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This section is designed to provide you with the basic keys to help get your IRB submission started.  Familiarizing yourself with these basics will ultimately save you time and reduce effort as you continue on with your study.

Getting Started

If you are wondering if you have to submit your study to the IRB for review, or if you need assistance in the preparation of your submission, this page is designed to help get you started. Familiarizing yourself with the points below will be helpful in facilitating the submission process.

How Do I Know If I Am Conducting Research With Human Subjects?

Research involving human subjects means any activity that either: 

  • Meets the DHHS definitions of "research" involving a "human subject" or 
  • Meets the FDA definitions of "clinical investigation" ("research") involving a "human subject

 *The OHRP provides a decision tree to assist in determining whether a study fits the criteria

Agency

Definition of Research*

Definition of Human Subject

DHHS

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

FDA

Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy individual or a patient. For research that evaluates the safety or effectiveness of a device, the definition includes a human on whom or on whose specimen an investigational device is used.  A subject may be in normal health or may have a medical condition or disease.

* The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part

The OHRP provides a decision tree to help you determine if an activity meets human research criteria: Chart 01: Is an Activity Human Subjects Research Covered by 45 CFR Part 46?

Exemption Criteria

Federal regulations recognize eight categories of research that are exempt from IRB review, listed below. For a full description of these categories, please visit the OHRP website.

The OHRP provides helpful decision trees to assist you in determining whether or not your reseach meets any of the exemption criteria:

  • Chart 02: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?
  • Chart 03: Does Exemption 45 CFR 46.104(d)(1) for Educational Practices Apply?
  • Chart 04: Does Exemption 45 CFR 46.104(d)(2) for Educational Tests, Surveys, Interviews, or Observation of Public Behavior Apply?
  • Chart 05: Does Exemption 45 CFR 46.104(d)(3) for Benign Behavioral Interventions Apply?
  • Chart 06: Does Exemption 45 CFR 46.104(d)(4) for Secondary Research that Does Not Require Consent Apply?
  • Chart 07: Does Exemption 45 CFR 46.104(d)(5) for Public Benefit or Service Programs Apply?
  • Chart 08: Does Exemption 45 CFR 46.104(d)(6) for Food Taste and Acceptance Studies Apply?

 

Does the NIH Single IRB (sIRB) Policy Apply To My Research?

If you are preparing an NIH application and your grant proposes use of asingle IRB for non-exempt multi-site research, please go to our webpage Single IRB (sIRB) Reliance.

The policy is applicable to new and competing renewal applications/proposals for NIH funding.  It is applicable to NIH-funded multi-site domestic studies involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

For more information on fulfilling the requirements of the NIH sIRB Policy, please read the NIH Single IRB Request Process document.

How do I know if my research is FDA-regulated?

Research involving fooddietary supplementsdrugs and biologics, medical devices and/or electronic products (that emit radiation) must adhere to the FDA regulations governing human subject protection and the conduct of ethical research. 

Please visit our FDA Research page for more information and how to determine whether or not your research is FDA-regulated. 

Research Team Roles and Responsibilities

Navigating the IRB review process and complying with federal regulations and institutional policy relating to human subjects protection can be challenging. The function of the IRB is to ensure investigators are meeting their primary responsibility to safeguard the rights and welfare of each research subject, and that the subjects' rights and welfare are taking precedence over the goals and requirements of the research.  At Weill Cornell Medicine, IRB review is required for both funded and non-funded human subjects research.

What Are the Eligibility Requirements for a Principal Investigator?

It is our Institutional policy that only those with whom the organization has or intends to have an ongoing employment or contractual relationship may serve as Principal Investigator (PI) on research projects submitted to the WCM IRB.  In practice, this means: 

  • the PI must be a faculty member with the rank of instructor or above; and
  • the PI must be properly credentialed by the facility at which the research is approved to take place; and
  • the PI must be employed (either full- or part-time) by WCM, and;
  • if the research involves the administration of a drug or use of a device for research purposes, the PI must be a licensed physician
  • Voluntary faculty cannot serve as PIs, but may serve as co-investigators

In addition, employees of New York Presbyterian Hospital/Weill Cornell Medicine (only pharmacists, nurses, dieticians) can serve as PIs on protocols, except clinical trials that include an intervention with human subjects. However, medical residents cannot serve as PIs, but may serve as co-investigators.

The PI assumes the responsibility of the whole of the research study, including any responsibility delegated to study coordinators and research teams.  The full scope of PI responsibilities is described in the Investigator Handbook.

What Is The Required Training for Researchers?

All PIs and research team members must complete the required training described on the Research Team Training and Education page before they can be included on a protocol submitted to the WCM IRB, and before they can submit in WRG-HS.  

I Am The Principal Investigator. What Are My Responsibilities and Expectations?

The full scope of the PI's responsibilities is outlined in a soon-to-be-published policy document, but can be summarized as follows:     

  • Selection of qualified individuals for roles on study team  
  • Complete knowledge of protocol, investigator's brochure(s), and consent form(s) 
  • Process for oversight of study team 
  • Process for monitoring subject safety and data collection 
  • Understanding of reporting obligations to funding sources, FDA (if applicable), and IRB 
  • Understanding of scope of responsibility for multi-site studies, PI-initiated studies, federally funded studies 
  • Understanding of federal, IRB, and institutional policies and regulations applicable to the research 

I Am Part Of The Research Team. What Are My Responsibilities and Expectations?

The research team plays an integral part in the administration of the research study.  It is therefore important that all members on a research team demonstrate:

  • Understanding of federal, IRB, and institutional regulations and policies applicable to the research
  • Appropriate knowledge (according to role) of the study's purpose(s), activities, risks, and benefits
  • Thorough understanding of the individual's role on the study and its relation to regulations and policies
  • Understanding of reporting obligations to the PI, IRB, and institution

BRANYplus

The WCM IRB has entered into a temporary partnership with the Biomedical Research Alliance of New York (BRANY), an independent IRB. This BRANYplusinitiative will go on through Spring 2022; thus, all new submissions from all departments must be submitted through BRANYplus.

We recently presented a TWIST on BRANYplus focusing on recent updates to submission processes, as well as an overview of the BRANYplus workflow. You can watch the recorded session here!

For more information on this initiative, and instructions on using BRANYplus, please visit BRANYplus online.

Project Guidance

Go to our Project Guidance page for information on the elements the IRB looks for when reviewing research protocols.

For guidance on preparing non-regulatory materials, the Joint Clinical Trials Office (JCTO) provides a JCTO Researcher's Toolbox to assist Researchers and Research Teams engaged in clinical research in the development of their research protocols.

Other Resources

Reminder: Informed Consent forms must be written in a way that is easily understandable by someone with an 8th grade reading level