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El. knyga: Conducting Research with Human Participants: An IRB Guide for Students and Faculty

(California State University, Northridge, USA)
  • Formatas: EPUB+DRM
  • Išleidimo metai: 15-Feb-2022
  • Leidėjas: SAGE Publications Inc
  • Kalba: eng
  • ISBN-13: 9781544348605
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Conducting Research with Human Participants: An IRB Guide for Students and FacultyDidesnis paveikslėlis
  • Formatas: EPUB+DRM
  • Išleidimo metai: 15-Feb-2022
  • Leidėjas: SAGE Publications Inc
  • Kalba: eng
  • ISBN-13: 9781544348605
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Conducting Research with Human Participants: An IRB Guide for Students and Faculty by Nathan Durdella is the only guidebook students and faculty will need to navigate the IRB process and secure swift approval of research protocols. This book serves as an advisor to walk researchers through all the details of drafting, submission, and revision of materials for Institutional Review Boards so they can complete their research projects or dissertations faster. This text walks readers through the history of Institutional Review Boards, the contemporary context of ethical research, strategies to effectively draft, submit, and revise an IRB protocol, and guidance on working with an approved protocol in the field. The latest updates to the Common Rule and other regulatory frameworks, including special protections for working with vulnerable groups, are covered throughout the text. Not every research project goes according to plan, so adverse events and reporting receive special coverage. A final chapter on ethical research practices beyond IRB compliance encourages researchers to think through how to exit the field of research and ensure their research benefits the individuals, families, and communities in which they work. Take the guesswork out of the IRB process from start to finish with this handy guide.
Preface xiii
Acknowledgments xxiii
About the Author xxv
PART 1 START HERE: THE INSTITUTIONAL REVIEW BOARD PROCESS ON YOUR CAMPUS
1(92)
Chapter 1 Understanding Why You Submit an IRB Protocol for Review of Your Research Plans
3(36)
Learning Objectives
3(1)
Chapter Purpose
3(1)
A Brief History of Abuses of Human Research Participants in Biomedical Research in the 1920s--1950s
3(4)
Systematic Abuses in Human Experimentation in Germany and Japan
4(3)
Early World Response: The Nuremberg Code and Declaration of Helsinki
7(10)
From Absolutely Essential in the Nuremberg Code to If at All Possible in the Declaration of Helsinki: The Idea and Practice of Voluntary Consent
10(6)
Ideals: Capacity to Consent, Freedom from Coercion, and Risks/Benefits
16(1)
Human Research Participants in US Clinical Trials: From Tuskegee to Terre Haute to Guatemala
17(2)
Where US Regulations Start: The Belmont Report
19(6)
Three Ethical Principles: Respect for Persons, Beneficence, and Justice
20(1)
Respect for Persons
21(1)
Beneficence
22(1)
Justice
23(2)
The Common Rule: What 45 Code of Federal Regulations Part 46 Means for You as a Researcher
25(8)
IRB Review: Federal Policy and General Principles
29(2)
Recent Updates to the Common Rule: Major (and Minor) Changes to the Research Governance Process
31(2)
The Common Rule in Practice Today: Observations on a Regulatory System of Research Governance
33(3)
Chapter Summary
36(1)
Implications for Your Protocol: Questions to Ask Yourself
36(1)
Concepts in Focus for Your IRB Work
37(2)
Chapter 2 IRB Considerations Hidden in Your Research Study and Coursework
39(32)
Learning Objectives
39(1)
Chapter Purpose
39(1)
Check Locally: State- and Institution-Level Policies of Human Participant Research
39(5)
IRB Connections to Your Research Study
44(11)
Study Background and Initial Justification of a Project
46(2)
Anticipated Outcomes and Benefits---Connecting a Project to the Involvement of Human Research Participants
48(1)
Participant Recruitment---Sampling, Inviting, and Selecting Individuals to Participate
49(2)
Data Collection and Analysis: From Interacting with Participants to Storing and Managing Research Data
51(2)
Special Topic: Identity, Power, and Conflict in the Context of Your Study
53(2)
Human Research Participant Considerations in Your Coursework
55(14)
Leveraging Graduate or Undergraduate Classes to Conduct IRB-Approved Studies
56(1)
Link Together Work for a Sequence of Courses or Assignments Within a Course
56(2)
Negotiate with Course Instructors to Shape Course Assignments that Support Research Development
58(1)
The Principle of No Retrospective Consent
58(2)
Consent Research Participants Prospectively---in Classroom Contexts
