IRB: Human Subjects Research

What is Human Subjects Research?

The federal regulations (45 CFR 46.102(d)(f)) define research as a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge on a living individual”. It further defines a living individual to include their “identifiable biospecimens and protected health information (PHI)”. Federal privacy regulations have additional requirements for research on deceased individuals’ PHI.

Human Subjects Research is sponsored and/or funded by a variety of entities, examples include but not limited to pharmaceutical companies, federal agencies, and institutions. People participate in research for a variety of reasons, such as gaining access to new treatments or contributing to scientific progress. If you are asked to take part in research, it is important to think carefully and consider your decision. Use the resources below to learn more about the informed consent process, the research review process, and resources available to you as a research participant.

Research involving human subjects research is regulated by federal agencies, such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP). Before a research study can begin, it must be approved by an Institutional Review Board (IRB)/Privacy Board (PB) to ensure safety and privacy protections for participants.

An Institutional Review Board (IRB) is a committee established to ensure that all human subject research is conducted in accordance with all federal, institutional, and ethical guidelines and regulations ensuring the protection of human subjects rights and welfare.

A Privacy Board (PB) is governed by the privacy regulations (i.e., HIPAA) set forth by the Office of Civil Rights. The purpose is to ensure research meets these requirements and proper review for authorization is in place for protection of participant data.

Several ethical principles for Human Subjects Research (The Belmont Report) were established to guide both researchers and IRBs. There are 3 ethical principles outlined in The Belmont Report, defined as follows:

The IRB ensures that the research meets criteria set by the FDA and OHRP and follows ethical principles, such as those outlined in the Belmont Report. To approve research, the IRB checks that all requirements are met, including:

The below are different types of reviews the IRB/PB carries out to ensure the above approval criteria are met and that there is ongoing oversight of the research once approved and opened to accrual:

• New Protocol and consent form(s)
• Amendments to approved research
• Continuing Review Reports for re-approval
• Single Patient Uses
• Non-Protocol Specific Advertisements
• Serious Adverse Events (SAEs)/ Unanticipated Problems (UPs) and Non- Compliance Reporting

Learn more about Institutional Review Boards here

What is the Informed Consent Process?

Before joining a research study, you may be asked to sign an informed consent form. This document ensures you understand the study and agree to participate. The consent form will explain the following, but not limited to:

• Why the study is being conducted
• The standard treatment or care options (if applicable)
• Possible risks and benefits
• What is required from you during the study
• Available alternatives if you do not participate
• Costs of participation
• How your personal data will be protected

Informed consent is an ongoing process to make sure you have all the information you need and the opportunity to ask questions at any time during your participation. Any new pertinent information added to the study with be presented to you for consideration on continued participation. You can withdraw from the study at any time without penalty. If you decide to withdraw, the research team will work with you to ensure your safety are monitored, as appropriate.

• Learn more about the Informed Consent Process here
• Questions to Ask During Informed Consent
• Common Terms in Research Consent Forms

What is the Clinical Research Review Process at MSK?

MSK is an NCI-designated cancer center, a distinction associated with the NCI P30 Cancer Center Support Grant. Through this program, the NCI recognizes centers around the country that meet rigorous standards for transdisciplinary, state-of-the-art research focused on developing new and better approaches to preventing, diagnosing, and treating cancer.

Before a research study can begin at MSK, it must go through several review steps. In addition to the IRB/PB, several other committees may have to review and approve the research prior to activating in our clinics. It is important to know that there are a lot of scientists, non-scientists and community members reviewing the research opened at MSK.

Departmental Review

Research proposals are first reviewed by the department or program associated with the study. Each department or program has its own committee that reviews and approves research submitted by its members and other involved departments. These committees focus on disease-and discipline-specific issues.

Research Council Review

MSK has two research councils, which serve as the scientific review committees. These councils assess the scientific design, feasibility, and alignment of the study with MSK’s goals. The councils ensure that the study is scientifically sound, appropriately designed, and complementary to other ongoing clinical trials. One of the councils specializes in minimal risk studies. The Research Council does not review protocols sponsored by the NCI, National Clinical Trials Network (NCTN Cooperative Group) mechanism as that is done by those organizations.

Advisory Committee Review

Some studies may undergo review by additional regulatory committees that focus on special concerns, like radiation or experimental drugs. These committees include:

• Committee on Radiation (COR): reviews studies involving added radiation exposure and focuses on the safety of the study related to the radioactive materials and radiation exposure.
• Investigational Drugs and Device Committee (INDC): reviews studies developed by an MSK investigator that uses an FDA approved drug or device, or an FDA approved product being used for an unapproved indication in a manner.
• Institutional Biosafety Committee (IBC): reviews studies using recombinant or synthetic DNA research to ensure basic and clinical recombinant DNA research is conducted in accordance with responsible research practices for the safety of personnel and the environment.
• Radioactive Drug Research Committee (RDRC): reviews studies using radioactive drugs in humans without an IND and is federally regulated by the FDA under 21 CFR 361.1.

Institutional Review Board/Privacy Board

MSK has three IRBs that review research studies involving human participants. Depending on funding and sponsorship, clinical research activated at MSK may be reviewed by our MSK IRB/PB or by an outside IRB/PB. As noted earlier, regardless of which IRB reviews and approves the research for MSK, we are all beholden to follow the regulations and ethical principles that guide human subjects research.

