The national bioethics committee
Vulnerable groups in scientific research
It is important to conduct research on different groups. Needs are different and diseases or other pathogens affect people in different ways. The laws on such research and all international conventions on bioethics in research emphasise special care when it comes to individuals or groups that are vulnerable.
In addition to the general respect for all involved in scientific research in the health field, special attention is needed to vulnerable groups. These are individuals who are not, for whatever reason, able to make an informed or non-compulsory decision. It should be stressed that it is important that research is carried out on these groups.
Vulnerable groups
Iceland has ratified the Council of Europe Convention on the Protection of Human Rights and Fundamental Dignity in the Field of Applied Biomedicine with regard to biological and medical activities and the Additional Protocol on Medical Research in Humans. Research involving children is subject to certain conditions. This is in accordance with the international medical ethics code, as it is recognized that children should be given special protection and immunity. The following conditions are taken into consideration when evaluating applications for research projects involving children:
The study cannot be conducted on adults with the same scientific results.
Informed consent of the parent or guardian shall be obtained. As far as the development of the child permits, consent shall also be obtained. The participation of the child, if it objects, may not be required.
Both parents/guardians and the child themselves shall be informed of the planned investigation in accordance with the rules. Information to the child shall be prepared taking into account its development and language comprehension.
In the case of a therapeutic study, the intervention being studied should be likely to be as beneficial as other treatments available.
The general principle is that the participation of a child in a study is a direct benefit to its health. However, exceptions may be made to this, if the above conditions are met, but in addition, it must be assumed that the results of the study may ultimately lead to benefits for the individual concerned, or for other individuals in the same age group or those with the same disease or health disorder as the participant. Furthermore, the study must have minimal risk or suffering for the child. The criteria for children's participation in studies are mostly applicable to other vulnerable groups.
Iceland has ratified the Council of Europe Convention on the Protection of Human Rights and Fundamental Dignity in the Field of Applied Biomedicine with regard to Biomedical Activities and the Additional Protocol thereto, on Medical Research in Humans. The Convention and other conventions to which Iceland is a party include research on vulnerable groups. These include children, senior citizens, women with reduced capacity, mourners, prisoners, victims of violence, those for whom the legal guardian has been appointed due to illness or disability and the depressed. Special care is stipulated when the population of a study is drawn from any of the above groups. Protection of individuals who cannot consent to participate in a study Investigations that require the participation of a person who cannot consent are only permitted if the following specific conditions are met:
The results of this study may lead to real and direct benefits for the health of the participant.
Similar studies cannot be conducted on individuals who are able to give consent.
The person involved in the investigation shall be informed of his rights and the rules which have been established to protect the participants, except that the person is not able to receive the information.
The necessary written authorisation has been obtained from a legal guardian or authority, as provided by law, and after information has been provided, taking into account the previously known wishes or reservations of the person concerned.
An adult who is not able to give consent shall participate in the authorisation process as far as possible. The position of minor shall be taken into account as far as age and maturity allow.
The person in question does not object.
In exceptional cases and with regard to protective legal provisions, an investigation may be authorized, although there is no possibility of it being of direct benefit to participants, the authorization process takes into account the above but also the following:
One of the goals of the study is to increase understanding of a condition, disease or disorder, which in the end can result in benefits for the person in question, others in the same age group or those with the same disease or health disorder as the participant.
The study only presents a minimal risk or suffering for the study participant; and that in addition, speculation about the potential benefits of the study does not lead to an unjustified increase in risk or suffering for the study participant.
If the person objects to participation, refuses to give consent or withdraws consent in a study, this shall not lead to any form of discrimination with regard to the right to medical treatment and care.
Disclosure of information before authorisation for minors participation
Those who are asked to authorise the participation of a person in a research project shall be provided with sufficient information in a comprehensible form. This information shall be in writing.
The information shall include the objectives of the study, the potential benefits and risks of participation in the study, and shall also inform the results of the ethics committee. Furthermore, the information shall inform the rights and safeguards provided by law for those who cannot consent to participate themselves, and in particular the right to withdraw consent to participate at any level, without prejudice to the right to medical treatment and care.
The information shall also be given to the person concerned if he/she is present to receive information.
Minimum risk and minimum distress
The minimum risk of a study is defined as, depending on the nature and extent of intervention, it is expected that it will have a largely negligible and temporary effect on the health of the participant.
The minimum level of distress is defined as the maximum level of distress that will be temporary and negligible for the person involved. In assessing distress, an individual who is trusted by the prospective participant shall assess distress where appropriate.