stigmas
- Loss of Respect in the Community
- Loss of Neighbors, Friends, and Family
- Fear of Retaliation from Peers
- Arrest and Prosecution
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:
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.
- 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
- 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.
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
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.
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
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,
Dr. Rogers provided the IRB with details of the safeguards designed
to detect, prevent, and treat all potential harmful effects of study
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
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.
to human subjects is not limited to physical injury. Research participants
are also at risk of psychological, social, economic, and legal harm.