Foundations of Human Subjects Protections

Certificate in the Foundations of Human Subjects Protections

Obtaining 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 selection of PRIM&R educational programs that comprise the certificate 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.

Requirements

Participants are responsible for tracking their progress through the required educational programs on the form provided. Once all requirements are completed, participants submit the tracking form with copies of relevant certificates of attendance for verification. All requirements must be completed within three years of enrollment.

Program requirements are flexible to meet an individual’s interests and professional needs:
One of the following introductory courses: 

• Institutional Review Board (IRB) 101^sm.
• Institutional Review Board (IRB) Administrator 101.
• EROC.

One of the following foundational conferences:

• PRIM&R Annual Conference (at least two days of content related to human subjects protections)
•  Advancing Ethical Research Conference (in-person or virtually)

One of the following PRIM&R electives related to human subejcts protections:

• Full-day PRIM&R On Demand Live Workshop program.
• Full-day preconference/workshop program or two half-day preconference/workshop programs.
• Full-day couse at a workshop or boot camp.
• Social, Behavioral, and Educational Research (SBER) Conference.
• Three webinars. (For this requirement, the webinars must be viewed live or recorded webinars must be less than one year old at the time of viewing.) 

Objectives

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 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 US Department of Health and Human Services regulations.
• Evaluate research protocols to identify and address issues related to the protection of human subjects in accordance with regulatory criteria for approval.
• 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 to identify effective models for implementing the informed consent process.

Submit for Your Certificate

If you have enrolled in the program and have completed all the requirements, submit for your certificate by completing the online tracking form.

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.

Certificate vs. Certification

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.