1. 1 Human Subjects Research at Johns Hopkins Medicine Introduction to Clinical Research - 2010 Human Subject Protection and IRBs

2. 2 Government Regulations Followed by the IRBs and JHM Administration Department of Health and Human Services regulations - requires submission of a Federal Wide Assurance Department of Health and Human Services regulations - requires submission of a Federal Wide Assurance Food and Drug Administration regulations Food and Drug Administration regulations Both groups require that JHU constitute an Institutional Review Board Both groups require that JHU constitute an Institutional Review Board State of Maryland statutes State of Maryland statutes AAHRPP (Association for the Accreditation of Human Research Protection Programs) AAHRPP (Association for the Accreditation of Human Research Protection Programs)

3. 3 Ellen Roche: Colleague and Research Subject Volunteer

4. 5/20/2015 Director - Office of Human Subjects Research Operations Judith Carrithers Dean /CEO Dr. Edward Miller Vice Dean for Clinical Investigation Dr. Daniel Ford Assistant Dean for Human Subjects Research Compliance Barbara L. Starklauf VP and General Counsel, JHU VP and General Counsel, JHM Office of Human Subjects Research Advisory Committee

5. 5 Institutional Review Board - IRB IRB is located within the School of Medicine Office Of Human Subjects Research IRB is located within the School of Medicine Office Of Human Subjects Research An IRB can approve, approve with required modifications, or disapprove an application An IRB can approve, approve with required modifications, or disapprove an application Review and completion of the approval process is required before a project may begin. Written approval document should be in hand. Review and completion of the approval process is required before a project may begin. Written approval document should be in hand.

6. 6 Administrative Actions Research approved by an IRB may be subject to further review by officials of the institution Research approved by an IRB may be subject to further review by officials of the institution Institutional officials may decide that an IRB approved study may not be done Institutional officials may decide that an IRB approved study may not be done Institutional officials may not approve the research if the IRB has disapproved it Institutional officials may not approve the research if the IRB has disapproved it

7. 7 IRB must determine Risks to participant are minimized, no better alternative Risks to participant are minimized, no better alternative Risks are reasonable in relation to anticipated benefits and the importance of the knowledge that is expected to result Risks are reasonable in relation to anticipated benefits and the importance of the knowledge that is expected to result Selection of participants is equitable Selection of participants is equitable Informed consent will be sought from participants or their legally authorized representatives Informed consent will be sought from participants or their legally authorized representatives Confidentiality is adequately maintained Confidentiality is adequately maintained

8. 8 Who is responsible Faculty and research team have the responsibility to understand policies and procedures and comply with them Faculty and research team have the responsibility to understand policies and procedures and comply with them IRBs and institutions have responsibility to comply with state laws and federal regulations IRBs and institutions have responsibility to comply with state laws and federal regulations

9. 9 Who may obtain consent from potential research subjects? Principal investigator Principal investigator Co-investigators listed on the application Co-investigators listed on the application Consent designees: Consent designees: Only if: trained by PI & approved by IRB Only if: trained by PI & approved by IRB

10. 10 What are human subjects? Living individuals about whom an investigator obtains either “data through intervention or interaction with the individual or “identifiable private information.” Living individuals about whom an investigator obtains either “data through intervention or interaction with the individual or “identifiable private information.”

11. 11 Private information Information that a person can reasonably expect is not being observed or recorded Information that a person can reasonably expect is not being observed or recorded Information that has been provided for specific purposes and that “the individual can reasonably expect will not be made public (a medical record)” Information that has been provided for specific purposes and that “the individual can reasonably expect will not be made public (a medical record)”

12. 12 What is the definition of research? DHHS and FDA regulations contain different definitions: DHHS and FDA regulations contain different definitions: DHHS: The systematic collection of data designed to contribute to generalizable knowledge DHHS: The systematic collection of data designed to contribute to generalizable knowledge FDA: Clinical investigation: Any experiment that involves a test article and one or more human subjects must be submitted to the FDA. FDA: Clinical investigation: Any experiment that involves a test article and one or more human subjects must be submitted to the FDA.

13. 13 What isn’t research? Clinical practice activities Clinical practice activities QA/QI activities QA/QI activities Research materials/information from only deceased persons - HIPAA issue Research materials/information from only deceased persons - HIPAA issue Purchased, de-identified biospecimens from a national repository Purchased, de-identified biospecimens from a national repository A single case study A single case study

14. 14 Types of Review Exempt Exempt Expedited Expedited Convened Convened

15. 15 Who can be the principal investigator? SOM and SON faculty SOM and SON faculty Senior staff - JHH Nursing, APL Senior staff - JHH Nursing, APL Senior staff – Howard County General Hospital Senior staff – Howard County General Hospital Physicians on the medical staff at one of the Johns Hopkins Hospitals Physicians on the medical staff at one of the Johns Hopkins Hospitals Fellows cannot be principal investigator Fellows cannot be principal investigator

