Certificate in the Foundations of Human Subjects Protections
The Certificate in the Foundations of Human Subjects Protections provides an understanding of the ethical and regulatory basis of human subject protections. The PRIM&R educational programs that make up the certificate offer expert advice, real-life examples, and new strategies to enhance understanding of the field and supplement work experience and related knowledge.
Certificate 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:
- Intro to the IRB
- Exploring the Common Rule
- IRB Administrator Core Training
- PRIM&R's Ethical Research Oversight Course
- Participation at the following foundational conference:
- 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 subjects protections:
- One full-day preconference workshop or two half-day preconference workshops
- IRB Administrator Core Training
- 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.
Enrollment and Certificate 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. Only participation in program requirements for a period of two years prior to enrollment and three years after enrollment will count toward the completion of the certificate.
The program is free to PRIM&R members. Nonmembers pay a nominal enrollment fee of $49.
The program is free to PRIM&R members. Nonmembers pay a nominal enrollment fee of $49.
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.
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.