Conducting research with human participants: an IRB guide for students and faculty
Gespeichert in:
1. Verfasser: | |
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Format: | Buch |
Sprache: | English |
Veröffentlicht: |
Los Angeles ; London ; New Delhi ; Singapore ; Washington, DC ; Melbourne
SAGE
[2023]
|
Schlagworte: | |
Online-Zugang: | Inhaltsverzeichnis |
Beschreibung: | xxv, 302 Seiten Illustrationen, Diagramme 24 cm |
ISBN: | 9781544348636 1544348630 |
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adam_text | Detailed Contents Preface xiii Acknowledgments xxiii About the Author xxv PART 1 START HERE: THE INSTITUTIONAL REVIEW BOARD PROCESS ON YOUR CAMPUS 1 Chapter 1 Understanding Why You Submit an IRB Protocol for Review of Your Research Plans 3 Learning Objectives 3 Chapter Purpose 3 A Brief History of Abuses of Human Research Participants in Biomedical Research in the 1920s-1950s 3 Systematic Abuses in Human Experimentation in Germany and Japan 4 Early World Response: The Nuremberg Code and Declaration of Helsinki From Absolutely Essential in the Nuremberg Code to If at AH Possible in the Declaration of Helsinki·. The Idea and Practice of Voluntary Consent Ideals: Capacity to Consent, Freedom from Coercion, and Risks/Benefits 7 10 16 Human Research Participants in US Clinical Thals: From Tuskegee to Terre Haute to Guatemala 17 Where US Regulations Start: The Belmont Report 19 Three Ethical Principles: Respect for Persons, Beneficence, and Justice 20 Respect for Persons 21 Beneficence 22 Justice 23 The Common Rule: What 45 Code of Federal Regulations Part 46 Means for You as a Researcher IRB Review: Federal Policy and General Principles 25 29 Recent Updates to the Common Rule: Major (and Minor) Changes to the Research Governance Process 31 v
The Common Rule in Practice Today: Observations on a Regulatory System of Research Governance 33 Chapter Summary 36 Implications for Your Protocol: Questions to Ask Yourself 36 Concepts in Focus for Your IRB Work 37 Chapter 2 IRB Considerations Hidden in Your Research Study and Coursework 39 Learning Objectives 39 Chapter Purpose 39 Check Locally: State- and Institution-Level Policies of Human Participant Research 39 IRB Connections to Your Research Study 44 Study Background and Initial Justification of aProject 46 Anticipated Outcomes and Benefits—Connecting a Project to the Involvement of Human Research Participants 48 Participant Recruitment—Sampling, Inviting, and Selecting Individuals to Participate 49 Data Collection and Analysis: From Interacting with Participants to Storing and Managing Research Data 51 Special Topic: Identity, Power, and Conflict in the Context of Your Study 53 Human Research Participant Considerations in Your Coursework 55 Leveraging Graduate or Undergraduate Classes to Conduct IRB-Approved Studies 56 Link Together Work for a Sequence of Courses or Assignments Within a Course Negotiate with Course Instructors to Shape Course Assignments that Support Research Development The Principle of No Retrospective Consent Consent Research Participants Prospectively—in Classroom Contexts 56 58 58 60 Thesis, Dissertation, and Capstone/Culminating Project Data Collection in Class 64 Faculty Considerations for Embedding IRBWork in Classes 66 Chapter Summary 69 Implications for Your Protocol: Reflective Questions to Ask Yourself 69 Concepts for Practice in Your
IRBWork 70
Chapter 3 Getting to Know Your Institutional Review Board 71 Learning Objectives 71 Chapter Purpose 71 Campus IRBs in Historical Perspective: US Regulatory Framework for Research Governance 71 IRBs Defined: Administrative Law, Technical Terms, and Practical Considerations 76 Internal Operations of Campus IRBs: From Compliance Officer to Committees 80 Behind the Scenes” Influences in Local IRBs: Factors that Shape IRB Committee Decision-Making 84 Insight: Getting to Know Your IRB Committee Chair, Committee Members, and Compliance Office Staff 88 Chapter Summary 92 Implications for Your Protocol: Reflective Questions to Ask Yourself 92 Concepts in Focus for Your IRB Work 92 PART 2 STRATEGIES FOR SUCCESS IN YOUR IRB PROTOCOL 93 Chapter 4 Categories of Review: Classification of Your Protocol 95 Learning Objectives 95 Chapter Purpose 95 Human Research Participant Considerations for Research Design Central to Your Study: Using Study Procedures to Determine Category of Review Determining Review Category: Full Committee, Expedited, or Exempt Review Exempt Research, Ethical Principles of Research, and Human Participant Research Likely You: Expedited Review of Research Protocols 95 97 Ә8 100 101
