Appendix 1

Background information about participants in the Delphi study

Country and total number per country (N) / Participation in Delphi round number / Discipline
Netherlands (7) / 1 & 2 / Patient Organisation
2 / Ethicist
2 / Ethicist
1 & 2 / Geneticist
1 & 2 / Geneticist
2 / Psychiatrist/Ethicist
1 / Ethicist
United Kingdom (4) / 1 & 2 / Ethicist
1 & 2 / Geneticist
1 & 2 / General Practitioner
1 / Psychiatrist
Belgium (2) / 1 & 2 / Ethicist
1 & 2 / General Practitioner
Sweden (1) / 1 & 2 / Physician/Geneticist
Greece (1) / 2 / Psychologist
Spain (1) / 2 / Psychiatrist/Ethicist
Rumania (1) / 2 / Psychiatrist
Israel (1) / 2 / Psychiatrist
Luxembourg (1) / 1 & 2 / Patient Organisation

Appendix 2

Questionnaire of the first Delphi round on ethical issues in research into Alzheimer’s Disease

The first question is related to traditional biomedical (i.e. non-genetic) research into AD

You may think, for example, about research into various risk factors for AD

  1. Please list below the ethical issues that in your view are the most important for current biomedical research into the causes of Alzheimer Disease. The importance may be explained, for example, by the following factors:

- Demented patients are more vulnerable and need more protection than other people;

- Certain ethical issues now may hamper biomedical research;

- Certain ethical issues in this area still need to be resolved;

- The societal or legislatory debate around an issue.

Please state shortly why a topic is of great importance on your list.

The following question is specifically related to genetic research into Alzheimer Disease

  1. Please list below the most important ethical issues of genetic research into Alzheimer Disease. The importance may be explained, for example, by the following factors:

- Demented patients are more vulnerable and need more protection than other people;

- Certain ethical issues now may hamper biomedical research;

- Certain ethical issues in this area still need to be resolved;

- The societal or legislatory debate around an issue.

Please state shortly why a topic is of great importance on your list.

Appendix 3

Questionnaire of the second Delphi round

Ethical issues in non-genetic research into Alzheimer Disease

Question 1

Are there topics you would like to add to this list?

Question 2

Please list below in order of priority the five ethical issues mentioned above, which you consider most important to be discussed in this project

Question 3

Please give some arguments for the priority of ethical issues as listed under question 2

Ethical issues of genetic research into Alzheimer Disease

Question 4

Are there topics you would like to add to this list?

Question 5

Please list below in order of priority the five ethical issues mentioned above, which you consider most important to be discussed in this project

Question 6

Please give some arguments for the priority of ethical issues as listed under question 8

Appendix 4

Results of the second Delphi round

1.Ethical issues in non-genetic research into AD

PriorityTopicScore

1.Informed consent issues52

2.Vulnerability (false hope; last chance/oppurtunity)19

3.Is therapy cost effective/evidence based?14

4.Therapeutic/preventive implications of research13

5.Proxy consent12

6.Negative side effects/risks of research10

6.Respect/dignity/integrity10

8.Availability of data for research (biobanks)9

8.Moral responsibility, Competence of decision-making

capacity/assessment of competence9

10.Supervision of patients8

11.Ethical decision makers not necessarily ethical issues

may hamper research6

11.AD patients should always be considered as ‘moral subjects’ in

the research and not as ‘research objects’/definition of moral subject6

11.Communication difficulties6

11.Availability of counselling6

15.Requirement of a specific patient evaluation before the study5

16.Stigma4

16.Double blind research hampers access to care4

16.Confidentiality data/bodily material4

16.Discriminatory effects/privacy issues4

20.Research results may have impact on life of family members3

20.Anonymised data should be available for research3

20.The risk the research reduces the autonomy of patients3

20.Protection of the patient’s rights, health and dignity3

20.Protection3

20.Advance directives3

20.Applicability of research models3

20.Information on research is not suitable for patients3

20.Involvement of family members3

29.Family2

29.Communication2

29.Ethical review committees2

29.Acquiring samples for research2

29.Withdrawal of consent2

29.Difficulties to find valid and universal inclusion and exclusion criteria2

29.Access to research results2

36.Restrictive legislation1

36.Bureaucracy1

36.Good methodology of research1

36.Public and user engagement1

2.Ethical issues in genetic research into AD

PriorityTopicScore

1.Informed consent issues27

2.Confidentiality of genetic information26

3.The right not to know/access to information23

4.Implications of results for relatives21

5.Proxy consent15

6.Awareness of the implications of participation in genetic research13

7.Treatment of AD with genetic approaches11

8.Different consequences for different subgroups of patients9

8.Interests of patients9

8.Involvement of patients in later stages of dementia research9

11.Discrimination8

11.Neglecting risks/burdens for patients8

13.Insurance/employment issues7

13.Availability of counselling7

13.Legal issues/EU legislation7

16.Genetic screening6

16.Implications of research results for health care delivery6

18.Cost-effectiveness of genetic screening5

18.Use and conservation of samples for clearly defined purposes5

20.No geneticisation: people are more than their genes4

21.Privacy issues3

21.Protection3

23.The role of review committees2

23.Geneticisation2

23.It concerns research, not standard clinical practice2

23.Diagnosis of AD with genetic approaches2