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1. CPHS: The Cliff Notes Robert Nobles, MPH
Assistant Director
Office of Research
3. Whitney, et al. Article Overview Qualitative e-mail survey with 14% response rate
Population: federally funded principal investigators
Comments were analyzed to show underlying themes
In general, there was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning
4. Whitney, et al. Article Overview (2) Six primary questions in survey:
1. What has been your experience with the human subjects protection system in general? What do you like? What would you change?
2. What has been your experience with the informed consent process with potential subjects? Is there anything you would change?
3. Do you feel your IRB does its job well? If so, what helps you the most? If not, how could it improve?
5. Whitney, et al. Article Overview (2) Six survey questions continued:
4. Do you feel that your IRB usually understands your protocols adequately?
5. Have you ever served on an IRB?
6. What other thoughts do you have on informed consent and the human subjects protection system?
6. Whitney, et al. Article Overview (3) Positive Comments:
IRB functions as a safeguard against overoptimistic investigators; protects subjects against both nonphysical and physical harms; and promotes “social justice.”
Negative Comments:
The constraints placed upon investigators and indeed research subjects by OHRP and so-called ethicists approaches the absurd.
7. Whitney, et al. Article Overview (4) Negative Comments Continued
Getting protocols approved gets worse each year because you have to document more and more and more USELESS stuff.
For most of my work I receive coded samples devoid of patient identifiers, yet I have to fill in all sorts of crap and repeat over and over again that I couldn't track down these subjects if I tried.
8. January 15, 2009 – Presentation Outline Research Quiz
IRB Overview
HIPAA Documents
Research Misconduct
Obtaining Informed Consent
Questions and Answers
9. Research Quiz Question #1:
What is the purpose of an IRB?
Question #2:
What is the definition of research and how does research differ from standard practice?
10. Research Quiz (2) Question #3:
What are quality improvement projects and when do they qualify as research projects?
Question #4:
How long does it take for studies to get approved? Why?
11. IRB Overview Mission:
To protect the rights and welfare of human research participants.
Definition of Research:
Systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
12. Key Features Of Research Intent: generate new knowledge, principles, or theories that revises or improves existing knowledge, programs or processes.
Systematic collection and/or analysis of data.
Anticipated results that are valid and generalizable
13. Functions of the IRB Reviewing research to ensure:
Risks are minimized
Risks are reasonable vs. benefits
Selection is equitable
Informed Consent is obtained
Data and Safety are protected/monitored
Privacy and confidentiality are upheld
Vulnerable population protections are enhanced
14. CPHS Logic Model
15. Materials Submitted for Review Application
Protocol
Consent Forms
Letters of Approval/Cooperation
Recruitment Flyers
HIPAA Forms
Investigator Brochure
Pediatric Risk Assessment
Grant Application
Data Collection Forms (questionnaires)
Translations
*Change Request
*Continuing Review
16. Protocol Elements literature review/current state of knowledge
justification for the study
potential use of study findings
study design and locations
hypothesis
Methodology
Description and source of study population
Inclusion and exclusion criteria
Number of participants
Sampling and participant selection
17. Protocol Elements (2) Recruitment/enrollment activities
Consenting process;
Confidentiality/privacy
Data monitoring
Explanation of study instruments
Data analysis plan.
18. Types of Review Exempt Research
Case studies and retrospective chart reviews
Expedited Review
Minimal Risk Protocols and minor changes to approved research
Collection of blood samples
Prospective collection of biological specimens by noninvasive means
Collection of data through noninvasive procedures routinely employed in clinical practice
Research on individual or group characteristics or behavior
Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
19. Types of Review Full Committee Review
Protocols that have risks that are unknown or more than minimal
Clinical trials
Including studies on drugs, devices, and procedures
Cohort Studies
Case Control Studies
Cross-sectional study techniques in certain settings
Bio-banking and sample repositories
20. HIPAA Documents and the IRB HIPAA Exempt
HIPAA Waivers subject to approval
Retrospective Chart Review
Screening and Recruitment
Decedent Data
HIPAA Authorization for PHI
21. Misconduct Defined (1) Fabrication, falsification, plagiarism and other forms of misappropriation of ideas, or additional practices that seriously deviate from those that are commonly accepted in the research community for proposing, conducting, or reporting research.
(2) Material failure to comply with federal and University requirements for the protection of researchers, human subjects, or the general public or for ensuring the welfare of laboratory animals.
22. Misconduct Defined (2) (3) Failure to adhere to other material legal requirements governing the field of research.
(4) Failure to comply with established standards regarding author names on publications.
(5) Retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.
23. Additional Definitions Plagiarism – appropriation of another person’s ideas, processes, results, or words without giving appropriate credit
Fabrication – making up data or results and recording or reporting them.