Full Committee Review: Be Prepared for a Longer Wait and Scrutiny from a Group of Experts 104 Determinations of Protocol Review Level: Assessing Risks and Benefits 105 Preparing for Protocol Review: Strategies to Minimize Risk to Participants 109 A Decision Framework for Risk of Harm to Participants that Guides IRB Outcomes 110 Chapter Summary 114 Implications for Your Protocol: Reflective Questions to Ask Yourself 114 Concepts for Practice in Your IRB Work 114 Chapter 5 The Protocol Approval Process·. From Draft IRB to Final Approval 115 Learning Objectives 115 Chapter Purpose 115 Writing to Win: Grammar, Syntax, Format, and Style 115 Start Here: IRB Protocol Approval from Start to Finish 117 Study Background: What to Include, What to Leave Out 119 Participant Recruitment and Screening 121 Consenting Participants 125 Audio and Video Recording: Special Requirements for Consent 134 Broad Consent: Plan for the Future, Focus on Now 135 Developing Data Collection Instruments and Articulating Study Interventions and Data Collection Procedures 135 Weighing Risks and Benefits in Your Study 139 Data Management and Storage: Tips and Tricks with Identifiable, Coded, and Deidentified Data The Waiting Game: Modifications Requests and Final Approval 141 143 Common Pitfalls in Applications: Or, How to Avoid a Long List of Modification Requests 144 General Themes in Feedback to Researchers from Modification Requests 146 Responding to Modification Requests: What to Expect, How to Proceed, and Strategies to Negotiate Changes to a Protocol 152
Chapter Summary 155 Implications for Your Protocol: Reflective Questions to Ask Yourself 155 Concepts in Focus for Your IRB Work 155 Chapter 6 Special Protections for Vulnerable Groups 157 Learning Objectives 157 Chapter Purpose 157 A Focus on Justice: Involving Vulnerable Groups in Research 157 IRB Rules Related to Diminished Autonomy: What the Common Rule Says 159 General Principles on Screening and Consenting Persons with Diminished Autonomy 164 Children in Research Studies 167 Considerations for Consenting: Age, Maturity, and Psychological States 170 Mandated Reporting Rules with Children 177 Studies Conducted with Students in Schools and on College Campuses Wading Through Educational Institutions, Privacy Regulations, Multiple Groups, and More than One IRB Working with Special Populations 177 178 179 People Who Are Pregnant, Fetuses, and Neonates in Research Projects 180 Research Studies Involving Individuals Who Are Imprisoned (Prisoners) or Criminal Justice System-Impacted (Protected) 182 Including Individuals Who Are Cognitively Impaired (Protected) in Your Study: Limited Ability to Consent 186 Individuals Who Experience Educational and Economic Disadvantage (Protected) 190 Chapter Summary 193 Implications for Your Protocol: Reflective Questions to Ask Yourself 193 Concepts in Focus for Your IRB Work 194
PART 3 APPROVED PROTOCOLS: YOUR ROLES AND RESPONSIBILITIES IN THE RESEARCH PROCESS Chapter 7 You’re Approved to Conduct Your Study, Now What? 195 197 Learning Objectives 197 Chapter Purpose 197 Using an Approved IRB Protocol in Your Research Project: Human Research Participant Implications as Next Steps in Fieldwork 197 Keep Calm and Avoid Noncompliance: Approved Protocols and IRB Compliance 198 Noncompliance with an Approved IRB Protocol—That Is, with IRB Guidelines 199 Potential Actions and Possible Outcomes Resulting from Noncompliance with IRB Guidelines 201 Amendments to Protocols: Strategies to Request Approval Modification and Avoid Noncompliance Observing Overlapping Sources of Change in a Study Anticipating Changes