Research Subject Protection, Research Integrity and Corporate Ethics

Institutional Review Board (IRB) policies & resources

Roswell Park IRB policies and procedures are available on our intranet.

Single IRB review

The Single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all the institutions. 

The NIH Single IRB Policy and Common Rule Cooperative Research Requirement are the two policies that require the use of a Single IRB.

NIH Policy: Effective January 25, 2018: All competing NIH grant applications (new, renewal, revision or re-submission) for multi-site studies with NIH receipt dates on or after January 25, 2018. 

• Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program.  It does not apply to Foreign Sites, career development (K), research training (T) or fellowship awards (F) and current awards.
• Exceptions: VA sites; international sites; sites involving tribal nations.

Common Rule Requirement: Effective January 20, 2020: Federally funded projects, involving multiple research locations conducting human subjects research, with IRB approval dates on or after January 20, 2020, must use a sIRB. This is mandated by the Cooperative Research provision which expands upon and supersedes the NIH’s Single IRB policy. 

• Applies to: All sites in the United States participating in a federally funded cooperative research study (involves more than one site).
• Exceptions: Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or Research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

Single IRB may also be useful for multi-site/collaborative studies that are not federally funded but wish to use a Single IRB. 

For more information regarding IRB Requirements for federally funded, multi-site/collaborative research, or IRB Reliance Agreements, please contact IRBReliance@RoswellPark.org or Leonard Caruana at 716-845-8769.

Participant education resources

The federal Office for Human Research Protections (OHRP) offers a series of short videos with basic information about research.

Resources include:

• Becoming a Research Volunteer (English)
• Becoming a Research Volunteer (Spanish)
• Deciding Whether to Enroll in Gene Transfer Research?
• The Importance of Tissue Samples in Research
• The Treatment Development Process: The Role of Tissue
• What is Tissue? Why is it Important?
• Why is it Important For Me to Consider Donating my Tissue for Research?

Additional resources

Research terms and definitions:

• Abbreviations - Commonly used abbreviations related to research
• Glossary - Terms and definitions related to research
• Lay Terms - Commonly used terms for the informed consent document
• NCCN Informed Consent Language Database - Commonly used terms for the informed consent document

Key agencies and organizations:

• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• U.S. Food and Drug Administration (FDA) guidance documents
• National Institutes of Health (NIH)
• NIH Biosafety, Biosecurity, and Emerging Biotechnology Policy Division
• Office for Human Research Protections (OHRP) regulations
• Public Responsibility in Medicine and Research (PRIM&R)
• New York State Department of Health

Regulatory affairs

Our goal is to facilitate interactions with the United States Food and Drug Administration (FDA) to support clinical investigations where FDA regulations are applicable. Staff from the Office of Research Subject Protection serve as liaisons with FDA and work in conjunction with investigators to prepare and submit required regulatory applications. We provide the following support to investigators:

• Regulatory guidance to help in developing regulatory strategies prior to and throughout the clinical investigation.
• Communication with the FDA which includes meetings and submissions.
• Assistance in the preparation, filing, and maintenance of all applicable regulatory documents required for Investigational New Drugs (IND), Investigational Device Exemptions (IDE), Investigational Tobacco Products (ITP) and Single Patient Expanded Access applications for submission to FDA.

Accreditation

Our office has received accreditation from: