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

Mosby items and derived items © 2006, 2002 by Mosby, Inc. Slide 1

LEGAL AND ETHICAL ISSUES:Informed Consent

Chapter 13


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.


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.


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?


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


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


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)


Belmont Principles

• Respect for persons

• Beneficence

• Justice


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.


Beneficence

• Acts of kindness or charity that go beyond duty

• Obligations derived from beneficence

– Benefit others

– Prevent harm

– Prevent evil

– Promote good


Justice

• Treat people fairly

• Fair sharing of burdens and benefits of research

• Distinguish procedural justice from distributive (society as a whole) justice


Principles Applied

• Beneficence: Sound research design, competent investigators, favorable risk-benefit ratio

• Respect: Informed consent, respect for privacy

• Justice: Equitable selection of subjects


Definition of Research

• A systematic investigation designed to develop or contribute to generalizable knowledge– 45 CFR 46.102(d)


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


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)


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


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


Recruitment

• Plans and materials must be reviewed by IRB

• Public service announcement or ads also reviewed


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


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


Informed Consent Process

Does NOT Equal

Informed Consent Form!!


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


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


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


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


Benefit Assessment

• Valued or desired outcome, an advantage

• Quantified by probability or magnitude

• Types: Medical, psychological, kinship

• May apply to individual or society


Special Considerations

• Vulnerable subjects– Children– Prisoners– Mentally disabled persons– Economically disadvantaged– Educationally disadvantaged– Subtle vulnerable: Language, culture,

pregnancy, students, employees, chemical use, health status


Elements of Informed Consent Form

• Study involves research

– Purpose of research

– Expected duration for subject

– Description of procedures

– Identification of experimental procedures


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



• Confidentiality

• Compensation for research-related injury

• Who can answer questions– About study and research-related injuries– About subject’s rights

• Voluntary participation



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



• Payment: total or prorated

• Who has access to records

• Probability of random assignment

• Special qualifications for investigator


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).


Critical Thinking Decision Path: Evaluating the Risk/Benefit Ratio of a

Research Study

Documents

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