Ethical Principles and Guidelines for Research Involving Human Subjects

Based on guidelines from the University of North Carolina Institutional Review Board

First … a Brief History of Our Current Human Subjects Protections

The Nuremberg Code

∆ Concern for the protection of people serving as research subjects was heightened following the Nuremberg war crime trials.

∆ The Nuremberg Code was drafted as a set of standards for judging doctors and scientists who conducted experiments on prisoners in concentration camps.

∆ The code became a prototype for later codes establishing standards for the ethical treatment of subjects of research.

The Declaration of Helsinki (1964)

∆ Established by the World Medical Association to guide medical doctors in research involving human subjects

The National Research Act (1974)

∆ Established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the United States

• The Belmont Report, issued by the commission set forth the basic ethical principles that should underlie the conduct of human research

Ethical Principles Underlying Acceptable Conduct of Research Involving Humans

∆ Respect for persons: recognition of the personal dignity and autonomy of individuals, with special protections for those with diminished autonomy

∆ Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing potential risks of harm

∆ Justice: benefits and burdens of research should be distributed fairly

If the PLACE Assessment Receives Funding from any U.S. Government Agency…

∆ All U.S.-funded research involving human subjects is required by U.S. law to be reviewed according to the rules set out in the U.S. Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects

∆ Each institution conducting research is required to have a formal mechanism for review, and must comply with all of the federal regulations

∆ An institutional review board (IRB) provides that formal mechanism within an institution

∆ Assurances link IRBs with a federal regulatory agency in the United States

What Do You Need to Consider When Conducting Research Involving Human Subjects?

When in Doubt ... Researchers Ask the Institutional Review Board (IRB)

What is a Human Subject?

A living individual about whom an investigator conducting research obtains the following:

∆ Data through interaction or intervention with the individual

∆ Identifiable private information

• Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information provided for a specific purpose

Exemptions

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices

2. Anonymous research UNLESS

∆ subjects could be identified, directly or through identifiers linked to subjects and

∆ disclosure of the subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation

Exemptions

3. Taste and food quality evaluation and consumer acceptance studies

4. Research involving the collection or study of existing data, documents, records, or specimens…

Be careful of the risk of deductive disclosure!!

Deductive Disclosure Example∆ From a sample of 90,000 participants in an adolescent health study,

you could identify one individual by knowing relatively few characteristics

∆ A 15 year old Asian male in grade 10, born in the U.S. and attending an urban, secondary school in New York, plays football

15 years old 14,575male 7,423grade 10 2,606 Asian 1,497born in U.S. 1,386football 79New York 16secondary school 13urban 1

Once It Is Determined that Human Subjects Are Involved….

∆ The institutional review board (IRB) must be presented with enough information to evaluate risks and benefits, adequacy of consent procedures, and protection of confidentiality

PLACE assessments are approved by the

IRB of the University of North Carolina

School of Public Health

and

<LOCAL IRB THAT APPROVED PROTOCOL>

Risks to Participants

Harm may result directly from research procedures or from breach of confidentiality

Types of risk:

∆ Physical (pain, drug side effects, injury)∆ Psychological (emotional distress)∆ Social (stigmatization)∆ Economic (loss of job for disclosing

information)

Minimal Risk

A risk is considered minimal “where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical examinations or tests.”

U.S. Code of Federal Regulations, Title 45, Part 46

Minimal Risk

Examples of what is considered minimal risk:

∆ Collection of hair and nail clippings, urine, blood samples <450 ml from non-pregnant adults

∆ Recording data using non-invasive procedures (blood pressure, anthropometry, EEG, EKG)

∆ Interviews, questionnaires, on non-sensitive subject matter

What Is Sensitive Information?

Depends on the context

∆ Usually or always sensitive: illegal behavior, immigration status, sexual behavior, health status (e.g. specific disease status)

∆ Potentially sensitive depending on cultural context: income (China), abortion data (Philippines but not Russia)

Benefits

Institutional review boards (IRBs) determine whether the benefits outweigh the risks to subjects

∆ Will subjects benefit directly?∆ Will the research result in generalizable

knowledge? Does it present an opportunity to understand, prevent, or alleviate a serious problem?

The scientific merit of the research is weighed in the risk/benefit analysis

Informed and Voluntary Consent

Basic Elements of Informed Consent:

∆ Statement that this is research

∆ Purpose of research, expected duration

∆ Procedures, reasonably foreseeable risks

∆ Benefits, alternative procedures

∆ Compensation

∆ Provisions for confidentiality

∆ Rights to withdraw or refuse specific aspects of protocols

∆ Information on whom to contact for additional information or problems

Important Aspects of Consent

Comprehension: Information must be presented so that subjects can understand

∆ Language, reading level, all the terms used

Voluntariness

∆ Freedom from coercion

Documentation of Informed Consent

∆ The PLACE interviews that you conduct will begin with a formal “verbal consent” step

∆ This insures that respondents who agree to be interviewed are giving a truly informed consent

Respecting Privacy and Insuring Confidentiality

Privacy:

∆ You will not be asking for the names or any other identifying information from respondents during the PLACE assessment.

∆ Interviews must be conducted where others cannot overhear the information given (even friends or family!)

Confidentiality:

∆ Interviewer confidentiality pledge ∆ Separation of data from identifying information

Special Provisions:Children

Research requires parental consent and assent of a child

Research on children is allowed if:

∆ It poses no more than minimal risk

∆ It poses more than minimal risk but offers direct benefit to the child

∆ There is no prospect of direct benefit to the child, but the research is likely to yield generalizable knowledge AND the risk represents a minor increase over minimal risk.

Special Provisions:Prisoners∆ Incarceration may affect prisoners’ ability to make a truly

voluntary and uncoerced decision about whether to participate

∆ Risks must be commensurate with risk that would be accepted by non-prisoners

∆ Incentives to participate must not be coercive

∆ To review research involving prisoners, the IRB must include a prisoner advocate

Ethical Review Questions

Example #1

You interview a community informant who tells you where sex workers solicit customers.

∆ Is it your duty to report this illegal activity to the police?

Example #2

During an interview with a respondent who is the manager of a bar, you notice that illegal drugs are being bought and sold on the premises. He knows that this illegal activity occurs at the venue but chooses not do anything about it.

∆ Is it your duty to report him to the police?

End of Interviewer Ethical Training