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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.