Human Subjects Research and Methodology
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Expires on Feb 19, 2024
Credit Offered
1 CME Credit
1 COP Credit

This activity discusses the importance of research in addiction medicine, including a description of applicable research designs. The activity will also describe the important components of human subjects protection in research such as the relevant federal regulations, informed consent process, responsible conduct of research, the importance of adverse event reporting, and the roles and responsibilities of the Institutional Review Board and the Data and Safety Monitoring Board.

Learning Objectives

At the end of this educational activity, the learner will be able to:

  • Describe research designs that are relevant to addiction medicine.
  • Explain the importance of federal regulations in preserving the rights of human subjects in research.
  • Describe the key components of the informed consent process.
  • Identify and define the Institutional Review Board’s (IRB) role in human subjects research.
  • Define adverse events and explain the importance of adverse event reporting in human subjects research.

Target Audience


Estimated Time to Complete

Estimated Duration: 1 hour
Begin Date: February 19, 2021
End Date: February 19, 2024

How to Earn Credit

After evaluating the program, participants will be provided with an opportunity to claim an hour of participation and print an official CME certificate (physicians) or certificate of participation (non-physicians) showing the event date and hours earned.


This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the American Psychiatric Association (APA). The APA is accredited by the ACCME to provide continuing medical education for physicians.

The American Psychiatric Association designates this live activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty and Planner Disclosures

  • Robert Schwartz, M.D., Medical Director/Senior Research Scientist, Friends Research Institute. Reports the following financial relationships with commercial interests: Consultant, Verily Life Sciences.
  • Frank Vocci, Ph.D., President/Senior Research Scientist, Friends Research Institute. Disclosures - Consultant: Takeda Pharmaceuticals, Lyndra Pharmaceuticals; Grant/Research: Braeburn Pharmaceuticals, NIH-funded clinical trial.
Program Planners
  • Adila Ibrahim, M.S., Research Associate, Friends Research Institute. Reports no financial relationships with commercial interests.
  • Sejal Patel, American Psychiatric Association. Reports no financial relationships with commercial interests.


  • Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet. 2017;390(10092):415-423. doi:10.1016/S0140-6736(16)31592-6
  • Hodge JG Jr., Gostin LO. Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations. JAMA. 2017;317(15):1521-1522. doi:10.1001/jama.2017.1633
  • Lewis RJ., Calis KA., DeMets DL. Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees. JAMA. 2016;316(22):2359-2360. doi:10.1001/jama.2016.16070

Accessibility for Participants with Disabilities

The American Psychiatric Association is committed to ensuring accessibility of its website to people with disabilities. If you have trouble accessing any of APA’s online resources, please contact us at 202-559-3900 for assistance.

Technical Requirements

This internet-based CME activity is best experienced using any of the following:

  • The latest and 2nd latest public versions of Google Chrome, Mozilla Firefox, or Safari
  • Internet Explorer 11+

This Web site requires that JavaScript and session cookies be enabled. Certain activities may require additional software to view multimedia, presentation, or printable versions of the content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Adobe Acrobat Reader, Microsoft PowerPoint, and Windows Media Player.

Optimal System Configuration:

  • Browser: Google Chrome (latest and 2nd latest version), Safari (latest and 2nd latest version), Internet Explorer 11.0+, Firefox (latest and 2nd latest version), or Microsoft Edge (latest and 2nd latest version)
  • Operating System: Windows versions 8.1+, Mac OS X 10.5 (Leopard) +, Android (latest and 2nd latest version), or iOS/iPad OS (latest and 2nd latest version)
  • Internet Connection: 1 Mbps or higher

Minimum Requirements:

  • Windows PC: Windows 8.1 or higher; 1 GB (for 32-bit)/2 GB (for 64-bit) or higher RAM; Microsoft DirectX 9 graphics device with WDDM driver; audio playback with speakers for programs with video content
  • Macintosh: Mac OS X 10.5 or higher with latest updates installed; Intel, PowerPC G5, or PowerPC G4 (867MHz or faster) processor; 512 MB or higher RAM; audio playback with speakers for programs with video content

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