Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 population, it would be unethical to focus subject recruitment on vulnerable or disadvantaged groups (e.g., institutionalized people or Prisoners; or patients at free clinics primarily patronized by people unable to afford other medical care) simply because they are easily accessible or can be persuaded to participate. An undue share of Research risks also should not burden groups already burdened by other factors. Rather attempts should be made to include a fair sampling of the populations who might benefit from the study. When Research involves persons whose autonomy is compromised, it is expected that the Research bear some direct relationship to the conditions or circumstances of the Research subject population. In addition, groups fully able to consider Research risks and informed consent should be asked to face Research risks before more Vulnerable Populations. For example, Investigational Drugs are usually tested in Adults before they are tested in Children. Certain Investigational Drugs and procedures may be tested in healthy volunteers before being tested in patients. Sharing Research Benefits: The Emory IRB should consider the desires of various groups to be included in Research. As individuals, and through advocacy groups, many patients have come to insist on having access to experimental treatments, as these experimental treatments may potentially provide the best medical care available. In addition, Researchers, ethicists and public officials have recognized that because many clinical trials focused primarily on white middle-class Research subject groups, the results of some trials were of questionable value to members of other social, racial, sexual and ethnic groups. As a result both the National Institutes of Health (NIH) and FDA now require that study design include as broad a range of Research subjects as feasible and the data be analyzed to uncover responses that differ between groups. Whereas women of child-bearing potential, Pregnant Women, and nursing women previously were routinely excluded from new drug trials, it is now required that whenever possible these women be asked to make their own choices regarding participation after being fully informed of the risks of the Research. Applicable Regulations: 45 CFR § 46.111(a)(2) 45 CFR § 56.111 Page 12 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 3 INSTITUTIONAL AUTHORITY The President of Emory University has the power and authority to designate the individual within the University who may serve as the Institutional Official (IO) responsible for carrying out Emory University’s Human Research Protections Program (HRPP). The person designated as Institutional Official must meet the qualifications set forth in these IRB Policies & Procedures (P&Ps). The President of Emory University has designated the Emory IRB as the body within Emory University that has jurisdiction over all Human Subjects Research conducted under the auspices of Emory University. PROCEDURES: Appointment of the Institutional Official (IO): The President of Emory University shall appoint the IO in writing. As of the effective date of these P&Ps, the President of Emory University has appointed the person named in Appendix 1 to serve as the IO. This Appendix 1 shall be updated by the IRB Director as necessary to reflect any changes in this appointment. Qualifications of the IO: In order to be eligible for appointment as the IO, an individual must be an employee of Emory University who holds a position within the University per which he/she has the legal authority to act and speak for Emory University as a whole, and per which he/she can ensure that Emory IRB will effectively fulfill its Research oversight functions. Term of Appointment of the IO: The IO shall serve in this position, until the earlier of the date on which: The IO leaves Emory University; The IO no longer has the ability or capacity to fulfill the role of IO; The President of Emory University, at his/her discretion, requests the IO’s resignation and appoints a new IO; or Until IO tenders a resignation from the position and the President appoints a new IO. Resignation shall be required at any time at which the IO does not meet the qualifications for holding this position. Designation of Emory IRB: The President of Emory University has designated the Emory IRB as the body within Emory University that has jurisdiction over all Human Subjects Research conducted under the auspices of Emory University, as described in the provision immediately below entitled Human Subjects Research Subject to Emory IRB Authority. Human Subjects Research Subject to Emory IRB Authority: The Human Subjects Research under the auspices of Emory University that is subject to the authority of the Emory IRB includes: Page 13 of 370
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Policies & Procedures - Emory IRB - Emory University

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