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List of References for IRB Members and Staff

 

Welcome to the UCLA Office of the Human Research Protection Program (OHRPP)! Below is a list of references, in order of priority, which will help you be successful in your new position. Please review at minimum the items in the first four sections of this list, and the section on FDA if you are working with one of the Medical Institutional Review Boards (MIRBs). You will likely need to refer to these materials regularly as you gain a deeper understanding of the ethical principles, guidelines and procedures used for human research protection at UCLA.

 

Online Training Certifications

 

Please complete either the IRB Member or HRPP Staff module, as appropriate.

This training is required by UCLA for all members of the UCLA workforce within the David Geffen School of Medicine at UCLA, any UCLA hospital and Faculty Practice Group.

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The Belmont Report

 

The Belmont Report outlines and describes the three primary principles and guidelines to be addressed during the the ethical conduct of human research. As these principles and their applications are the foundation of the work we do in this office and on the IRBs, it is very important that all of us working with human research be very familiar with this document. Information about these principles is included in the CITI training.

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OHRPP Website

 

The OHRPP Website provides contact information for the staff, information about the OHRPP, policies, guidance and forms, links to other useful resources and information for prospective research subjects. IRB staff must know and IRB members are encouraged to know how to navigate and refer to the information on this site. See especially:

  • webIRB links to the OHRPP web-based IRB submission and review program.
  • OHRPP Guidance, Procedures and Policies links to information used in both screening and reviewing applications and in responding to investigator inquires. Staff will use this information to prepare correspondence conveying the IRB decisions.
  • For and About IRB Members on the OHRPP home page includes this section which provides meeting calendars, copies of the checklists used for IRB reviews, and other information targeted to members.

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Institutional Review Board Member Handbook

by Robert J. Amdur, M.D.

 

This is a small handbook provided to all IRB members and staff upon start or hire which provides an easily accessible introduction to IRBs, a description of the Full Committee IRB Meeting, and then a discussion of specific topics as well as additional references at the end. Everyone should read Parts 1 as soon as possible and Part 2 as soon as practicable. Part 3 may be referred to for specific topics.

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DHHS Office for Human Research Protection (OHRP) Website and Regulations

 

  • DHHS OHRP provides information on a wide variety of topics. It also includes a set of Frequently Asked Questions (FAQs). 
  • 45 Code of Federal Regulations 46 links to the actual federal regulations for the protection of human research subjects. These regulations are referred to and applied by the IRB members and staff on a daily basis.

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US Food and Drug Administration Guidance, Information Sheets, and Regulations

 

  • USA - FDA Guidance provides alphabetically ordered documents that are much more user friendly than the actual regulations. This information applies to studies involving FDA-regulated drugs, devices and/or biologics. 
  • 21 Code of Federal Regulations Parts 50 & 56 are the primary, though not the complete, set of FDA regulations. These apply to studies involving investigational drugs, devices or biologics. These are also the regulations most typically referred to by industry sponsors. These regulations include additional requirements above and beyond but do not conflict with 45CFR46 (see above).

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Additional References

 

  • IRB Guidebook from the federal Office for Human Research Protection (OHRP) can be downloaded from the OHRP website. 
  • Institutional Review Board: Management and Function, by Elizabeth A. Bankert and Robert J. Amdur. This is a large hard copy reference manual used to accompany the handbook mentioned in above. There are office copies available for each of the five IRB groups. Do not remove this book from the office.

Note: This is the text that most people study in order to pass the Certification for IRB Professionals (CIP) examination and is used as a reference in developing policies.

  • National Institutes of Health Health Information: This website contains a variety of information about research and health that might be useful to browse and/or review.
  • Online glossaries: These are three of the several glossaries that available for free online:
  • Acronyms Commonly Used in Human Research at UCLA
  • Protecting Study Volunteers in Research: A Manual for Investigative Sites, by Cynthia McGuire Dunn and Gary L. Chadwick. This is another manual, paperback, that IRB professionals also often refer to. There are some copies floating around the office. More copies can be ordered if there is an interest.
  • Stedman’s Medical Dictionary is a large reference dictionary. There are a few hard copies available of this dictionary throughout the office, but there is currently not one available in every location noted above.
  • California Health and Safety Code 24170-24179.5: Chapter in the state regulations that links to the Protection of Human Subjects in Medical Experimentation and includes a discussion of the Experimental Subjects Bill of Rights as well as the laws for the use of surrogates in consent.

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Page Last Updated: November 30, 2012