Research A to Z

National Institute of Mental Health

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.

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

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.

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.

Noninvasive procedures do not involve tools that break the skin or physically enter the body. Noninvasive procedures for research purposes are usually deemed to pose minimal physical risk, though this is also dependent on other contextual factors.

OHRP's list Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) includes many examples:

#3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

#4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing....
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

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.

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.