Ethical Considerations and Data Confidentiality in Human Intervention Studies

Ethical Considerations in Human Intervention Studies

• Ethics is the discipline of dealing with moral duty and obligation, a set of moral principles or values, and the principle of conduct governing an individual or group.

• Nazi Medical War Crimes and Tuskegee Syphilis Study are some of the first large-scale known violations against human subjects in research.

• The Code of Hammurabi is one of the earliest written provisions in the field that comes about 1750 BC.

• The Nuremberg Code and the Helsinki Declaration are established ethical principles for medical research involving human subjects.

• Justification of research in humans is necessary to reach important conclusions, specifically for human physiologic studies, epidemiological studies, and drugs for treating humans.

• Basic principles of research on human subjects include respect for persons, beneficence, and justice.

• Assessment of benefits and risks is necessary to assure that benefits outweigh risks for the research participant, and risks or harms and benefits may be physical, psychological, social, economic, or legal.

• Informed consent is a communication process between the researcher and the participant, and it is essential to describe the research, risks, benefits, confidentiality, compensation, participant contacts, and voluntary participation.

• Vulnerability to incentives, community pressure, perceived power of investigators, and inability to understand research requirements can influence voluntary consent.

• Ethical requirements for international public health research include social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, respect for potential and enrolled subjects, and responsiveness to community health needs.

• Researchers/sponsors should ensure that the research responds to the health needs and priorities of the target community and that any product developed will be made available to the community.

• Community approval is necessary, and research controversies in developing countries include placebo groups, care beyond the trials, and privacy vs. confidentiality.

• Privacy is about people, and confidentiality is about data. Private information must be individually identifiable, and confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission.Protecting Subject Data Confidentiality

• Encryption software can be used to protect data from unauthorized access.

• Storing subject identifiable data on a laptop computer should be minimized to prevent loss or theft.

• Certificates of Confidentiality can protect data from being subpoenaed.

• Anonymous data is collected from individuals who were not identified at the time of collection.

• Unlinked or anonymized data have identifiers or codes that were unlinked to prevent linking to identifying information or individuals.

• Collecting anonymous data or anonymizing data after collection is the best way to protect subjects' confidentiality.

• Anonymous data collection or anonymization can be appropriate for protecting sensitive information.

• Anonymization can help to reduce the risk of re-identification of individuals.

• Privacy risks can arise if data is not protected.

• Data breaches can lead to the loss of sensitive data.

• Protecting data confidentiality is important for maintaining trust with research participants.

• Researchers have a responsibility to ensure that data is collected, stored, and shared in a secure and confidential manner.