M

Major Modification

A significant change to a protocol where subjects would be engaging in activities not previously approved during the review process or where there is an increased level of risk to the physical, emotional, or psychological well-being of participants, especially in relation to the loss of confidentiality.

Masked

The knowledge of intervention assignment. See Blind.

Masked Study Designs

Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs. See also: Double-Masked Design and Single-Masked Design

Matching Grant

A grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources. The required match may be more or less than the amount of the grant. Some matching grants require that the additional funds be obtained from sources outside the recipient organization. Many matching grants are paid in installments, the payments coinciding with the attainment of pre-specified levels of additional funding. Matching grants are very common in the sciences, especially for equipment. They are standard practice in some government agencies.

Material Transfer Agreement (MTA)

A MTA is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. Each call for different terms and conditions.

Mature Minor

Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. See also: Emancipated Minor

Maximally Tolerated Dose

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity.

Medical Center Information Technology (MCIT)

MCIT is the information technology and telecommunications service provider to the faculty and staff of the UM Health System.

Medical Device

• A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (that is, not a drug or biologic). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment. (OHRP)
• A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals… The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the information sheets entitled "Medical Devices," "FAQ about IRB Review of Medical Devices" and "Significant Risk and Non-significant Risk Medical Device Studies." (FDA)

Medical School

University of Michigan Medical School.

Medical School Information Services (MSIS)

MSIS manages technology infrastructure and provide technical support to administrative and academic departments within the Medical School. We maintain partnerships with campus units, clinical departments, and external organizations to develop and provide services and technology to support the academic, clinical, and research missions of the UM. We make technology and support services more accessible and cost-effective to our faculty, staff, and students and we aggressively strive to enhance the overall quality of the Medical School.

MedWatch

The voluntary FDA Safety Information and Adverse Event Reporting Program that both healthcare professionals and the medical product-using public use to report adverse events involving FDA regulated products. MedWatch provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and, special nutritional products (e.g., medical foods, dietary supplements and infant formulas). IRBMED monitors MedWatch reports and may notify investigators of MedWatch information and/or request changes to research protocols or consent documents based on MedWatch reports.

Mentally Disabled

See: Cognitively Impaired.

Messenger RNA (mRNA)

RNA that serves as a template for protein synthesis.

Metabolism

The manner in which a substance is acted upon (taken up, converted to other substances, and excreted) by various organs of the body.

Michigan Billing Enrollment Calendar Tool (MBECT)

A tool to assist researchers with one point of data entry for building a clinical research budget and billing calendar and tracking your subject enrollment.

Michigan Clinical Research Unit (MCRU)

MCRU provides the clinical staff, resources, and infrastructure necessary to conduct human clinical research protocols at the UM. MCRU hosts investigators funded by federal, state, and local agencies as well as those funded by the private sector. MCRU also serves as an institutional resource for investigators to perform pilot studies that may result in further agency funding. Investigators whose research protocol is federally, departmentally, or philanthropically funded currently can access resources and services without fee. Industry-sponsored studies are billed differently but all research discounts apply.

Michigan Department of Community Health (MDCH)

The MDCH is one of 18 departments of state government. The department, one of the largest in state government, is responsible for health policy and management of the state's publicly-funded health service systems. About 2 million Michigan residents will receive services this year that are provided with total or partial support from MDCH. Services are planned and delivered through these integrated components:

• Medicaid health care coverage for people with limited incomes
• Mental health services for people who have a mental illness or a developmental disability, and services for people who need care for substance abuse
• Health needs assessment, health promotion, disease prevention, and accessibility to appropriate health care for all citizens
• Drug law enforcement, treatment, education and prevention programs
• Promoting independence and enhancing the dignity of Michigan's older persons and their families
• Administering the crime victim’s rights fund, investigating and processing crime victim compensation, and administering federal Victims of Crime Act grants

Michigan Institute for Clinical and Health Research (MICHR)

MICHR’s mission is to enable & enhance clinical & translational research. Their aim is to make UM a world leader in translating scientific discoveries into real health gains. MICHR educates funds, connects, & supports research teams across U-M and the communities we serve. MICHR is proud to be a part of a national consortium of 60 medical research institutions working together with a common vision, funded through Clinical & Translational Science Awards (CTSA).

