Participating in research
The necessity to obtain informed consent
Before anyone participates in a study, they should have given their informed consent to the researchers or doctors in charge of the study. Giving informed consent involves more than just accepting to take part as the decision must be based on a full understanding of what is involved. The information concerning the study should be provided by the organisers and be understandable to potential participants who should be given time to take in the information and ask any questions. For this reason, informed consent should be seen as a process rather than simply a document to be signed.
Different studies involve different levels of risk and inconvenience (e.g. having an interview, filling out a questionnaire, being observed, giving a blood sample, having a scan or taking medication which may have possible side-effects). Part of the process of informed consent involves finding out what is involved in a specific study and then taking the necessary time to decide when that is acceptable.
For studies involving medical treatment or drugs, the consent procedure is a medico-legal requirement covered by laws and codes of medical ethics. Depending on the country in which the research is being carried out, there may be additional specific laws on research which lay down conditions for obtaining consent. People with limited mental capacity or who lack the capacity to consent may still participate in research under certain conditions (which may be fairly strict).
Consent in case of incapacity or reduced capacity to consent
Many people who are in the early stages of dementia have the capacity to consent to participation in research. However, it is important that researchers understand that people with dementia may have certain difficulties with comprehension, attention span, memory and communication. For this reason, researchers need to take extra care to ensure that the information they have given has been understood and to respect each person’s pace. Printed information can be helpful as a support to memory and going back over what has been said can help the person remember what is involved. Involving a carer can also be helpful provided that the person with dementia agrees to this.
Sometimes research can only be carried out on people who are in a fairly advanced stage of dementia (e.g. in the case of research into palliative care or for experimental drugs to be used in more advanced stages of dementia). This raises an ethical issue if the person with dementia is no longer able to give fully informed consent. In some countries, there are laws on research which address this issue and this is also covered by the Convention on Human Rights and Biomedicine (1997), which has been either signed or ratified by most countries in Europe.
The provisions of the Convention on Human Rights and Biomedicine (1997) provide for consent to be given on behalf of a person who does not have the capacity to consent. This could be a legal representative or body, or anyone who has the authority to do so. Nevertheless, the person with incapacity (i.e. the person with dementia in this case) should be involved in the consent process as far as possible. In addition to standard requirements linked to participating in research, the Convention lays down additional laws for research involving people who are unable to consent. For example, the results of the research must have the potential to produce real and direct benefits to his/her health, comparable research cannot be carried out on other people who are capable of consent and the person does not object. These provisions would interfere with people with advanced dementia taking part in research (which could only be carried out on people at that stage). However, additional articles provide for this situation. For example, article 17, paragraph 2. states that research which does not have the potential to produce direct benefits to the health of the person concerned, such research may be authorised provided that:
- the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition.
- the research entails only minimal risk and minimal burden for the individual concerned.
Advance directives for research
Whilst it is often not possible to obtain consent to research from people in the late stage of dementia, there is a need to balance their protection with their right to choose to participate in research should they wish to do so. One solution would be to encourage people in the early stages of dementia to consider this issue and record their wishes in an advance directive. Alternatively, they could record their wish not to take part in research. In most countries, such statements about research would not be legally binding but, as an example of previously expressed wishes, could be taken into account in any discussions about possible participation. However, before deciding to write an advance directive for research, there are a few issues to consider. Please see below:
- According to Berghmans (1998), a high level of decision-making capacity is needed to give valid consent to participation in future non-therapeutic research involving more than minimal risk or burden. He questions whether people even in the early stage of dementia would satisfy such a demanding criterion. Moreover, people with dementia may be susceptible to the therapeutic illusion whereby they concentrate on possible benefits and ignore or underestimate possible disadvantages. If the research is proposed by the doctor responsible for the care of the person with dementia, the distinction between care and experiment may become blurred even if the research is clearly non-therapeutic (Gezondheidsraad, 2002)
- Writing an advance directive for care/treatment is more straightforward than writing one for research. For the former, the person can refer to specific known interventions or use more general terms such as “all life-saving interventions” whereas for the latter, it is difficult to give consent for a future experiment which has not yet been devised and which by the nature of research is likely to be innovative. Furthermore, it would be difficult to formulate wishes in terms that are neither too vague nor too restrictive. In view of the amount of time that could pass between making the advance directive and the research starting, it is difficult for someone to have a clear idea of what they might be letting themselves in for.
- Another problem linked to consent to research (through an advance directive), particularly in the later stages of dementia, is that many potential subjects would by that time be in an institutionalised or semi-institutionalised setting. Consent given in such a setting could, according to Lötjönen (2003), lack genuine voluntariness in that the person may feel vulnerable, at the mercy of the care staff and/or want to please the treating physician. The illness itself not only affects their decision-making capacity but also creates a situation of dependency.
An alternative to relying on consent through an advance directive would be to also appoint a health care proxy (please seen following sub-section for details) with power to consent or who has been designated by a person in advance of incapacity to be informed and consulted about healthcare and personal welfare issues on his/her behalf. This person could, in addition to contributing towards the consent process, also keep an eye on the personal wellbeing of the person with dementia if the latter does eventually participate in a study.
