Glossary

Glossary
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  • Scientific Review Group
    A group of highly regarded experts in a given field, convened by NIH to advise NIH on the scientific merit of applications for research grants and contracts. Scientific review groups are also required to review the ethical aspects of proposed involvement of human participants. Various kinds of scientific review groups exist, and are known by different names in different institutes of the NIH (e.g., Study Sections, Initial Review Groups, Contract Review Committees, or Technical Evaluation Committees).

    Secretary
    A U.S. Cabinet Officer. In the context of DHHS-conducted or -supported research, usually refers to the Secretary of Health and Human Services.

    Significant Risk Device
    An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.

    Single-Masked Design
    Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

    Site Visit
    A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.

    Social Experimentation
    Systematic manipulation of, or experimentation in, social or economic systems; used in planning public policy.

    Sponsor (of a Drug Trial)
    A person or entity that initiates a clinical investigation of a drug-usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The drug is administered to participants under the immediate direction of an investigator who is not also a sponsor. A clinical investigator may, however, serve as a sponsor-investigator. The sponsor assumes responsibility for investigating the new drug, including responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.

    Sponsor-Investigator
    An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies, or other institutions do not qualify as sponsor-investigators.

    Statistical Significance
    A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion [See pg. 2 of McLarty, J. W., "How Many Subjects are Required for a Study?" IRB 9 (No. 5, September/October 1987): 1-3.]. If the probability is less than or equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis is rejected at that significance level (0.05 or 0.01).

    Sterility (1)
    The absence of viable contaminating microorganisms; aseptic state.

    Sterility (2)
    The inability to procreate; the inability to conceive or induce conception.

    Study Section
    See: Scientific Review Group.

    Subjects (Human)
    See: Human Subjects.

    Substance Abuse and Mental Health Services Administration (SAMSHA)
    Includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services. Formerly the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). (See also: ADAMHA.) (www.samhsa.gov/)

    Surveys
    Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.