|
Human Research Protections Certificate
About Human Research Protections
The SRA Human Research Protections certificate provides individuals with an introduction to human research protections as a critical component of an institution's research integrity program. The Human Research Protections (HRP) certificate is ideal for research administrators or related professionals who are unfamiliar or new to research involving human research subjects. This may include but are not limited to: principal investigators, research fellows, research coordinators, research associates and assistants. The certificate offers individuals a broad based perspective that reinforces communication and transparency among the many institutional aspects of conducting human subject research (research administration, finance, legal, sponsored programs, etc.) in various facilities that conduct human subject research in the United States and in international settings.
Human Research Protections Certificate Course Requirements
HRP is comprised of one full-day workshop, six required sessions and two elective sessions. The required courses are listed below; the electives may vary from meeting-to-meeting.
Required Workshop (full-day)
Required Sessions (must take six)
-
Institutional Responsibilities for Monitoring Human Subjects Research
-
Shades of Gray: Determining What Is and Isn’t Human Subjects Research
-
The Pack Rat Syndrome: Databases, Bio-Banks, Drawers of Documents and Records
-
Research Integrity: The Institutional Perspective
-
Clinical Trials: Rules and More Rules
-
Clinical Trials Budget Negotiations
-
Challenges Facing Investigators and Institutional Review Boards when Research Studies are Conducted at Non-U.S. Sites Drawers of Documents and Records
-
Research Support: The Transition and Growth of Monitoring an Education Program
-
Human Research Protection Programs
Elective Sessions (must take two)
The elective sessions will vary meeting-to-meeting
About the Certificate Tracking Booklet
The tracking booklet allows members to easily record their progress. Obtain a stamp at the conclusion of each workshop or session. Once all coursework has been completed turn in your documentation to the Registration Desk at the meeting or e-mail it to Certificates@srainternational.org to receive your certificate of completion. If you attended a workshop or session at a previous SRA meeting, list the meeting on the line next to the course. SRA staff will verify your attendance at previous meetings. The blank lines under electives are for future meetings where new sessions may be held.
Courses given over the past three years (Fall 2009 - Fall 2012)
2012 Annual Meeting - Orlando, FL
Workshop
Fundamentals of Human Subject Research
Required Sessions
Responsible Conduct of Research (RCR) for Research Administrators
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiations
Elective Sessions
Human Subjects Research and Non-Compliance
Responding to Serious Wrongdoing in Research
From Chaos to Control: Surviving a False Claims Act Investigation
Responsible Authorship: The Key to Professionalism in Science
Principles of Data Management
2012 Midwest/Southern Section Meeting - Cincinnati, OH
Workshop
Fundamentals of Human Research Protections
Required Sessions
Research Integrity: The Institutional Perspective
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiation
Electives
Case Studies in Research Ethics: A Historical Perspective
Implementing the 2011 PHS Final Rule on Conflict of Interest
Best Practices in the Responsible Conduct of Research
Science and the Global Public: Integrity and the Social Contract
Biobanking for Research and Clinical Trials
PHS Financial Conflict of Interest: The New Rules and Implementation Considerations
A Hard Look at Research Misconduct: Is Academia Responsible?
The FDA is Coming: Who Will You Coordinate With Your Sponsor?
2012 Western/Northeast Section Meeting - San Francisco, CA
Required Session
RCR for Research Administrators
Electives
Research Misconduct – “FFP” and Responsibilities to the Research Community and Society
Authorship: Role of Institutional Guidelines and RCR Training
for International Collaborations
Understanding the Various Types of IRB Review
If Publications are the Coin of the Realm, Data is the Gold
Henrietta Lacks: A Discussion about Research Ethics and Social Responsibility
Ethical Research Yields Better Science
IRB, HSE, SIM, and CBPR? Talk About a Foreign Language!
2011 Annual Meeting - Montréal, Canada
Required Sessions
Research Integrity: The Institutional Perspective
RCR for Research Administrators
Human Research Protection Program: Beyond the IRB
Electives
Introduction to Research Integrity
Research Compliance 101
Clinical Trials: The Industry Perspective
Beyond the Embryo: Understanding Ethical and Policy Issues in Stem Cell Research
Authorship: Role of Institutional Guidelines and RCR Training for International Collaborations
Case Studies in Research Misconduct: A Historical Perspective on Ethics
The Role of the Medical Humanist in Human Subject Protection Programs
2010 Annual Meeting - Chicago, IL
Workshop
Fundamentals of Human Research Protection
Required Sessions
Institutional Responsibilities for Monitoring Human Subjects Research
Research Integrity: The Institutional Perspective
The Pack Rat Syndrome: Databases, Bio-Banks, Drawers of Documents and Records
Electives
Ethical Issues in International Human Research Protections
Practice Patterns of the Research Coordinator: Challenges Ahead for a Clinical Research Institute
Increasing Importance of Conflicts in Research Regulatory Landscape
Human Subject Protection: A Collaborative Approach
Reimbursement to Subjects Enrolled in Clinical Research Studies
2010 NE/MW - Philadelphia, PA
Workshop
Fundamentals of Human Research Protection
Required Sessions
Shades of Gray: Determining What Is and Isn't Human Subjects Research
Research Integrity: The Institutional Perspective
The Pack Rat Syndrome: Databases, Bio-Banks, Drawers of Documents and Records
Clinical Trials: Rules and More Rules
Clinical Trial Budget Negotiations
Human Research Protection Programs
Electives
Conflict of Interest: How Best to Manage at Your Institution
Good Clinical Practice (GSP) and the IRB
2009 Annual Meeting - Seattle, WA
Workshop
Fundamentals of Human Research Protection
Required Sessions
Shades of Gray: Determining What Is and Isn't Human Subjects Research
Research Integrity: The Institutional Perspective
Clinical Trials: Rules and More Rules
Clinical Trial Budget Negotiations
Challenges Facing Investigators and Institutional Review Boards when Research Studies are Conducted at Non-U.S. Sites
Research Support: The Transition and Growth of Monitoring an Education Program
Electives
Conducting Research Integrity in a New Ballpark
Utilization and Implementation of a Clinical Trail Management System
|
