NOHSP Definitions - R

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

A

B

C

D

E

F

G

H

I

L

M

N

O

P

Q

R

S

T

U

V

W

R

Reciprocity: An agreement by an IRB to accept the review and approval of another IRB. (HSP#044)

Recruitment: Seeking individuals to enroll or participate in a research study. (HSP#045)

Regulatory authority: The law or regulation that takes precedent at a specific Nemours site, based on the “more stringent” standard. (HSP-055)

Related: A reasonable possibility that the adverse event or problem may have been caused by the test article (study drug/biologic/device) or research participation. Related should be interpreted to mean that experience/evidence supports a reasonable causal relationship. Remotely possible, or not entirely impossible, associations are not considered ‘related’ for reporting purposes. (HSP#067)

Renewal Date: see Expiration Date.

Research involving human participants (human subject research): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge involving human participants.

“Research” as defined by DHHS means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)] (HSP#050)

“Research” as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirement for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

• “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
• “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 5209(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]

“Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)](HSP#050)

Research Team: All individuals, whether Nemours associates or not, participating in the conduct of a human subject research protocol under the supervision / direction of a Principal Investigator are members of a Research Team. (HSP#005)

Risk: The probability, or likelihood, and magnitude (e.g., severity, duration, reversibility) of harm or discomfort anticipated in the research. IRB review is concerned with:

• The risks associated with the protocol directly related to the research, as opposed to those risks associated with the standard of care procedures that provide the framework for the research.
• The immediate or reasonably foreseeable risks of the research rather than the risks associated with the long-term outcome or consequences of applying the knowledge gained from the research. (HSP#025)