Certificate in the Foundations of Human Subjects Protections Overview

Completing the Certificate in the Foundations of Human Subjects Protections will provide those who participate an understanding of the ethical and regulatory basis of human subject protections. The program combines expert advice, real-life examples, and new strategies to enhance understanding of the field and to supplement an individual’s own work experience and related knowledge.


After completing a Certificate in the Foundations of Human Subjects Protections, recipients will be able to:

  • Describe the basic ethical principles that pertain to research with human subjects—respect for persons, beneficence, and justice—and analyze research protocols to determine whether they appropriately meet the obligations that stem from these principles.
  • Review proposed projects to determine whether the activity is research involving human subjects in accordance with the US Department of Health and Human Services regulations at 45 CFR 46.
  • Evaluate research protocols to identify and address issues related to the protection of human subjects in accordance with the regulatory criteria for approval at 45 CFR 46.111.
  • Delineate between institutional, state, local, and federal policies that may apply to research involving human subjects and understand best practices in applying specific policies to a given protocol.
  • Use this knowledge about ethical principles, regulatory requirements, and best practices to identify effective models for implementing the informed consent process.

Program Requirements

Program requirements are flexible to meet an individual’s interests and professional needs. All requirements must be completed within three years of enrollment.

Please note that a program can only count towards one requirement. For example, you may not use the same preconference program towards both the Introductory Course and the Elective requirements.

Core Requirements (must complete one from each box)

Elective Requirement (select one from the box)

Introductory Course:

Full-Day At Your Doorstep

Full-Day Preconference Program or Two Half-Day Preconference Programs

Full-Day Course at a PRIM&R Workshop or Boot Camp

Social, Behavioral, and Educational Research (SBER) Conference

Three PRIM&R webinars related to human subjects protections*

PRIM&R Workshop On Demand

Institutional Review Board (IRB) 101sm

Institutional Review Board (IRB) Administrator 101


Foundational Conference:


Expanded Virtual Meeting AER/SBER (2017, 2018, 2019)

*Webinars viewed live and webinars that are less than one year old count toward the elective requirement. Users should provide a certificate of attendance as proof of participation. Viewing PRIM&R webinars that are over one year old in the Knowledge Center will not count as an elective.

Participation in eligible programs and webinars that took place two years prior to the participants enrollment date may count toward the completion of the certificate. Participants must be able to provide documentation of attendance.

Participants are responsible for tracking their progress. Once all requirements are completed, participants submit the tracking form with copies of relevant certificates of attendance to PRIM&R.

After successful completion of the requirements has been verified, participants will receive a certificate documenting their accomplishment.

Enrollment and Cost

Enrollment in the program is required. Once enrolled, participants will receive a form that can be used to track their progress toward completion of the program requirements. They will also receive regular updates via email about upcoming programs that meet certificate requirements. All requirements must be completed within three years.

The program is free to PRIM&R members. Nonmembers pay a nominal enrollment fee of $49.

The Certificate in the Foundations of Human Subjects Protections is not a prerequisite to, nor does it count toward, eligibility for the Certified IRB Professional (CIP)® certification. Additionally, some position announcements state a requirement for CIP certification. This certificate DOES NOT fulfill that requirement, nor is it intended to demonstrate the same level of competency. Rather, it demonstrates a basic understanding of human subjects protections.