Resources

• Procedures and information about FWAs from OHRP
• Terms and conditions of the FWA for domestic institutions
• OHRP on-line FWA training for Signatory Officials and Human Protections Administrators
• NIH on-line Human Subjects Protections training
• DHHS guidance about engagement of institutions in research involving human subjects
• Yale University's Researchers’ Guide to HIPAA (Health Insurance Portability and Accountability Act of 1996) Handbook
• Yale University IRB Operations Manual
• Yale School of Medicine Human Investigation Committees
• Yale University Human Subjects Committee
• RA Application and Institutional Policy Template
• Belmont Report

Glossary of Acronyms

DHHS (U.S. Department of Health & Human Services)

FWA (Federalwide Assurance)
The FWA is an agreement between the organization and OHRP in which the organization commits itself to certain standards of conduct in research involving human subjects.
FAQs on Assurance

HIPAA (Health Insurance Portability and Accountability Act of 1996)

HIPAA Privacy Board
A committee formed within a HIPAA covered entity to review requests to waive authorization for access to protected health information for research purposes.

HPA (Human Protections Administrator)
An individual capable, both in experience and available resources, of overseeing and managing the day-to-day operations of the organization’s human subjects protection program. The HPA serves as the primary contact for OHRP regarding human subjects protection issues for the organization. The HPA exercises operational responsibility for the organization’s program for protecting human subjects in research. The HPA should have comprehensive knowledge of all aspects of the organization’s system of protections for human subjects, as well as be familiar with the organization’s commitments under the FWA, and play a key role in ensuring that the organization fulfills its responsibilities under the FWA. (DHHS, OHRP, “Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States”)

IAA (IRB Authorization Agreement)
If an organization relies on the IRB of another organization, the arrangement must be documented in writing between the two organizations. The agreement must be kept on file at both organizations and must be available for review by OHRP upon request. Yale’s IAA with an RA typically describes (1) the authority of the Yale IRB(s); (2) the responsibilities of the RA regarding human subjects protection education, training, policies, and reporting; (3) HIPAA (if applicable); and (4) the term of the IAA and the number of protocols to be reviewed.

IRB (Institutional Review Board)
A committee charged with responsibility to review proposed research in order to ensure that the rights of human subjects are protected and that risk of harm to subjects is minimized. Yale has four IRB committees:

• Two Human Investigation Committees (HIC I, HIC II) for the School of Medicine.
• The Human Subjects Committee (HSC) (serving the Faculty of Arts and Sciences and the Schools of Management, Forestry and Environmental Studies, Law, Divinity, Art, Architecture, Drama, and Music).
• The Human Subjects Research Review Committee (HSRRC) for the School of Nursing.

“IRB of record”
An IRB that assumes IRB responsibilities for another organization.

OHRP (Office for Human Research Protections)

RA (Research Affiliate)
In the context of human subjects research, a Yale Research Affiliate (RA) is an organization for which Yale has agreed to serve as the IRB of record.

SO (Signatory Official)
The Signatory Official must be a senior official who has the authority to commit the entire organization named in the FWA, as well as all of the components listed in the FWA, to a legally binding agreement.  The SO must also have the authority to assure compliance of the organization and all of its components to the Terms of the FWA. Generally, this is someone at the level of President, Chief Executive Officer (CEO), or Vice President of a company, or at the level of President, Provost, Chancellor, Vice President, or Dean of an academic institution, unless another official has been specifically delegated with this authority. Typically, the Signatory Official is not a department chair, division director, or another official who only has authority over a portion of the organization. (DHHS, OHRP, “Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States”)