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Non-Affiliated Member

To be eligible for participation on IRBMED as a community representative/non-affiliated member, neither the member nor any member of his/her immediate family may otherwise have a direct affiliation (i.e., as an employee, contractor, student in a degree program, or active emeritus faculty member) with the University. Immediate family includes spouse, parents, grandparents, children and grandchildren, brothers, sisters, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, sons-in-law, adopted, half, and step members.


Failure (intentional or unintentional) to comply with applicable federal regulations, state or local law, the requirements or determinations of the IRB, or University policy regarding research involving human subjects. Non-compliance can result from action or omission. Non-compliance may be non-serious (minor) or serious, and may also be continuing.

Non-Financial Conflict of Interest

An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultant’s) obligation to protect research participants and potentially compromises the objectivity and credibility of the research review process.

Non-physiological Adverse Event

An Adverse Event involving social or psychological trauma, insult or injury rather than physiological or biomedical harm.


An individual appointed to the IRB who (due to training, background, and/or occupation) is inclined to view research activities from the standpoint of someone outside the scientific or scholarly discipline of the IRB on which he/she serves.

Non-Serious or Minor Non-Compliance

Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subject protection program. Examples of minor noncompliance may include, but are not limited to: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.

Non-Significant Risk Device (NSR)

An investigational medical device that does not present significant risk. The determination that a device presents a non-significant risk is first made by the sponsor. If the IRB agrees with the sponsor’s finding that a device presents non-significant risk, the device is considered a non-significant risk device.

Non-Therapeutic Research

Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.

Non-Viable Fetus

An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. See also: Viable Infant.

Normal Subject

Subjects used in study of normal physiology and behavior, or subjects who do not have the condition under study in a particular protocol used as comparisons with subjects who do have the condition. “Normal” does not necessarily connote normal in all respects. For example, patients with broken legs may serve as normal volunteers in studies of metabolism, cognitive development and the like. Similarly, patients with heart disease but without diabetes may be “normal” in a study of diabetes complicated by heart disease.

Notice of Outcome

Written acknowledgement from the IRBMED, faxed to the study coordinator and/or investigator at the fax number provided in the submission application, regarding the outcome of the review of that application. Outcomes may be "approved", "acknowledged", or "disapproved". Adverse Event and ORIO reports are generally acknowledged, but if accompanying changes to the protocol or consent form are requested these require approval in order to take effect.

Null Hypothesis

The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.

Nuremberg Code

A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.

Off-Label Use

A drug prescribed for conditions other than those approved by the FDA. The off-label use of a marketed drug in the course of medical practice 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.

Office for Civil Rights (OCR)

Office for Civil Rights (OCR) - Federal civil rights laws and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, together protect your fundamental rights of nondiscrimination and privacy. Civil Rights help to protect you from unfair treatment or discrimination, because of your race, color, national origin, disability, age, gender, or religion. Federal laws also provide conscience protections for health care providers. The Privacy Rule protects the privacy of your health information; it says who can look at and/or receive your health information, and also gives you specific rights over that information.

Office for Human Research Protection (OHRP)

The Department of Health and Human Services Office (DHHS), Office for Human Research Protection (OHRP) is responsible for implementing DHHS regulations (45 CFR 46) governing research involving human subjects. The office within the NIH, an agency of the Public Health Service, DHHS, responsible for implementing DHHS regulations governing research involving human subjects.

Office of Human Research Compliance Review (OHRCR)

The mission of the OHRCR at UM is to facilitate safe, ethical, efficient and high quality human subject research. They accomplish this mission through: Compliance Reviews of research studies and components of the UM HRPP; Education of individuals and groups engaged in the research enterprise; Outreach to the University research community and Innovation and Leadership. OHRCR conducts a number of not-for-cause audits each year within the University.  The report received from OHRCR needs to be submitted to the IRBMED via eResearch and the ORIO function.

Office of Research and Sponsored Projects (ORSP)

ORSP’s is to assist faculty and staff members in all aspects of externally funded research projects and other scholarly activities throughout the life of the project. ORSP Project Representatives provide liaison with specific groups of sponsors. They keep apprised of agency policies and programs in technical, scientific, and scholarly fields and devote attention to the specific requirements of the sponsoring agencies. ORSP is formally known as the Division of Research Development and Administration (DRDA).

