Purdue Extension Human Subjects Training

1. Purdue ExtensionHuman SubjectsTraining Based on CITI Course in the Protection of Human Subjects Research Fall 2004

2. History and Ethical Principles Defining Research with Human Subjects Regulatory Overview Assessing Risk Informed Consent Privacy and Confidentiality Research with Prisoners Research with Children Research in Public Schools Internet Research Topics To Be Covered

3. History and Ethical Principles • Provides a Structure for Analysis and Decision making • Supports – Reminds to Protect Human subjects • Aids in Assessing Risks and Benefits

4. Historical Influences • Nuremberg Code • Resulted from Nazi Doctors Atrocities • The Code didn’t Impact U.S. Scientists • Declaration of Helsinki • Broadened Nuremberg Code

5. Historical Case Studies • Obedience to Authority Study • Involved Deception of Subjects • Caused Some Emotional Problems • Public Health Service Syphilis Study • 1932-1972 • Withheld Available Treatment • Led to Establishment of National Research Act • Current Protections for Human Subjects

6. Ethical Problems • Lack of Informed Consent • Coercion • Use/Exploitation of Vulnerable Populations • Withholding information including about risks • Failure to Assess Risks vs. Benefits • Deception • Violation of Rights

7. The Belmont Report • 1974 National Commission formed to study Human subjects concerns • 1979 Belmont Report • Respect For Persons • Beneficence • Justice • No One Principle “Trumps” Another • All must be weighed equally

8. Respect Beneficence Justice Informed Consent Voluntariness Risks/Benefits Privacy/Confidentiality = Burdens =Benefits Diversity From Principles to Practice

9. Regulatory Overview • Common Rule (45 CFR 46) • Department of Health and Human Services • All Institutions that Receive DHHS Funds • Subparts to Common Rule • Special Protections for • Prisoners- Subpart C • Children – Subpart D • Pregnant Women (when their pregnancy affects their ability to participate) fetuses, neonates -Subpart B

10. The Common Rule • Dictates What an IRB Should do • The basic criteria for IRB review of protocols • Description of the types of review • Composition of the IRB • Primary Purpose • Protect the rights and welfare of research subjects

11. Institutional Review Board (IRB) • Evaluates Research • According to Belmont Report Principles • Respect for Persons • Beneficence • Justice • Federal Regulations derived from it • Common Rule • IRB Committee Decision is Final • No one can override a decision of the IRB

12. Defining Research • A Systematic Investigation • Research Development, Testing, Evaluation • Contributes to Generalizable Knowledge • Will it be Disseminated? • Will it be Read by others outside of Purdue Extension? • Poster Sessions • Journal Articles • Impact Statements

13. Human Subjects • Definition • “A living Individual about whom an investigator conducting research obtains: • Data through intervention or interaction with the individual • Identifiable private information” • Private Information • Reasonable Expectation of Privacy • Provided for Specific Purpose – not to be made public

14. Benefit • A positive value to the individual of participating in a study • Direct Benefits • Indirect Benefits • Benefits to Science and society

15. Risk • Harms that may occur to individual • Probability and Magnitude • May be: • Physical • Social • Economic • Legal • Psychological • Weigh Risks against Potential Benefits • Not all Risks and Benefits may be known

16. Assessing Risk • Falls into 3 General Categories • Invasion of Privacy • Information accessed without knowledge or consent • Breach of Confidentiality • May be unintentional • Information disclosed outside to research setting • Study Procedures • Just participating can cause stress or issues of privacy • Can be culturally determined

17. Managing Risks • Collect Data without Identifiers • Remove all Direct Identifiers • Code Data • Keep code lists and data separately • Aggregate Data so as not to identify • Secure Technology/computers • Minimize risks of exposure from Participation • Sensitive to Psychological Risks

18. Privacy in Research • Privacy/of participant • About the person • Identifying and Recruiting subjects • Covert observation • Privacy of Third parties • Sensitive Questions • Limits to Confidentiality • Child/Elder Abuse Reporting • Focus Groups

19. Research with Prisoners • Definition: • Some one in the legal system • Consent Issues with Prisoner • Free Choice • Undue Inducements • Breach of Confidentiality • Sensitive Questions when there is no support • IRB must include an Prisoner Advocate when reviewing

20. Research with Children • Definition: • Persons who have not yet attained the legal age of consent. In IN it is 18 • In Commonly Accepted Educational Settings • Research about educational Tests • “Is your survey to find out what they learned, or what behavior changed?”

