Human Research Protections
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ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use):

Guidance published by the ICH in the Federal Register on May 9, 1997 (62 FR 25692)

Identifiable Biospecimen:

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]

Identifiable Private Information:

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]

Immediate Family:

Spouse, domestic partner or dependent children.

Immediately Life-Threatening Disease:

A stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

Incidental Finding:
  • AnticipatedResults that are outside the original purpose for which a test or procedure was conducted, but that are known to be associated with the test or procedure: Study is designed to discover A, but learns B, a result known to be associated with the test or procedure in use. B is an anticipated incidental finding.
    • Example: Researchers use the Patient Health Questionnaire (PHQ) assess for depression and learn a participant is having suicidal thoughts.
  • UnanticipatedResults that are outside the original purpose for which a test or procedure was conducted and that could not have been anticipated given the current state of scientific knowledge: Study is designed to discover A, but learns C, a unexpected result.  C is an unanticipated incidental finding.
    • Example: Genetic testing identifies a health risk based on a newly discovered genetic association (not known at the time the study was designed).
Inclusion/Exclusion Criteria:

The pre-determined conditions of a clinical trial that allow or exclude participation. These criteria are factors such as age, gender, type and stage of a disease, previous treatment history, and/or other medical conditions.

Incomplete Disclosure:

Investigators withhold information from participants related to the specific purpose, nature, or other key aspect of the research.

IND Safety Reports:

Sponsor notifications to FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing a drug under its or investigators' INDs) which may include:

  1. Serious and unexpected suspected adverse reaction;
  2. A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure;
  3. One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug;
  4. An aggregate analysis of specific events observed in a clinical trial that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group;
  5. Findings from other studies that suggest a significant risk in humans exposed to the drug;
  6. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug; or
  7. A clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
Individually Identifiable:

The identity of the research participant is or may readily be, ascertained by the investigator or associated with the information.

Individually Identifiable to a Private Person (as defined by the justice department):

Information which either is labeled by name or other personal identifiers; or by virtue of sample size or other factors, be reasonably interpreted as referring to a particular private person.

Informed Consent:
  • A process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form approved by an IRB, unless such documentation is waived by the IRB (45 CFR 46).
    • A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25] (OHRP).
Informed Consent Form:

A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.


Institution means any public or private entity, or department or agency (including federal, state and other agencies).

Institution Employees/Agents:

Individuals who:

  1. Act on behalf of the institution.
  2. Exercise institutional authority or responsibility.
  3. Perform institutionally designated activities. "Employees and agents" can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.
Institutional Conflict of Interest:

Situations in which the University's beneficial relationship with corporate entities may place it in conflict with its responsibilities as a public institution of higher education. The conflict may involve equity interest in companies, receipt of significant financial donations from external entities, certain licensing situations and Board and other leadership positions held by University faculty or administrators.

Institutional Official:

A senior official named in the FWA who has the authority to commit the entire organization, as well as all of the components listed in the FWA, to a legally binding agreement. The Institutional Official (IO) also has the authority to assure compliance of the organization and all of its components to the Terms of the FWA. At the University, the IO is the Vice President of Research.

Institutional Review Board (IRB):

An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.

International Studies:

Procedures and policies that apply to research taking place outside the U.S. often differ from those set forth in the U.S. federal policies. U.S. federally funded research activities in a foreign country may be approved only if the ethical protections are equivalent to those in the U.S. This is also true for FDA approval of drugs/devices/biologics tested outside the United States.


A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes (45 CFR 46.102(f)). Interventions can also include noninvasive approaches such as surveys, education, and interviews.

Investigational Brochure (IB):

In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product or "study drug" obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the study drug in human subjects gathered during preclinical and other clinical trials.

  • An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: dose (of the study drug), frequency of dosing interval, methods of administration, and safety monitoring procedures.
  • An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product".
  • The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.
Investigational Device:

According to the Food and Drug Administration (FDA), an investigational device is a device, including a transitional device, that is the object of a [clinical] investigation involving one or more subjects to determine the safety or effectiveness of the device (21 CFR 812.3). Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.

  • Also, see IDE Definitions and Acronyms for more definitions related to this term.
  • The use of an investigational device in human subjects requires approval by the IRB and may also require approval from the FDA.
Investigational Device Exemption (IDE):

IDEs are exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].

Investigational New Drug (IND):

According to the Food and Drug Administration (FDA), investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous. (21 CFR 312.3)

  • The use of an investigational drug (IND) in human subjects requires approval by the FDA and the IRB.
  • An IND number is generally required for a drug (including a drug with marketing authorization) if it is intended to:
    • Support a new indication for use, establish safety or efficacy of the drug, support a change in the approved route of administration (including method of assembly) or dosage level;
    • Support a change in the approved patient population (e.g. pediatric vs. adults) or a population at greater/increased risk (e.g. immunocompromised, elderly, etc.);
    • Support a change in the promotion/ advertising/ labeling/ packaging of an approved drug.
  • An IND number may also be required for investigations that attempt to gain further information about an approved use. The study sponsor and/or investigator cannot represent (in a promotional context) that the drug is safe and effective for the purposes in which it is under investigation.

Investigator is any WCM personnel, regardless of title or position, who is responsible for the design, conduct, or reporting of research.

Investigator includes, but is not limited to, the Principal Investigator(PI), Project Director (PD), Co-principal investigator (CO-PI), and may also include key personnel, a postdoctoral fellow, graduate student, trainee, staff member, collaborator, or consultant, depending on the person’s role in the research.

NOTE: For specific research projects funded by the U.S.  Department of Energy (DOE), the relevant DOE program office may expand the definition of an investigator for Conflict of Interest disclosure purposes to include any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE.  This expansion will be noted in the applicable Funding Opportunity Announcement (FOA) and/or the terms and conditions of the awarding contract. The primary factor to be used in determining who is an investigator is based on the significance of the tasks assigned to the individual with regard to the design, conduct, and reporting of the Research and the degree of independence that individual may have in performing such Research-related tasks.

Investigator's Brochure:

A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.

Investigator-Initiated Research:

Research that is initiated and conducted by an individual rather than a sponsor/pharmaceutical company. The investigator has the same responsibilities that a sponsor would have.

IRB Approval:

The review process for Full Board studies and, rarely, a few Expedited studies where the researcher renews their IRB approval once every 12 months (or more frequently as determined by the convened Full Board). 45 CFR 46.109(e) and 45 CFR 46.109(f)(1)

IRB of Record:

An Institutional Review Board (IRB) designated as the Reviewing IRB for human subject research as specified in an IRB Authorization Agreement, Cooperative Agreement, Memorandum of Understanding, or other contract between the University and an external institution. The IRB of Record assumes all of the IRB responsibilities for human research activities subject to the agreement.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200