Office of the Vice President for Research (OVPR)

OVPR has central responsibility for nurturing excellence in research, scholarship and creative activity across the entire campus. It has primary responsibility for research policy, oversight of responsible conduct of research education and compliance, and oversight of administration and support of research activity by the faculty. OVPR has administrative responsibility for several independent, interdisciplinary research units, as well as units which provide support to the research and technology transfer activities on campus. OVPR works with the deans and department chairs to develop and support interdisciplinary research initiatives and symposia.


The HRPP Operations Manual (OM) is designed to illuminate the system and its overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.


On Arm

Date the patient is assigned to receive the device or not (device studies)

On Follow-Up

Date after procedure occurs (on follow-up indefinitely)

On Study

Date the sponsor approves the patient to be eligible (device studies)

On Treatment

Date that procedure/sham is conducted (device studies)

Open Design

An experimental design in which both the investigator(s) and the subjects know the treatment group to which subjects are assigned.

Open-Label Trial

A clinical trial in which doctors and participants know which drug or vaccine is being administered.


Office of Protection from Research Risks, now known as the OHRP


Office of Research Compliance Review

Orphan Drugs

An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a Manufacturer specific financial incentives to develop and provide such medications.

Other Reportable Information or Occurrence (ORIO)

Other Reportable Information or Occurrence - Any event not an adverse event, that occurs during a clinical research study.

Oversight Body or Agency

Reports to or from internal oversight bodies (such as the CC CTO or the OVPR) or outside agencies (such as the FDA, NCI, NIH, or sponsor) should be submitted to the IRBMED for review according to the IRB Timetable for AE or ORIO OR as required in the Study Specific AE Reporting Timetable which may allow for non-concurrent reporting.  The terms Oversight Body or Agency or Entity are interchangeable.

PAN (Project Award Notice)

A Project Award Notice (PAN) is prepared and distributed by ORSP via eResearch to the Principal Investigator and all signers off on a PAF serves to establish the project/grant number (PGN) for the project.

Parallel Track IND

The FDA's Parallel Track policy permits wider access to new drugs for life-threatening diseases under a separate treatment protocol (Parallel Track IND) that "parallels" the controlled Phase II and III clinical trials performed to establish the safety and effectiveness of investigational new drugs. For example, under this prospective mechanism, persons with AIDS and HIV-related diseases who are not able to take standard therapy or for whom standard therapy is no longer effective, and who are not able to participate in ongoing controlled clinical trials, can have access to promising investigational new drugs. Applications to permit expanded availability of an investigational new drug under the Parallel Track mechanism must be submitted (typically by the manufacturer of the drug) to the FDA as an amendment to the existing IND.


When participation is anonymous, it is impossible to know whether or not an individual participated in a study. When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff that has legitimate access to participation records.

Pass Thru Procedures

These charges are billable to the sponsor. When a procedure marked Pass Thru occurs on a subject visit, the charge appears as its own invoiceable item in the Financials Console. When added to an invoice, each Pass Thru procedure is listed as its own line item. Pass Thru charges are not included in the total calculated cost for billable milestones.

PC (Professional Component)

Money to Physician for services provided (CPT)

Phase 0 Trial

Phase 0 is a designation for exploratory, first-in-human trials conducted in accordance with the FDA’s Guidance on Exploratory IND Studies. Phase 0 trials are also known as human micro-dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub-therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

Phase I Trial

Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-100 healthy volunteers will be recruited. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organizations who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer. The tested range of doses will usually be a fraction of the dose that caused harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. Volunteers are paid a fee for their time spent in the volunteer center. Pay depends on length of participation. There are different kinds of Phase I trial: Single Ascending Dose; Multiple Ascending Dose; and Food effect. 

Phase II Trial

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB.                                  

  • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
  • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Phase III Trial

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.                                  

Studies in this phase are by some companies categorized as "Phase IIIB studies." While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA. Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life.

This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities. They will review the submission, and, it is hoped, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.