Human Subjects Protection in Human Subjects Protection in ResearchResearch

Carnegie Mellon UniversityRegulatory Compliance Administration5000 Forbes Avenue, UTDC Bldg., Rooms 108 & 109Pittsburgh, PA 15213Facsimile: 412-268-2050

Susan M. ShingleCompliance OfficerTelephone: 412-268-4727sshingle@andrew.cmu.edu

Mary Lynn BrownCompliance AssistantCarnegie Mellon UniversityTelephone: 412-268-1901mlbrown@andrew.cmu.edu

Introduction and OverviewIntroduction and Overview

Basic Principles Historical Review Oversight Process Guidance Conclusion

Basic PrinciplesBasic 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 Historical Review – Ethical Codes Nuremberg CodeCodes 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 Historical Review – Ethical Codes Nuremberg CodeCodes 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 Historical Review – Ethical Codes Codes Belmont ReportBelmont 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 Historical Review – Ethical Codes Belmont Report 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

OversightOversight 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

OversightOversight 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

OversightOversight

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

OversightOversight

HIPAA – the Health Insurance Portability and HIPAA – the Health Insurance Portability and Accountability Act of 1996 (effective 4/14/2003)Accountability Act of 1996 (effective 4/14/2003)

Designed to improve the efficiency and Designed to improve the efficiency and effectiveness of the healthcare systemeffectiveness of the healthcare system

The Privacy Rule – additional regulation that The Privacy Rule – additional regulation that relates directly to organizations involved in relates directly to organizations involved in healthcare operations that transmit health healthcare operations that transmit health information electronically (Health plans, Health information electronically (Health plans, Health care clearinghouses and Health care providers)care clearinghouses and Health care providers)

OversightOversight

The Privacy Rule – establishes Federal protections for The Privacy Rule – establishes Federal protections for the privacy of the privacy of protected health informationprotected health information (PHI) (PHI)

Directly affects research with human participants Directly affects research with human participants where:where:

a) the researcher’s data is PHI obtained from a third a) the researcher’s data is PHI obtained from a third party source such as a physician’s office, hospital, or party source such as a physician’s office, hospital, or clinic clinic

b) the researcher is a physician whose study b) the researcher is a physician whose study participants are receiving treatment as part of the participants are receiving treatment as part of the researchresearch

OversightOversight

Six primary “pathways” permitting Six primary “pathways” permitting access to PHI for research related access to PHI for research related purposes:purposes:1. Review preparatory to research1. Review preparatory to research

2. Patient (participant) authorization2. Patient (participant) authorization

3. Waiver of authorization by IRB/Privacy Board3. Waiver of authorization by IRB/Privacy Board

4. De-identification of data (18 categories)4. De-identification of data (18 categories)

5. Limited data set and data use agreement5. Limited data set and data use agreement

6. Research on decedent’s information6. Research on decedent’s information

OversightOversight

HIPAA impacts CMU researchers whose studies HIPAA impacts CMU researchers whose studies involve:involve:

a) the collection and analysis of existing medical a) the collection and analysis of existing medical record information (PHI) obtained from a third record information (PHI) obtained from a third party source such as UPMC Health System, party source such as UPMC Health System, Children’s Hospital, West Penn (the collaboration Children’s Hospital, West Penn (the collaboration with a third party source) ORwith a third party source) OR

b) the use of medical records for the identification b) the use of medical records for the identification of potential research subjects (the use of de-of potential research subjects (the use of de-identified data) identified data)

OversightOversight

Collaboration with a third party Collaboration with a third party source:source:

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

OversightOversight

The use of de-identified data:The use of de-identified data:

CMU researchers submit the “Human CMU researchers submit the “Human Subjects Clearance Request Form – Subjects Clearance Request Form – Exemption Request” and include Exemption Request” and include supporting documentation that supporting documentation that states the data was de-identified states the data was de-identified (protocol approval, limited data set (protocol approval, limited data set agreement, etc.)agreement, etc.)

OversightOversight

CMU Researchers MUST also complete the CMU Researchers MUST also complete the University of Pittsburgh’s online training, University of Pittsburgh’s online training, Module 6: Privacy Requirements for Module 6: Privacy Requirements for Researchers Under HIPAA located at Researchers Under HIPAA located at http://http://rpf.health.pitt.edu/rpfrpf.health.pitt.edu/rpf//

More information regarding HIPAA can be More information regarding HIPAA can be obtained from the Regulatory Compliance obtained from the Regulatory Compliance Administration website located at Administration website located at http://www.cmu.edu/provost/spon-res/compliance/hipaa.htmhttp://www.cmu.edu/provost/spon-res/compliance/hipaa.htm

ProcessProcess

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

ProcessProcess Requests for a Human Subjects Clearance Request Packet are

obtained from:

Regulatory Compliance AdministrationUTDC Building, Room 108 & 109 (Henry Street, off South Craig)Telephone No. 412-268-1901 or 412-268-4727Email 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

ProcessProcess 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/)

ProcessProcess The human subjects clearance request application

(human subjects protocol) and supporting documents are forwarded to (or as an email attachment):

Regulatory Compliance AdministrationUTDC Building, Room 108 & 109 (Henry Street, off South Craig)

Telephone No. 412-268-1901 or 412-268-4727Email at mlbrown@andrew.cmu.edu or sshingle@andrew.cmu.edu

ProcessProcess 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

GuidanceGuidance

The Belmont Reporthttp://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 Teamshttp://cme.nci.nih.gov/

  Office for Human Research Protections (OHRP)

http://ohrp.osophs.dhhs.gov/  

GuidanceGuidance

Institutional Review Board Guidebookhttp://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm

  National Institutes of Health (NIH) Guidelines for the

Conduct of Research Involving Human Subjects at NIHhttp://ohsr.od.nih.gov/guidelines.php3

  National Science Foundation (NSF) Behavioral and Cognitive

Scienceshttp://www.nsf.gov/search97cgi/vtopic

  National Science Foundation (NSF) The Common Rule

http://www.nsf.gov/search97cgi/vtopic