For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the proxy consent of a properly authorized representative.
Before requesting an individual's
consent to participate in research, the investigator must provide
the individual with the following information, in language that
he or she is capable of understanding:
- that each individual is invited to participate as a subject in research, and the aims and methods of the research;
- the expected duration of the subject's participation;
- the benefits that might reasonably be expected to result to the subject or to others as an outcome of the research;
- any foreseeable risks or discomfort to the subject, associated with participation in the research;
- any alternative procedures or courses of treatment that might be as advantageous to the subject as the procedure or treatment being tested;
- the extent to which confidentiality of records in which the subject is identified will be maintained;
- the extent of the investigator's responsibility, if any, to provide medical services to the subject;
- that therapy will be provided free of charge for specified types of research-related injury;
- whether the subject or the subject's family or dependants will be compensated for disability or death resulting from such injury; and
- that the individual is free to refuse to participate and will be free to withdraw from the research at any time without penalty or loss of benefits to which he or she would otherwise be entitled.
The investigator has a duty to:
- communicate to the prospective subject all the information necessary for adequately informed consent;
- give the prospective subject full opportunity and encouragement to ask questions;
- exclude the possibility of unjustified deception, undue influence and intimidation;
- seek consent only after the prospective subject has adequate knowledge of the relevant facts and of the consequences of participation, and has had sufficient opportunity to consider whether to participate;
- as a general rule, obtain from each prospective subject a signed form as evidence of informed consent; and
- renew the informed consent of each subject if there are material changes in the conditions or procedures of the research.
Subjects may be paid for inconvenience and time spent, and should be reimbursed for expenses incurred, in connection with their participation in research; they may also receive free medical services. However, the payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in the research against their better judgment ("undue inducement"). All payments, reimbursements and medical services to be provided to research subjects should be approved by an ethical review committee.
Before undertaking research involving
children, the investigator must ensure that:
- children will not be involved in research that might equally well be carried out with adults;
- the purpose of the research is to obtain knowledge relevant to the health needs of children;
- a parent or legal guardian of each child has given proxy consent;
- the consent of each child has been obtained to the extent of the child's capabilities;
- the child's refusal to participate in research must always be respected unless according to the research protocol the child would receive therapy for which there is no medically-acceptable alternative;
- the risk presented by interventions not intended to benefit the individual child-subject is low and commensurate with the importance of the knowledge to be gained; and
- interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child-subject as any available alternative.
Before undertaking research involving
individuals who by reason of mental or behavioural disorders are
not capable of giving adequately informed consent, the investigator
must ensure that:
- such persons will not be subjects of research that might equally well be carried out on persons in full possession of their mental faculties;
- the purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental or behavioural disorders;
- the consent of each subject has been obtained to the extent of that subject's capabilities, and a prospective subject's refusal to participate in non-clinical research is always respected;
- in the case of incompetent subjects, informed consent is obtained from the legal guardian or other duly authorized person;
- the degree of risk attached to interventions that are not intended to benefit the individual subject is low and commensurate with the importance of the knowledge to be gained; and
- interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual subject as any alternative.
Prisoners with serious illness or at risk of serious illness should not arbitrarily be denied access to investigational drugs, vaccines or other agents that show promise of therapeutic or preventive benefit.
Before undertaking research involving
subjects in underdeveloped communities, whether in developed or
developing countries, the investigator must ensure that:
- persons in underdeveloped communities will not ordinarily be involved in research that could be carried out reasonably well in developed communities;
- the research is responsive to the health needs and the priorities of the community in which it is to be carried out:
- every effort will be made to secure the ethical imperative that the consent of individual subjects be informed; and
- the proposals for the research have been reviewed and approved by an ethical review committed that has among its members or consultants persons who are thoroughly familiar with the customs and traditions of the community.
For several types of epidemiological research individual informed consent is either impracticable or inadvisable. In such cases the ethical review committee should determine whether it is ethically acceptable to proceed without individual informed consent and whether the investigator's plans to protect the safety and respect the privacy of research subjects and to maintain the confidentiality of the data are adequate.
Individuals or communities to be invited to be subjects of research should be selected in such a way that the burdens and benefits of the research will be equitably distributed. Special justification is required for inviting vulnerable individuals and, if they are selected, the means of protecting their rights and welfare must be particularly strictly applied.
Pregnant or nursing women should in no circumstances be the subjects of non-clinical research unless the research carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge about pregnancy or lactation. As a general rule, pregnant or nursing women should not be subjects of any clinical trials except such trials as are designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects.
The investigator must establish secure safeguards of the confidentiality of research data. Subjects should be told of the limits to the investigators' ability to safeguard confidentiality and of the anticipated consequences of breaches of confidentiality.
Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependants are entitled to material compensation. The right to compensation may not be waived.
All proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees. The investigator must obtain such approval of the proposal to conduct research before the research is begun.
Externally sponsored research entails
two ethical obligations:
· An external sponsoring agency should submit the research protocol to ethical and scientific review according to the standards of the country of the sponsoring agency, and the ethical standards applied should be no less exacting than they would be in the case of research carried out in that country.
· After scientific and ethical approval in the country of the sponsoring agency, the appropriate authorities of the host country, including a national or local ethical review committee or its equivalent, should satisfy themselves that the proposed research meets their own ethical requirements.