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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
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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
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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
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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