Federal Regulations

The U.S. Department of Health and Human Services (HHS) human subject protection regulations require that any institution engaged in human subjects research conducted or supported by HHS must submit a written assurance of compliance to the Office for Human Research Protections (OHRP). The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46, also known as the Common Rule. Each FWA must designate at least one Institutional Review Board (IRB) registered with OHRP.

Institution Name

The Institution Name listed on the IRB is Lawrence U Wisconsin. The Institution Name listed on the FWA is Lawrence U.

IORG Number

The Institution or Organization (IORG) number is a unique number assigned by the Office for Human Research Protections (OHRP) to an institution or organization the first time they register an IRB. The IORG Number for Lawrence is IORG0003680 and it expires 9/18/2017.

IRB Registration Number

Each IRB registered under an FWA has a unique number assigned by OHRP. The IRB Name for our institution is Lawrence U Wisconsin IRB # 1 and the IRB Registration Number is IRB00004369 and it expires 9/18/2017.

FWA

The FWA number for Lawrence is FWA00009820 and it expires on 7/14/2016.

National Institutes of Health (NIH) Funded Research

Institutions engaged in NIH research must:  (1) obtain or hold a current FWA and (2) certify to NIH that grant applications and contract proposals involving human subjects research were reviewed and approved by the IRB designated in the FWA, and are subject to continuing review by an IRB. Any research funded by NIH is subject to all HHS regulations for protections and NIH policy requirements for inclusion of women, minorities, and children.

Please be sure to familiarize yourself with the following NIH Policies and Guidelines on the:

Training & Certification

Training for the protection of human subjects in research is federally mandated for all researchers receiving federal research funds. The OHRP strongly encourages all researchers regardless of funding to complete training. It is the policy of Lawrence that all researchers, including students, participate in human subjects protection training. The Lawrence University IRB requires the Signatory Official and Human Protections Administrator (as listed on the IRB and FWA documents) be trained and certified in research ethics. In addition, all IRB committee members must complete training. The IRB will not process any applications until required training is completed by appropriate individuals.

Ethical Guidelines

Belmont Report:  The National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research was formed as one of the outcomes of the Syphilis Study at Tuskegee. The Commission drafted the Belmont Report, which is the foundation for the ethical principles and U.S. Department of Health and Human Services (HHS) regulations for the protection of research subjects. The three basic ethical principles are:

1)      Respect for persons
2)      Beneficence
3)      Justice

Code of Federal Regulations (45 CFR 46):  This basic policy for the protection of human research subjects was developed by the HHS as one of the outcomes of the Syphilis Study at Tuskegee. The Code has four subparts (A-D).  Subpart A is referred to as the Common Rule. Subparts B-D address one of the ethical principles (Respect for Persons, specifically those with diminished autonomy) as put forth in the Belmont Report.   Subpart E addresses IRB registration.

Helsinki declaration (pdf):  “The World Medical Association drafted the first international agreement recommending ethical standards for clinical research. Like the Nuremberg Code, the Declaration makes informed consent a central requirement for ethical research. The Declaration does, however, allow for surrogate consent when the research subject is incompetent, physically or mentally incapable of giving consent, or a minor. The Declaration, which has undergone multiple revisions, also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons.”

Nuremberg Code  The verdict from the Nazi Medical War Crimes Tribunal at Nuremberg included a section titled “Permissible Medical Experiments”, otherwise known as the Nuremberg Code. The Code provides ten Directives for Human Experimentation and was the first international code of research ethics:

1)      Voluntary consent of the human subject is absolutely essential
2)      The experiment must yield generalizable knowledge that could not be obtained in any other way and
          is not random and unnecessary in nature
3)      Animal experimentation should precede human experimentation
4)      All unnecessary physical and mental suffering and injury should be avoided
5)      No experiment should be conducted if there is reason to believe that death or disabling injury will
          occur
6)      The degree of risk to subjects should never exceed the humanitarian importance of the problem
7)      Risks to the subjects should be minimized through proper preparations
8)      Experiments should only be conducted by scientifically qualified investigators
9)      Subjects should always be at liberty to withdraw from experiments
10)    Investigators must be ready to end the experiment at any stage if there is cause to believe that
          continuing the experiment is likely to result in injury, disability or death to the subject

Office of Human Research Protections (OHRP):

The Office of Human Research Protections (OHRP) replaced the NIH Office for Protection from Research Risks (OPRR), thereby elevating it to the level of HHS. The OHRP regulates the protection of human research subjects and policies/procedures for Institutional Review Boards (IRB).

Source:

PHRP Website (http://phrp.nihtraining.com). “Protecting Human Research Subjects.” Office of Extramural Research, National Institutes of Health.  Developed 3/1/2008.  Updated 2/4/2011.

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