MICHR IND/IDE Investigator Assistance Program (MIAP)

MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA. The MIAP program offers regulatory assistance to Investigators planning to utilize either a drug or biological product classified by the FDA as an IND per 21 CFR 312, or an investigational medical device subject to IDE regulations, per 21 CFR 812.

Mild Adverse Event

An event which does not pose any significant or permanent risk of harm to the subject. A mild adverse event is considered Grade I using CTC Common Toxicity Criteria. See also Severity.

Minimal Lethal Dose

The smallest amount of product that will kill an experimental animal.

Minimal Risk

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests. 45 CFR 46.102(i)
Prisoners: Research projects with Prisoners automatically incur a higher risk level than those of non-Prisoners.

Minor Changes

Changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research. A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.

Misconduct in Science

Fabrication, plagiarism, falsification or destruction of data, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

Mission

A sponsor's stated purpose, which is designed to address a specified set of problems. Almost all federal research agencies are designated as mission agencies.

Moderate Adverse Event

An event which causes discomfort and perhaps requires treatment, but does not pose any significant or permanent risk or harm to the subject or require in-patient hospitalization. An event that is Grade II by CTC Common Toxicity Criteria.

Modification

An award document that modifies any aspect of an existing award other than those named above.
Example: Carryover approvals, adding or deleting special terms and conditions, changes in funding levels, administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator, etc.

Modifications Required

An IRB action that specifies conditions under which research can be approved, pending the completion of minor, non-substantive (i.e., not directly relevant to the determinations required for approval by the IRB) clarifications or modifications to the protocol and/or informed consent process/document. Review of the investigator’s response(s) may be performed by expedited review.

Modified Total Direct Costs (MTDC)

The basic indirect costs are calculated on a subset of direct costs, normally excluding among other costs, equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.

Monitor

Designated individual selected by a sponsor or contract research organization to oversee the progress of a clinical investigation.

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, good clinical practice, and the applicable regulatory requirement(s). The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.

Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOP's.

Multicenter Research Project

A research project conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one set of investigators.

Mutagenicity

In biology, a mutagen is a physical or chemical agent that changes the genetic material, usually DNA, of an organism and thus increases the frequency of mutations above the natural background level. As many mutations cause cancer, mutagens are typically also carcinogens. Not all mutations are caused by mutagens: so-called "spontaneous mutations" occur due to errors in DNA replication, repair and recombination.

N

National Academy of Sciences (NAS)

The NAS is a private, non-profit society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the public good. Since 1863, the nation's leaders have turned to the NAS for advice on the scientific and technological issues that frequently affect policy decisions.

National Aeronautics and Space Administration
(NASA)

NASA is a leading force in scientific research and in stimulating public interest in aerospace exploration, as well as science and technology in general.

National Bioethics Advisory Board (NBAC)

The Presidential Commission for the Study of Bioethical Issues (the Commission) is an advisory panel of the nation’s leaders in medicine, science, ethics, religion, law, and engineering. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.

National Cancer Institute (NCI)

Research and training aimed to eliminate the suffering and death due to cancer. 1937

National Center on Minority Health and Health Disparities (NCMHD)

The mission of the NCMHD is to promote minority health and to lead, coordinate, support, and assess the NIH effort to reduce and ultimately eliminate health disparities.

National Council on Disability (NCD)

NCD is a small, independent federal agency charged with advising the President, Congress, and other federal agencies regarding policies, programs, practices, and procedures that affect people with disabilities.

National Endowment for the Arts (NEA)

The National Endowment for the Arts provides national recognition and support to significant projects of artistic excellence, thus preserving and enhancing our nation's diverse cultural heritage.

National Endowment for the Humanities (NEH)

NEH is an independent grant-making agency of the United States government dedicated to supporting research, education, preservation, and public programs in the humanities.

National Eye Institute (NEI)

Conducts and supports research that helps prevent and treat eye diseases and other disorders of vision.

National Heart, Lung, and Blood Institute (NHLBI)

An institute in NIH. The NHLBI provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative.

