Chapter 3 Using cells for research: the case of minors

Question 1

types of biobanks

Answer 1

1. related to a speicifc condition
2. related to diagnostic
3. of healthy patients in which they collect data from persons from a speicifc area e.g. cohort from Rotterdam newborn babies.

Question 2

Differences in anonymizing sample and coding a sample?

Answer 2

Anonymizing = to completely tcut off link between name and sampel
Coding = to provide code with sample and the code is linked to the person. The code + name is protected by 3 ‘keyholders’ (instanties) that can open this black box if deemed necessary

Question 3

general benefits of biobanks

Answer 3

1. better understanding of genetic variation
2. better understanding of relationships of genetics and phenotype
3. ultimately contribute to better treatment

Question 4

general risks biobank

Answer 4

Physically: very little
Emotionally: very little
Privacy:
1. fear of third parties accessing your data
2. personal stigmatization: use of biobanks for a specific disease might lead to people being linked to a disease, even if they dont have the disease, leading to emotional distress
3. sensitivity of medical data as such Medical and genetic information is inherently sensitive because it can reveal intimate details about an individual’s health, predisposition to certain diseases, and family medical history. Unauthorized access or exposure of this information can lead to privacy breaches and misuse of the data.
4. group stigmatization Data from biobanks can sometimes lead to stigmatization of specific groups based on shared genetic traits or medical conditions. If research findings are misinterpreted or misused, entire populations (such as ethnic or genetic subgroups) could face discrimination, reinforcing stereotypes or leading to social and economic disadvantages.

Question 5

How to protect against group stigmatization?

Answer 5

Good governance e.g. only people with a badge can have access, ethics committees, and groups that protect these samples

Question 6

How to protect against individual stigmatization?

Answer 6

Good governance e.g. only people with a badge can have access, ethics committees, and group that protect these samples

Question 7

how to protect against third party access to biobank?

Answer 7

Privacy protection, e.g. coding.
Cant have completely anonymized data, because human material MUST bre tracable in belgium

Question 8

Reason that human body material cant be anynoymized in belgium ?

Answer 8

1. Belgian law requires that human body material be traceable to ensure accountability and ethical management of the samples. This traceability is crucial for respecting donor consent, allowing individuals to withdraw their consent at any time, and ensuring that the use of the samples adheres to the terms agreed upon by the donor. Complete anonymization would prevent this accountability, as the samples could no longer be linked back to the individuals who provided them.
2. Maintaining a link between the samples and the donors is essential for medical follow-up and the integrity of ongoing or future research. Researchers might need to access additional data or follow up with donors for further information, updates on their health status, or additional samples. Anonymization would disrupt this process, potentially compromising the quality and continuity of research, and limiting the ability to obtain comprehensive and accurate study results.

Question 9

Informed consent can have different tasks

Answer 9

Allowing people to assess the risks for themselves
Honoring their participation (by giving them oppertunity to say yes)
Stressing the divide between research and medical care (to avoid the therapeutic misconception)
Generating trust

Question 10

annoying things about informed consent

Answer 10

Many patients/donors are not interested in too complex consent procedures
Maybe stress too much on (a particular interpretation of) the autonomy model

Question 11

other issues about biobanks

Answer 11

-commercialization
-ownership
-what kind of research can be performed with your samples e.g. many people dont want their samples to be studied for 1. reproductive cloning 2) bioweapons 3) full genome sequencing

Question 12

issues in children research

Answer 12

1. different metabolization (minors are not small adults)
2. very heterogenous group (age, developmental)
3. small group
4. recruitment issues
5. some diseases only occur in children

Question 13

why clinical trials with children is generally not very attractive

Answer 13

1. scientific issues (metabolization, heterogeneous, small group)
2. psychosocial issues (informed consent)
3. economical issues (commercial interest limited)

Question 14

What is the legal protection of minors with regards to international law (Helsinki)?

Answer 14

-trials must only be done in children if it cannot be done in adults
-children must be able to refuse

Question 15

major issues in biobank for children?

Answer 15

informed consent

Question 16

Informed consent issues in children biobank

Answer 16

1. Who should consent ? (parents, child?)
2. Scope of consent?
   a. timewise? Should child give consent again at age of adult?
3. age of assent/consent
4. scope of disease? Only the DISEASE, not other diseases! bc children cant really understand this
5. right to withdraw: from 15/16 year old?
6. both parents and child?
7. who should inform the child that their sample is used, the parents or the researcher ddilectly

Question 17

Risks biobank children

Answer 17

non-therapeutic research on children should carry minimal risk
three types of risks
- phusical/emotional
-privacy risks (e.g. stigmatization)
- breacheing the values of the child (e.g. values change over time which might not be in line with valeus of parent hence they might want the withdraw consent)

moreover, the risks are differently perceived in adults v.s. children (e.g. needle)

Question 18

Biobank materials: necessary useful therapeutic for the children?

Answer 18

No, because biobanks often are not therapeutic. Therefore, it is also sufficient if the research benefit children of the same age / disease.

Question 19

Benefits biobank children

Answer 19

in context of general medical research, it is often stated that it must benefit the participant. This is difficult to apply to biobank bc here there is no therapeutic benefit
-research should at least have direct benefit to children in general or children with the same disease however two issues with the latter
1. hard to pin down what group benefit is, in context of fundamental research (so maybe too strict?
2. risk of therapeutic misconception

Question 20

Biobank children: return of results issues

Answer 20

1. Can parents refuse results?
2. Should parents have rights to all the genetic data?
3. should parent or child receive data>

Question 21

Ethical issues biobanks

Answer 21

1. informed consent
2. return of individual results
3. return of group results
4. commercialization
5. ownership

Question 22

Principles of good practice regarding biobanking in children

Answer 22

1. Genetic research on stored biological samples from minors should only be done if the research questions cannot be answered by a study of adults (subsidiarity principle).
2. The collection and use of biological samples and data from minors should minimise physical and psychological burden.
3. The focus of who decides about the collection, storage and use of samples gradually shifts from the parents to the minor as he or she grows older and/or reaches the age of majority.
4. Minors should receive age-appropriate information about the collection, storage and use of their samples, and a minor’s assent or dissent should be respected.
5. Minors should be given the opportunity to contact researchers and to withdraw their samples, if they so wish, when they are mature enough or when they reach adulthood.
6. A best effort should be made to communicate the progress of research. The purpose of ongoing research should be transparent, either through direct communication with the participants or through communication via for instance a website or newsletters.
7. Biobanks should have a policy about returning information about preventable or treatable conditions of early onset when participants are minors. Details of this should be included in the consent forms.
8. The right of parents to receive or not to receive genetic information about their children is limited. In the rare case that information about a preventable or treatable early-onset disease is found, they should be notified regardless of their wishes providing the findings are subject to assessment of clinical validity and utility.