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The Institutional Review Board Policies and Procedures Manual for Research with Human Subjects Updated 8/2017 Office of the Vice President for Research Human Research Protection Program Lubbock, TX 79409- 1075 Phone (806) 742-2064 Fax (806) 742-3947 http://www.hrpp.ttu.edu

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  • The Inst itutional Review Board Pol ic ies and Procedures Manual

    for Research with Human Subjects

    Updated 8/2017

    Office of the Vice President for Research Human Research Protection Program Lubbock, TX 79409- 1075 Phone (806) 742-2064 Fax (806) 742-3947 http://www.hrpp.ttu.edu

    http://www.hrpp.ttu.edu/

  • Texas Tech University | Institutional Review Board | Revised: 08/14/2017 | Page i

    TABLE OF CONTENTS Section 1: Introduction

    1.0 Background .................................................................................................................... 1

    1.1 Institutional Review Board ............................................................................................ 1

    1.1.1 Administration of Research Ethics at Texas Tech University................................ 1

    1.1.2 Composition of the Institutional Review Board ................................................... 2

    Section 2: The IRB and Training

    2.0 Committee Members ..................................................................................................... 3

    2.1 Education/Training ........................................................................................................ 6

    Section 3: Institutional Review Board Procedures

    3.0 Does the project involve human subjects research? ..................................................... 7

    3.1 Proposal Processing and Assignments........................................................................... 9

    3.2 Types of Proposals ........................................................................................................ 9

    3.2.1 Exempt Proposals ............................................................................................... 10

    3.2.2 Expedited Proposals ........................................................................................... 10

    3.2.3 Full Board Proposals ........................................................................................... 10

    3.3 Review Criteria ............................................................................................................. 11

    3.4 Appeals of IRB Decisions .............................................................................................. 12

    Section 4: Background of Proposals

    4.0 General......................................................................................................................... 13

    4.1 IRB Approval from TTUHSC and other Institutions ..................................................... 13

    4.2 Proposals involving external funding . 13

    4.3 Payment to research subjects .. ..14

    4.4 Recruiting of Subjects by Subjects .. .14

    4.5 Risk . 14

    4.6 Electronic Data Policy.... 14

  • Texas Tech University | Institutional Review Board | Revised: 08/14/2017 | Page ii

    4.7 Subject Pools15

    Section 5: Preparing and Submitting Proposals

    5.0. About Proposals ................................................................................................. 16

    5.1 Recruiting materials ..16

    5.2. Informed Consent ....................................................................................................... 17

    5.2.1 Written Consent Form ........................................................................................ 17

    5.2.2 Elements of Consent ........................................................................................... 18

    5.2.3 Multiple Form Written Consent Part I, Part II and Part III ............................... 18

    5.2.4. Internet Research Consent ................................................................................ 18

    5.2.5 Waiver or Alteration of the Elements of Consent .............................................. 18

    5.2.6 Waiver of Written Consent Form ....................................................................... 19

    5.3 Continuing Review, Annual Progress Reports, and Termination of Projects .............. 19

    5.4 Reporting Adverse Events or Noncompliance ............................................................. 21

    5.5 Modifications to Approved Protocols .......................................................................... 21

    Section 6: Procedures for Research with Vulnerable Populations

    6.0 Protected Populations in Research .............................................................................. 22

    6.1 Inclusion of Fetuses, Pregnant Women, and Human In Vitro Fertilization ................. 22

    6.2 Inclusion of Children in Research ................................................................................ 22

    6.3 Inclusion of Prisoners in Research ............................................................................... 22

    6.4 Inclusion of People with Limited Competence ............................................................ 23

    Appendices

    A. Nuremberg Code.......................................................................................................... 25 B. The Belmont Report ..................................................................................................... 27 C. 45 CFR 46 ................................................................................................................... 39 D. 63 FR 60364-60367, November 9, 1998 ...................................................................... 70 E. Memorandum of Understanding between Texas Tech University and Texas Tech

    University Health Sciences Center ............................................................................... 73

  • Texas Tech University | Institutional Review Board | Revised: 08/14/2017 | Page i

    F. Electronic Data Policy Statement ................................................................................ 76

    G. Example Cayuse Proposal for Research Using Human Subjects.................................. 79

    H. Required Elements of Consent .................................................................................. 112

    I. Reviewer Checklist for IRB Proposals ........................................................................ 114

    J. Recruiting Materials . ........................................................................................ 116

    K. Consent Form Instructions, Examples, Assent Form, and Waivers ........................... 121

    L. IRB Approval Criteria for Prisoner Research .............................................................. 134

  • Texas Tech University | Institutional Review Board | Revised: 08/14/2017 | Page 1

    Section 1: Introduction

    1.0 Background

    Federal regulation of human subjects research began in 1971. With the background of the

    Nuremberg Code, shown in Appendix A, in 1974 the National Research Act created the National

    Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. This

    law required every institution applying for federal funds for the conduct of human research to

    establish an Institutional Review Board (IRB) to protect the rights of the human subjects

    involved in biomedical and behavioral research.

    After meetings at the Smithsonian Institutions Belmont Conference Center in 1976 and

    extensive deliberations over the next three years, the National Commission for the Protection of

    Human Subjects of Biomedical and Behavioral Research issued a 1979 statement, Ethical

    Principles and Guidelines for the Protection of Human Subjects of Research, (The Belmont

    Report, Appendix B), laying out basic ethical principles to assist individuals in resolving ethical

    issues in the conduct of research with human subjects. In 1981, the Food and Drug

    Administration (FDA) and the National Institutes of Health (NIH) set forth the regulatory

    standards for the protection of human subjects and for the operation of Institutional Review

    Boards. In 1983, the U.S. Department of Health and Human Services (DHHS) issued new

    regulations and mandated special protection for vulnerable populations such as prisoners and

    children. In 1989, the National Institutes of Health became the coordinator of all the human

    subjects protection activity of the federal government through what is now known as the Office

    for Human Research Protections (OHRP). In 1991, OHRP issued regulations to protect human

    subjects in research (Title 45 of the Code of Federal Regulations, Part 46, Appendix C). It is

    these regulations, also known as 45 CFR 46 or the Common Rule, that govern human research

    activity at Texas Tech University.

    To certify that Texas Tech complies with these federal regulations, the university has filed a

    Federalwide Assurance (FWA 00001568; expires 7/19/2020). The assurance commits the

    university, the Instit