Ethics of dementia research
The following list provides examples of some of the main points which should generally be included in a consent form (depending on the type of research and the methods adopted). They are phrased in the form of questions or statements requiring the potential participant to tick or cross boxes marked YES and NO. For some studies, there may be additional issues to consider and some researchers may prefer to have additional consent forms for specific issues (e.g. for video recording or to waive the right to anonymity under certain conditions).
The consent form should contain a reference number and date (e.g. Version 3, 18 March 2011), the title of the study and the name of the chief researcher.
SAMPLE QUESTIONS AND STATEMENTS FOR A CONSENT FORM
- 1. Have you received the Participant Information Sheet (reference and date of the participant information sheet) or had it explained to you? YES NO
- Have you had the opportunity to talk about the study and ask questions? YES NO
- Are you satisfied with the answers to any questions you may have had? YES NO
- Do you understand that it is your choice to take part in the study? YES NO
- Do you understand that refusal to take part in the study or withdrawal will not adversely affect your current or future care and treatment? YES NO
- Do you understand that your anonymity and confidentiality will be protected as stated in the Participant Information Sheet? YES NO
- Do you understand that you will be filmed/photographed/recorded[researcher to state which, if any]for the purpose of this study? YES NO
- Do you agree to any images or recordings (as mentioned above) being used in the context of this study?[or in future publications if this is the case – researcher to specify] YES NO
- Do you agree to information obtained during this study being reproduced in professional or academic journals and reports? YES NO
- Do you agree to any of the data from this study (e.g. information, recordings and images) being used for future research? YES (without restriction)r; NO;YES (on the following conditions) ____________________________
- I would be pleased to be consulted about the interpretation of the results of this study YES NO
- In the event of my future incapacity or death, I would like data that has already been collected to be used in the study. YES NO
- In the event of my future incapacity, I would like to continue to participate in the study (if still possible and valuable to the researchers). YES; NO;Only if the person mentioned hereafter consents to this after having been given all the necessary information to make a decision on my behalf:
- I understand that if during the course of the research, I disclose something unlawful, illegal or unethical or which causes harm to another party, the researcher is duty bound to report it to the proper authorities.
- I understand that I can withdraw from the study or refuse to take part in any activity at any time without having to explain why? YES NO
- I authorize the researchers to inform my general practitioner that I am taking part in this study YES NO (to include if appropriate)
- Based on my responses to the above questions, I consent to taking part in this study YES NO
- Numbers of statements or questions that I have neither ticked nor crossed:
Name: ___________________ Date: ___________ Signature: ___________________
The Participant Information Sheet should provide the relevant information that a person would need in order to make an informed decision about whether or not to take part in the proposed study. The content of the information will differ greatly depending on the type of study being carried out and especially with regard to possible burdens and risks linked to taking part in the study. Participant Information Sheets for clinical trials, for example, would contain considerable detail about the kinds of tests to be carried out, the risk of side effects and various medical issues. Observational studies might provide more detail about the manner and extent to which participants will be observed as well as limits to such observation. Nevertheless, as with the consent form, there are likely to be several common issues. These include:
- The title and reference number of the study.
- The name of the chief researcher.
- How the study has been organised and funded, including any commercial partnerships.
- The purpose of the Participant Information Sheet.
- What giving “informed consent” means.
- What the study is about and why it is being carried out.
- Clarification that the aim of research is not to benefit individual participants.
- Why the person has been chosen.
- What will happen to participants and how this might affect their daily lives.
- That the person would be able to withdraw without having to explain why at any time.
- Whether there are any costs involved and if so, whether they will be reimbursed.
- Whether there are any potential benefits to taking part.
- Whether there are any risks or burdens linked to taking part.
- Whether taking part in the study will be kept confidential.
- Whether the person’s identity and personal information will be anonymised.
- How details and data will be anonymised.
- How the data will be handled and analysed.
- Whom to contact in case of complaint.
- How the scientific quality of the study has been evaluated.
- Details of any ethical approval which has been obtained for the study.
- What the person should do if s/he has further questions.
- What the person should do if interested in participating.
Possible additional information for medical research:
- What side effects are possible and if so, how will they be handled?
- Whether participants have other treatment choices.
- Whether participants will have to pay for the medication or care they receive as part of the study.
- Whether samples of human tissue or blood will be taken.
- Whether genetic information will be collected.
- How various samples and genetic information will be handled.
- Whether participants (or their treating doctor) will be informed of any additional important medical information of relevance to their health in the course of the study.
- Whether participants will be entitled to receive details of personal data resulting from the study or obtained during the study once it has ended.