60(4)
Thesis, Dissertation, and Capstone/Culminating Project Data Collection in Class
64(2)
Faculty Considerations for Embedding IRB Work in Classes
66(3)
Chapter Summary
69(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
69(1)
Concepts for Practice in Your IRB Work
70(1)
Chapter 3 Getting to Know Your Institutional Review Board
71(22)
Learning Objectives
71(1)
Chapter Purpose
71(1)
Campus IRBs in Historical Perspective: US Regulatory Framework for Research Governance
71(5)
IRBs Defined: Administrative Law, Technical Terms, and Practical Considerations
76(4)
Internal Operations of Campus IRBs: From Compliance Officer to Committees
80(4)
"Behind the Scenes" Influences in Local IRBs: Factors that Shape IRB Committee Decision-Making
84(4)
Insight: Getting to Know Your IRB Committee Chair, Committee Members, and Compliance Office Staff
88(4)
Chapter Summary
92(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
92(1)
Concepts in Focus for Your IRB Work
92(1)
PART 2 STRATEGIES FOR SUCCESS IN YOUR IRB PROTOCOL
93(102)
Chapter 4 Categories of Review: Classification of Your Protocol
95(20)
Learning Objectives
95(1)
Chapter Purpose
95(1)
Human Research Participant Considerations for Research Design
95(3)
Central to Your Study: Using Study Procedures to Determine Category of Review
97(1)
Determining Review Category: Full Committee, Expedited, or Exempt Review
98(7)
Exempt Research, Ethical Principles of Research, and Human Participant Research
100(1)
Likely You: Expedited Review of Research Protocols
101(3)
Full Committee Review: Be Prepared for a Longer Wait and Scrutiny from a Group of Experts
104(1)
Determinations of Protocol Review Level: Assessing Risks and Benefits
105(4)
Preparing for Protocol Review: Strategies to Minimize Risk to Participants
109(1)
A Decision Framework for Risk of Harm to Participants that Guides IRB Outcomes
110(4)
Chapter Summary
114(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
114(1)
Concepts for Practice in Your IRB Work
114(1)
Chapter 5 The Protocol Approval Process: From Draft IRB to Final Approval
115(42)
Learning Objectives
115(1)
Chapter Purpose
115(1)
Writing to Win: Grammar, Syntax, Format, and Style
115(2)
Start Here: IRB Protocol Approval from Start to Finish
117(26)
Study Background: What to Include, What to Leave Out
119(2)
Participant Recruitment and Screening
121(4)
Consenting Participants
125(9)
Audio and Video Recording: Special Requirements for Consent
134(1)
Broad Consent: Plan for the Future, Focus on Now
135(1)
Developing Data Collection Instruments and Articulating Study Interventions and Data Collection Procedures
135(4)
Weighing Risks and Benefits in Your Study
139(2)
Data Management and Storage: Tips and Tricks with Identifiable, Coded, and Deidentified Data
141(2)
The Waiting Game: Modifications Requests and Final Approval
143(12)
Common Pitfalls in Applications: Or, How to Avoid a Long List of Modification Requests
144(2)
General Themes in Feedback to Researchers from Modification Requests
146(6)
Responding to Modification Requests: What to Expect, How to Proceed, and Strategies to Negotiate Changes to a Protocol
152(3)
Chapter Summary
155(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
155(1)
Concepts in Focus for Your IRB Work
155(2)
Chapter 6 Special Protections for Vulnerable Groups
157(38)
Learning Objectives
157(1)
Chapter Purpose
157(1)
A Focus on Justice: Involving Vulnerable Groups in Research
157(2)
IRB Rules Related to Diminished Autonomy: What the Common Rule Says
159(8)
General Principles on Screening and Consenting Persons with Diminished Autonomy
164(3)
Children in Research Studies
167(10)
Considerations for Consenting: Age, Maturity, and Psychological States
170(7)
Mandated Reporting Rules with Children
177(1)
Studies Conducted with Students in Schools and on College Campuses
177(2)
Wading Through Educational Institutions, Privacy Regulations, Multiple Groups, and More than One IRB
178(1)
Working with Special Populations
179(14)
People Who Are Pregnant, Fetuses, and Neonates in Research Projects
180(2)
Research Studies Involving Individuals Who Are Imprisoned (Prisoners) or Criminal Justice System-Impacted (Protected)
182(4)
Including Individuals Who Are Cognitively Impaired (Protected) in Your Study: Limited Ability to Consent
186(4)
Individuals Who Experience Educational and Economic Disadvantage (Protected)
190(3)
Chapter Summary
193(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
193(1)
Concepts in Focus for Your IRB Work
194(1)
PART 3 APPROVED PROTOCOLS: YOUR ROLES AND RESPONSIBILITIES IN THE RESEARCH PROCESS
195(72)
Chapter 7 You're Approved to Conduct Your Study, Now What?