National Human Genome Research Institute (NHGRI)

The NHGRI began as the National Center for Human Genome Research (NCHGR), which was established in 1989 to carry out the role of the NIH in the International Human Genome Project (HGP). The HGP was developed in collaboration with the US Department of Energy and begun in 1990 to map the human genome. In 1993, NCHGR expanded its role on the NIH campus by establishing the Division of Intramural Research to apply genome technologies to the study of specific diseases. In 1996, the CIDR was also established to study the genetic components of complex disorders.

National Institute for Nursing Research (NINR)

An institute in NIH. The NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span-from management of patients during illness and recovery to the reduction of risks for disease and disability, the promotion of healthy lifestyles, promoting quality of life in those with chronic illness, and care for individuals at the end of life.

National Institute of Allergy and Infectious Diseases (NIAID)

An institute in NIH. The NIAID conducts and supports research that strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten hundreds of millions of people worldwide. The Institute's mission is driven by a strong commitment to basic research and the understanding that the fields of immunology, microbiology, and infectious disease are related and complementary.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

An institute in NIH. The mission of the NIAMSD is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases.

National Institute of Biomedical Imaging and Bioengineering
(NIBIB)

The newest of the research institutes at the NIH. The mission of the NIBIB is to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics, materials science, and computer sciences.

National Institute of Child Health and Human Development
(NICHD)

An institute in NIH. The NICHD seeks to assure that every individual is born healthy and wanted, that women suffer no adverse consequence from the reproductive process, and that all children have the opportunity to fulfill their potential for a healthy and productive life unhampered by disease or disability. In pursuit of this mission, the NICHD conducts and supports laboratory, clinical, and epidemiological research on the reproductive, neurobiologic, developmental, and behavioral processes that determine and maintain the health of children, adults, families, and populations.

National Institute of Dental and Craniofacial Research
(NIDCR)

An institute in NIH. The mission of the NIDCR is to promote the general health of the American people by improving their oral, dental and craniofacial health.

National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)

An institute in NIH. The NIDDK conducts and supports research on many of the most serious diseases affecting public health. Research encompasses the broad spectrum of metabolic diseases such as diabetes, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, nutrition, pathology, histochemistry, chemistry, physical, chemical, and molecular biology, pharmacology, and toxicology.

National Institute of Environmental Health Sciences
(NIEHS)

An institute in NIH. The mission of the NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate.

National Institute of General Medical Sciences
(NIGMS)

An institute in NIH. The NIGMS primarily supports basic biomedical research that is not targeted to specific diseases or disorders.

National Institute of Justice (NIJ)

The NIJ, the research, development and evaluation agency of the US Department of Justice is dedicated to improving knowledge and understanding of crime and justice issues through science. NIJ provides objective and independent knowledge and tools to reduce crime and promote justice, particularly at the state and local levels.

National Institute of Mental Health
(NIMH)

An institute in NIH. The mission of the NIMH is to diminish the burden of mental illness through research.

National Institute of Neurological Disorders and Stroke (NINDS)

An institute in NIH. The mission of NINDS is to reduce the burden of neurological disease-a burden borne by every age group, by every segment of society, by people all over the world.

National Institute of Nursing Research (NINR)

NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span.

National Institute of Occupational Safety and Health (NIOSH)

The NIOSH is the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. The mission of NIOSH is to generate new knowledge in the field of occupational safety and health and to transfer that knowledge into practice for the betterment of workers. To accomplish this mission, NIOSH conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard evaluations. NIOSH provides national and world leadership to prevent work-related illness, injury, disability, and death by gathering information, conducting scientific research, and translating the knowledge gained into products and services, including scientific information products, training videos, and recommendations for improving safety and health in the workplace.

National Institute of Standards and Technology (NIST)

Founded in 1901 and now part of the US Department of Commerce, NIST is one of the nation's oldest physical science laboratories. Congress established the agency to remove a major handicap to US industrial competitiveness at the time—a second-rate measurement infrastructure that lagged behind the capabilities of England, Germany, and other economic rivals. Today, NIST measurements support the smallest of technologies—nanoscale devices so tiny that tens of thousands can fit on the end of a single human hair—to the largest and most complex of human-made creations, from earthquake-resistant skyscrapers to wide-body jetliners to global communication networks. We invite you to explore our web site to learn about our current projects, to find out how you can work with us, or to make use of our products and services.

