Glossary

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Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by the Office for Civil Rights, HHS. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the grantee organization. (See HIPAA Privacy Rule.)

Health Professional School or College

In the context of NIH's R15 program, health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, DPT, BME, MSEE, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH. Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics & prosthetics, kinesiology, biomedical engineering, occupational therapy and psychology. Accreditation must be provided by a body approved for such purpose by the Secretary of Education.

As related to the definition of a clinical trial, the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Hedge Fund

For purposes of the SBIR/STTR programs, hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

HHSAR

Health and Human Services Acquisition Regulation

High Risk/High Impact (HR/HI)

A category of applications identified by a scientific review group as having a high degree of uncertainty in approach but also a high potential for impact. NIH tracks how many of these applications are identified and funded.

Historically Black College or University (HBCU)

Any historically black college or university established prior to 1964 whose principal mission was and is the education of black Americans, and is accredited by a nationally recognized accrediting Agency or Association determined by the Secretary [of Education] to be a reliable authority as to the quality of training offered or is, according to such an Agency or Association, making reasonable progress toward accreditation.

Historically Underutilized Zone (HUBZone)

A small business concern meeting the following criteria:
1. Located in a “historically underutilized business zone or HUBZone area located in one or more of the following:

  • A qualified census tract (as defined in section 42(d)(5)(C)(i)(l) of the Internal Revenue Code of 1986; or
  • A qualified ‚Äúnon-metropolitan county (as defined in section 143(k)(2)(B) of the Internal Revenue Code of 1986) with a median household income of less than 80 percent of the state median household income or with an unemployment rate of not less than 140 percent of the statewide average, based on U.S. Department of Labor recent data; or
  • Lands within the boundaries of Federally recognized Indian reservations.

2. Owned and controlled by one or more U.S. Citizens.
3. At least 35% of its employees must reside in a HUBZone.

hormones

One of many substances made by glands in the body. Hormones circulate in the bloodstream and control the actions of certain cells or organs. Some hormones can also be made in the laboratory.

HSI

Hispanic Serving Institution

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues, and body fluids from identifiable individuals as human subjects and to graphic, written, or recorded information derived from such individuals. (See Public Policy Requirements and Objectives-Human Subjects Protections).

Human Subjects Assurance

A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021