Institutional Review Board (IRB) Resource Guide ______________________________ The IRB Resource Guide was compiled by Ada Sue Selwitz and Jennifer Harris, University of Kentucky Updated August 2014 Copyright 2014 by Public Responsibility in Medicine and Research (PRIM&R), Inc. All rights reserved. This book or parts thereof may not be used or reproduced in any manner without written permission. 2014 IRB Resource Guide: Table of Contents Page Ethics of Human Subjects Research.…………………………………………….. 1-24 Nuremburg Code.……………………………………………………….… 1 Declaration of Helsinki...…………………………………………………. 2 Belmont Report.………………………………………………….……….. 10 Council for International Organizations of Medical Sciences……………. 22 Basic IRB Regulations.……………………………………………………………. 25-80 FDA 21 CFR 50.………………………………………………………….. 25 FDA 21 CFR 56..………..………………………………………….…….. 40 DHHS 45 CFR 46.………..………………………………………………. 53 Selected Auxiliary Regulations/Policy …………..………………………………………... 81-298 Department of Health and Human Services (DHHS).………………..…. 81-166 OHRP Human Research FAQs……...…………………………... 81 OHRP Compliance Activities – Common Findings & Guidance… 149 Food and Drug Administration (FDA).………………………………... 167-270 21 CFR 312 Investigational New Drug Application ...…………... 167 21 CFR 812 Investigational Device Exemptions ........…………… 221 Acute Care Waiver of Informed Consent Reference …………….. 246 Summary of FDA Regulations on Exemption from IND Requirements…………………....………………………………... 251 Summary of FDA Regulations on Investigational Device Exemptions and Exemption from IDE Requirements……………. 261 Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices……………………………. 265 Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drugs……………………………… 268 FDA Bioresearch Monitoring Program.………………………….. 270 Other Selected Agency Information…...……………………………….. 271-298 Summary of Requirements for Department of Defense Supported Human Research………………………………………………….. 271 U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA).…………………………………………………………… 277 Summary of Department of Education (DoED) Requirements…... 280 Summary of Department of Energy (DoE) Requirements………... 282 Summary of Department of Justice (DoJ), National Institute of Justice (NIJ), and Bureau of Prisons (BoP) Requirements……… 284 U.S. Department of Veteran Affairs……………………………… 289 Summary of Environmental Protection Agency (EPA) Requirements……………………………………………………... 290 University of Kentucky (UK) Family Educational Rights and Privacy Act (FERPA) Guidance...................................................... 294 Table of Contents (Continued) Page IRB Expedited and Exemption Review Mechanisms …………………………... 299-312 Issues to be Addressed When Conducting Exempt Review…………….... 299 Issues to be Addressed When Conducting Expedited Review.…………... 309 Educational Materials and Useful References ………………………………….. 313-335 Educational Materials…...………………………………………………... 313 OHRP LISTSERV………………………………………………………... 320 Electronic/Web Sites……………………………………………………… 321 OHRP Contacts.……………………………………….……………………….... 326 FDA Contacts.………………………………....…………………………. 329 U.S. Department of Veterans Affairs Contacts.………………………….. 333 Return to TOC Return to TOC http://www.hhs.gov/ohrp/archive/nurcode.html Accessed 07/22/14 The Nuremberg Code 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible. 10. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.] Return to TOC 1 Return to TOC http://www.wma.net/en/30publications/10policies/b3/ Accessed July 22, 2014 WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59th WMA General Assembly, Seoul, Republic of Korea, October 2008 64th WMA General Assembly, Fortaleza, Brazil, October 2013 Preamble 1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. 2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles. General Principles 3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of 2 http://www.wma.net/en/30publications/10policies/b3/ Accessed July 22, 2014 “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.” 4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty. 5. Medical progress is based on research that ultimately must include studies involving human subjects. 6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. 7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. 8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights