PA-ETH 6: Research Protections
Interpretation: All research involving service recipients is conducted in accordance with applicable legal requirements. For purposes of PA ETH 6, research includes all forms of internal or external research involving service recipients, except internal program evaluation and outcomes research, and educational projects carried out by students and interns as part of their professional training.
Agencies serving children and youth who are wards of the state are advised to consult Code of Federal Regulations 45 CFR § 46.4.09 and 21 CFR § 50.56. These regulations specify who can participate in research and that an advocate must be appointed for each participating child.
NA The agency does not permit research involving service recipients.
The identity and privacy of participants is safeguarded in all phases of research conducted by, or with the cooperation of, the agency.
Statistical analyses, reports, and summaries are compiled and presented in a manner that masks the identity of the research participants. Case
examples from individual case records
must be prepared, prior to dissemination, in a manner that masks the individual’s identity.
The agency has a mechanism to review research proposals involving service recipients, such as a human subjects committee or an internal review board, that reports to the agency head or senior management.
The committee makes recommendations regarding the ethics
of proposed or existing research, decides whether or not to approve research proposals, and monitors ongoing research activities.
Research participants, or a parent or legal guardian, sign a consent form that includes:
- a statement that he or she voluntarily agrees to participate;
- a statement that the agency will continue to provide services whether or not he or she agrees to participate;
- an explanation of the nature and purpose of the research;
- a clear description of possible risks or discomfort; and
- a guarantee of confidentiality.