Ethics in Research - Chapter 5

Chapter 5: Ethics in Research

• This chapter is considered the most important in the book.

Historical Background

• 1930s and 1940s: Nazi medical experiments involved subjects being exposed to harm and forced to participate.

• 1932-1972: The Tuskegee Syphilis Study, conducted by the US Public Health Service, withheld medical treatment from participants to observe the natural progression of syphilis. Tests included blood tests, X-rays, spinal taps, and autopsies. Participants were misled about the treatment they were receiving. The study ended when a whistleblower revealed the unethical practices in 1972; at that time 74 participants remained alive, 128 had died of syphilis or complications, 40 wives were infected, and 19 children acquired congenital syphilis infections.

• 1940s: US federal agencies conducted radiation experiments on hundreds of people, many of whom were prisoners or elderly hospital patients.

• 1930s and 1940s: Nazi and Imperial Japanese medical experiments involved subjects exposed to harm and forced to participate in freezing, high-altitude, sea water, sulfanilamide, TB, wound, poison, sterilization & artificial insemination, and twin experiments.

Codes of Ethics

• 1949: Nuremberg Code, a response to Nazi atrocities, established international ethical standards.
• 1964: Declaration of Helsinki, by the World Medical Association, establishes an ethical standard.
• 1978: Belmont Report, a landmark document on ethical principles related to human subjects research.
• 1995: ANA Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research.
• 2002: CNA- Ethical Research Guidelines for RNs
• 2015: ANA revised Code of Ethics for Nurses with Interpretive Statements.

Ethical Dilemmas in Research

• Ethical dilemmas arise when the rights of study participants conflict with the requirements of the study.
• Examples:
  • Giving a new medication to AIDS patients where no control group receives no medication
  • Considering empathy in ICU treatment of patients of different genders

Ethical Principles: The Belmont Report

• Beneficence: Researchers have an obligation to minimize harm and maximize benefits to participants. This includes the right to freedom from harm and discomfort.
• Respect for human dignity: This includes the right to self-determination, meaning participants can voluntarily choose to participate and withdrawal from participation; and the right to full disclosure, meaning participants must be given all relevant information before deciding to participate.
• Justice: Participants have a right to fair treatment and their rights to privacy must be maintained.

Principle of Beneficence

• The principle of beneficence aims at minimizing harm, maximizing benefits and ensuring not to place participants at a disadvantage.

Principle of Respect for Human Dignity

• The right to self-determination: Study participants have the freedom to choose participation and withdrawal from a study.
• A person's right to ask questions and to drop out of a research project without penalty is also included.
• The right to full disclosure: All relevant information about a study, including the possibility of risks and benefits, must be provided to participants before their participation.

Principle of Justice

• Right to fair treatment: Researchers must ensure equal treatment of all participants in a study; equitable distribution of the benefits/burdens.
• Right to Privacy: Data privacy for participants must be ensured and protected through procedures such as anonymity and confidentiality.

Procedures for Protecting Study Participants

• Risk-benefit assessment: The potential risks and benefits of a study must be weighed.
• Informed consent: Participants must have adequate information about the research in a format that they can comprehend.
• Confidentiality procedures: Steps must be taken to protect the privacy of participants. Anonymity and confidential data and information handling are included.
• Debriefings and referrals: Debriefings ensure that possible concerns about the research procedure are discussed following data collection. Participants might be offered to discuss study findings after the study. Participants might require referrals related to their health, social, or psychological well-being.
• Treatment of vulnerable groups: Vulnerable groups require special protections due to their inability to consent or have a high risk of complications.
• External reviews and the protection of human rights: Ethical aspects of a study are reviewed by a research ethics board or committee.
• Ethical issues in using animals in research: Ethics for animal research are included.

Potential Benefits and Risks to Study Participants

• Participants are informed about their rights and obligations.
• Participants have the freedom to decide voluntary participation.

Informed Consent

• Participants have adequate information about the research.
• Participants can comprehend the information and have a free choice.
• Participants have the option to withdraw from a research study or to refuse to answer specific questions.
• Informed consent usually involves a written consent form that participants sign.

Consent Form

• Informed consent is necessary for a research procedure in order for participants to have adequate information allowing them to understand and make informed decisions about research participation or non-participation.
• Types of consent: Informed consent, implied consent, and process consent.

Confidentiality Procedures

• Anonymity: Participants and their data are not linked.
• Confidentiality: Confidentiality procedures must ensure information privacy and no link to a specific participant.
• Certificate of Confidentiality: Research that needs confidentiality might be awarded a certificate from NIH to protect information from being divulged.

Debriefings and Referrals

• Debriefing: Occurs after research to ensure that there are no lingering concerns or questions from participants.
• Referrals: Participants might require referrals.

Treatment of Vulnerable Groups

• Vulnerable groups in research require special protection due to their inability to consent (e.g., pregnant women, children).

Groups Considered Vulnerable

• Children
• Mentally or emotionally disabled people
• Severely ill, or physically disabled people
• Terminally ill people
• Institutionalized people
• Pregnant women

External Review and Protection of Human Rights

• Ethical review processes, such as Institutional Review Boards (IRBs) and Research Ethics Boards (REBs) are put in place to assess the ethical aspects of a study.

Question: True or False – Children require special protection in research studies

• Answer: True (Children lack the ability to make informed decisions about participation, thus require special protection.)

Guidelines for Critiquing the Ethical Aspects of a Study

• The guidelines cover the core aspects of a research study.