21. Not Exempt • Studies with Children cannot be Exempt when: • Interviews and or surveys outside of an educational experience • Observations when the researcher participates in the activities observed • Will require an Expedited or Full Review

22. Issues with Children • Potential Coercion • Peer Pressure • Child Abuse/Neglect Reporting • Age Appropriateness • Compensation

23. Written Informed Consent • Required for Expedited and Full Reviews • Include: • Purpose of the Research • Procedures to be Followed • Risks or Discomforts • Benefits • How records will be Maintained • Compensation if any • Contact Information • Voluntary Statement/Ability to Withdraw

24. Issues of Informed Consent • Recruitment • Language/Cultural Appropriateness • Reading Levels • Rights and Welfare Subjects • Potential Coercion • Waivers of parental consent may be granted: • Parent’s knowledge of situation my cause harm • Child is emancipated

25. Research in Public Schools • Regulations affecting schools • Common Rule • Common Rule –Subpart D for Children • Family Education Rights and Privacy Act FERPA • Educational Records • Protection of Pupil Rights Amendment PPRA- • Written Notification to Parents for Surveys • No Child Left Behind Act • Surveys containing sensitive Topics

26. Internet Research • Observing On-Line Communications • Are they Public or Private? • Technical Issues • Email is not secure • IP Addresses can be used to Identify Subjects • Ensure Servers are secure • Encrypt Data • Storage of data must be protected

27. Issues with Internet Research • Ensuring Comprehension • Underage Participants • Withdrawal • Documenting Consent • Privacy • Identifiers • Breach of Confidentiality • Assessing Risks

28. Workers • Some Argue that Workers are a Vulnerable population • Issues of workers as subjects • Effects of individual entitlements • Impairment of Family Relationships • Possible threats to job retention • Peer Pressure • Constraints to Job Advancement • Findings may affect individuals, corporations, unions, government

29. Exempt Research • Educational Settings • Surveys, Interviews, and Observation of Adults • Research on Public Officials • Existing Data • Federal Govt. Public Benefit • Consumer Evaluation/Taste Testing • Implied Consent- Voluntary

30. Expedited Review • No More than Minimal Risk • Falls into one of the 9 eligible categories • Medical drugs and devices approved by FDA • Collection of biological specimens • Collection of data from audio, video, or image recording • Non-exempt research using surveys, interviews, observations • Others

31. Full Review • Greater than Minimal Risk • Use of a Vulnerable Population • Must be present at IRB Committee meeting • Continuing Reviews will go back to the full committee for approval

32. Continuing Reviews/Revisions • Approval is for 364 Days • Continuing Review for Exempt Approval • Approximately 10 months after approval • Email continuing review form • Complete and send back • Same process for an Expedited or Full Review • Revisions- for all • Complete the Revision form for all revisions, • Send to IRB who approved

33. CITI Site for Quiz • https://www.citiprogram.org/default.asp • Log –in • Choose “Purdue Extension Educators” • Click on Basic Course • Complete Introduction • Complete Extension Institutional Page • Scroll down to complete the quiz • If you pass, download a completion report • If not, try again, using the CITI Modules

37. Extension Exempt Process • Complete X-HS-03-1 • Attach Instrument and Publicity • Send Electronically to DD • He/she will Forward to IRB coordinator • Reviewed by Extension Human Subjects Comm. • Sent to Three Reviewers • When all agree, approval is Emailed, with • Official notification sent from Director’s office

38. Process for Expedited and Full Reviews • Complete Application on IRB website • Write a Narrative Describing Research • Develop a Consent Form • Send to Director’s office to sign as P.I. • Will be sent to Purdue IRB for review • IRB will review the research component of the project • IRB will review and asks for clarification • Plan ahead for Questions

39. Questions???? • If you have questions, please contact Janet Bechman, Extension Plan of Work & Accountability Coordinator, jcb@purdue.edu • Prepared by • Catherine E. Burwell, Ph.D. • Extension IRB and Reporting Coordinator • ceb@purdue.edu