Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 4

Individual Informed Consent

For all biomedical research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law. Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an ethical review committee.

Commentary on Guideline 4

General considerations. Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation.

Informed consent is based on the principle that competent individuals are entitled to choose freely whether to participate in research. Informed consent protects the individual's freedom of choice and respects the individual's autonomy. As an additional safeguard, it must always be complemented by independent ethical review of research proposals. This safeguard of independent review is particularly important as many individuals are limited in their capacity to give adequate informed consent; they include young children, adults with severe mental or behavioral disorders, and persons who are unfamiliar with medical concepts and technology (See Guidelines 13, 14, 15).

Process. Obtaining informed consent is a process that is begun when initial contact is made with a prospective subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and explanation, by answering their questions as they arise, and by ensuring that each individual understands each procedure, investigators elicit their informed consent and in so doing manifest respect for their dignity and autonomy. Each individual must be given as much time as is needed to reach a decision, including time for consultation with family members or others. Adequate time and resources should be set aside for informed-consent procedures.

Language. Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather, the investigator must convey the information, whether orally or in writing, in language that suits the individual's level of understanding. The investigator must bear in mind that the prospective subject's ability to understand the information necessary to give informed consent depends on that individual's maturity, intelligence, education and belief system. It depends also on the investigator's ability and willingness to communicate with patience and sensitivity.

Comprehension. The investigator must then ensure that the prospective subject has adequately understood the information. The investigator should give each one full opportunity to ask questions and should answer them honestly, promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise determine whether the information has been adequately understood.

Documentation of Consent. Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express consent orally, or sign a consent form. As a general rule, the subject should sign a consent form, or, in the case of incompetence, a legal guardian or other duly authorized representative should do so. The ethical review committee may approve waiver of the requirement of a signed consent form if the research carries no more than minimal risk - that is, risk that is no more likely and not greater than that attached to routine medical or psychological examination - and if the procedures to be used are only those for which signed consent forms are not customarily required outside the research context. Such waivers may also be approved when existence of a signed consent form would be an unjustified threat to the subject's confidentiality. In some cases, particularly when the information is complicated, it is advisable to give subjects information sheets to retain; these may resemble consent forms in all respects except that subjects are not required to sign them. Their wording should be cleared by the ethical review committee. When consent has been obtained orally, investigators are responsible for providing documentation or proof of consent.

Waiver of the Consent Requirement. Investigators should never initiate research involving human subjects without obtaining each subject's informed consent, unless they have received explicit approval to do so from an ethical review committee. However, when the research design involves no more than minimal risk and a requirement of individual informed consent would make the conduct of the research impracticable (for example, where the research involves only excerpting data from subjects' records), the ethical review committee may waive some or all of the elements of informed consent.

Renewing Consent. When material changes occur in the conditions or the procedures of a study, and also periodically in long-term studies, the investigator should once again seek informed consent from the subjects. For example, new information may have come to light, either from the study or from other sources, about the risks or benefits of products being tested or about alternatives to them. Subjects should be given such information promptly. In many clinical trials, results are not disclosed to subjects and investigators until the study is concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.

Cultural Considerations. In some cultures an investigator may enter a community to conduct research or approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority. Such customs must be respected. In no case, however, may the permission of a community leader or other authority substitute for individual informed consent. In some populations the use of a number of local languages may complicate the communication of information to potential subjects and the ability of an investigator to ensure that they truly understand it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts such as those of placebo or randomization. Sponsors and investigators should develop culturally appropriate ways to communicate information that is necessary for adherence to the standard required in the informed consent process. Also, they should describe and justify in the research protocol the procedure they plan to use in communicating information to subjects. For collaborative research in developing countries the research project should, if necessary, include the provision of resources to ensure that informed consent can indeed be obtained legitimately within different linguistic and cultural settings.

Consent to Use for Research Purposes Biological Materials (Including Genetic Material) from Subjects in Clinical Trials. Consent forms for the research protocol should include a separate section for clinical-trial subjects who are requested to provide their consent for the use of their biological specimens for research. Separate consent may be appropriate in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a necessary part of the clinical trial), but not in others (e.g., the clinical trial requires the use of subjects' biological materials).

