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.

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—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.

Core Requirements

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Electives

Participation in one of the following:

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.