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Governing Principles

Governing Principles

The SEKESC-IRB operates in accordance with both 45 CFR 46 and The Belmont Report, Ethical Principals and Guidelines for the Protection of Human Subjects and Research, April 18, 1979, regardless of whether the research being conducted is subject to Federal Regulations with or with whom the source of support originated.

SEKESC and its staff recognize the importance of the responsibility for protection of the rights and welfare of human subjects in research. No human subject involved in a research activity will be exposed to unreasonable risk to health or well-being.

Research involving minors (persons less than 18 years of age) and others who may have limited ability to provide informed consent and which involves greater than minimal risk must be approved by SEKESC-IRB.

Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in research are not greater in and of themselves than those extraordinary encountered in daily life or during the performance or routine physical or psychological examinations or tests.” (45 CFR 46.102(j)).

Research involving children, prisoners/inmates, pregnant women, human fetuses, and neonates as defined in 45 CFR 46, Subparts B, C, and D, must be approved by SEKESC-IRB. Departments are not authorized to exempt these types of research from review.

Except for research exempted (see Criteria Review for exemption criteria or waived IAW §46.104(d)(2)(iii), (d)(3)(1C), (d)(7) and (d)(8) informed consent will be:

  • (a) sought from each prospective subject or the subject’s legally authorized representative, IAW, and to the extent required by §46.116;
  • (b) appropriately documented, IAW, and to the extent required by §46.117.

Confidentiality of information received from human research subjects will be fully protected, both during and after the conduct of a research activity within IAW.

Requests by any human research subject for withdrawal from a research activity will be honored promptly without penalty or loss of benefits to which the subject is otherwise entitled.