Research Ethics

Question 1

What is ethics?

Answer 1

An area of study that deals with ideas about what is good and bad behaviour

A branch of philosophy dealing with what is morally right or wrong

Question 2

What document established the standard for the requirement of voluntary consent from research participants?

Answer 2

The Nuremberg Code

Question 3

What guideline outlines the requirements for ethical research?

Answer 3

Tri-Council Policy Statement

Question 4

What groups are involved in the development of the Tri-Council Policy Statement?

Answer 4

Known collectively as the Tri-Council Agencies

• Canadian Institutes of Health Research
• Natural Sciences and Engineering Research Council of Canada (NSERC)
• Social Sciences and Humanities Research Council of Canada
• Research involving humans

Question 5

What are the three core principles of the Tri-Council Policy Statement?

Answer 5

1. Respect for persons
2. Concern for welfare
3. Justice

Question 6

What is “Respect for persons”?

Answer 6

It is the intrinsic value of humans

Participants should have autonomy (ability to deliberate about decison and have the freedom to act accordingly)

Question 7

What is involved with having “Concern for welfare”?

Answer 7

• Have well-being of study participants in mind
• Quality of a person’s experiences of life
• Determinants (housing, employment, education, privacy, control of information)
• Evaluation of risks
• Group and community welfare

Question 8

What is justice in research ethics?

Answer 8

• Obligation to treat people fairly and equitably
• Be mindful of vulnerable populations and power imbalance

Question 9

What are some limitations of conducting medical research in smaller cities?

Answer 9

• The number of research participants can be smaller
• If subject of study is complex, there may only be a few specialists qualified to conduct such a study (researchers and clinicians may be the same)

Question 10

What types of research require research ethics board approval?

Answer 10

• Involving living human participants
• Involving human biological materials, embryos, reproductive materials, stem cells from living and desceased individuals

Question 11

What is the purpose of research ethics boards?

Answer 11

REBs review the ethical acceptability of all research involvng humans conducted within their jurisdiction (by their faculty, staff, or students regardless of where the research is conducted)

Question 12

Who is on research ethics boards?

Answer 12

At least five members, including both men and women
- At least two members with expertise in relevant research disciplines
- At least one member is knowledgable in ethics:
- At least one member is knowledgable in the relevant law (mandatory for biomedical research)
- At least one community member who has no affiliation with the institution

Question 13

What are some requirements for consent?

Answer 13

Must be free and voluntary
- have respect for persons
- Prior to research
- Special cases (power of attorney)

Consent shall be given voluntarily

Consent can be withdrawn at any time (can also withdraw their data from a study)

Should be free from influence and manipulation

Informed

Question 14

What is clinical equipoise?

Answer 14

This occurs when researchers have genuine uncertainty about which one of their comparator groups will perform better

Do not conduct studies for which you already have answers for

Question 15

What is duty of care?

Answer 15

It is a clincian’s or researcher’s duty to act in the best interest of the patient balanced with the generation of new knowledge

Question 16

What is therapeutic misconception?

Answer 16

This occurs when participants are not fully congnizant of the primary goals of clinical trials. They may take inclusion into a clinical trial as equal in intent as clinical treatment. Outcomes are often unknown in clinical trials

The researchers involved are interested in both knowledge gathering and patient care

Question 17

What are the four stages in clinical trials?

Answer 17

1. Phase I
2. Phase II
3. Phase III
4. Phase IV

Question 18

What are some safety concerns seen in Phase I clinical trials?

Answer 18

This is the first stage where drug is used in human patients

There are some unexpected events that can occur in this stage that were not caught in pre-clinical trials

Question 19

What are some safety concerns seen in Phase II clinical trials?

Answer 19

This is the first time sick patients are included in the clinical trial

These patients have exhausted every other therapeutic option (treatment resistant patients)

Question 20

What are some safety concerns seen in Phase III clinical trials?

Answer 20

Large numbers of participants are randomly assigned to comparator or control groups

Question 21

What are some safety concerns seen in Phase IV clinical trials?

Answer 21

insert answer from recording

Question 22

In what conditions are placebo controlled trials acceptable?

Answer 22

• No established effective therapies for a given population or indication
• Evidence raises doubt on existing therapeutic options
• Treatment resistant patients
• When comparing adjunct therapies, a placebo in addition to established therapeutic agent can be given to maintain blinding
• Patients have refused established effective therapy and witholding therapy will not cause serious or irreversible harm

Question 23

What are some ethical considerations when it comes to the use of human biological materials in research?

Answer 23

Who can access and use these samples can be concerning to participants

The following can help address these concerns:
- Outline how information will be used
- Ensure patient anonymity

Question 24

What are some ethical concerns for the collection and storage of human biological materials?

Answer 24

Participants should be able to withdraw their samples, or should become untraceable to original participants

Ethics boards are usually in charge of sample release for research on biological materials (usually impractical to track participants and ask for consent for new study)