Ensuring safe and ethical research practices
The Office of Research Subject Protection and Corporate Ethics supports Roswell Park’s mission of eliminating cancer’s grip on humanity:
- Promoting and advancing a culture of corporate ethics that fosters ethical behavior – acting in ways consistent with one’s personal values and the values of Roswell Park.
- Advancing responsible and ethical research practices, to ensure that the rights, dignity and welfare of all research subjects are protected.
- Minimizing the risks associated with such endeavors in accordance with the Belmont Report, FDA, OHRP, USDA, OLAW, NIH, and OBA by providing oversight, education and monitoring.
- Promoting and advocating for research subjects, especially those who are vulnerable and/or susceptible to manipulation and exploitation.
- Fostering a culture of compliance oversight for protection of research subjects and enhancing protections for those in research studies.
Our office provides education for investigators, research and administrative staff, and board members including but not limited to:
- Human Subject Protection Training (Citi Course)
- IACUC Training (AALAS Course)
- Biosafety Training
- IRB Advisor
- Journal of Empirical Research on Human Research Ethics
Institutional Review Board (IRB) policies & resources
Additional 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 thar 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.
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 specifically for Roswell Park patients 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?
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
Research Subject Protection committees
The Conflict of Interest Committee (COIC) is a permanent committee arising out of the Roswell Park's policy and state and federal law requirements for the management, reduction and/or elimination of conflicts of interest for Roswell faculty and staff.
COIC members are charged with:
- Reviewing disclosures to determine if a conflict at an individual or institutional level exists that could bias the research we do.
- Advising on methods of compliance for the recording and maintenance of conflict of interest/time commitment records.
- Assessing the compliance status of research-related components for apparent conflicts of interest.
- Assisting in the management, elimination, and/or reduction of any conflicts of interest or time commitment of any faculty or unclassified staff which are disclosed or otherwise known.
- Advising on actions/sanctions necessary to resolve conflicts of interest to comply with federal, state, and Roswell Park policies.
- Serving as a resource to faculty and staff regarding possible perceived or potential conflicts of interest related to their research.
The Roswell Park Comprehensive Cancer Center Ethics Committees promote integrity and strive for clarity in the midst of what can be complex and confusing ethical situations.
- Respond to requests for help to resolve ethical conflicts, issues, or questions involving patient care.
- Provide assistance with practical interpretation of ethical standards and applicable law.
- Act as an advisory and resource to patients, family members or health professionals to address ethical questions using appropriate ethical standards and values.
- Provide appropriate ethical recommendations while promoting responsible conduct in sensitive matters.
- Facilitate discussion, analysis and understanding of ethical issues in patient care and research involving human subjects, and provide ethically appropriate recommendations for solving problems arising in health care practice and research.
- Promote and improve knowledge of principles of scientific and research ethics in order to facilitate the responsible conduct of science.
- Develop and recommend guidelines and/or mechanisms for internal controls for any scientific test/invention that is to be further developed or promoted outside the laboratory.
- Adopt industry guidelines and recommendations for keeping and maintaining research data, lab notebooks, etc.
- Reinforce through education the concept of and regulations that define scientific integrity to all Institute investigators, technicians, as well as pre and post doctoral students.
- Strengthen our Institute mechanism to facilitate reporting of questions or concerns regarding any aspect of science including potential scientific misconduct without fear of repercussion.
The primary reason for needing animals for research at Roswell is to gain the scientific, medical and surgical knowledge necessary for the improvement of health and well-being of cancer patients, and to prolong their life by conducting research to prevent, treat and someday cure cancer.
The Institute Animal Care and Use Committee (IACUC) is a group of representatives from the scientific community, Radiation Safety, Environmental Safety, Laboratory Animal Resources, University at Buffalo (UB), and the community members to represent the views of the general public.
The IACUC is committed to:
- The humane and ethical treatment of all animals needed in research, teaching or toxicity testing.
- Reviewing all requests for appropriate use of animals in research Inspecting all facilities where animals are held or procedures are performed at least once every six months.
- Oversight for the Roswell Park program for humane care and use of animals including facilities, training, and all policies.
- Reviewing investigating and providing resolution for all concerns involving the care and use of animals at Roswell Park resulting from public complaints or reports of noncompliance by personnel.
The Institute Biosafety Committee (IBC) is comprised of representatives from the scientific community, Radiation Safety, Environmental Safety, Employee Health Services, Laboratory Animal Resources and the community members to represent the views of the general public.
The IBC is responsible for:
- Reviewing all research protocols involving recombinant DNA, infectious agents and carcinogens Setting the required level of safety for research using biohazardous materials.
- Ensuring that all research is conducted under the NIH Guidelines for Research Involving Recombinant DNA Models.
- Conducting periodic reviews and laboratory inspections to ensure compliance.
- Formulating emergency plans covering accidental spills and personnel contamination by recombinant agents, as developed and recommended by the Office of Environmental Safety.
- Reporting significant problems or accidents and violations of the NIH Guidelines to NIH’s Office of Biotechnology Activities.
The Institutional Review Board (IRB) at Roswell Park is a convened group of physicians, scientists and members of the community dedicated to advancing responsible and ethical research practices and to ensure that the rights, dignity and welfare of human subjects are protected. A full explanation of when research activities may require IRB review can be found here.
The IRB at Roswell is committed to:
- Minimizing the risks associated with such research related endeavors in accordance with the Belmont Report and the Common Rule, by providing oversight, education and monitoring.
- Promoting and advocating for human rights of research subjects, especially those who are vulnerable and/or susceptible to manipulation and exploitation.
- Providing leadership on human research subject protections.
- Fostering a culture of compliance oversight for protection of human subjects and enhancing protections for those in research studies.
- Providing education for investigators, research and administrative staff, and board members.
The Stem Cell Research Oversight (SCRO) Committee is comprised of members from Roswell Park, the University at Buffalo, and community members to represent the views of the general public.
The UB /Roswell SCRO committee is committed to:
- Maintaining the highest ethical standards in research.
- Permitting and encouraging qualified investigators to engage in appropriate, responsible and ethical research.
- Reviewing and approving research applications requiring the use of human stem cells.
- Reviewing and implementing training in the field of stem cell research and ethics.
- Ensuring that all stem cells are obtained, and research conducted with appropriate oversight and in accordance with applicable laws, rules and regulations.