Human Subject means:
- OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
- FDA: “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 human or a patient.” 21 CFR 50.3 (g) and 21 CFR 56.102 (e)
Humanitarian Device Exemption (HDE)
An application that permits the marketing of a humanitarian use device.
Humanitarian Use Device (HUD)
An FDA regulated medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affect fewer than 4000 individuals in the US per year, but not yet approved for unrestricted use. The use of a HUD is subject to IRB oversight. Contact IRMBED Office for guidance.
IRB (Institutional) Authorization Agreement
Institutional Biosafety Committee
Informed Consent Document; see also ICF
the numeric code designating a diagnosis.
Informed Consent Form; see also ICD
IDS refers to the Investigational Drug Service, which is part of the University of Michigan Hospital and Health Centers
Individual Investigator Agreement
Inclusion / Exclusion Criteria
The medical or other standards determining whether a person may or may not be allowed to enter a research study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
Individual Investigator Agreement (IIA)
This agreement is used when a collaborating investigator engages in research with a collaborating investigator who is not affiliated with the covered entity; a collaborating investigator who is affiliated with an institution/hospital/clinic that may not have its own IRB to review the study; a collaborating investigator who is not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the institution.
Individually Identifiable Health Information
The term 'individually identifiable health information' means any information, including demographic information collected from an individual, that:
- is created or received by a health care provider, health plan, employer, or health care clearinghouse; and
- relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and--
- identifies the individual; or
- with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.
Informed consent is the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required.
- Use of a written consent form that includes all of the basic elements.
- The process of learning the key facts about a research study.
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular research project.
- Informed consent is documented by means of a written, signed, and dated informed consent form unless such documentation is waived by the IRB. (45 CFR 46.116)
- 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 (21 CFR 50.20 and 50.25).
- It is a continuing process throughout the study to provide information for participants.
Informed Consent Document (ICD) or Informed Consent Form (ICF)
A document that describes the rights of the study participants, and includes 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. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Institutional Conflict of Interest (iCOI)
A common understanding is that an institutional conflict of interest (iCOI) occurs when the university, members of senior administration (chairs, deans, vice chancellors, directors), or affiliated organizations have a financial interest in a company that is associated with university research that may financially benefit the institution. Examples include, but are not limited to, grant and contract dollars, license fees and royalty payments, gifts to the institution, investments in start-up companies associated with faculty inventions, research relationships with companies that make significant contributions for facilities or endowed chairs, or stock ownership in companies that conduct research at the university.
Institutional Review Board (IRB)
- Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520 (g) of the act. (FDA)
- A specially constituted review body established or designated by an institution to protect the welfare of human subjects recruited to participate in biomedical or behavioral research (OHRP)
Institutional Review Board of the Medical School (IRBMED)
The University of Michigan Medical School Institutional Review Boards contain 5 individual review Boards. They are designated as A1, A2, B1, B2 and C1. Boards A and B meet on alternate Thursdays and C1 meets on Friday.
Intent to Treat
Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment. See Randomization.
A research related communication or interface between an investigator and a research subject other than those that involve an investigational agent or procedure as it relates to a disease or disorder (an intervention). Interactions may occur in person, by phone, computer, fax, or mail. Examples include surveys, focus groups, fMRI, and tests on healthy normal subjects.
Internal Account No.
A Shortcode represents a string of Chartfield values. Shortcodes are required to process payroll transactions and may be used with Service Unit Billings in place of Chartfields.
Internal Adverse Event
From the perspective of an Investigator engaged in a multi-center clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the Investigator(s) or at their site. In the context of a single-site study, all adverse events would be considered internal adverse events.
True Cost budget used in determining feasibility of sponsor budget. Used in planning meeting as a communication tool with PI and study team. Aids in determining changes to sponsors budget for fixed price contracts.
A qualified interpreter is an individual who is fluent (can speak, read and write) in English and the language of the subject, and (preferably) understands human research informed consent requirements. The interpreter should not be a member of the potential subject's family. Family members may have their own biases regarding research participation.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interventions may occur in person, by phone, computer, fax, or mail. Examples include clinical trials, behavioral or nutritional counseling, and surgeries.
Clinical investigation means any experiment in which a test article, even an approved drug, is administered or dispensed to, or used involving, one or more human subjects. (FDA) The use of a marketed drug in the course of medical practice that is outside the label indications ("off-label" use or innovative care) does not in and of itself constitute investigational use of a drug, unless that use is part of an experiment or systematic investigation meeting the criteria for human subject research.
A device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Devices are classified as significant and non-significant risk. A significant risk device means an investigational device thatpresents a potential for serious risk to the health, safety, or welfare of a subject. (FDA)
Investigational Device Exemption (IDE)
Approval by FDA for investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully across state and international boundaries for the purpose of conducting investigations of that device. (FDA) Most devices under investigation should have an IDE.
A new drug or biologic (i.e., not approved for marketing by FDA) used in a clinical investigation, including a biological product used in vitro for diagnostic purposes.
Investigational Drug Service (IDS)
The IDS at UMHS ensures that investigational drug studies and other drug related research at the Hospitals and Clinics are conducted in a safe and efficient manner. In doing so, the IDS assists investigators in complying with the requirements of the FDA, study sponsors, Michigan State Board of Pharmacy Regulations, JCAHO and hospital and pharmacy policies. The IDS will only handle protocols that have approval of IRBMED.
Investigational New Drug (IND)
A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Use of investigational drugs requires application to the FDA and is usually limited to subjects enrolled in clinical studies covered by an Investigational New Drug agreement with the FDA.
Investigational New Drug (IND) Application
An application that permits an investigational drug that would otherwise be required to have pre-market approval by FDA to be legally shipped for a clinical investigation.
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
- A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH Guidelines)
- An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader. (FDA)
See also Co-Investigator and/or Sub-Investigator.
Investigator Initiated Protocol
Protocols that are written by a UM investigator.
An assessment made by the investigator and/or sponsor regarding whether or not an adverse event, or DSMB or other Report, necessitates a change to the study protocol, informed consent document or process, or investigator's brochure in order to promote subject safety and/or autonomy.
A proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.
Investigator’s Brochure (IB)
The IB is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is critically important 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 investigational product in human subjects gathered during preclinical and other 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 protocol, such as:
- Dose (of the study drug),
- Frequency of dosing interval,
- Methods of administration, and
- Safety monitoring procedures.
- 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.
Select Yes if this is a therapeutic trial involving investigational drugs or devices; otherwise, select No.