Learn more about MSK’s IRB/PB here.

What Groups are Managing the Research Review Process at MSK?

The Clinical Research Administration office supports our clinical research portfolio. Within the department the Protocol Activation, Review, and Human Research Protection Program (HRPP) unit oversees the clinical research review and components of the ongoing monitoring process at MSK. It consists of three groups:

What happens to a study after it is opened to accrual?

Ongoing Monitoring of Research Studies at MSK

At MSK, once a study is open and enrolling patients, it is carefully monitored to ensure it runs smoothly, safely, and ethically. Several teams oversee different aspects of the study to ensure compliance and participant protection, including:

• Ethical Review: The IRBs review and re-approve studies at least annually, must approve any requested changes made to the research plan, and ensure any issues related to participate safety and rights are addressed promptly.
• Scientific Review: the Research Councils review requested major changes to a study’s design or changes that could affect the previously approved scientific plan.
• Performance Monitoring: the Performance Monitoring Committee checks whether the study is meeting enrollment and completion goals. They check studies regularly to identify any that are falling behind and work to get them back on track or close.
• Data and Safety Monitoring: Three DSM committees oversee primarily MSK-sponsored studies to ensure safety, data integrity, and compliance.
• Audit Program: Internal auditors can audit any study at MSK to assess adherence, regulatory and policy compliance, protection of human research subjects, and data integrity. This ensures compliance with institutional policies, ICH GCP Guidelines, and federal regulations, and helps support efficient and effective clinical research operations.
• Monitoring Program: internal monitors focus on reviewing studies where MSK is the sponsor, especially those that involve investigational new drugs or devices.
• External auditors/monitors: if clinical research is externally sponsored, the outside entity will have their own audit/monitoring programs to ensure participant safety, regulatory compliance and ongoing monitoring.

About the MSK Institutional Review Board/Privacy Board

All research involving human subjects must be reviewed and approved by the IRB/PB prior to implementation. The MSK IRB has robust Standard Operating Procedures (SOPs) to ensure full compliance and is continuously working with the MSK HRPP Office on improving workflows for greater efficiency and overall quality.

MSK has three Institutional Review Boards/Privacy Boards (IRB/PB) that are responsible for protecting the rights and welfare of human research participants in accordance with the federal regulations and internal standard operating procedures. As noted earlier, research may be reviewed and approved by an outside IRB/PB, instead of MSK’s.

MSK has a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) to certify compliance with the federal regulations. The MSK IRB and HRPP is also accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

At MSK the Institutional Review Board/Privacy Board (IRB/PB) is a committee consisting of a physicians, nurses, non-scientific advisors and non-affiliated members of our community. The Board can only conduct a meeting when the majority of the members are present. Their main responsibility is to ensure the protection of the rights and welfare of everyone who participates in a research study at our institution.

Resources for Sites Relying on MSK IRB

The Standard Working Procedure for Relying on MSK IRB guidance describes the processes and regulatory requirements for sites relying on MSK IRB to ensure compliance with MSK institutional guidelines. The SWP includes a list of MSK IRB/SOPs that sites relying on MSK IRB must follow which are located here.

Accreditation of MSK’s Human Subjects Protection Program

MSK was awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) on December 19, 2016, Full Reaccreditation on December 16, 2019 and again in December 2024. The next reaccreditation cycle is in 2029.

To earn AAHRPP accreditation, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to high standards for research. MSK is one of many national and international organizations earning full accreditation status from AAHRPP.

Learn more about AAHRPP:

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an international, independent nonprofit organization that reviews and accredits an institution’s human research protection program (HRPP). More information on AAHRPP is available at www.aahrpp.org.

Why get AAHRPP accreditation?

The primary purpose of AAHRPP accreditation is to improve systems that protect the rights and welfare of research participants and to promote excellent, ethically sound research. Accreditation benefits research organizations, participants, and the overall research enterprise. The accreditation process requires organizations to take a comprehensive look at their Human Research Protection Programs (HRPPs). The result is improved human research protections program, research compliance, and fosters alliances with accredited organizations.

How does an institution get accredited?

Accreditation standards are based on the regulations, GCP, and HRPP best practices. AAHRPP standards apply to the organization, the IRB, the researcher, and research staff. To get accredited, a site must demonstrate its commitment to ethical scientific and scholarly research and to continuous quality improvement.

For any questions about the MSK IRB/PB, contact us:

Institutional Review Board/Privacy Board (IRB/PB)
Memorial Sloan Kettering Cancer Center
1275 York Avenue
New York, NY 10065
IRB/PB Main Number: 212-639-7592
IRB/PB Main Email: [email protected]

Additional Resources to help you find a clinical trial:

• Click here to learn what you need to know about clinical trials at MSK
• Click here to search the listing of MSK clinical trials
• Click here to find NIH-supported clinical trials
• Click here to find an NCI-supported clinical trial
• Click here for a searchable registry of federally and privately supported clinical trials

Additional resources related to being a research participant at MSK:

• Click here for the contact information to reach a patient representative.
• Click here for help with language and communication, such as interpreter or translator
• Click here to learn about our privacy practices
• Click here to learn more about your rights as a patient here.