Human Protection of Subject _ Ethics

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					Human Protection of Subject
      May T. Dobal, PhD, RN
New York University College of Nursing
         October 17, 2008
Elsevier Student Rep – ebook
– Human Subjects Certification
– Research Critique #1
Brief overview of ethics and human
subject protection
Deadly Deception
Historical review

Ethical principles

Unethical research studies

Documentary, “Deadly Deception”
        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 men
San Antonio contraceptive study
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
          Belmont Principles
Respect for persons


Treat individuals as autonomous agents.

Do not use a person as a means to an

Allow people to choose for themselves.

Give extra protection to those with limited
Acts of kindness or charity that go beyond

Obligations derived from beneficence
– Do no harm
– Prevent harm
– Prevent evil
– Promote good
Treat people fairly

Fair sharing of burdens and benefits of

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

Justice: Equitable selection of subjects
        Definition of Research
A systematic investigation designed to
develop or contribute to generalizable

– 45 CFR 46-DHHS Policy for Protection of Human Research
  Subjects (Subparts A, B, C, D)
   Definition of Human Subject
A living individual about whom an
investigator . . . conducting research
 – 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

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
               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
Plans and materials must be reviewed by

Public service announcement or ads also
         Approval Categories
Exempt: Low risk, non-vulnerable, not sensitive,
short duration (6 categories [e.g., educational])

Expedited review: Minimal risk (no substantive
increase beyond risks of ordinary life), non-
vulnerable, non-sensitive 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
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
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      Procedures for consent
Risks balanced by    Data monitoring
benefit              provisions
Subject selection    Privacy and
equitable            confidentiality
Procedures for       Safeguards for
obtaining informed   vulnerable subjects
          Risk Assessment
Probability of harm occurring as a result of

Quantified by probability and magnitude

Types: Social, legal, physical, economic,

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
Elements of Informed Consent Form
 Reasonably foreseeable risks or
 – How can risks be minimized?

 Reasonably foreseeable benefits for
 subjects or others
 – How can benefits be maximized?

 Alternative procedures or treatments
Elements of Informed Consent Form

 Compensation for research-related injury

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

 Voluntary participation
Elements of Informed Consent Form
 Informed consents for intervention studies
 may include
 – Unexpected risks
 – Situations where researcher can terminate
   subject’s participation
 – Any additional costs
 – Consequences and procedures for subject’s
   early withdrawal
 Elements of Informed Consent

Payment: total or prorated

Who has access to records

Probability of random assignment

Special qualifications for investigator
    Assurance of Anonymity and
The right to privacy is also protected through individually
identifiable health information (IIHI)

– IIHI must be de-identified under HIPAA (Health
  Insurance Portability and Accountability Act) Privacy

– 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).
Tuskegee Syphilis Study - Timeline
  KEY DATES: 1926, 1931, 1932, 1940, 1945, 1972, and 1997

1895 Booker T. Washington at the Atlanta Cotton Exposition, outlines
his dream for black economic development and gains support of
northern philanthropists, including Julius Rosenwald (President of
Sears, Roebuck and Company).

1900 Tuskegee educational experiment gains widespread
support. Rosenwald Fund provides monies to develop schools,
factories, businesses, and agriculture.

1915 Booker T. Washington dies; Robert Motin continues work.

1926 Health is seen as inhibiting development and major health
initiative is started. Syphilis is seen as major health problem.
Prevalence of 35 percent observed in reproductive age population.

1929 Aggressive treatment approach initiated with mercury and
bismuth. Cure rate is less than 30 percent; treatment requires months
and side effects are toxic, sometimes fatal.

1929 "Wall Street Crash"--economic depression begins.
1931 Rosenwald Fund cuts support to development projects. Clark
and Vondelehr decide to follow men left untreated due to lack of funds
in order to show need for treatment program.

1932 Follow-up effort organized into study of 399 men with syphilis
and 201 without. The men would be given periodic physical
assessments and told they were being treated. Motin agrees to
support study if " Tuskegee gets its full share of the credit" and black
professionals are involved (Dr. Dibble and Nurse Rivers are assigned
to study).

1934 First papers suggest health effects of untreated syphilis.

1936 Major paper published. Study criticized because it is not known
if men are being treated. Local physicians asked to assist and asked
not to treat men. It was also decided to follow the men until death.

1940 Efforts made to hinder men from getting treatment ordered
under the military draft effort.

1945 Penicillin accepted as treatment of choice for syphilis.

1947 USPHS establishes "Rapid Treatment Centers" to treat syphilis;
men in study are not treated, but syphilis declines.
1962 Beginning in 1947, 127 black medical students are
rotated through unit doing the study.

1968 Concern raised about ethics of study by Peter Buxtun
and others.

1969 CDC reaffirms need for study and gains local medical
societies' support (AMA and NMA chapters officially
support continuation of study).

1972 First news articles condemn studies.

1972 Study ends.
1973 Congress holds hearings and a class-action lawsuit is
filed on behalf of the study participants.

1974 A $10 million out-of-court settlement is reached and
the U.S. government promised to give lifetime medical
benefits and burial services to all living participants. The
Tuskegee Health Benefit Program (THBP) was established
to provide these services.

1975 Wives, widows and offspring were added to the

1995 The program was expanded to include health as well
as medical benefits.

1997 On May 16th President Clinton apologizes on behalf
of the Nation.

     Deadly Deception

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