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Human Subjects Research created April, 2009. RCR – Human Subjects RCR – Human Subjects Short pre-test Presentation Objectives NIH Comment background regulation,

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Presentation on theme: "Human Subjects Research created April, 2009. RCR – Human Subjects RCR – Human Subjects Short pre-test Presentation Objectives NIH Comment background regulation,"— Presentation transcript:

1 Human Subjects Research created April, 2009

2 RCR – Human Subjects RCR – Human Subjects Short pre-test Presentation Objectives NIH Comment background regulation, policy and Federal Assurance considerations SIT institutional processes involved in animal research ethical considerations available resources Reference Material Faculty Presentation Case Study and Discussion Short post-test created April, 2009

3 RCR – Human Subjects RCR – Human Subjects “Investigators must balance their interest in gathering data and answering research questions with society’s mandate to protect the rights and safeguard the welfare of research subjects.” (1) National Institutes of Health “Society has granted a conditional privilege to perform research on human beings……the condition is that it must be conducted in a way that puts the rights and welfare of human subjects first.” (1) National Institute of Health created April, 2009

4 RCR – Human Subjects RCR – Human Subjects created April, 2009 Nuremberg Code of 1947 (2) result of medical experiments performed in German concentration camps during World War II. “…The great weight of evidence before us it to the effect that certain types of medical experiments…conform to the ethics of the medical profession generally…however…certain basic principles must be observed in order to satisfy moral, ethical and legal concepts…” Declaration of Helsinki adopted in 1964 (3) adopted by World Medical Association and forms the basis of most subsequent documents addressing human subjects research. Introduced concept of oversight by an ‘independent committee’ which became a system of Institutional Review Boards Belmont Report (4) culmination of the work a national commission began in 1974. It was adopted by NIH in its entirety.

5 RCR – Human Subjects RCR – Human Subjects Stevens’ Federal Wide Assurance with National Institutes of Health, Office for Human Research Protections (NIH OHRP) – FWA00014433 Stevens’ Institutional Policy “Human Subjects/IRB” created April, 2009 45 CFR 46 – Protection of Human Subjects -- (5) Stevens’ IRB Registration with NIH/OHRP – IORG0004982

6 RCR – Human Subjects RCR – Human Subjects created April, 2009 The three most often cited concepts associated with human subjects research are: Autonomy Beneficence Justice

7 RCR – Human Subjects RCR – Human Subjects created April, 2009 AUTONOMY (voluntary informed consent) > Controversy in Berlin Led to Ethical Code & Inf. Consent Dr. Albert Neisser “treated” Berlin prostitutes without their knowledge using serum from recovering syphilis patients in the belief he was discovering a cure Caused epidemic of syphilis among prostitutes & their customers. Rudolf Virchow recommended code for research with humans to prevent future breaches of ethics. > Berlin Code of 29 Dec 1900 Required unambiguous consent Required study be conducted or directed by the institute medical director Excluded use of minors or incompetent subjects Req. documentation of fulfillment of code requirements in subjects records Did not interfere with standard diagnostics, care and prophylaxis (Slide information taken from “Time Passages: Local Military Medical History Connections” Art Anderson MD, Office of Human Use and Ethics, USAMRID) (6)

8 RCR – Human Subjects RCR – Human Subjects created April, 2009 BENEFICENCE (good science & favorable benefit to risk ratio) > 1777 Variolation* of the Troops Helped Win the Revolutionary War George Washington's experiences during the French and Indian War convinced him that Smallpox was a bar to success of the Revolution Washington proclaimed smallpox to be his ““most dangerous foe;””and, by 1777 he had all his soldiers variolated He also ordered all new recruits to be variolated as soon as they enlisted Fortunately, in this case, the ends of these actions did justify the means (Slide information taken from “Time Passages: Local Military Medical History Connections” Art Anderson MD, Office of Human Use and Ethics, USAMRID) (6)

9 RCR – Human Subjects RCR – Human Subjects created April, 2009 JUSTICE (7) (equal opportunity to participate and to not participate) > “Tuskegee Study of Untreated Syphilis in the Negro Male” study conducted by the Public Health Service between 1932-1972 human subjects were 399 poor, mostly illiterate, African American sharecroppers study for research related to the natural progression of the disease if left untreated researchers failed to treat patients appropriately after 1940s validation of penicillin as effective cure for syphilis participants were prevented from accessing syphilis treatment programs available to other people in the area a leak to the press in 1972 resulted in its termination

10 RCR – Human Subjects RCR – Human Subjects Often, human subjects research is done in conjunction with a sponsored research project. Proposals for sponsored projects should be submitted to the Faculty Support Center Protocols for human subjects research as part of a sponsored project are separate activities. Human subjects protocols should be submitted to the IRB Investigator must initiate and submit the human subjects research protocol to the IRB – understanding sponsor requirements for approvals and proposal deadlines Funding for sponsored projects involving the use of human subjects WILL NOT be enabled until IRB approval is received and verified in OSR created April, 2009