to Instruments and Procedures in a Study 207 208 210 Updates to Participant Recruitment and Consent Procedures 210 Changes to Data Collection Procedures 212 Revisions to Data Collection and Participant Recruitment Instruments 212 Categories of Modifications in Instruments and Procedures of a Study Adjustments to Data Analysis Procedures 214 216 Protocol Renewals: The What, When, and How of Continuing Review 216 Chapter Summary 222 Implications for Your Protocol: Reflective Questions to Ask Yourself 222 Concepts in Focus for Your IRB Work 222 Chapter 8 What Happens If Something Unexpected Happens: Adverse Events and Unanticipated Problems 223 Learning Objectives 223 Chapter Purpose 223
How to Recognize and When to Report an Unanticipated Problem and Adverse Event What Regulations Say About Unanticipated Problems and Adverse Events Resolution: Steps to Follow and Strategies to Respond During and After an Unanticipated Problem and/or Adverse Event Use Standard Definitions and a Decision Tree to Guide What to Report 223 226 232 233 Identifying and Reporting Unanticipated Problems 233 Identifying and Reporting Adverse Events 234 Identifying and Reporting (or Not) Incidents of Noncompliance or Deviations from Approved Protocols 237 Work within Reporting Timeframes on Campus 240 Document in Descriptive Detail and Retain Study Records for Reporting 241 Strategies to Reduce the Likelihood of Unanticipated Problems in the Field 242 Chapter Summary 243 Implications for Your Protocol: Reflective Questions to Ask Yourself 243 Concepts in Focus for Your IRB Work 243 Chapter 9 Beyond Compliance in Research Governance.· Ensuring Your Work with Human Research Participants Benefits Individuals, Families, and Communities 245 Learning Objectives 245 Chapter Purpose 245 Ending Data Collection and Leaving the Field: How to Negotiate Closure and Manage Data 245 Approaches to Strengthen Relationships with Participants During and at the End of Data Collection 247 Maintaining Relationships: A Relational Approach and Participatory Work in the Field 251 Using a Relational Approach to Exit the Field and Transition from Data Collection to Data Analysis 255 General Strategies to Work Relationally at the End of Data Collection 256 Doing Member Checks in the Context of a Participatory
Research Project 259 Consulting with a Community Advisory Board to Support Collaborative Research Work 261
Chapter Summary 265 Implications for Your Protocol: Reflective Questions to Ask Yourself 265 Concepts in Focus for Your IRB Work 266 Appendix: Sample IRB Protocol 267 References 287 Index 297
|
adam_txt |
Detailed Contents Preface xiii Acknowledgments xxiii About the Author xxv PART 1 START HERE: THE INSTITUTIONAL REVIEW BOARD PROCESS ON YOUR CAMPUS 1 Chapter 1 Understanding Why You Submit an IRB Protocol for Review of Your Research Plans 3 Learning Objectives 3 Chapter Purpose 3 A Brief History of Abuses of Human Research Participants in Biomedical Research in the 1920s-1950s 3 Systematic Abuses in Human Experimentation in Germany and Japan 4 Early World Response: The Nuremberg Code and Declaration of Helsinki From Absolutely Essential in the Nuremberg Code to If at AH Possible in the Declaration of Helsinki·. The Idea and Practice of Voluntary Consent Ideals: Capacity to Consent, Freedom from Coercion, and Risks/Benefits 7 10 16 Human Research Participants in US Clinical Thals: From Tuskegee to Terre Haute to Guatemala 17 Where US Regulations Start: The Belmont Report 19 Three Ethical Principles: Respect for Persons, Beneficence, and Justice 20 Respect for Persons 21 Beneficence 22 Justice 23 The Common Rule: What 45 Code of Federal Regulations Part 46 Means for You as a Researcher IRB Review: Federal Policy and General Principles 25 29 Recent Updates to the Common Rule: Major (and Minor) Changes to the Research Governance Process 31 v
