1. Familiarize yourself with ethical and regulatory requirements for human subjects research, as well as relevant institutional policies and procedures. These can be found on the IRB-HSBS and Human Research Protection Program websites.

2. Complete the PEERRS “Human Subjects Research Protections” course.

3. Consult with the IRB to ensure activities that meet the definition of human subjects research undergo IRB review and approval before initiated. Use the eResearch Regulatory Management system to prepare and submit your project to the IRB for approval or determination of exemption. Submit your application well before the time you expect to conduct your research.

4. Conduct research as described in your IRB-approved protocol. Use the approved versions of consent documents and recruitment materials found under the Documents tab in your eResearch application.

5. Perform or delegate to qualified individuals tasks that are necessary to carry out your study. Faculty advisors share responsibility for the ethical conduct of research and must provide support to junior investigators as they conduct their research.

6. Obtain and document informed consent unless the IRB has issued a waiver. Provide the participant with a copy of the consent document and retain a copy of the full consent document with signature for your records (when signed consent is required).

7. Minimize risks and protect subjects’ rights and welfare. This includes protections for subjects’ privacy and the confidentiality of their data. See tips for data management and security

8. Request approval for any proposed changes via an amendment. Use this tip sheet to prepare your amendment.

9. Report protocol deviations, subject complaints or other reportable events (Other Related Information or Occurrences), or adverse events involving risks to subjects.

10. Create and securely maintain accurate study records.