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Managing Human Subjects Research Projects: A Tool Kit for Project Managers

Table of Contents

Introduction

1.	Staffing Research Projects 1.1 Hiring Staff 1.2 Orienting and Training Staff 1.3 Supervising Staff 1.4 Delegating Responsibilities 1.5 Increasing Staff Motivation
2.	Involving Community Members in Health Research 2.1 Involving Community Members in the Research Process 2.2 Recruiting Community Advisors 2.3 Interacting with Community Partners 2.4 Promoting your Research Study 2.5 Linking the Community with Resources 2.6 Disseminating Research Findings to the Community 2.7 Establishing and Maintaining University/Community Subcontracts
3.	Regulatory Guidelines for Human Subjects Research 3.1 The Federal Institutional Review (IRB) Guidebook 3.2 The Office for Human Research Protections (OHRP) Policy Guidance 3.3 The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 3.4 Working with the Office of Protection for Research Subjects at Your Institution 3.5 Attending Ethics and Human Subjects Training 3.6 Submitting and Maintaining IRB Approval 3.7 Reporting and Identifying Adverse Events
4.	Fielding Research Projects 4.1 Managing Data Collection 4.2 Recruiting and Retaining Respondents 4.3 Reviewing Data Quality 4.4 Collecting Biological Samples
5.	Preparing for Data Collection 5.1 Establishing the Study Design, Timeline and Budget 5.2 Designing the Study Questionnaire and Qualitative Data Guides 5.3 Drafting and Documenting Research Procedures 5.4 Developing a Study Procedures Manual and Codebook 5.5 Effective Communication and Meeting Facilitation Strategies
6.	Finalizing Data Collection 6.1 Collecting Post-Interview Data 6.2 Preparing Final Deliverables 6.3 Preparing a Methodological Report 6.4 Reporting Study Outcomes

Acknowledgments: Project Managers Working Group