Chapter 2 Returning individual results

Question 1

aggregate v.s. individual disclosure

Answer 1

aggregtate disclosure = patients are offered a mailing with the general findings of the study. This is quite common. Individual disclosure = patient themselve receiving infomration about their own data. this is more controversial

Question 2

Passive or active disclosure

Answer 2

Passive disclosure = disclosure on request of the participant. The right to have acfess to ones data is reconginzed in many international and national legal guidelines.
Active disclosure - actively offering results to participants.

Question 3

What are the issues in disclosure

Answer 3

1) passive or active disclosure
2) scope of disclosure

Question 4

Arguments against disclosure

Answer 4

1. Misconception of therapeutic gain
2. Mistaken on wrong interpretation of autonomy
3. Disclosure would burden research infrastructure too much
4. Disclosure is not feasible
5. Disclosure has harmful consequences

Question 5

What is meant with the discloscure rests on mistaken interpretation of autonomy?

Answer 5

Individuals who understand the information-nondisclosure policies, and still choose to consent, are not violated in their autonomy. Counterargument: does this resolve the underlying moral questions regarding responsibilities of researchers?

Question 6

Disclosure would burden research infrastructure too much. Explain

Answer 6

It would e.g. require additional training, and is time-consuming and costly. It is therefore not practical and also unethical to put these resources in feedback while they could have been used for research

Question 7

Misconception of therapeutic gain

Answer 7

The border between research and clinical care become vaguer. Participants might expect to get results if they participate.

Question 8

Explain: disclosure is not feasible as an argument for not disclosing?

Answer 8

1. Research participants simply do not understand the wide array of possible finding. Especially genetic data is very complex to understand because the data is probabilistic or pleiotropic that information can provide information about multiple conditions
2. Bench researchers are not responsible and should not be responsible for communicating with the patients about their individual data, as it is not their duty, and they are also not trained to do it.

Question 9

Explain argument against disclosure: Disclosure has harmful consequences

Answer 9

This is based on the principle of non-maleficence: 1) knowing to be at risk of a certain disease could have adverse psychological effects
2) could have social and financial consequences, e.g. losing one’s health insurance
3) could be stigmatizing
4) could be against beliefs and myths of ethnic groups

Question 10

Arguments in favor of a disclosure

Answer 10

1. beneficence requires disclosure
2. autonomy requires disclosure
3. reciprocity requires disclosure
4. the blurring of the distinction between research and clinical care is not necessarily negative
5. disclosure improves public understanding of genetics

Question 11

Explain argument in favor of disclosure: beneficence requires disclosure

Answer 11

Benificence means that we have the moral obligation to do good to the patient. In order to help him, we must disclosure the information that can be of benefit to the patient e.g. in decision making and life-planning.

Question 12

Explain argument in favor of disclosure: autonomy requires disclosure

Answer 12

A person must decide on their own whether they want to be informed or not, even if that brings them risk or potential harmful effects, we must respect their autonomy to accept these risks.

Question 13

Explain argument in favor of disclosure: reciprocity requires disclosure

Answer 13

It is reasonable that participants expect something in retturn. This can also help increasing the number of patients donating e.g. their material to a biobank.

Question 14

Explain argument in favor of disclosure: the blurring of the distinction between research and clinical care is not necessarily negative

Answer 14

To offer cinical care in a trial can help the patient and it does not have to be confusing as long as we explain well enough what the participants can expect.

Question 15

Explain argument in favor of disclosure: disclosure improves public understanding of genetics

Answer 15

Disclosing the results to patients may help them understand how genetics work e.g. that the risks of disease are probabilistic and not necessarily going to happen. Moreover, this might help them understand the need for biomoedical research in general, and the appreciation might help them to support biomedical research. Increased knowledge about genetics might also help them voice an opinion on whether they want to have individual research results or not.

Question 16

Top reasons for patients to know their amyloid beta results

Answer 16

1. Want to know whats going on, because it helps them understand, get less angry,
2. Plan the future
3. Treatment

Question 17

Advantages knowing beta amyloid results (patients)

Answer 17

Plan the future
Treatment
More certainty

Question 18

Disadvantages knowing beta amyloid results

Answer 18

most indicate
1) no disadvantages
2) emotional risk
3) fear of regression

Question 19

Reasons in favor for the disclosure of incidental findings

Answer 19

its confirmed clinical utility and the possibilty of treatment or prevention, also for family members. The latter can override the right of the original subject to oppose disclosure.

Question 20

Reasons opposing the disclosure of incidental findings

Answer 20

1. unlikely/unsurebenefit –> dont disclosure. e.g. CNV and autism
   and no expertise to judge
2. harm outweight benefit e.g. Alzheimers
3. therapeutic misconception ‘‘routine’’
4. timing –> after 10y, still duty of researcher?
5. too much burden on research, might discourage new forms of genetic research

Question 21

Reasons cautioning the disclosure of incidental findings

Answer 21

Respect for the right not to know and the autonomy of the patient. There is the general consensus that IFs with clinicla utility should be disclosed but theres also consern that compulsory disclosure might harm respect for the autonomy of the patient.
2. IFs can have implications for family members and for the community, which can be to the advantage or disadvantage for them. Patients should be encouraged to discuss this with their family memebers.