1. Slide 1 Mosby items and derived items © 2006, 2002 by Mosby, Inc. LEGAL AND ETHICAL ISSUES: Informed Consent Chapter 13

2. Slide 2 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Learning Outcomes Describe the historical background that led to the development of ethical guidelines for the use of human subjects in research. Identify the essential elements of an informed consent form. Evaluate the adequacy of an informed consent form. Describe the institutional review board’s role in the research review process. Identify populations of subjects who require special legal and ethical research considerations.

3. Slide 3 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Learning Outcomes (cont’d) Appreciate the nurse researcher’s obligations to conduct and report research in an ethical manner. Describe the nurse’s role as patient advocate in research situations. Discuss the nurse’s role in ensuring that FDA guidelines for testing of medical devices are followed. Discuss animal rights in research situations. Critique the ethical aspects of a research study.

4. Slide 4 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Ethics and History History places ethics in perspective. Those who fail to study history are condemned to repeat it. Ethics: Disciplined study of morality Morality: What should one’s behavior and character be?

5. Slide 5 Mosby items and derived items © 2006, 2002 by Mosby, Inc. History Exposed Nazi experiments Untreated syphilis in black males San Antonio contraceptive study Thalidomide Jewish chronic disease study Beecher (1966) NEJM 22 studies performed unethically Milgram study

6. Slide 6 Mosby items and derived items © 2006, 2002 by Mosby, Inc. National Commission Identify the basic ethical principles that underlie the conduct of human research Develop guidelines to ensure that human research is conducted in accordance with those principles Belmont Report, 1974

7. Slide 7 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Federal Regulations and Policy Office of Human Research Protection (OHRP) 45 CFR 46-DHHS Policy for Protection of Human Research Subjects (Subparts A, B, C, D)

8. Slide 8 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Belmont Principles Respect for persons Beneficence Justice

9. Slide 9 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Respect Treat individuals as autonomous agents. Do not use a person as a means to an end. Allow people to choose for themselves. Give extra protection to those with limited autonomy.

10. Slide 10 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Beneficence Acts of kindness or charity that go beyond duty Obligations derived from beneficence –Benefit others –Prevent harm –Prevent evil –Promote good

11. Slide 11 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Justice Treat people fairly Fair sharing of burdens and benefits of research Distinguish procedural justice from distributive (society as a whole) justice

12. Slide 12 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Principles Applied Beneficence: Sound research design, competent investigators, favorable risk- benefit ratio Respect: Informed consent, respect for privacy Justice: Equitable selection of subjects

13. Slide 13 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Definition of Research A systematic investigation designed to develop or contribute to generalizable knowledge –45 CFR 46.102(d)

14. Slide 14 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Definition of Human Subject A living individual about whom an investigator... conducting research obtains: –Data through intervention or interaction with the individual, or –Identifiable private information

15. Slide 15 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Institutional Review Boards (IRBs) Review research projects and assess that ethical standards are met in relation to the protection of the rights of human subjects 1.At least 5 members of various backgrounds to promote complete and adequate project review 2.Members qualified by virtue of expertise, experience, and reflect professional, gender, racial, and cultural diversity 3.Membership must include 1 member whose concerns are primarily nonscientific (lawyer, clergy, ethicist)

16. Slide 16 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Institutional Review Boards (cont’d) 4.At least 1 member from outside the agency 5.IRB members have mandatory training in scientific integrity and prevention of scientific misconduct, as do principal investigators of a research study and research team members 6.IRB is responsible for protecting subjects from undue risk and loss of personal rights and dignity

17. Slide 17 Mosby items and derived items © 2006, 2002 by Mosby, Inc. IRB Role Assessing recruitment: Is it fair? Evaluating inclusion and exclusion criteria Investigator-subject relationship Role of IRB in study? Consent: Maximize autonomy Additional protections Assessing risk and benefit Assessing consent forms and process

18. Slide 18 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Recruitment Plans and materials must be reviewed by IRB Public service announcement or ads also reviewed

19. Slide 19 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Approval Categories Exempt: Low risk, nonvulnerable, not sensitive, short duration (6 categories [e.g., educational]) Expedited review: Minimal risk (no substantive increase beyond risks of ordinary life), nonvulnerable, nonsensitive topic (9 categories [e.g., chart review, questionnaires]) Full board review

20. Slide 20 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Full Board Review All members participate and review All members participate in discussion and make comments Decision is rendered by a majority of assembled quorum No member has a conflict of interest

21. Slide 21 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Informed Consent Process Does NOT Equal Informed Consent Form!!

22. Slide 22 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Informed Consent What it is –Ongoing process of communications and mutual understanding –Shared responsibility for protection What it is not –Piece of paper –Moment in time –Legal contract

23. Slide 23 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Comprehension Not valid unless subject understands Responsibility for understanding rests with researcher, who must consider: –Nature of population –Type of information –Circumstance and timing –Language and culture

24. Slide 24 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Approval Criteria Risks minimized Risks balanced by benefit Subject selection equitable Procedures for obtaining informed consent Procedures for consent documentation Data monitoring provisions Privacy and confidentiality measures Safeguards for vulnerable subjects

25. Slide 25 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Risk Assessment Probability of harm occurring as a result of participation Quantified by probability and magnitude Types: Social, legal, physical, economic, psychological May apply to individual or society

26. Slide 26 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Benefit Assessment Valued or desired outcome, an advantage Quantified by probability or magnitude Types: Medical, psychological, kinship May apply to individual or society

27. Slide 27 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Special Considerations Vulnerable subjects –Children –Prisoners –Mentally disabled persons –Economically disadvantaged –Educationally disadvantaged –Subtle vulnerable: Language, culture, pregnancy, students, employees, chemical use, health status

28. Slide 28 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Elements of Informed Consent Form Study involves research –Purpose of research –Expected duration for subject –Description of procedures –Identification of experimental procedures

29. Slide 29 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Elements of Informed Consent Form (cont’d) Reasonably foreseeable risks or discomforts –How can risks be minimized? Reasonably foreseeable benefits for subjects or others –How can benefits be maximized? Alternative procedures or treatments

30. Slide 30 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Elements of Informed Consent Form (cont’d) Confidentiality Compensation for research-related injury Who can answer questions –About study and research-related injuries –About subject’s rights Voluntary participation

31. Slide 31 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Elements of Informed Consent Form (cont’d) Present in consents that generally involve an intervention May involve unforeseeable risks Situations where researcher can terminate subject’s participation Any additional costs Consequences and procedures for subject’s early withdrawal Revelation of new findings

32. Slide 32 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Elements of Informed Consent Form (cont’d) Payment: total or prorated Who has access to records Probability of random assignment Special qualifications for investigator

33. Slide 33 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Assurance of Anonymity and Confidentiality The right to privacy is also protected through individually identifiable health information (IIHI) –IIHI must be deidentified under HIPAA Privacy Rule. –Data are part of a limited data set, and data use agreement with the researcher is in place. –Individual who is a potential research subject provides authorization for the researcher to use and disclose his or her protected health information (PHI). –Waiver or alteration of authorization requirements is obtained from institutional review board (IRB).

34. Slide 34 Mosby items and derived items © 2006, 2002 by Mosby, Inc. Critical Thinking Decision Path: Evaluating the Risk/Benefit Ratio of a Research Study