Research A to Z

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).

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

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.

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).

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.

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

Federal-Wide Assurance

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.

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.

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.

 Genetic Information Nondiscrimination Act of 2008

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.

"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.

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

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

HIPAA Protected Health Information is considered identifiable if any of the following identifiers are included:

1. Name
2. Geographic subdivisions smaller than a state.
3. All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age
4. Telephone numbers
5. Fax numbers
6. Email addresses
7. Social security numbers
8. Medical record numbers
9. Health plan numbers
10. Account numbers
11. Certificate or license numbers
12. Vehicle identification/serial numbers, including license plate numbers
13. Device identification/serial numbers
14. Universal Resource Locators (URLs)
15. Internet protocol (IP) addresses
16. Biometric identifiers, including finger and voice prints
17. Full face photographs and comparable images
18. Any other unique identifying number, characteristic, or code

For details and exceptions, see Research A-Z webpage Protected Health Information, heading "HIPAA identifiers."

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.

University of Michigan’s Human Research Protection Program

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.