In some countries, there is as yet no national system for the ethical appraisal of research proposals, although some studies may be required to obtain ethical approval from universities or other institutions. It may also be the case that ethical approval is obligatory for certain types of study (e.g. clinical trials) but not for others (e.g. psycho-social studies, observational studies or survey-based studies). Alzheimer Europe has stated in its recommendations that all researchers should consider the ethical issues linked to their study and seek, whenever possible, ethical approval from a recognised body.
Where this is not possible due to the absence of appropriate reviewing bodies, researchers are nevertheless encouraged to consider ethical issues related to their study. Individuals or organisations funding research are encouraged to consider whether such issues have been adequately addressed before proposing funding. The following examples are intended to guide both. The term “participant” will be used to refer to people who are approached with a view to their participation in a study, even if they eventually decide not to participate.
The aim of this list is to encourage researchers and funders to consider ethical issues linked to dementia research. The aim is not to hinder good quality research or to dampen the enthusiasm of researchers interested in conducting valuable research in the field of dementia. For this reason, the list could be helpful to researchers who are not familiar with these issues in the preparation of their research proposals and in deciding on the design of their studies.
An excellent document also exists in French, published by the Fondation Médéric Alzheimer (FMA), which provides an ethical framework for reflection (http://www.fondation-mederic-alzheimer.org). It is targeted at researchers carrying out dementia research in the social sciences but it is also used by FMA to guide its own research and to evaluate research proposals submitted by external researchers.
The study in general
Have details of the main ethical and design issues been adequately considered?
What is the scientific justification for the study?
Does the research team have the necessary skills and expertise?[If not, how could they obtain these e.g. through training in methodological issues?]
What is the original contribution of this study?[need to avoid unnecessary duplication/redundancy of studies]
What is the potential social value of the study?
How have/will people with dementia, carers and patient organisations be involved in the various stages of the study (e.g. design of the study, data collection, data analysis, interpretation and dissemination of the results)?
What are the criteria for including and excluding participants?
What are the reasons for the exclusion of specific groups (e.g. older people or people from ethnic minority groups)?
How will participants be approached and by whom?
Will access to participants involve negotiating with other people (e.g. nurses, social workers or carers)?
If so, how will researchers ensure that this does not lead to the unfair exclusion or coercion of some people?
Will participants receive any payment or other incentives? If so, please give details.
Will the chief researchers or others involved in the study receive any payment or other incentives for any aspects of the study (e.g. for recruitment, conducting the study etc.)
Protecting the wellbeing of participants
What are the potential risks and burdens to participants and how will they be minimised or overcome?
Has the researcher considered any risks to him/herself or to others involved in conducting the study and if so, how would s/he deal with them, should they occur?
Does the researcher already have an adequate understanding of dementia?
If not, how could the researcher familiarise him/herself with dementia?
Has the researcher sought the support of carers in studies involving people with dementia?[This must be done with tact and not if the person with dementia clearly objects to the carer being consulted or involved.]
Is the study likely to bring up issues that are sensitive, embarrassing or upsetting and if so, how does the researcher intend to deal with this?
Does the researcher have insurance against possible harm to research participants?
Anonymity and confidentiality
How will participants, samples or records be obtained?
Will the researcher be obtaining personal information from participants?
Will measures will be taken to ensure that consent forms or other documents containing personal information are stored separately from the data obtained from them?
Will data be anonymised and if so, how?
Who will have access to data?
How will data or samples be stored? Please include precise details of any storage of data on computerised or digital equipment.
How long will data be stored?
How will data eventually be disposed of?
Does the study have the potential to result in the disclosure of illegal acts or misdemeanours? If so, how does the researcher plan to handle this?
Consent and capacity
In what way will informed consent be obtained and from whom?
Does the researcher (or somebody in the research team) have the necessary expertise and know-how to obtain informed consent from a person with dementia? If not, how could this be organised?
In what way and for how long will proof of informed consent be stored?
Will the researcher seek the assent of participants who lack the capacity to give informed consent and if so,how?
What steps have been taken to ensure that informed consent has been given freely and that participants do not feel under any kind of pressure to participate?
How will the researcher ensure that participants have fully understood the information they were given?
If the participant loses the capacity to consent to the study during the study (even if s/he had the capacity to consent at the start of the study), will s/he be kept in the study and what will happen to data already collected?
Dissemination of the results
What means will the researcher use to disseminate the results of the study (e.g. presentations at conferences, articles in peer reviewed journals, publications etc.)?
Last Updated: Thursday 29 March 2012