National Institute on Aging (NIA)

An institute in NIH. The NIA leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life.

National Institute on Alcohol Abuse and Alcoholism
(NIAAA)

An institute in NIH. The NIAAA supports and conducts biomedical and behavioral research on the causes, consequences, treatment, and prevention of alcoholism and alcohol-related problems.

National Institute on Deafness and other Communication Disorders
(NIDCD)

An institute in NIH. NIDCD is mandated to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, smell, taste, voice, speech, and language.

National Institute on Drug Abuse
(NIDA)

An institute in NIH. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. This charge has two critical components: The first is the strategic support and conduct of research across a broad range of disciplines. The second is to ensure the rapid and effective dissemination and use of the results of that research to significantly improve drug abuse and addiction prevention, treatment, and policy. NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction.

National Institute on Minority Health and Health Disparities
(NIMHD)

Promotes minority health, conducts and supports research, training, research infrastructure, fosters emerging programs, disseminates information, and reaches out to minority and other health disparity communities.

National Institutes of Health (NIH)

The NIH are an agency of the US DHHS and are the primary agency of the US government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation. It consists of 27 separate institutes, centers, and offices. Francis S. Collins is the current Director. As of 2003, the NIH was responsible for 28% - about $26.4 billion - of the total biomedical research funding spent annually in the US, with most of the rest coming from industry. The NIH's research is divided into two parts: the Extramural Research Program is responsible for the funding of biomedical research outside the NIH, while the Intramural Research Program is the internal research program of the NIH, known for its synergistic approach to biomedical science.

National Library of Medicine
(NLM)

The NLM on the campus of the NIH in Bethesda, Maryland, is the world's largest medical library. The Library collects materials in all areas of biomedicine and health care, as well as works on biomedical aspects of technology, the humanities, and the physical, life, and social sciences.

National Science Foundation (NSF)

The NSF is an independent agency of the US Government. Their mission is to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense.

Natural History Study

Study of the natural development of something (such as an organism or a disease) over a period of time.

Necrosis

Death of cells or tissues through injury or disease, especially in a localized area of the body.

Neonate

A newborn.

New and Competing Proposals

Proposals that are submitted for the first time or ongoing projects that must re-compete for funding prior to expiration of the original award.

New Award

An award not previously awarded or a renewal or continuation award treated as a new award by the sponsor and given a new agency number.

New Drug Application (NDA)

An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.

NIH Guidelines for Research Involving Recombinant DNA Molecules

A document created in 1976 that outlines principles for the safe conduct of research employing recombinant DNA technology. The NIH Guidelines detail practices and procedures for the containment of various forms of recombinant DNA research, for the proper conduct of research involving genetically modified plants and animals, and for the safe conduct of human gene transfer research. As a ‘living’ document, it is periodically revised to keep pace with the changing state of science.

No Cost Time Extension

An extension of the period of performance beyond the expiration date to allow the principal investigator to finish a project. Usually, no additional costs are provided.

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.

Non-Compliance

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.

Non-Scientist

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.

North Atlantic Treaty Organization (NATO)

NATO’s fundamental purpose is to safeguard the freedom and security of its members through political and military means. NATO brings together 28 member countries from Europe and North America, consulting and cooperating in the fields of security and defense. In this respect, NATO provides a unique transatlantic link for political and security cooperation. Since its founding in 1949, the Alliance remains an essential and unique source of stability in an unpredictable geopolitical environment. Threats such as the proliferation of weapons of mass destruction and ballistic missile technologies, cyber-attacks and terrorism know no borders. NATO has also found itself called upon to help protect civilian populations from government repression.

