You are on page 1of 24

Human Subjects Protection in Research

Carnegie Mellon University


Regulatory Compliance Administration
5000 Forbes Avenue, UTDC Bldg., Rooms 108 & 109
Pittsburgh, PA 15213
Facsimile: 412-268-2050

Susan M. Shingle
Compliance Officer
Telephone: 412-268-4727
sshingle@andrew.cmu.edu

Mary Lynn Brown


Compliance Assistant
Carnegie Mellon University
Telephone: 412-268-1901
mlbrown@andrew.cmu.edu
Introduction and Overview
 Basic Principles
 Historical Review
 Oversight
 Process
 Guidance
 Conclusion
Basic Principles
 RESEARCH is defined as “a systematic
investigation, including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge”

 HUMAN SUBJECT is defined as “a living


individual about whom an investigator (whether
professional or student) conducting research
obtains: (1) data through intervention or
interaction with the individual, or (2) identifiable
private information
Historical Review – Ethical Codes
Nuremberg Code
 Nuremberg Code: developed in October 1946 for
the Nuremberg Military Tribunal as standards by
which to judge the human experimentation
conducted by the Nazis

 The Code captures many of what are now taken


as the basic principles governing the ethical
conduct of research involving human subjects
Historical Review – Ethical Codes
Nuremberg Code
 Voluntary consent of the human subject is absolutely essential

 Freely given consent to participation in research the


cornerstone of ethical freedom from coercion, and comprehension of
the risks and benefits involved

 Minimization of risk and harm

 Favorable risk/benefit ration

 Qualified researchers using the appropriate research design

 Freedom for the subject to withdraw at any time


Historical Review – Ethical Codes
Belmont Report
 9/30/1978 the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research
submitted its report entitled “The Belmont Report:
Ethical Principles and Guidelines for the Protection of
Human Subjects of Research”

 The Report, named after the Belmont Conference Center


at the Smithsonian Institution where the discussions
were held, sets forth the basic ethical principles
underlying the acceptable conduct of research involving
human subjects
Historical Review – Ethical Codes
Belmont Report
 Respect for persons – informed consent which
contains the three elements: information,
comprehension and voluntariness

 Beneficence – risk/benefits assessment: study is


carefully designed so that the benefits are maximized
and any potential harm is minimized (benefit is not
monetary!)

 Justice – requires all subjects be treated fairly:


selection of research subjects must be the result fair
selection procedures and fair selection outcomes
Oversight
 Federal law requires the Department of Health and Human
Services (DHHS) to issue regulations for the protection of
human subjects in research projects [codified at Title 45,
Part 46 of the Code of Federal Regulations, Protection of
Human Subjects]

 The Office of Human Research Protections (OHRP) is the


unit within DHHS that implements the regulations for the
protection of human subjects
Oversight
 Title 45, Part 46 mandates CMU to register a
Federalwide Assurance (FWA) with OHRP every three
(3) years with periodic updates within 36 months of
a procedural or membership change

 The FWA is a legally binding written document that


commits CMU to compliance with applicable Federal
standards for the protection of human subjects

 Federalwide Assurance – FWA00004206


IRB Registration Number – IRB00000603
Oversight
 Title 45 CFR Part 46 provides the prospective review and
approval of human research activities by an Institutional
Review Board (IRB) whose primary mandate is to
protect the rights and welfare of humans who are the
subjects of research

 The IRB at CMU is established under the Provost to


ensure adequate safeguards to the protection of the
rights and welfare of human subjects in ALL research
investigations
Oversight
 HIPAA – the Health Insurance Portability and
Accountability Act of 1996 (effective 4/14/2003)

 Designed to improve the efficiency and effectiveness of


the healthcare system

 The Privacy Rule – additional regulation that relates


directly to organizations involved in healthcare
operations that transmit health information electronically
(Health plans, Health care clearinghouses and Health
care providers)
Oversight
 The Privacy Rule – establishes Federal protections for
the privacy of protected health information (PHI)

