Compliance

Compliance refers to investigators’ obligation to abide by federal, state, and local requirements when seeking approval to conduct research with human subjects and when conducting research. Investigators are accountable to ensure that all applicable laws and regulations are adhered to, so that participants and the institution are protected from harm. Failure to comply with the terms and conditions of an approved protocol can result in the suspension of the investigator’s research and possibly the suspension of all human subjects research at the investigator’s institution.

Federal regulations require that federally funded research involving human subjects undergo a review for ethical propriety by an institutional review board (IRB). Most institutions where research is conducted require that all human subjects research be reviewed by an IRB, whether or not it is federally funded. An investigator is required to provide complete and accurate information regarding the study’s aims, the proposed methodology, and any potential risks to participants. The investigator’s qualifications are submitted as truthful evidence to conduct the research. When the IRB approves the protocol, the investigator agrees to comply with federal and IRB conditions.

Data collection cannot begin until the IRB has approved the research. Even if the research qualifies for an exemption because it involves certain categories of people (e.g., political officials), it [Page 335]must still be reviewed and approved by the IRB. Once the research has been approved, investigators agree to several stipulations. For example, they agree to obtain and maintain informed consent from all participants.

Consent may be provided on paper or in an electronic format and must be available for inspection by the institution or by federal regulatory agencies. In addition, investigators agree to conduct the research as proposed and to not change anything without IRB review and approval. Changes to an approved protocol require that the investigator submit a request for an amendment or modification to the study, and when the request has been evaluated and approved by the IRB, changes may be made.

During the course of the research, investigators agree to provide progress reports to the IRB and to submit periodic (typically annual) applications to obtain renewed approval for the study. If adverse events occur, such as participant injury or a breach of security or confidentiality, investigators should report the event to the IRB immediately. The IRB then evaluates the event to decide if adjustments to the protocol must be made or if the research must be suspended or ended. The investigator agrees to comply with all IRB decisions in this regard. Finally, the investigator agrees to cease data collection when the approved period for data collection has expired.

Failure to comply with any of these requirements may result in a suspension of the investigator’s authorization to conduct future research with human subjects. Because the consequences of noncompliance are serious and potentially severe, it behooves investigators to understand and comply with all research regulations.