Falsification – manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
24. Additional Definitions (2) Noncompliance: Noncompliance is a failure by an investigator to abide by research related requirements, good clinical practice requirements, CPHS requirements and applicable regulatory requirements. :
Failure to obtain approval for research prior to initiating the research activities,
Continuing research activities beyond the expiration date without obtaining continuing review approval,
Failure to obtain informed consent when required,
Failure to file an adverse event report,
Implementing changes to the protocol without prior approval.
25. Examples of Violated Research Ethics 1945-1946 - Nuremburg Trials
Included studies on hypothermia, infectious disease, altitude, pharmacologics, sterilization, surgery and traumatic injuries
1950’s – Willowbrook Hepatitis Study (New York)
Intentionally infected healthy “retarded” children by feeding them feces from children with active hepatitis (with food)
1955 – The Wichita Jury Study (Kansas)
Audiotaped jurors to analyze decision-making without consent
1962 – The Thalidomide Experience (nationwide)
Investigational treatment given to pregnant women to alleviate “unpleasant symptoms”
26. Examples of Violated Research Ethics Cont…. 1966 – “Ethics of Clinical Research” published by Dr. Beecher (Harvard Medical School), NE Journal of Medicine
Cited ethical violations in 22 published articles
1960’s – Jewish Chronic Disease Hospital Studies (New York)
Injected live cancer cells in demented patients with weakened immune systems
1960’s – Milgram Studies of Obedience to Authority (Yale University)
Participants deceived into thinking the study was evaluating the role of negative reinforcement on learning
1970’s – San Antonio Contraception Study
Clinic randomized patients to active birth control or placebo
27. Examples of Violated Research Ethics Cont…. 1970’s – Tearoom Trade Study
PhD Dissertation of Laud Humphrey’s from Washington University
Observed men participating in sexual activities, served as a “watch queen”, copied license plates, and followed up with men one year later in disguise to gather additional information (i.e. marital status, employment, etc.)
1932 – 1972 – Tuskegee Syphilis Study (Alabama)
Evaluated the natural history of untreated syphilis
Led to the creation of NIH Office for the Protection
from Research Risks (now OHRP) and IRB’s
28. Oversight Of Human Subject Research 1949 – Nuremberg Code
1964 – WMA Declaration of Helsinki
1966 – PHS policy leading to IRBs
1974 – National Research Act of 1974 established 45 CFR 46
1978 – The Belmont Report
1991 – Common rule
29. Overview of Informed Consent Process and Forms
30. Informed Consent Overview All modern codes of ethics concerning research with human subjects affirm the moral importance of a principle of informed consent.
“The voluntary consent of the human subject is absolutely essential”
31. Overview (2) Obtaining consent is an ongoing process of communication and mutual understanding
The process is misrepresented as:
A piece of paper
A moment in time
A legal contract
32. Overview (3) Must be obtained for each research subject
Must be obtained prior to initiation of screening procedures
Must be tailored to the level of understanding
If a medical term is essential, a lay definition is needed
Sufficient opportunity must be given for consideration, no coercion
33. Four Tenets Accurate Information
Understanding
Voluntariness
Decision Making Capacity
34. Practical Benefits Increases subject adherence to the protocol and the quality of the research.
Provides the benefit of an additional layer of risk review tailored to the interests of the individual subject.
Fosters public trust
35. Four Reasons to Waive Informed Consent 1) Investigations that do not constitute research involving human subjects
2) Human subjects research that is exempt from compliance with federal regulations
36. Four Reasons to Waive Informed Consent (2) 3) Non-exempt human subjects research in which it is not possible to obtain participants’ written informed consent
For reasons of age, cognitive impairment, or the like, some individuals are incapable of providing informed consent
Research in emergency medicine
37. Four Reasons to Waive Informed Consent (2) 4) Non-exempt human subjects research in which it is not desirable to obtain participants’ written informed consent.
a signed informed consent document may pose a risk to subjects, and
obtaining informed consent may diminish the scientific merit of the research.
38. CPHS Reviewer Checklist
39. Office of Research Support Website
40. https://iris.uth.tmc.edu/Login.jsp
Electronic submission of protocols to the IRB
Initial submission
Change requests and amendments
Continuing reviews
Adverse Events, etc.
Electronic routing and review by CPHS
Notifications are electronic and available via e-mail and within iRIS IRIS
41. iRIS Web Site: http://iris.uth.tmc.edu
CPHS Web Site: http://www.uth.tmc.edu/orsc/index.html
iRIS assistance: 713-500-7960
Office of Research Support Committees: 713-500-7943
Robert Nobles: 713-500-7937 Important Information
42. Discussion/Questions