11 RCR – Human Subjects RCR – Human Subjects createdApril, 2009 NIH, the most common federal agency to which PI’s would submit research proposals that might include human subjects typically has three submission cycles each year. The timeline shown below is offered to help with planning the preparation and submission of various required materials: EARLIEST FUNDING Cycle 1 Cycle 2 Cycle 3 Dec. April July PROPOSAL SUBMISSION Cycle 1 Cycle 2 Cycle 3 Feb. 5 June 5 Oct. 5 PROPOSAL SUBMISSION Cycle 1 Cycle2 Cycle 3 Feb 5 June 5 Oct 5 PEER REVIEW Cycle 1 Cycle 2 Cycle 3 Jun-Jul Oct-Nov Feb-Mar COUNCIL REVIEW Cycle 1 Cycle 2 Cycle 3 Sep-Oct Jan-Feb May-Jun Feb. 5 Proposal Deadline = mid January FSC Deadline Sep-Oct Council Review = full SIT IRB approval submitted for JIT Mar-Apr = protocol submitted to SIT IRB SIT IRB review process

12 RCR –Animal Research RCR –Animal Research Be aware of the need for Institutional Review Board review and approval -- ‘exempt’ is a category, it does not imply an investigator is ‘exempt’ from the application process created April, 2009 (8)

13 RCR – Human Subjects RCR – Human Subjects Office of Sponsored Research Can provide assistance and direction for investigators contemplating animal research 201.216.8762 – Barbara DeHaven, Executive Director Institutional Review Board Duly constituted committee at Stevens charged with the review and approval of all human subjects research done at the Institute 201.216.5032 – Dr. Zvi Aronson, IRB Chair Office of Institutional Risk, Compliance and Audit Chuck Shaw – 3 rd Floor Howe Center – 201.216.8568 created April, 2009

14 RCR – Human Subjects RCR – Human Subjects 1.“Guidelines for the Conduct of Research Involving Human Subjects at the National Institute of Health” 2.“Nuremberg Code of 1947” 3.“The Helsinki Declaration” 4.“The Belmont Report” 5.“45 CFR 46 6.“Time Passages: Local Military Medical History Connections” Art Anderson MD, Office of Human Use and Ethics, USAMRID) 7.“The Tuskegee Study of Untreated Syphilis in the Negro Male” created April, 2009

15 RCR – Human Subjects RCR – Human Subjects Dr. Peter Dominick - Asst. Professor, Howe School of Technology Management created April, 2009

16 @ P. Dominick, 2009  Academic  Zvi Aronson, Ph.D. Industrial/Organizational Psychology  Peter Dominick, Ph.D. Industrial/Organizational Psychology  Patricia Holahan, Ph.D. Organizational behavior  Ann Mooney, Ph.D. Organizational behavior  Medical and Mental Health  Glen Atlas, M.D. Anesthesiologist at UMDNJ  Terence Hannigan, Ph.D. Clinical Psychologist  Vincent Grasso M.D.

17 @ P. Dominick, 2009  Twelve Submissions in the past two years  Ten accepted with no or minimal revisions  Two were rejected each after two rounds of review

18 @ P. Dominick, 2009  Any studies that will involve human subjects  Medical and biomedical  Social sciences  Psychology  Sociology  Anthropology  Ethics  Management practices  Computer science  Some studies in biology and chemistry

19 @ P. Dominick, 2009  Subjects ostensibly assigned to be “learners” or “teachers”  “Teachers” must administer shocks to “learners” each time they make a mistake  “Learners” and “teachers” located in different rooms  Shocks are painful but not harmful  “teachers” will hear “learners” react to the pain

20 @ P. Dominick, 2009  What concerns would you have?  Who do you think might be harmed by this research?  What questions would you ask of the researcher?  Would you reject it?  Might you seek to modify the experiment?

21 @ P. Dominick, 2009  Original Studies made profound contributions to Social Psychology  68 percent of “teachers” complied with experimenters instructions and administered 450 volt shocks repeatedly  Also considered the paradigmatic example of why psychology experiments must be reviewed by IRB’s  Many said they “would never be replicated”

22 @ P. Dominick, 2009  Studies were replicated in 2006  Stopped at 150 volts instead of 450 volts  Immediate feedback to participants  15 volt “test shock”  Two step screening process to ensure participants could handle the experience  “Of course, I also needed IRB approval. I knew from my own participation on the IRB that the proposal would be met with concern and perhaps a little fear by the board’s members.... To address these concerns, I created a list of individuals who were experts on Milgram’s studies and the ethical questions surrounding this research. I offered to make this list available to the IRB. More important, Steven Breckler, a social psychologist who currently serves as the executive director for science at the American Psychological Association, graciously provided an assessment of the proposal’s ethical issues that I shared with the IRB. “ Jerry Burger

