Institutional Review Board: Investigator Responsibilities When Conducting Human Subjects Research

This booklet is designed to help investigators better meet their obligations for conducting human subject research by clarifying their responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties, and (2) to protect the rights, safety and welfare of study subjects.

Target Audience

All investigators responsible for human subject research. 

Learning Objectives

  • Describe the history and importance of human subjects protection. 
  • Explain why additional protections are needed for vulnerable populations.
  • Delineate the appropriate procedures for recruiting research participants.
  • Implement the requirements and process for obtain informed consent following national evidence-based guidelines and Baptist Health IRB policies and procedures. 
  • Recognize the importance of study design in the protection of research participants.
  • Explain the responsibilities of a principal investigator.
Additional information
Bibliography: 

Office for Human Research Protection
Office for Human Research Protection Compliance Oversight 
Office for Human Research Protection Policy and Guidance for Investigators
http://www.hhs.gov/ohrp

Office for Human Research Protection IRB Guidebook 1993
http://wayback.archive-it.org/org-745/20150930181805/http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 
Federal Register Document
http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

Code of Federal Regulations DHHS Part 45 CFR 46 Protection of Human Subjects
Revised January 15, 2009   Effective July 14, 2009

Code of Federal Regulations DHHS Part 45 CFR 46 Protection of Human Subjects
Revised January 15, 2009   Effective July 14, 2009
45 CFR 46 Subpart B
45 CFR 46 Subpart C
45 CFR 46 Subpart D

Baptist Health South Florida Institutional Review Board Policies and Procedures
BHSF 833.03 Vulnerable Subjects

Code of Federal Regulations DHHS Part 45 CFR 46 Protection of Human Subjects
Revised January 15, 2009   Effective July 14, 2009
45 CFR 46.116
45 CFR 46.117

Food and Drug Administration Clinical Trial Guidance Documents 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122046.htm

Baptist Health South Florida Institutional Review Board Policies and Procedures
BHSF 832.01 Advertisements and Recruiting Materials
BHSF 833.00 The Consent and Its Understanding
BHSF 833.01 General Requirements of Informed Consent 

Baptist Health South Florida Institutional Review Board Policies and Procedures
BHSF 832.04 Medical Devices
BHSF 832.07 Investigational Drugs and Biologics
BHSF 832.08 Off-Label Use of Marketed Drugs, Biologics and Medical Devices 
BHSF 832.09 Emergency Use of a Drug, Device or Biological Product
BHSF 832.10 Data Safety Monitoring

Food and Drug Administration Warning Letters 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Public Responsibility in Medicine and Research (PRIM&R)
Good Clinical Practice (GCP) – December 5, 2010

Baptist Health South Florida Institutional Review Board Policies and Procedures
BHSF 834.01 IRB Audit Program
BHSF 834.02 Notification of Noncompliance

Course summary
Available credit: 
  • 1.50 AMA PRA Category 1 Credit™
  • 1.50 Nurse Practitioners
  • 1.50 General certificate of attendance
Course opens: 
01/01/2016
Course expires: 
12/01/2018

Faculty Disclosure and Conflict of Interest Resolutions: It is the policy of Baptist Health South Florida to ensure fair balance, independence, objectivity and scientific rigor in all CME programming. Individuals participating in this CME activity are expected to identify and reference off-label product use and disclose any relevant relationships. All conflicts of interest of any individuals who control the content of this CME activity, including faculty and members of the Continuing Medical Education Committee and the Continuing Medical Education Department, have been identified and resolved prior to the taping of this educational activity.

Non-faculty contributors and others involved in the planning, development, and editing/review of the content have no relevant financial relationships to disclose. 

Disclosure Policy and Disclaimer

Baptist Health South Florida is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Baptist Health has been re-surveyed by the ACCME and awarded Commendation for 6 years as a provider of CME for physicians.
              
Baptist Health South Florida designates this enduring material for a maximum of 1.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Available Credit

  • 1.50 AMA PRA Category 1 Credit™
  • 1.50 Nurse Practitioners
  • 1.50 General certificate of attendance

Accreditation Period

Course opens: 
01/01/2016
Course expires: 
12/01/2018
Please login or register to take this course.

Required Hardware/software

This site is best viewed on the two most recent stable releases of the following browsers for all public pages:

PCs Running Windows

  • Google Chrome (Preferred): Download free web browser for PC, Mac, phone and tablet
  • Internet Explorer (IE 11 and above recommended): You will be prompted to download videos before you are able to view. Click “download” to view video.  After a momentary pause, the recording will play. 
  • Mozilla Firefox: You may be prompted under the “This Connection is Untrusted” screen to add “cmeonline.baptisthealth.net” and “cdn.baptisthealth.net” under “add exceptions”.

Apple Computers Running OSX

  • Google Chrome (Preferred): Download free web browser for PC, Mac, phone and tablet
  • Safari
  • Mozilla Firefox: You may be prompted under the “This Connection is Untrusted” screen to add “cmeonline.baptisthealth.net” and “cdn.baptisthealth.net” under “add exceptions”.

This site uses a responsive design, which allows the page layout of elements to change depending on the screen resolution. Certain functionality may change based on the screen resolution of smaller screens, such as the number of columns in a table.

Technical Support: If you are experiencing technical difficulties or have received an error message, please send an email to CME@BaptistHealth.net and include a print screen of the error message, your browser name and version, username and URL where the error occurred. You can expect a response within 48 hours.