1 | 2 | 4 | 5 | 7 | A | B | C | D | E | F | G | H | I | J | L | M | N | O | P | Q | R | S | T | U | V | W

Fetal Material

The placenta, amniotic fluid, fetal membranes, and umbilical cord.

Fetus

The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See also: embryo.

Financial Conflict of Interest

An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Financial interests include, but are not limited to: salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

Finding of Non-Compliance

An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).

FOIA

Freedom of Information Act

Follow up report

A supplemental report from a sponsor or investigator providing additional information, clarification, or corrections to a previously reported (to IRBMED) Adverse Event.

Follow-up

A study that is no longer open to accrual but still has subjects

Food and Drug Administration (FDA)

The FDA oversees safety of foods, drugs, devices, biologics and cosmetics for human use. The FDA also works with the blood banking industry to safeguard the nation's blood supply.

For-Cause Audit/Review

An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subject research and/or human subject protection.

Form 483

The FDA-483 is the written notice of objectionable practices or deviations from the regulations that is prepared by the FDA investigator at the end of an inspection. The items listed on the form serve as the basis for the exit discussion with the researcher at which time the PI can either agree or disagree with the items and can offer possible corrective actions to be taken. The PI may also respond to the district office in writing after it has had sufficient time to properly study the FDA-483 (hyperlink). The receipt of and a PI’s response to the Form 483 is submitted to IRB as an ORIO (hyperlink).

Freedom of Information Act (FOIA)

The FOIA is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the US government. The Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute.

Full Board / Committee Review

Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Full Feasibility Review

All new clinical trials will undergo a Feasibility Review. When a trial protocol has not undergone prior scientific review by a recognized peer review body, then the trial is subject to a Scientific Review (which also includes the Administrative Review).

Full Review

If the study does not meet the criteria for exempt or expedited review, then it must be submitted for full review.

Fund Acct. No.

The Proposal Approval Form (PAF), which is part of the eResearch Proposal Management system, accompanies the proposal to record the appropriate signatures to indicate approval of the proposed project.

FWA

Federal-Wide Assurance

GCP

Good Clinical Practice

Generalizable Knowledge

Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.

Genetic Information Nondiscrimination Act (GINA)

GINA is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health. The new law prevents discrimination from health insurers and employers.

Genetic Screening

Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.

Genome

All the genetic material in the chromosomes of a particular organism; its size is generally given as its total number of base pairs.

Genome-Wide Association Studies (GWAS)

A GWAS is an approach that involves rapidly scanning markers across the complete sets of DNA, or genomes, of many people to find genetic variations associated with a particular disease. Once new genetic associations are identified, researchers can use the information to develop better strategies to detect, treat and prevent the disease. Such studies are particularly useful in finding genetic variations that contribute to common, complex diseases, such as asthma, cancer, diabetes, heart disease and mental illnesses.

Genotype

The genetic constitution of an individual.

GINA

 Genetic Information Nondiscrimination Act of 2008

GMP

Good Manufacturing Practice

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Good Laboratory Practice (GLP)

GLP Standard compliance monitoring program ensures the quality and integrity of test data submitted in support of product registration.

Group C Treatment IND

"Group C" Treatment IND was established by agreement between the FDA and the National Cancer Institute (NCI). The Group C program is a means by which oncologists can use investigational drugs for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are generally Phase III study drugs that have shown evidence of relative and reproducible efficacy in a specific tumor type. They can generally be administered by properly trained physicians without the need for specialized supportive care facilities. Group C drugs are distributed only by the NIH under NCI protocols. Although treatment is the primary objective and patients treated under Group C guidelines are not part of a clinical trial, safety and effectiveness data are collected.

GWAS

Genome-Wide Association Studies

HC (Hospital Component)

Money to Hospital for space, equipment, supplies, staff etc. (CDM/EAP)

Health Information Technology for Economic & Clinical Health (HITECH)

The HITECH Act was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. Subtitle D of the HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by "covered entities" (generally, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions). By regulation, the DHHS extended the HIPAA privacy rule to independent contractors of covered entities who fit within the definition of "business associates". PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.

 

HHS

 the U.S. Health and Human Services; see also DHHS

HIPAA

Health Insurance Portability and Accountability Act of 1996, as amended, and privacy regulations promulgated pursuant to the Act

HITECH

Health Information Technology for Economic & Clinical Health

 

Hospital Account No.

When initial IRBMED approval is obtained,OnCore Support sends the RPE to RCRB who creates the RMRN. For studies in OnCore, a RMRN request form does not have to be completed and submitted.

hPSCRO

Human Pluripotent Stem Cell Research Oversight Committee

HRPP

University of Michigan’s Human Research Protection Program

HUM Number

The number assigned to project applications through eResearch.  Through the life of a study, each project will only ever have one HUM Number, though for Amendments and AE/ORIO submissions will be given a second identifying number. For example: HUM0001234, ADV0004567.

Human Pluripotent Stem Cell Research Oversight Committee (hPSCRO)

The hPSCRO provides local oversight of ethical issues related to derivation and research use of human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. The HPSCRO also provides local oversight of research with human pluripotent stem cells in experiments designed or expected to yield gametes (oocytes or sperm) or with the intent or potential to integrate these cells into the central nervous system of animals.

Pages