Privacy & Confidentiality

Dr Robyna I Khan

Given our modern research setting, with growing dependence on computers, the Internet, and the need for databases, protection of an individual’s privacy is now one of the greatest challenges in research.

A breach of confidentiality violates a person’s rights and poses a risk of harm to the research participant, ranging from social embarrassment and shame, to stigmatization, and even damage to social and economic status, such as loss of employment and health insurance.

How do you define privacy?

• Privacy refers to how an individual decides what personal information to share with others.

• What individuals choose to let other people know about themselves.

• Private information can include thoughts, identifying information, and even information contained in bodily tissues and fluids.

How do you define confidentiality?

Confidentiality is an implicit expectation that privacy will be protected by those entrusted with the information—in this case, that the individual’s personal information will be kept private by the researcher.

Benefits of Maintaining Confidentiality

• It helps establish trust between the research participant and the researcher.

• It reduces worry on the part of the individual.

• It maintains the participant’s dignity.

• The participant feels respected. • It gives the participant control and

promotes autonomy.

• A researcher's obligation to protect confidentiality is higher than a clinician’s since research often does not provide benefit to the participant and provides no compelling reason to become involved in the research.

• In almost all situations, research needs do not trump an individual's basic privacy rights.

• Those involved in designing, approving, and carrying out research must determine how to conduct research that maintains participants’ confidentiality.

What Researchers should do

• Identify who has access to the data • Identify who is maintaining the

confidentiality of the data • Describe the measures for protecting

the physical security and software security of the data

• Ensure that authentication and authorization are required for those who have access to medical data by providing firewalls, data encryption, and password protection

• A contingency plan for dealing with any breach of confidentiality

World Medical Association Declaration of Helsinki

Declares, as a basic human right, that all medical and personal data be confidential except:

• If disclosure would prevent serious harm to public health.

• By order of a court of law for a criminal case.

The Belmont Report (1979)

• The report sets out three fundamental ethical principles: respect for persons, beneficence, and justice.

• Individual privacy and autonomy are described in the report as necessary to honor these ethical principles.

Information

The study objectives. The procedure/requirements. Possible risks. Possible benefits. Compensation. Confidentiality. Withdrawal.