16. 16 What must be submitted for IRB review? Research Research Regardless of funding or lack of funding Regardless of funding or lack of funding Regardless of site where conducted Regardless of site where conducted Examples are : Examples are : Clinical trials Clinical trials Retrospective chart reviews Retrospective chart reviews Lab research with existing specimens Lab research with existing specimens Prospective collection of specimens Prospective collection of specimens

17. 17 How to handle case studies? A single case study does not meet the definition of research A single case study does not meet the definition of research IRB will not review and approve IRB will not review and approve IRB will acknowledge and provide letter to the journal IRB will acknowledge and provide letter to the journal IRB policy posted on the web site at http://irb.jhmi.edu IRB policy posted on the web site at http://irb.jhmi.edu

18. 18 JHM IRBs that review research proposals East Baltimore campus: JHM IRBs 1, 2, 3 & X East Baltimore campus: JHM IRBs 1, 2, 3 & X JHMBC campus - JHM IRB 5 JHMBC campus - JHM IRB 5 Western Institutional Review Board (WIRB) - Olympia, Washington Western Institutional Review Board (WIRB) - Olympia, Washington

19. 19 Assignment of Applications to IRB X IRB X reviews the majority of projects that qualify for an expedited review process and requests for exemption, regardless of topic or department of origin IRB X reviews the majority of projects that qualify for an expedited review process and requests for exemption, regardless of topic or department of origin IRB X does not review projects submitted by their members or projects submitted from KKI IRB X does not review projects submitted by their members or projects submitted from KKI

20. 20 General Assignment of Applications Applications may be assigned to any JHM IRB Applications may be assigned to any JHM IRB May be transferred to another JHM IRB after original assignment at the request of the IRB or the Vice Dean for Clinical Investigation May be transferred to another JHM IRB after original assignment at the request of the IRB or the Vice Dean for Clinical Investigation Convened versus expedited review Convened versus expedited review

21. 21 How to start the IRB review process – E-IRB Obtain training in e-IRB procedures – call 5-3008 to schedule Obtain training in e-IRB procedures – call 5-3008 to schedule On line submission required as of 9/1/2005 for new applications. On line submission required as of 9/1/2005 for new applications.

22. 22 What are the presubmission requirements for JHM IRBs Completion of JHUSOM on-line human subjects training course at https://secure.lwservers.net (revised July 2005) Completion of JHUSOM on-line human subjects training course at https://secure.lwservers.net (revised July 2005) Department chair signatures, when applicable Department chair signatures, when applicable Cancer treatment trials Cancer treatment trials review by the Oncology Center Clinical Research Office - regardless of Dept of origin review by the Oncology Center Clinical Research Office - regardless of Dept of origin Review by the Kennedy Krieger Institute (KKI) when subjects are recruited from the KKI, KKI facilities used Review by the Kennedy Krieger Institute (KKI) when subjects are recruited from the KKI, KKI facilities used

23. 23 How to obtain answers to IRB process questions Generic questions may be sent to the office e-mail site at ohsceb@jhmi.edu Generic questions may be sent to the office e-mail site at ohsceb@jhmi.edu Contact the Director of the Office of Human Subjects Research - Judith Carrithers (5-3008) Contact the Director of the Office of Human Subjects Research - Judith Carrithers (5-3008) Contact the IRB Associate Managers via e-mail or phone (5-3008) Contact the IRB Associate Managers via e-mail or phone (5-3008) IRB Chairs/Co-Chairs may be contacted with specific questions about issues raised in the review process - membership lists are on the IRB website IRB Chairs/Co-Chairs may be contacted with specific questions about issues raised in the review process - membership lists are on the IRB website Consent specialists Consent specialists Guidance documents available on the IRB web site at: http://irb.jhmi.edu Guidance documents available on the IRB web site at: http://irb.jhmi.edu

24. 24 Answers to HIPAA Questions Research related questions - OHSR regulatory specialists and Assistant Dean for Human Subjects Research Compliance (5-3008) Research related questions - OHSR regulatory specialists and Assistant Dean for Human Subjects Research Compliance (5-3008) General questions - HIPAA Privacy Officer - Carol Richardson (410-735-6509) General questions - HIPAA Privacy Officer - Carol Richardson (410-735-6509)

25. 25 Who is in the middle? SUBJECT INSTITUTION IRB GOV’T SOCIETY INDUSTRY INVESTIGATOR

26. 26 Impact of Non-compliance Institutional Institutional Protocol Protocol Investigator – warning letters published on FDA Website Investigator – warning letters published on FDA Website

27. Responsibilities of PI Human subjects protection is more than creating an acceptable consent form Human subjects protection is more than creating an acceptable consent form Train and manage the study team Train and manage the study team Treat each research participant with respect Treat each research participant with respect Report adverse events in a timely manner Report adverse events in a timely manner Ask for help if you have questions Ask for help if you have questions Think beyond the regulations Think beyond the regulations 27

28. 28 New Initiatives IRB Data Safety Monitoring Boards Data Safety Monitoring Boards Payment of services in clinical trials Payment of services in clinical trials Quality improvement activities as research Quality improvement activities as research Policy on Incidental Findings Policy on Incidental Findings