Human Subjects Protection in Research Carnegie Mellon University Regulatory Compliance Administration 5000 Forbes Avenue, UTDC Bldg., Rooms 108 & 109 Pittsburgh, PA Facsimile: Susan M. Shingle Compliance Officer Telephone: Mary Lynn Brown Compliance Assistant Carnegie Mellon University Telephone:

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 – FWA IRB Registration Number – IRB

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) 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 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) 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) The Privacy Rule – establishes Federal protections for the privacy of protected health information (PHI) Directly affects research with human participants where: 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: 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: 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: 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: 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 CMU Researchers MUST also complete the University of Pittsburgh’s online training, Module 6: Privacy Requirements for Researchers Under HIPAA located at More information regarding HIPAA can be obtained from the Regulatory Compliance Administration website located at More information regarding HIPAA can be obtained from the Regulatory Compliance Administration website located athttp://

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 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 or at or or Regulatory Compliance Administration web site at

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 (

Process The human subjects clearance request application (human subjects protocol) and supporting documents are forwarded to (or as an attachment): Regulatory Compliance Administration UTDC Building, Room 108 & 109 (Henry Street, off South Craig) Telephone No or at or

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 The Nuremberg Code NIH online training Human Participant Protections Education for Research Teams Office for Human Research Protections (OHRP)

Guidance Institutional Review Board Guidebook National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects at NIH National Science Foundation (NSF) Behavioral and Cognitive Sciences National Science Foundation (NSF) The Common Rule