Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 18

Safeguarding Confidentiality

The investigator must establish secure safeguards of the confidentiality of subjects' research data. Subjects should be told the limits, legal or other, to the investigators' ability to safeguard confidentiality and the possible consequences of breaches of confidentiality.

Commentary on Guideline 18

Confidentiality between Investigator and Subject. Research relating to individuals and groups may involve the collection and storage of information that, if disclosed to third parties, could cause harm or distress. Investigators should arrange to protect the confidentiality of such information by, for example, omitting information that might lead to the identification of individual subjects, limiting access to the information, anonymizing data, or other means. During the process of obtaining informed consent, the investigator should inform the prospective subjects about the precautions that will be taken to protect confidentiality.

Prospective subjects should be informed of limits to the ability of investigators to ensure strict confidentiality and of the foreseeable adverse social consequences of breaches of confidentiality. Some jurisdictions require the reporting to appropriate agencies of, for instance, certain communicable diseases or evidence of child abuse or neglect. Drug regulatory authorities have the right to inspect clinical-trial records, and a sponsor's clinical-compliance audit staff may require and obtain access to confidential data. These and similar limits to the ability to maintain confidentiality should be anticipated and disclosed to prospective subjects.

Participation in HIV/AIDS drug and vaccine trials may impose upon the research subjects significant associated risks of social discrimination or harm; such risks merit consideration equal to that given to adverse medical consequences of the drugs and vaccines. Efforts must be made to reduce their likelihood and severity. For example, subjects in vaccine trials must be enabled to demonstrate that their HIV seropositivity is due to their having been vaccinated rather than to natural infection. This may be accomplished by providing them with documents attesting to their participation in vaccine trials, or by maintaining a confidential register of trial subjects, from which information can be made available to outside agencies at a subject's request.

Confidentiality between Physician and Patient. Patients have the right to expect that their physicians and other health-care professionals will hold all information about them in strict confidence and disclose it only to those who need, or have a legal right to, the information, such as other attending physicians, nurses, or other health-care workers who perform tasks related to the diagnosis and treatment of patients. A treating physician should not disclose any identifying information about patients to an investigator unless each patient has given consent to such disclosure and unless an ethical review committee has approved such disclosure.

Physicians and other health care professionals record the details of their observations and interventions in medical and other records. Epidemiological studies often make use of such records. For such studies it is usually impracticable to obtain the informed consent of each identifiable patient; an ethical review committee may waive the requirement for informed consent when this is consistent with the requirements of applicable law and provided that there are secure safeguards of confidentiality. (See also the Commentary on Guideline 4: Waiver of the Consent Requirement.) In institutions in which records may be used for research purposes without the informed consent of patients, it is advisable to notify patients generally of such practices; notification is usually by means of a statement in patient-information brochures. For research limited to patients' medical records, access must be approved or cleared by an ethical review committee and must be supervised by a person who is fully aware of the confidentiality requirements.

Issues of Confidentiality in Genetic Research. An investigator who proposes to perform genetic tests of known clinical or predictive value on biological samples that can be linked to an identifiable individual must obtain the informed consent of the individual or, when indicated, the permission of a legally authorized representative. Conversely, before performing a genetic test that is of known predictive value or gives reliable information about a known heritable condition, and individual consent or permission has not been obtained, investigators must see that biological samples are fully anonymized and unlinked; this ensures that no information about specific individuals can be derived from such research or passed back to them.

When biological samples are not fully anonymized and when it is anticipated that there may be valid clinical or research reasons for linking the results of genetic tests to research subjects, the investigator in seeking informed consent should assure prospective subjects that their identity will be protected by secure coding of their samples (encryption) and by restricted access to the database, and explain to them this process.

When it is clear that for medical or possibly research reasons the results of genetic tests will be reported to the subject or to the subject's physician, the subject should be informed that such disclosure will occur and that the samples to be tested will be clearly labeled.

Investigators should not disclose results of diagnostic genetic tests to relatives of subjects without the subjects' consent. In places where immediate family relatives would usually expect to be informed of such results, the research protocol, as approved or cleared by the ethical review committee, should indicate the precautions in place to prevent such disclosure of results without the subjects' consent; such plans should be clearly explained during the process of obtaining informed consent.

The Islamic Point of View Concerning Guideline 18

Safeguarding Confidentiality

Resolution 79 (10/8) of the Islamic Jurisprudence (Fiqh) Academy in Jeddah sets forth, in articles 4, 5, and 6, the rulings on confidentiality in medical professions, as follows:

Fourth: Safeguarding confidentiality is a definite requirement for all workers in professions where releasing confidential information creates disorder, such as the medical professions. People who need advice and assistance seek the help of such professionals and confide in them information and data that may help in the performance of the vital tasks required, including details that a person normally conceals from everyone else, including those closest to him.

Fifth: Exceptions from the requirement of safeguarding confidentiality are made in cases where concealing the confidential information causes greater harm, for the person involved, than that caused by revealing it, or when revealing it brings a benefit that outweighs that of concealing it. Such cases are of two types:

A. The first types is that of cases where revealing confidential information is required in accordance with the rule that calls for commission of the slighter of two injuries to prevent the greater, or the rule of pursuing public interest, which calls for tolerating a private instance of harm to prevent a public one, when necessary. Such cases fall into two categories:

cases of preventing social harm, and

cases of preventing individual harm.

B. The second type is that of cases where revealing confidential information is permitted, because it

brings a social benefit, or

prevents public harm.

In all these cases the objectives and priorities of Islamic Law - namely, the preservation of faith, life, reason, offspring and wealth - must be observed.

Sixth: Exceptions relevant to cases that require, or allow, the disclosure of confidential information should be provided for in the practice regulations of medical professions. They should be listed clearly and inclusively, with details explaining how and to whom the disclosure should be made. Concerned authorities should make everybody aware of these cases.

These rules follow the third article of the resolution which says, "The normal thing is to prohibit any disclosure of confidential information, and revealing it without a justification entails legal liability." Islamic Center of Southern California