Ethical issues in health research in children

Question 1

What are the ethical principles impacting research in children?

Answer 1

1. Beneficence
2. Non-maleficence
3. Distributive justice
4. Respect for informed consent
5. Respect for privacy and confidentiality

Question 2

How does beneficence impact research in children?

Answer 2

Applying evidence-based care generated from research specific to children

Question 3

How does non-maleficence impact research in children?

Answer 3

Avoiding harmful therapies extrapolated from adult patient data or experience

Question 4

How does distributive justice impact research in children?

Answer 4

Allowing research benefits to be available to all populations

Question 5

How does respect for informed consent impact research in children?

Answer 5

Supporting developing autonomy in children considering research participation

Question 6

How does respect for privacy and confidentiality impact research in children?

Answer 6

Providing confidentiality within the limits of legal requirements

Question 7

What must all human research in Canada go through?

Answer 7

REB approval

TCPS governs

Question 8

How does the TCPS restrict risk?

Answer 8

1. Therapeutic risk are allowable if the benefits are greater than risks
2. Non-therapeutic (research only) risks are restricted to no greater than those encountered by persons in everyday life that relate to research

Question 9

What is the role of REB?

Answer 9

1. Uphold the principle of respect and human dignity
2. Ensure the tenets are upheld in research: free and informed consent, respect for privacy and confidentiality, respect for justice and inclusiveness, and respect for vulnerable persons
3. Provide balanced review of the scholarly nature of the research
4. Ensure potential risks are proportionate to potential benefits
5. Ensure clinical equipose

Question 10

What are the elements of informed consent?

Answer 10

1. Adequate information
2. Voluntariness
3. Capacity to understand the information

Question 11

What are examples of potential financial conflicts of interest?

Answer 11

Employment or leadership position in commercial firm, employment as consultant for commercial firm, stock ownership, honoraria, research funding or grant support, expert testimony, patents, or other remuneration, family member investments

Question 12

What are examples of potential academic conflicts of interest?

Answer 12

Promotion or tenure based on productivity, stature based on publication impact scores, agenda of academic in conflict with research agenda of potential donors/sponsors

Question 13

What are examples of personal conflicts of interest?

Answer 13

Research results supporting an ideology or preconceived conclusions, recruitment of own patients to research (duty of care)

Question 14

What populations are at special risk with respect to adequately informed consent?

Answer 14

1. Those needing emergency care
2. Incarcerated or institutionalized
3. Participants in genetic or early phase drug research studies
4. Socially disadvantaged children
5. Children in international health research settings
6. Aboriginal children
7. Those with life-threatening disease

Question 15

What is a Phase I drug study?

Answer 15

translate experimental models tested in tissue culture or animals to humans, and are primarily focused on establishing safety profiles and toxicity information of new drugs in patients with advanced disease for which there is no effective treatment

Question 16

What is a Phase II drug study?

Answer 16

Apply drugs in doses that are found to be reasonably safe to determine a preliminary assessment of potential efficacy and develop expanded toxicity profiles, again in patients with advanced disease

Question 17

What are the CPS recommendations re: ethical research in pediatrics?

Answer 17

1. Advocate for research to be conducted in children (to allow for evidence based care)
2. Researchers should be aware to conduct research according to TCPS and REB review
3. In Quebec know about article 21 of the Quebec Civil Code
4. Pediatricians should obtain consent or assent from children as developmentally appropriate
5. Educational programs should promote research
6. Pediatric HCP should support importance of scientific review and participate on REB
7. Pediatric health researchers should strive to publish negative and positive research results
8. Researchers should provide a summary of the results to community and individual participants
9. Canadian researchers should participate in international health research
10. Participants in developing countries have equal rights and should still follow Canadian and local REB review