This section is designed to provide you with the basic information 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.
NOTE: If you are considering conducting research on data or specimens from deceased people, please contact the Privacy Office at privacy@med.cornell.edu.
Projects that meet the definition of human subjects research require submission to the IRB. We do not recommend investigators make their own determination of whether or not their activities are exempt from IRB review and oversight, or if their study should receive a not human subjects research (NHSR) determination. If an investigator fails to obtain a research determination prior to implementing activities and those activities require IRB review and oversight, they are liable for noncompliance!
Investigators are frequently unsure of whether their project meets the definition of human subjects research, requiring IRB review and oversight. Some projects that cause uncertainty are:
If you are uncertain about whether or not your proposed activities meet the definition of human subjects research, reach out to us for a quick consultation.
Many activities fail to meet the definition of research and therefore do not require IRB review and approval. Most case reports and much of Quality Improvement (QI) activities that take place do not meet the definition of research; however, only the IRB may make the determination that your activities do not involve research and therefore do not fall under the IRB's purview.
HHS regulations (45 CFR 46.102(d)) define research as:
A systematic* investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purpose of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.
*Systematic means that the activity follows a written plan and adheres to scientifically accepted principles for research design.
FDA regulations (21 CFR 53.102(c)) define the term, clinical investigation or research, as:
Any experiment that involves a test article* and one or more human subjects, and...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.
The FDA considers the term clinical investigation as being synonymous with the following: research, clinical research, study, and clinical study.
*regulated by the FDA, including food or color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. This includes any new or unapproved item regulated by the FDA and the application of approved items to new populations or indications.
Many different types of research activity are encompassed by these two definitions.
For example, research objectives may range from understanding normal and/or abnormal physiological or psychological functions or social phenomena, to evaluating diagnostic, therapeutic or preventive interventions and variations in services and practices.
The activities or procedures involved in research may be invasive or noninvasive, and include removal of body tissues or fluids; administration or application of chemical substances or forms of energy; surgical interventions; modification of diet, daily routine or service delivery; alteration of environment; observation; administration of questionnaires or tests; randomization of subjects; review of records, and so forth.
Research activities may also be conducted or supported within a program or activity that otherwise may not be considered research, such as some demonstration and service programs. As such, the research aspect of the program falls under the jurisdiction of the WCM IRB.
For IRB review and project implementation, a research project must be described in a protocol or, for an exempt submission, in the IRB initial review application.
Research involving human subjects means any activity that either:
HHS regulations define a human subject as:
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 regulations define a human subject as:
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 difference between these definitions relate to the FDA's role in regulating investigational test articles (drugs, biologics or devices). If a person receives an investigational test article, then they are human subjects, regardless of the study design. Therefore, treatment with an investigational agent in a protocol designed to treat a single individual is enough to sufficient that individual a human subject even though generalizable knowledge will not result.
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?
It is often unclear to investigators whether or not an individual should be considered human subject. The following are common scenarios where individuals are involved in the research but their involvement does not fit the definition of human research subject.
When information is obtained about individuals other than the research participant, then these individuals become secondary subjects of the research. If the medical history includes information about family members or others and it is recorded in a way so that the investigator can readily identify the other individuals, then both the index subject and the other family members must be considered human research subjects. Common secondary subjects include:
The investigator must justify the need to gather identifiable data from secondary subjects. For example, a relative could be identified as Maternal Uncle 1 rather than by name.
If the secondary subjects will be contacted and offered an opportunity to participate, the research should include plans for the following:
The informed consent form must include statements on the signature page to make clear that consent is being granted for all research participants. If family members will not be present, a waiver of consent and HIPAA Authorization will be needed.
At WCM, only the IRB can make the determination that an activity is exempt from IRB review. Thus, studies involving human subjects research must be submitted to the IRB for a determination of exemption. Submit an Intake Form through WRG-HS to formally request an IRB determination. Please note: Initial IRB applications are required for exempt studies - do not submit research determinations forms. See this KB article for instructions on how to submit an initial application.
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 research meets any of the exemption criteria:
If you are preparing an NIH application and your grant proposes use of a single 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.
Quality improvement activities are an important component of hospital operations. Because QI activities are data-driven and involve human participants, it is not surprising that there can be overlap with research methodologies common to human subjects research. Where there overlap exists between QI and research methodologies, the federal regulations that protect human research participants may apply. Whether the QI activity is human subjects research or not, it is vital that it be executed in a manner that is ethical and respects the rights and welfare of the human participants.
Both research and quality improvement are systematic investigations that may involve human participants but they differ in important ways. The table below is based on information adapted from The Ethics of Using QI Methods to Improve Health Care Quality and Safety.
Human Subjects Research | Quality Improvement | |
Purpose | designed to develop or contribute to generalizable knowledge | designed to implement knowledge, assess a process or program as judged by established/accepted standards |
Starting Point | knowledge-seeking is independent of routine care and intended to answer a question or test a hypotheses | knowledge-seeking is integral to ongoing management system for delivering health care |
Benefits | might or might not benefit current subjects; intended to benefit future patients | directly benefits a process, system or program; might or might not benefit patients |
Participant Obligation | no obligation of individuals to participate | responsibility to participate as component of care |
Endpoint | answer a research question | improve a program, process or system |
Analysis | statistically support or disprove hypothesis | compare program, process or system to established standards |
Adoption of Results | disseminate results to research/academic community | results adopted for internal purposes |
Publication/Presentation | investigator obliged to share results | QI practitioners encouraged to share systematic reporting of insights |
IRB approval may be required when the activity involves some of the following characteristics:
Quality Improvement/Program Evaluation vs. Research Checklist:
This checklist will help you assess whether a proposed project is Quality Improvement/Program Evaluation (QI/PE).
If there is uncertainty about whether or not WCM or an investigator at WCM is engaged in the research, the Office of Human Research Protections (OHRP) provides a Guidance on Engagement of Institutions in Human Subjects Research. The FAQs for this section provide examples of when IRB Review is needed and when it is not.
It is important to note that, in general, institutions whose employees or agents obtain identifiable private information or identifiable specimens for non-exempt human subjects research are considered engaged in the research, even if the institution’s employees or agents do not directly interact or intervene with human subjects.
Research involving food, dietary supplements, drugs 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.
Weill Cornell Medicine (WCM) and NewYork-Presbyterian Brooklyn Methodist Hospital (BMH) have entered into a Master Reliance Agreement for the WCM IRB to serve as the IRB of Record for oncology research. For trials considered cooperative research, multi-site, or industry-sponsored, BMH may use a third party ("external IRB") for review. Please visit the Single IRB Reliance: Collaborative Oncology Research page for more information.
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.
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:
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.
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.
The full scope of the PI's responsibilities is outlined in a soon-to-be-published policy document, but can be summarized as follows:
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:
Reminder: Informed Consent forms must be written in a way that is easily understandable by someone with an 8th grade reading level.