197(26)
Learning Objectives
197(1)
Chapter Purpose
197(1)
Using an Approved IRB Protocol in Your Research Project: Human Research Participant Implications as Next Steps in Fieldwork
197(1)
Keep Calm and Avoid Noncompliance: Approved Protocols and IRB Compliance
198(9)
Noncompliance with an Approved IRB Protocol---That Is, with IRB Guidelines
199(2)
Potential Actions and Possible Outcomes Resulting from Noncompliance with IRB Guidelines
201(6)
Amendments to Protocols: Strategies to Request Approval Modification and Avoid Noncompliance
207(9)
Observing Overlapping Sources of Change in a Study
208(2)
Anticipating Changes to Instruments and Procedures in a Study
210(1)
Updates to Participant Recruitment and Consent Procedures
210(2)
Changes to Data Collection Procedures
212(1)
Revisions to Data Collection and Participant Recruitment Instruments
212(2)
Categories of Modifications in Instruments and Procedures of a Study
214(2)
Adjustments to Data Analysis Procedures
216(1)
Protocol Renewals: The What, When, and How of Continuing Review
216(6)
Chapter Summary
222(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
222(1)
Concepts in Focus for Your IRB Work
222(1)
Chapter 8 What Happens If Something Unexpected Happens: Adverse Events and Unanticipated Problems
223(22)
Learning Objectives
223(1)
Chapter Purpose
223(1)
How to Recognize and When to Report an Unanticipated Problem and Adverse Event
223(9)
What Regulations Say About Unanticipated Problems and Adverse Events
226(6)
Resolution: Steps to Follow and Strategies to Respond During and After an Unanticipated Problem and/or Adverse Event
232(10)
Use Standard Definitions and a Decision Tree to Guide What to Report
233(1)
Identifying and Reporting Unanticipated Problems
233(1)
Identifying and Reporting Adverse Events
234(3)
Identifying and Reporting (or Not) Incidents of Noncompliance or Deviations from Approved Protocols
237(3)
Work within Reporting Timeframes on Campus
240(1)
Document in Descriptive Detail and Retain Study Records for Reporting
241(1)
Strategies to Reduce the Likelihood of Unanticipated Problems in the Field
242(1)
Chapter Summary
243(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
243(1)
Concepts in Focus for Your IRB Work
243(2)
Chapter 9 Beyond Compliance in Research Governance: Ensuring Your Work with Human Research Participants Benefits Individuals, Families, and Communities
245(22)
Learning Objectives
245(1)
Chapter Purpose
245(1)
Ending Data Collection and Leaving the Field: How to Negotiate Closure and Manage Data
245(10)
Approaches to Strengthen Relationships with Participants During and at the End of Data Collection
247(4)
Maintaining Relationships: A Relational Approach and Participatory Work in the Field
251(4)
Using a Relational Approach to Exit the Field and Transition from Data Collection to Data Analysis
255(10)
General Strategies to Work Relationally at the End of Data Collection
256(3)
Doing Member Checks in the Context of a Participatory Research Project
259(2)
Consulting with a Community Advisory Board to Support Collaborative Research Work
261(4)
Chapter Summary
265(1)
Implications for Your Protocol: Reflective Questions to Ask Yourself
265(1)
Concepts in Focus for Your IRB Work
266(1)
Appendix: Sample IRB Protocol 267(20)
References 287(10)
Index 297
Nathan Durdella (he/him/his) works to enhance graduate education and advance support for students in masters and doctoral degree programs. Nathan writes about qualitative research methodology, human participant research, and family socialization and parent relationships with children who are students in graduate school. Nathan has published two books with SAGE Publishing Inc.Conducting Research with Human Participants: An IRB Guide for Students and Faculty (2023) and Qualitative Dissertation Methodology: A Guide for Research Design and Procedures (2019)and has previously authored or co-authored journal articles, chapters in edited volumes, blog posts, and more. Nathan is a professor in the Department of Educational Leadership & Policy Studies at California State University, Northridge (CSUN), where he advises doctoral students, supervises doctoral student dissertation studies, and teaches graduate-level courses. In addition, Nathan currently serves as director of the education doctorate program at CSUN and enjoys guiding doctoral students on their journeys. Nathan has a bachelors degree in sociology and political science, a masters degree in Latin American studies, a masters degree in education, and a Ph.D. in educationall from UCLA.
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