The Common Rule in Practice Today: Observations on a Regulatory System of Research Governance 33 Chapter Summary 36 Implications for Your Protocol: Questions to Ask Yourself 36 Concepts in Focus for Your IRB Work 37 Chapter 2 IRB Considerations Hidden in Your Research Study and Coursework 39 Learning Objectives 39 Chapter Purpose 39 Check Locally: State- and Institution-Level Policies of Human Participant Research 39 IRB Connections to Your Research Study 44 Study Background and Initial Justification of aProject 46 Anticipated Outcomes and Benefits—Connecting a Project to the Involvement of Human Research Participants 48 Participant Recruitment—Sampling, Inviting, and Selecting Individuals to Participate 49 Data Collection and Analysis: From Interacting with Participants to Storing and Managing Research Data 51 Special Topic: Identity, Power, and Conflict in the Context of Your Study 53 Human Research Participant Considerations in Your Coursework 55 Leveraging Graduate or Undergraduate Classes to Conduct IRB-Approved Studies 56 Link Together Work for a Sequence of Courses or Assignments Within a Course Negotiate with Course Instructors to Shape Course Assignments that Support Research Development The Principle of No Retrospective Consent Consent Research Participants Prospectively—in Classroom Contexts 56 58 58 60 Thesis, Dissertation, and Capstone/Culminating Project Data Collection in Class 64 Faculty Considerations for Embedding IRBWork in Classes 66 Chapter Summary 69 Implications for Your Protocol: Reflective Questions to Ask Yourself 69 Concepts for Practice in Your
IRBWork 70
Chapter 3 Getting to Know Your Institutional Review Board 71 Learning Objectives 71 Chapter Purpose 71 Campus IRBs in Historical Perspective: US Regulatory Framework for Research Governance 71 IRBs Defined: Administrative Law, Technical Terms, and Practical Considerations 76 Internal Operations of Campus IRBs: From Compliance Officer to Committees 80 "Behind the Scenes” Influences in Local IRBs: Factors that Shape IRB Committee Decision-Making 84 Insight: Getting to Know Your IRB Committee Chair, Committee Members, and Compliance Office Staff 88 Chapter Summary 92 Implications for Your Protocol: Reflective Questions to Ask Yourself 92 Concepts in Focus for Your IRB Work 92 PART 2 STRATEGIES FOR SUCCESS IN YOUR IRB PROTOCOL 93 Chapter 4 Categories of Review: Classification of Your Protocol 95 Learning Objectives 95 Chapter Purpose 95 Human Research Participant Considerations for Research Design Central to Your Study: Using Study Procedures to Determine Category of Review Determining Review Category: Full Committee, Expedited, or Exempt Review Exempt Research, Ethical Principles of Research, and Human Participant Research Likely You: Expedited Review of Research Protocols 95 97 Ә8 100 101
Full Committee Review: Be Prepared for a Longer Wait and Scrutiny from a Group of Experts 104 Determinations of Protocol Review Level: Assessing Risks and Benefits 105 Preparing for Protocol Review: Strategies to Minimize Risk to Participants 109 A Decision Framework for Risk of Harm to Participants that Guides IRB Outcomes 110 Chapter Summary 114 Implications for Your Protocol: Reflective Questions to Ask Yourself 114 Concepts for Practice in Your IRB Work 114 Chapter 5 The Protocol Approval Process·. From Draft IRB to Final Approval 115 Learning Objectives 115 Chapter Purpose 115 Writing to Win: Grammar, Syntax, Format, and Style 115 Start Here: IRB Protocol Approval from Start to Finish 117 Study Background: What to Include, What to Leave Out 119 Participant Recruitment and Screening 121 Consenting Participants 125 Audio and Video Recording: Special Requirements for Consent 134 Broad Consent: Plan for the Future, Focus on Now 135 Developing Data Collection Instruments and Articulating Study Interventions and Data Collection Procedures 135 Weighing Risks and Benefits in Your Study 139 Data Management and Storage: Tips and Tricks with Identifiable, Coded, and Deidentified Data The Waiting Game: Modifications Requests and Final Approval 141 143 Common Pitfalls in Applications: Or, How to Avoid a Long List of Modification Requests 144 General Themes in Feedback to Researchers from Modification Requests 146 Responding to Modification Requests: What to Expect, How to Proceed, and Strategies to Negotiate Changes to a Protocol 152