 Directly affects research with human participants where:

a) the researcher’s data is PHI obtained from a third


party source such as a physician’s office, hospital, or
clinic

b) the researcher is a physician whose study participants


are receiving treatment as part of the research
Oversight

 Six primary “pathways” permitting access to


PHI for research related purposes:
1. Review preparatory to research
2. Patient (participant) authorization
3. Waiver of authorization by IRB/Privacy Board
4. De-identification of data (18 categories)
5. Limited data set and data use agreement
6. Research on decedent’s information
Oversight
 HIPAA impacts CMU researchers whose studies involve:

a) the collection and analysis of existing medical record


information (PHI) obtained from a third party source
such as UPMC Health System, Children’s Hospital, West
Penn (the collaboration with a third party source) OR

b) the use of medical records for the identification of


potential research subjects (the use of de-identified
data)
Oversight

 Collaboration with a third party source:


CMU researchers submit the “Human
Subjects Clearance Request Form HIPAA”
and include a current copy of the third
party source’s IRB protocol application and
approval
Oversight

 The use of de-identified data:


CMU researchers submit the “Human
Subjects Clearance Request Form –
Exemption Request” and include
supporting documentation that states the
data was de-identified (protocol approval,
limited data set agreement, etc.)
Oversight
 CMU Researchers MUST also complete the
University of Pittsburgh’s online training, Module
6: Privacy Requirements for Researchers Under
HIPAA located at http://rpf.health.pitt.edu/rpf/

 More information regarding HIPAA can be


obtained from the Regulatory Compliance
Administration website located at
http://www.cmu.edu/provost/spon-res/compliance/hipaa.htm
Process
 ALL researchers/experimenters working with human
subjects in research investigations are required to obtain
clearance from CMU’s IRB PRIOR to running the
experiments/studies

 ALL researchers/experimenters are required to complete


the online training course entitled “Human Participant
Protections Education for Research Teams” located at
http://cme.nci.nih.gov/

 The IRB WILL NOT release its final decision until all
training certificates are on file
Process
 Requests for a Human Subjects Clearance Request Packet are obtained
from:

Regulatory Compliance Administration


UTDC Building, Room 108 & 109 (Henry Street, off South Craig)
Telephone No. 412-268-1901 or 412-268-4727
Email at mlbrown@andrew.cmu.edu or sshingle@andrew.cmu.edu

or Regulatory Compliance Administration web site at


http://www.cmu.edu/provost/spon-res/compliance/compliance.htm
Process
 The Human Subjects Clearance Request Packet (Human
Subjects Protocol application) includes:

*ethical principles and guidelines page


*guideline for submitting the clearance request
*the protocol request application
*consent form checklist
*a sample consent form
*online training course (http://cme.nci.nih.gov/)
Process
 The human subjects clearance request application (human
subjects protocol) and supporting documents are forwarded
to (or as an email attachment):

Regulatory Compliance Administration


UTDC Building, Room 108 & 109 (Henry Street, off South Craig)
Telephone No. 412-268-1901 or 412-268-4727
Email at mlbrown@andrew.cmu.edu or sshingle@andrew.cmu.edu
Process
 Human subjects protocols are preliminary reviewed to ensure that all the
required documents have been submitted

 Human subjects protocols qualify for either “exempt” “expedited” or “full


board” review

 Exempt and expedited reviews take between 1-3 weeks and full board
reviews take between 1-4 weeks

 Letter of Certification and “stamped” consent form (approval and


expiration date)

 Human subjects protocols are renewed yearly

 Studies CANNOT begin until IRB approval is given


Guidance
 The Belmont Report
http://ohsr.od.nih.gov/guidelines.php3
 
 The Nuremberg Code
http://ohrp.osophs.dhhs.gov/irb/irb_appendices.htm#j5
 
 NIH online training
Human Participant Protections Education for Research Teams
http://cme.nci.nih.gov/
 
 Office for Human Research Protections (OHRP)
http://ohrp.osophs.dhhs.gov/
 
Guidance
 Institutional Review Board Guidebook
http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
 
 National Institutes of Health (NIH) Guidelines for the Conduct of
Research Involving Human Subjects at NIH
http://ohsr.od.nih.gov/guidelines.php3
 
 National Science Foundation (NSF) Behavioral and Cognitive
Sciences
http://www.nsf.gov/search97cgi/vtopic
 
 National Science Foundation (NSF) The Common Rule
http://www.nsf.gov/search97cgi/vtopic

You might also like