50 SHADES OF GRAY: WHY AND WHEN IS IRB APPROVAL REQUIRED?

Transcription

1 50 SHADES OF GRAY: WHY AND WHEN IS IRB APPROVAL REQUIRED? Kevin L. Nellis, MS, CIP Executive Director, Human Research Protections and Quality Assurance Kathleen E. Powderly, CNM, PhD Director, John Conley Division of Medical Ethics & Humanities

2 Objectives 2 1) Understand the history and ethical principles which serve as a foundation to promote science while protecting human research participants. 2) Understand which activities require IRB approval. 3) Understand which activities that DO NOT require IRB approval.

3 Atrocities in Human Research : Walter Reed Yellow Fever Study Humans deliberately infected with yellow fever Subjects informed that death from yellow fever was a possible risk (2 subjects died as a result) Research identified mosquito as source of transmission and led to a decrease in mortality rates for yellow fever : Syphilis Study in Tuskegee, AL Funded by Public Health Service Test subjects not informed of disease status and not given penicillin by researchers once it was discovered as an antibiotic Press exposure set the stage for National Research Act, which requires IRB review of all federallyfunded studies 1939: Stuttering Study Aimed to show that stuttering is a learned behavior that can be induced in children through psychological pressure Children in study group subjected to harassment and negative therapy in an attempt to induce stuttering 1963: Jewish Chronic Disease Hospital Researchers, funded by NIH, at Sloan-Kettering Cancer Institution injected live cancer cells into indigent, chronically ill elderly patients without their consent Research intended to measure patients ability to reject the cancer cells and was not related to treatment

4 Before IRBs, the only consent required was that of a researcher's department head. The Nuremberg Code was ignored in practice. As I look back on it, the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people... Dr. William Silverman, Columbia pediatrician, on the postwar mentality

5 NEJM, 274: , June 16, 1966

6 Ethical lapses are almost never cases of bad people, doing bad things, for no good reason. Rather, they are good people, doing bad things, for good reasons. Loosely quoting Marcia Angell, MD former Editor-in-Chief, NEJM

7 Development of Legislation : Nazi Doctors Trial Addressed German doctors participation in unethical experimentation on humans involving painful and oftentimes fatal procedures 1947: Nuremberg Code Adopted following Nazi Doctor s Trial Established 10 basic principles related to the moral, ethical, and legal obligations associated with human subjects research Formed basis for The Belmont Code 1964: Declaration of Helsinki Developed by World Medical Association as an international statement of ethical principles to guide medical professionals conducting human subjects research 1974: National Research Act Created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research : HHS and FDA Regulations Commission for Protection of Human Subjects issue reports and recommendations identifying basic ethical principles that should underlie human subjects research Led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research 1979: The Belmont Report The Ethical Principles and Guidelines for the Protection of Human Subjects of Research Defined 3 fundamental ethical principles for human subjects in research: respect for persons, beneficence, and justice 1991: Common Rule Core HHS regulations (45 CFR Part 46, Subpart A) are formally adopted by 16 Departments and Agencies of the federal government that conduct or fund human subjects research

8 U.S. National Research Act (1974) 8 Established National Commission for Protection of Human Subjects The Belmont Report, 1979 Code of Federal Regulations, 1981 Institutional Review Boards (IRBs) Informed Consent Common Rule, 1991

9 The Belmont Report 9 Respect for Persons Autonomous consent Protect those with diminished autonomy Beneficence & Nonmaleficence Bene=good, fica=to make Justice The burdens and benefits of research should be equally distributed

10 Conflict Among Ethical Principles 10 Respect for Persons Beneficence This tension was anticipated and expected. Principles carry equal moral weight Requires subjective judgment calls Reasonable people will disagree Justice

11 image cannot currently be displayed. The Twin Pillars of Protection Rights This 11 and Welfare of Human Subjects Independent Review Informed Consent

12 Activities Requiring IRB Review 12 Clinical Trials involving drugs, biologics, devices; including use of specimens to validate medical device, diagnostic instrument, or laboratory test (FDA) Research involving Protected Health Information (PHI) from living or deceased patients or employees (HIPAA) Patient recruitment materials for external research (draft IRB policy) Human (Subjects) Research as defined by Common Rule (45 CFR Part 46)

