Human Subjects in Research
|POLICY TITLE:||Human Subjects in Research at Carnegie Mellon University|
|ACCOUNTABLE DEPARTMENT/UNIT:||Office of the Vice President for Research. Questions on policy content should be directed to the Assistant Vice Provost for Research Compliance, ext. 8-4727.|
|ABSTRACT:||The university is committed to the protection of the rights and welfare of human subjects in research investigations conducted under the jurisdiction of the university. All research involving human subjects is conducted in accordance with federal regulations.|
|FORMS AND RELATED INFORMATION:||See the Office of Research Integrity and Compliance website.|
The university is committed to the protection of the rights and welfare of human subjects in research investigations conducted under the jurisdiction of the university. The university believes that review independent of the investigator is necessary to safeguard the rights and welfare of human subjects of research investigations. All research involving human subjects is conducted in accordance with federal regulations, including Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46). Under federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
An Institutional Review Board (IRB) is established under the provost to ensure adequate safeguards. The provost is responsible for the composition of the IRB with respect to: (1) the qualifications of IRB members in terms of educational background and research or other relevant experience, and (2) broad representation of relevant university interests.
This IRB is responsible for reviewing investigational procedures involving human subjects prior to the initiation of the research procedure in reference to (1) the rights and welfare of the individuals involved, (2) the appropriateness of the methods used to obtain informed consent, and (3) the risks and potential benefits of the investigations. The IRB is responsible for determining when additional expertise is required for adequate review and for obtaining that additional expertise. The IRB is further responsible for maintaining records of its review activities and decisions and for ensuring that records of informed consent are developed and kept by investigators where appropriate.
It is the responsibility of investigators who plan to use human subjects in research to obtain written consent from the IRB prior to conducting an investigation involving human subjects. It is the investigator's further responsibility to take whatever steps are determined necessary for the protection of the subjects, and to meet the reporting requirements established by the IRB.