Use of Medical Records and Biological Specimens. Medical records and biological specimens taken in the course of clinical care may be used for research without the consent of the patients/subjects only if an ethical review committee has determined that the research poses minimal risk, that the rights or interests of the patients will not be violated, that their privacy and confidentiality or anonymity are assured, and that the research is designed to answer an important question and would be impracticable if the requirement for informed consent were to be imposed. Refusal or reluctance of individuals to agree to participate would not be evidence of impracticability sufficient to warrant waiving informed consent. Records and specimens of individuals who have specifically rejected such uses in the past may be used only in the case of public health emergencies. (See the Commentary on Guideline 18, Confidentiality between Physician and Patient)

Secondary Use of Research Records or Biological Specimens. Investigators may want to use records or biological specimens that another investigator has used or collected for use, in another institution in the same or another country. This raises the issue of whether the records or specimens contain personal identifiers, or can be linked to such identifiers, and by whom. (See also Guideline 18: Safeguarding Confidentiality.) If informed consent or permission was required to authorize the original collection or use of such records or specimens for research purposes, secondary uses are generally constrained by the conditions specified in the original consent. Consequently, it is essential that the original consent process anticipate, to the extent that this is feasible, any foreseeable plans for future use of the records or specimens for research. Thus, in the original process of seeking informed consent a member of the research team should discuss with prospective subject, and, when indicated, request their permission as to:

i) whether there will or could be any secondary use and, if so, whether such secondary use will be limited with regard to the type of study that may be performed on such materials;

ii) the conditions under which investigators will be required to contact the research subjects for additional authorization for secondary use;

iii) the investigators' plans, if any, to destroy or to strip of personal identifiers the records or specimens; and

iv)the rights of subjects to request destruction or anonymization of biological specimens or of records or parts of records that they might consider particularly sensitive, such as photographs, videotapes or audiotapes. (See also Guidelines 5: Obtaining Informed Consent: Essential Information for Prospective Research Subjects; 6: Obtaining Informed Consent: Obligations of Sponsors and Investigators; and 7: Inducement to Participate.)

The Islamic Point of View Concerning Guideline 4

Individual Informed Consent

On the basis of the Islamic Law principle that calls for respect of the independence of every individual and his right to make his personal choices and arrive at decisions suitable for him, without any trace of coercion or deception, and to be protected from injury, misleading inducement, or exploitation by others - no biomedical research involving human subjects should be conducted unless the subject's explicit permission, i.e. voluntary informed consent, is obtained. It should be given willingly after the subject, if fully competent, receives and understands the necessary information. If the subject has only partial or no competence, his permission cannot be considered valid at all.

This rule is based on the following.

1. Islamic law establishes the right of an individual to live and to be sound in body. It is a right safeguarded by the law. Therefore, no party is permitted to subject to experiments, trials, or research a fully competent individual without his voluntary permission, given while he is fully aware of the case. This is stipulated in Islamic jurisprudence (fiqh), where a rule says, "No one is entitled to dispose of the right of a human being without his permission," and "no right of a human being can be canceled without his consent."

Item 3/d of Resolution 67 of Islamic Jurisprudence Academy says, "In conducting medical research, the consent of a fully competent individual must be obtained, without any coercion, as may be exercised in the case of prisoners, or temptation, as may be exercised in the case of the needy. In addition, this research should involve no harm."

1.2. Coercion, deception, and misleading inducement are flaws that spoil consent and annul a permission given under any of them.

1.3. Providing the individual, i.e. subject, with full information on the research he is invited to be involved in and on its potential or certain risks is a prerequisite for consent validity. Unless the prerequisite is met, the conditional article is invalid. The consent of a person to the performance of something without awareness of its implications and full understanding of its nature, makes it contrary to his real intention and it is not given out of his truly free will. Real intention and truly free will are contingent on awareness and full understanding. A rule of Islamic jurisprudence stipulates that "The rights of human beings are placed in safekeeping and under precautionary measures."

1.4. When the research involves no more than minimal risk, the risk that is no more likely and not greater than that involved in routine medical or psychological examination, there is no need to document the consent obtained, verbal consent being sufficient.

1.5. The condition of informed consent may be waived in emergency situation which call for research interventions, when the subject is incapable of giving his informed consent, for the investigator has consent by inference. In jurisprudence it is stipulated that "an inferred permission is the same as an explicit one," "as it can be made explicitly, a permission can be obtained by inference," and "what is established by inference ranks the same as that established by explicit expression."

1.6. In the case of an incompetent, or a partially competent, individual, who is unable to protect himself and handle his own affairs and needs someone else to handle them and guard his interests, his permission, i.e. "informed" consent, is by no means valid for conducting research involving him. Nor is permission by his guardian relevant, except in very unusual cases which will be pointed out in the commentary on Guidelines 13 and 14.

Article 3/d of resolution 67 (5/7) of the Islamic Jurisprudence Academy says: "It is not permissible to conduct medical research involving subjects with only partial or no competence, even with the consent of guardians." Islamic Center of Southern California