Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to general knowledge. Activities that meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
SAR/RRC approval means the determination of the SAR/RRC is that the research has been reviewed and may be conducted at an institution within the constraints set forth by the SAR/RRC and by other institutional and federal requirements. Approval is provided for a single year. Projects continuing beyond a year need to reapply and provide a summary of the first year’s activities.
Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Key Criteria for SAR/RRC Approval
The SAR/RRC shall determine that all of the following requirements are satisfied in order to approve the research application:
- Risks to subjects are minimized:
- by using procedures that are consistent with sound research design and do not unnecessarily expose subjects to risks, and
- whenever appropriate, by using procedures already performed on the subjects for diagnostic or treatment purposes.
- Risks to the subjects must be reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected.
- Selection of subjects must be “equitable.”
- Informed consent must be obtained from each prospective subject or a legally authorized representative, (except in specified limited circumstances where waivers may be granted).
- Informed consent must be appropriately documented.
- Where appropriate, there must be adequate provision to protect the privacy of subjects and to maintain the confidentiality of data.
- Where subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards must be included to protect the rights and welfare of subjects. Such subjects include children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.