Criteria for Approval of Research
All of the following requirements must be met before research involving human subjects
can be approved.
- Risks to subjects are minimized by using procedures that are
consistent with sound research design and that do not unnecessarily expose
subjects to risk.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to the
subjects, and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable unless justified by the research
question and design. Particular attention should be paid to the special
problems of research involving vulnerable populations, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or educationally disadvantaged
persons.
- Informed consent will be sought from each prospective subject or his legally authorized
representative in accordance with official guidelines (see below). Information given to
subjects as part of informed consent must also conform to these guidelines. The
institutional review board may require that additional information be given if in its
judgment the information would meaningfully add to the protection of the rights and
welfare of the subjects.
- When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of the subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data. When some or all of the subjects are likely to be
vulnerable to coercion or undue influence, additional safeguards must be included to
protect the rights and welfare of those subjects.
- When appropriate, the application must include documentation of
approval to conduct research at other sites. For example, if a researcher
intends to carry out research at UD and at Wright State (or any other
institution), the researchers must apply to and receive approval from
Wright State. In situations where the research site is a school building
or another organization (e.g. a treatment center, or a grade school)
documented permission to conduct the research there must be included in
your application.
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● Informed Consent