North Campus Research Complex (NCRC)

The NCRC is an opportunity for the University to broaden its contributions as one of the nation's premier research universities and strengthen its ability to stimulate new business through partnerships with businesses in the private sector. By bringing together researchers and partners from different disciplines and industries, the NCRC will foster a collaborative environment that encourages discovery, innovation and creativity and helps catalyze the transformation of the regional economy. The mission is NCRC, is to expand the University’s capabilities as one of the nation's top translational research institutions and be a driver in the resurgence of the Michigan economy.  Part of the North Campus, the complex of 28 buildings comprising 2.1 million square feet of office, research and manufacturing space acquired from Pfizer in 2009 allows U-M to bring together people and activities.

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.

O

Occupational Safety and Health Administration (OHSA)

Congress created OSHA to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. OSHA standards are rules that describe the methods employers are legally required to follow to protect their workers from hazards. Construction, General Industry, Maritime, and Agriculture standards protect workers from a wide range of serious hazards.
Examples of OSHA standards include requirements to provide fall protection, prevent exposure to some infectious diseases, prevent exposure to such harmful substances as asbestos and lead, put guards on machines, provide respirators or other safety equipment, and provide training for certain dangerous jobs.

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)

An office within the DHHS 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 Biotechnology Activities (OBA)

An office within NIH which monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA, Genetic Testing, and Xenotransplantation; develops and implements NIH policies and procedures for the safe conduct of Recombinant DNA Activities, and Human Gene Transfer; Reviews and evaluates the composition of Institutional Biosafety Committees; and develops registries of activities related to Recombinant DNA Research and Human Gene Transfer.

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 Lab Animal Welfare
(OLAW)

An office within NIH which is responsible for developing and monitoring, as well as exercising compliance oversight relative to PHS Policy on Humane Care and Use of Laboratory Animals involved in research conducted or supported by any component of the Public Health Service.

Office of Management and Budget (OMB)

Part of the Executive Office of the President. Working cooperatively with the grant-making agencies and the grantee community, OMB leads development of government-wide policy to assure that grants are managed properly and that Federal dollars are spent in accordance with applicable laws and regulations. OMB does not award grants.

Office of Management Assessment
(OMA)

An office within the Office of the Director of NIH. The OMA is responsible for reviewing allegations related to NIH programs and activities. The OMA also provides broad management oversight and advice to the Associate Director for Administration and the Institutes and Centers on management reviews, corrective actions, and the NIH-wide management of activities related to regulations, delegations of authority, Privacy Act requirements, records and forms management, organizational and functional analysis, and manual issuances.

Office of Naval Research (ONR)

The ONR sponsors science and technology in support of the US Navy and Marine Corps. Founded in 1946, ONR today funds work at more than 450 universities, laboratories, and other organizations.

Office of Public Health and Science (OPHS)

OPHS is under the direction of the Assistant Secretary for Health, who serves as the Senior Advisor on public health and science issues to the Secretary of Health and Human Services. The Office serves as the focal point for leadership and coordination across the Department in public health and science; provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary.

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 Research Integrity (ORI)

The Office of Research Integrity promotes integrity in biomedical and behavioral research supported by the Public Health Service at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science (OPHS) within the Office of the Secretary of Health and Human Services.

Office of Research on Women's Health (ORHW)

ORWH works in partnership with the NIH Institutes and Centers to ensure that women’s health research is part of the scientific framework at the NIH—and throughout the scientific community. The ORWH promotes, stimulates, and supports efforts to improve women's health through biomedical and behavioral research including study of the role of sex and gender in health and disease.

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.

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.

Off-site Event

In multi-center studies, an event that does not occur at UM or under the supervision of a UM PI or the IRBMED.

Off-Site Research

Human subject research sponsored or performed at a location/site that is not owned by or under the direct control of the organization responsible for the research.

OMB Circulars

Regulatory circulars issued by the Office of Management & Budget (OMB). Definitions included in OMB Circulars A-21, 110, 122, 128 and 133.

Open Design

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

Open meeting

A conference, seminar or other gathering where all technically qualified members of the public are eligible to attend and attendees are permitted to take notes or otherwise make a personal record of the proceedings and presentations.

Open-Label Trial

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

Operations Manual (OM)

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

Other Reportable Information or Occurrence
(ORIO)

Any event not an adverse event, that occurs during a clinical research study.

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.

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.