IRB
Conflict of Interest
Post Approval Monitoring
PRISM

Frequently Used Services

  • Getting Started
     

    Information on topics such as who may be a Principal Investigator, NYSPI IRB research review requirements, and serious adverse event reporting

  • Education and Training

    CITI training requirements for all persons involved in human subjects research design or conduct of the research.

 
  • Forms & Templates
     

    The consent form template, MRI Director approval form, serious adverse event form, protocol violation form, conflict of interest form, and many other forms and templates.

  • Links & External Resources
     

    Various resources such as links to Office of Human Research Protections, RFMH, FDA, Nathan Kline Institute, Office of Research Integrity, and CUMC.

  • FAQS
     

    Answers to questions regarding PRISM, protocol submission, serious adverse event reporting, CITI training, recruitment materials, and more.

News

January 21, 2019
New Common Rule Changes Implemented

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule).

The general compliance date for the Revised Common Rule is January 21, 2019. A number of NYSPI IRB policies, procedures, and systems will be updated as a result of the changes to the rule.

NYSPI IRB policies, procedures, and systems

Please see Guidance under the Investigator tab for further information about the updated federal regulations regarding human subject research protections. The Consent Form Template has also been revised and may be accessed under the Investigator tab then Consent.

Oct 17, 2017
Revisions to the Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule).

Oct 17, 2017
Good Clinical Practice Training Policy

NIH released a policy establishing the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6

Oct 17, 2017
Single IRB Policy

NIH has issued a policy “establishing the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board.”

Resources

Resources

  • Oct 10, 2017
    Certificate of Confidentiality Policy

    NIH now automatically issues Certificates of Confidentiality (CoCs) to all research funded by NIH that is collecting or using identifiable, sensitive information. New disclosure rules apply to everyone. Researchers not funded by HHS can continue to apply to NIH or the FDA as appropriate to request a CoC for HHS-mission relevant research.

  • Oct 10, 2017
    Multi-Site Trials Review

    In order to provide timely review for industry- or NIH-sponsored multisite trials that are especially time-sensitive, guidelines are provided to promote high quality submissions and help Investigators anticipate problems that typically arise in the review of such trials.

  • Oct 10, 2017
    CITI Training

    The Collaborative Institutional Training Initiative (CITI) Program provides online training for key personnel who are directly involved in conducting research with study participants or who are directly involved with handling private information related to study participants during the course of a research project.

  • Oct 10, 2017
    PRIM&R

    The Public Responsibility in Medicine and Research (PRIM&R) organization advances the highest ethical standards in the conduct of biomedical, behavioral, and social science research.

Events

Events

  • Oct 10, 2017
    Advancing Ethical Research Conference

    The annual Advancing Ethical Research Conference (AER), hosted by the PRIM&R organization, is a 3-day meeting where attendees will learn about ethical issues and the federal regulations governing human subjects research, best practices for the review and monitoring of research, changes to the Common Rule, and other timely and late-breaking topics to build and strengthen effective human subjects protections programs that oversee research.

  • Oct 10, 2017
    PRIM&R Webinars

    PRIM&R webinars offer information on important topics in the fields of human subjects protections and animal care and use. Webinars may be used to obtain continuing education (CE) credit from professional associations.