Substitute decision making
In some countries, it is possible for a person who still has sufficient capacity to appoint a healthcare proxy. Alternatively, a court may appoint a health care proxy on behalf of someone who has already lost capacity. Healthcare proxies differ from general guardianship measures, which are rarely limited to health care decisions and do not always permit the same degree of freedom with regard to the choice of the substitute decision maker. The role of the health care proxy is to take health-related decisions on behalf of a person who no longer has the capacity to do so and/or to receive information on his/her behalf and be consulted when health-related decisions are being made. This might, depending on current national legislation, cover research of a medical nature.
Again, depending on national legislation and codes of medical ethics, researchers may be obliged or expected to consult relatives and legal representatives (e.g. guardians or in some cases, people who have been granted durable powers of attorney covering health and welfare issues). However, the person with dementia should still be involved in the decision-making process as much as possible. In some studies, especially longitudinal ones, a person may have consented at the beginning and lost capacity during the study.
Substitute decision makers (whether they be healthcare proxies, legal guardians or relatives) could also discuss the issue of research with the person with dementia, speak to the researchers about interpretation of the advance directive, monitor the research process and signal any problems. However, it must be borne in mind that their views about research may differ to those of the person they are representing. They may be over-protective or simply unaware of what the person with dementia would have wanted. Moreover, they are supposed to act in the person’s best interests or at least not act against them, which would be problematic in the case of non-therapeutic research involving more than minimal risks and/or burdens (as they may consider any risk or burden as not being in the person’s best interests). For this reason, it is important that when people designate a health care proxy, they discuss their preferences and feelings about different types of care with him/her, and any views about participation in research.
In addition to typical research which is organized and planned in advance, and for which people are invited to participate, situations sometimes arise whereby a person is in a critical condition and the only chance of survival is an approach which has not yet been scientifically proven. This would be covered by legal provisions relating to consent but might also necessitate consultation with substitute decision-makers if the patient lacks capacity.
The general procedure
People who are considering taking part in a clinical trial are often invited to a meeting with the researchers who provide them with information and give them a consent document. They are free to bring along another person (e.g. their doctor, a social work, a legal representative, a close friend, relative or another trusted person) and to ask questions. Sometimes, the researchers will have brochures or DVDs which people can take home and look at before making a final decision. This gives them the time to make sure that they fully understand, to discuss the matter with friends and family and to formulate any additional questions they may have.
It is also the researchers’ responsibility to ensure that potential participants fully understand what is involved as this is the basis for informed consent. Once the study is underway, the researchers may acquire additional information which they need to share with participants.
For other studies, irrespective of whether ethical approval is required, researchers should obtain informed consent by providing information about the study, allowing participants to ask questions, giving them time to think about it and finally, obtaining their signature. Nobody should feel under any pressure to sign a consent form immediately.
For questionnaires or surveys, the situation is sometimes different as the researchers do not necessarily have direct face-to-face contact with the participants e.g. in the case of random postal surveys. Participants’ consent is implied by their action in returning the completed questionnaire as invited. However, the researchers should have provided background information about the study and how the information obtained will be used either on the questionnaire or in a cover letter. The fact that a person has consented to a face-to-face interview does not necessarily imply that they have also consented to being filmed or recorded. It is therefore important that researchers ask additional consent to use recording equipment during an interview.
Research Ethics Committees
Most countries have research ethics committees to which researchers must apply for approval before starting their research. Research ethics committees may be governmental, independent, linked to local health authorities or linked to educational institutions. Depending on the kind of research being carried out and the subjects involved, researchers may have to seek approval from more than one committee. The approval is usually granted on the basis of a detailed description of the planned research, containing details of the methods to be used, the people to be involved, the kind of analysis to be carried out, evidence of the scientific justification for the study, ethical issues envisaged and methods to be adopted so as to avoid subjects or even researchers coming to any physical or psychological harm. The committee may also invite the researcher to a meeting to discuss certain issues.
In some cases, ethical approval is a legal requirement, whereas in others it is an academic requirement. Some researchers would not have access to such research ethics committees but would nevertheless be expected to have considered relevant ethical issues and to have obtained informed consent from all participants.
People participating in research are entitled to confidentiality even if the results of research are made public. Information should not be divulged to anyone outside the research team unless prior authorization has been obtained. In most cases, anonymity is guaranteed and participants may be assigned code names or numbers. This enables the researchers to quote people without revealing their true identity. Moreover, any personal/private information that researchers learn of in the course of the study, which is not related to the study, should not be disclosed to anyone.
In some studies, particularly small-scale qualitative studies or action research, researchers may decide to show the preliminary results to the participants and invite them to comment. This gives them the opportunity to confirm or query anything that has been written about them as well to be more fully involved in the study. This is very important in studies which have involved very personal contact or with participants who have shared very personal information about themselves.
Last Updated: Friday 21 August 2009