Chapter Summary 155 Implications for Your Protocol: Reflective Questions to Ask Yourself 155 Concepts in Focus for Your IRB Work 155 Chapter 6 Special Protections for Vulnerable Groups 157 Learning Objectives 157 Chapter Purpose 157 A Focus on Justice: Involving Vulnerable Groups in Research 157 IRB Rules Related to Diminished Autonomy: What the Common Rule Says 159 General Principles on Screening and Consenting Persons with Diminished Autonomy 164 Children in Research Studies 167 Considerations for Consenting: Age, Maturity, and Psychological States 170 Mandated Reporting Rules with Children 177 Studies Conducted with Students in Schools and on College Campuses Wading Through Educational Institutions, Privacy Regulations, Multiple Groups, and More than One IRB Working with Special Populations 177 178 179 People Who Are Pregnant, Fetuses, and Neonates in Research Projects 180 Research Studies Involving Individuals Who Are Imprisoned (Prisoners) or Criminal Justice System-Impacted (Protected) 182 Including Individuals Who Are Cognitively Impaired (Protected) in Your Study: Limited Ability to Consent 186 Individuals Who Experience Educational and Economic Disadvantage (Protected) 190 Chapter Summary 193 Implications for Your Protocol: Reflective Questions to Ask Yourself 193 Concepts in Focus for Your IRB Work 194
PART 3 APPROVED PROTOCOLS: YOUR ROLES AND RESPONSIBILITIES IN THE RESEARCH PROCESS Chapter 7 You’re Approved to Conduct Your Study, Now What? 195 197 Learning Objectives 197 Chapter Purpose 197 Using an Approved IRB Protocol in Your Research Project: Human Research Participant Implications as Next Steps in Fieldwork 197 Keep Calm and Avoid Noncompliance: Approved Protocols and IRB Compliance 198 Noncompliance with an Approved IRB Protocol—That Is, with IRB Guidelines 199 Potential Actions and Possible Outcomes Resulting from Noncompliance with IRB Guidelines 201 Amendments to Protocols: Strategies to Request Approval Modification and Avoid Noncompliance Observing Overlapping Sources of Change in a Study Anticipating Changes to Instruments and Procedures in a Study 207 208 210 Updates to Participant Recruitment and Consent Procedures 210 Changes to Data Collection Procedures 212 Revisions to Data Collection and Participant Recruitment Instruments 212 Categories of Modifications in Instruments and Procedures of a Study Adjustments to Data Analysis Procedures 214 216 Protocol Renewals: The What, When, and How of Continuing Review 216 Chapter Summary 222 Implications for Your Protocol: Reflective Questions to Ask Yourself 222 Concepts in Focus for Your IRB Work 222 Chapter 8 What Happens If Something Unexpected Happens: Adverse Events and Unanticipated Problems 223 Learning Objectives 223 Chapter Purpose 223
How to Recognize and When to Report an Unanticipated Problem and Adverse Event What Regulations Say About Unanticipated Problems and Adverse Events Resolution: Steps to Follow and Strategies to Respond During and After an Unanticipated Problem and/or Adverse Event Use Standard Definitions and a Decision Tree to Guide What to Report 223 226 232 233 Identifying and Reporting Unanticipated Problems 233 Identifying and Reporting Adverse Events 234 Identifying and Reporting (or Not) Incidents of Noncompliance or Deviations from Approved Protocols 237 Work within Reporting Timeframes on Campus 240 Document in Descriptive Detail and Retain Study Records for Reporting 241 Strategies to Reduce the Likelihood of Unanticipated Problems in the Field 242 Chapter Summary 243 Implications for Your Protocol: Reflective Questions to Ask Yourself 243 Concepts in Focus for Your IRB Work 243 Chapter 9 Beyond Compliance in Research Governance.· Ensuring Your Work with Human Research Participants Benefits Individuals, Families, and Communities 245 Learning Objectives 245 Chapter Purpose 245 Ending Data Collection and Leaving the Field: How to Negotiate Closure and Manage Data 245 Approaches to Strengthen Relationships with Participants During and at the End of Data Collection 247 Maintaining Relationships: A Relational Approach and Participatory Work in the Field 251 Using a Relational Approach to Exit the Field and Transition from Data Collection to Data Analysis 255 General Strategies to Work Relationally at the End of Data Collection 256 Doing Member Checks in the Context of a Participatory