23 @ P. Dominick, 2009  Instructional strategies conducted in established or commonly accepted educational settings  The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior  Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if sources are publicly available, or if the information is recorded with complete anonymity  Taste and food quality evaluation and consumer acceptance studies, if:  wholesome foods without additives  food that contains an ingredient that is found to be safe  agricultural chemical or environmental contaminant at or below the level FDA, EPA and or the Food Safety and Inspection Service of the U.S.D.A. deems to be safe

24 @ P. Dominick, 2009  Collection of hair and nail samples  Collection of excreta and external secretions  Recording of data from subject 18 years of age or older using noninvasive procedures  Collection of blood samples in minimal amounts  Collection of dental plaque and calculus  Voice recording  Moderate exercise by health volunteers  Study of existing data  Research on an individual or group behavior that involves no manipulation of the subjects and is not stressful

25 @ P. Dominick, 2009  Most research that involves children, prisoners, pregnant women, fetuses and other vulnerable populations  Research that involves experimental drugs or devices  Research that involves most invasive procedures  Survey research that involves sensitive questions or is likely to be stressful for the subject

26 @ P. Dominick, 2009  Contact Zvi Aronson if engaging in any research that involves human subjects  Confidentiality form (Anonymity)  Consent Form (Justice)  Rationale Form (Beneficence)  Brief descriptions of ( usually just a few paragraphs)  key research question  types of participants sought  experimental procedures/protocol (including any deception)  procedures for ensuring confidentiality and subject well- being  Procedures for attaining consent

27 @ P. Dominick, 2009  Autonomy  Will people have the opportunity to opt in or out of my research?  Are those involved capable of making an informed decision about participation?  Beneficence  What are the major benefits to be derived from my research?  How do they compare to any risks?  In what ways might people better off because of my study?  Subjects  General population?  Are there other less invasive ways to learn the same things?  Justice  Is this study fair to those who are involved?  Will it deny them other opportunities that may be of benefit to them?  How might they be affected or changed as a result of their experience?

28 RCR –Human Subjects RCR –Human Subjects Bob is working hard to complete his Master’s degree in the Psychology Department’s program of Research and Related Ethics through the Institute for Social and Humane Ethics at Prestigious University. His thesis focuses on the residual effects of severe psychological trauma throughout a lifetime. Specifically, he’s chosen to focus on Holocaust survivors from World War II. He’s gotten into a significant time crunch as the literature review took longer than anticipated and he had an unexpected family emergency during that same time. He needs interviews with survivors in order to make his data credible but knows he needs to submit a protocol to his institutional IRB for review and approval. That will add an additional two months (minimum) to his timeline that he frankly doesn’t have. Bob is sensitive to his research population and he’ll be careful. He really needs the interview data and decides to go ahead without submitting the protocol for review. Since he’s doing the interviews without IRB approval he decides he doesn’t need to be concerned about the informed consent. Consider the following: created April, 2009

29 RCR –Human Subjects RCR –Human Subjects Q: Who will, or might be affected by Bob’s decision to forego the required IRB application, review and approval process? A:-- The Holocaust survivors -- Bob -- The Institute for Social and Humane Ethics -- Prestigious University created April, 2009

30 RCR –Human Subjects RCR –Human Subjects Q: What are the possible consequences of Bob’s decision not to observe the requirement for protocol application, review and approval? A:The Holocaust survivors could definitely be affected as recalling memories of such experiences could be severely distressing, cause panic, or even result in an adverse medical event for this extremely aged population Bob will be affected if it is discovered that he has violated one of the integral tenets of human subjects research. His degree could be in jeopardy and he would be disgraced. There is a likelihood that none of his data would be accepted in support of the thesis. Lastly, the Institute for Social and Humane Ethics would probably be embarrassed……at a minimum created April, 2009

31 RCR –Human Subjects RCR –Human Subjects Q: Are there any laws, regulations, or institutional policies that may apply to this situation? A:-- The Nuremberg Code -- The Helsinki Declaration -- The Belmont Report -- 45 CFR 46 -- Prestigious University’s Policy on the inclusion of human subjects in research -- Code of professional ethics of the American Psychological Association created April, 2009

32 RCR –Human Subjects RCR –Human Subjects Q: If Bob had submitted the protocol for review as required, what items might the IRB have been concerned with? A: -- Informed Consent * IRB would have wanted adequate description of the benefits and risks for this population * IRB would have wanted a warning that some of the questions might cause distress and that subjects could stop at any time * IRB would have wanted to ensure Bob had planned for the possibility that recalling the subject matter content for some of the subjects might even result in an adverse medical event and what were his plans if that happened * IRB would have required Bob to include resources for subjects who might need psychological assistance as the result of recalling repressed memories created April, 2009


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