Patients, clients and persons with impaired consent capacity
Will you be recruiting patients/clients to your research project? The most common procedure is to have someone from the institution (who through their work have natural access to contact information) make first contact with potential informants on behalf of the researcher, so that the duty of confidentiality is maintained.
Further, it is important to ensure that the aspect of voluntary participation is maintained. This is important both when it comes to formulating the request, and when it comes to any possible dependent relationships between the persons involved.
If you are employed at the institution (e.g. hospital, NAV office, nursing home) from where you are planning to recruit informants, there are several factors you should be aware of. Read more about research in one's own place of work.
Relevant information to the sample
- If contact with the sample is conveyed through an institution (hospital, NAV, etc.), information about that should be enclosed, and it should be stressed that the researcher/student does not know the identity of the persons asked before they possibly agree to participate.
- Patients and others in dependent positions must be clearly informed that whether they decide to participate in the study or if they later decide to withdraw, this will not affect their relationships with clinicians or others.
- If the information is obtained from sources other than the research participants themselves (registers, medical records, etc.) it must be made clear what information is collected, and from where.
When the participant has impaired consent capacity
When persons with impaired or absent capacity to consent are to be included in research, the general rule is that the next of kin is informed and asked to consent to the person’s participation. Furthermore, participants must receive information and request adapted to their situation, to the extent that this is possible. If the person in any way expresses that he/she does not want to participate must be respected. In addition, the following conditions must be met:
- It must be necessary for the purpose of the project to include persons with impaired consent capacity
- Any risk or inconvenience to the person must be insignificant
- There must be reason to believe that the results of the research may be of benefit to the person or group
- There should be no reason to believe that the person would have objected to participation in the research project if they whould have had the capacity to give consent
In some projects it may be appropriate to contact the Regional Committee for Medical and Health Research Ethics (REC) to clarify the necessity of any exemption from the duty of confidentiality, for example, in observational studies.
The Health Research Act applies to medical and health research which aims to generate new knowledge about health and disease. Read more about which projects should be approved by REC?
Sist endret: Thu Mar 23 14:24:53 CET 2017