Research Project 259 Consulting with a Community Advisory Board to Support Collaborative Research Work 261
Chapter Summary 265 Implications for Your Protocol: Reflective Questions to Ask Yourself 265 Concepts in Focus for Your IRB Work 266 Appendix: Sample IRB Protocol 267 References 287 Index 297 |
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author | Durdella, Nathan |
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discipline_str_mv | Gesundheitswissenschaften Psychologie |
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illustrated | Illustrated |
index_date | 2024-07-03T19:49:29Z |
indexdate | 2024-07-10T09:32:12Z |
institution | BVB |
isbn | 9781544348636 1544348630 |
language | English |
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publisher | SAGE |
record_format | marc |
spelling | Durdella, Nathan Verfasser (DE-588)1160444986 aut Conducting research with human participants an IRB guide for students and faculty Nathan Durdella, California State University, Northridge Los Angeles ; London ; New Delhi ; Singapore ; Washington, DC ; Melbourne SAGE [2023] xxv, 302 Seiten Illustrationen, Diagramme 24 cm txt rdacontent n rdamedia nc rdacarrier Psychologie (DE-588)4047704-6 gnd rswk-swf Versuchsperson (DE-588)4124401-1 gnd rswk-swf Wissenschaftsethik (DE-588)4066602-5 gnd rswk-swf Menschenversuch (DE-588)4038649-1 gnd rswk-swf Human experimentation in psychology / Evaluation Human experimentation in psychology / Moral and ethical aspects Institutional review boards Expérimentation humaine en psychologie / Évaluation Expérimentation humaine en psychologie / Aspect moral Psychologie (DE-588)4047704-6 s Menschenversuch (DE-588)4038649-1 s Versuchsperson (DE-588)4124401-1 s Wissenschaftsethik (DE-588)4066602-5 s DE-604 Erscheint auch als Online-Ausgabe 978-1-5443-4861-2 Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033594961&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
spellingShingle | Durdella, Nathan Conducting research with human participants an IRB guide for students and faculty Psychologie (DE-588)4047704-6 gnd Versuchsperson (DE-588)4124401-1 gnd Wissenschaftsethik (DE-588)4066602-5 gnd Menschenversuch (DE-588)4038649-1 gnd |
subject_GND | (DE-588)4047704-6 (DE-588)4124401-1 (DE-588)4066602-5 (DE-588)4038649-1 |
title | Conducting research with human participants an IRB guide for students and faculty |
title_auth | Conducting research with human participants an IRB guide for students and faculty |
title_exact_search | Conducting research with human participants an IRB guide for students and faculty |
title_exact_search_txtP | Conducting research with human participants an IRB guide for students and faculty |
title_full | Conducting research with human participants an IRB guide for students and faculty Nathan Durdella, California State University, Northridge |
title_fullStr | Conducting research with human participants an IRB guide for students and faculty Nathan Durdella, California State University, Northridge |
title_full_unstemmed | Conducting research with human participants an IRB guide for students and faculty Nathan Durdella, California State University, Northridge |
title_short | Conducting research with human participants |
title_sort | conducting research with human participants an irb guide for students and faculty |
title_sub | an IRB guide for students and faculty |
topic | Psychologie (DE-588)4047704-6 gnd Versuchsperson (DE-588)4124401-1 gnd Wissenschaftsethik (DE-588)4066602-5 gnd Menschenversuch (DE-588)4038649-1 gnd |
topic_facet | Psychologie Versuchsperson Wissenschaftsethik Menschenversuch |
url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033594961&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
work_keys_str_mv | AT durdellanathan conductingresearchwithhumanparticipantsanirbguideforstudentsandfaculty |