13 IRB Decision Aid Available in IRBNet

14 Is IRB Review Required for Human Research? (Under the Common Rule) 1) Is it research? YES If NO to either question, consult IRB Decision Aid or call X8480 2) Does it Involve Research Participants (Human Subjects)? YES Submit IRB Application

15 15 Is it Research? (Under the Common Rule) A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

16 Systematic Investigation In general, a systematic investigation is an activity that is planned, orderly, methodical, and uses data collection and analysis to answer a question Pilot studies, feasibility studies, and other preliminary studies are considered a systematic investigation, for example: Convening a focus group to help researchers develop a questionnaire Pilot testing a questionnaire

17 Generalizable Knowledge Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study) that may be applied to populations outside of the specific study population.

18 Does it Involve Research Participants 18 (Human Subjects)? (Under the Common Rule) Living individuals about whom an investigator conducting research, obtains either Data through intervention or interaction with the individual, or Individually identifiable private information (including identifiable specimens)

19 Living Individuals 19 Research about deceased people does not meet the definition of human research under the Common Rule CAUTION: The use of protected health information (PHI) of deceased people is human research under the HIPAA regulations

20 About Whom 20 If the focus of an investigation is on the opinions, characteristics, or behavior of individuals, research participants are involved. Which are the following involve research participants? A. Asking clinic managers for the average length of stay in their units and other aggregate data about their patient population B. Asking nurses about how they cope with stress C. Asking parents how their children feel about pain D. B & C E. All of the above

21 Interventions for Research Purposes 21 Examples: Physical procedures through which data are gathered Collecting blood Obtaining vital signs Behavioral interventions Evaluating an unknown psychotherapy procedure Manipulation of research participants environment Playing music in operating room to determine influence on patient outcomes

22 Interactions For Research Purposes 22 Examples: Communication Face-to-face Electronic (including online surveys without identifiers) Interpersonal contact Observations Interviews

23 Individually Identifiable Private Information 23 Private information includes: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the research participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute human research

24 Is IRB Approval Required for Performance Improvement Activities? Performance improvement activities do not meet the definition of human research when the intent is to improve internal operations and not to contribute to generalizable knowledge Example: A clinic conducts a survey of patients to find out if the clinic is meeting the needs of Downstate. The activity is systematic, but is not considered research because the intent of the project is to improve the service to its patients, rather than contribute to a body of knowledge. Clinic staff could share the results of their performance improvement activity at a conference or publish the results without changing the intent.

25 25 Is IRB Approval Required for Pilot or Feasibility Studies? Is it a systematic investigation? In general, YES Is it designed to develop or contribute to generalizable knowledge? YES, if it develops or contributes to generalizable knowledge, including the development of future human research Does it involve living individuals about whom an investigator conducting research, obtains data through an intervention or interaction or individually identifiable private information? It depends on the activity.

26 Is IRB Approval Required for? 26 Exempt human research - always Publicly available data -it depends Data that is already in the possession of the PI -it depends Class projects -it depends Use of anonymous data -it depends Oral history -it depends

27 27 Activities That DO NOT Require IRB Approval Emergency use of an investigational drug, device, or biologic (must notify IRB within 5 days of use). Off-label use of an FDA approved drug (requires Pharmacy approval) for clinical purposes Internal Healthcare Operations Activities (e.g., performance improvement; not intended for research). Case Reports/Series (up to 3 individuals, living or deceased). Research with de-identified data set (based on IRB definitions). Preparatory to Research Activities (with Certification Form) When SUNY Downstate is not engaged in Human Research. See:

28 Summary Society s response to atrocities has lead to many ethical deliberations and highly regulated research enterprise The devil is always in the details when determining whether IRB approval is required Definitions are key for determining which activities require IRB approval

29 IRB Contacts Phyllis G. Supino, EdD, IRB Chair, Boards A, B and E (718) Daniel Cukor, PhD, Vice Chair, Board A (718) Stanley Friedman, MD, Vice Chair, Board B (718) Kevin L. Nellis, MS, CIP, Executive Director, Human (718) Research Protection & Quality Assurance Diann Johnson, MPH, Associate IRB Administrator (718) Angela Cartmell, PhD, CIP, Associate IRB (718) Administrator Nakih Gonzales, IRB Assistant (718) IRB Office (718)