Ethics and consent

Question 1

What is the declaration of Helsinki?

Answer 1

A statement of ethical principals for medical research involving human subjects, including research on identifiable human material and data.

Question 2

What is being referred to in the risks, burdens and benefits section of the declaration of Helsinki

Answer 2

Medical research involving human subjects may only be concluded if the importance of the objective outweigh the risks and burdens to the research subjects. Risk must be minimised wherever possible. When risk outweighs potential benefits, or when a conclusive proof of definitive outcomes is seen, physicians must assess whether to continue, modify or stop the study.

Question 3

What is being referred to in the vulnerable groups and individuals section of the declaration of Helsinki

Answer 3

All vulnerable groups and individuals should receive specifically considered protection

Question 4

What is being referred to in the scientific requirements and research protocols section of the declaration of Helsinki

Answer 4

The trial must conform to generally accepted scientific principles, be based on thorough knowledge on the scientific literature, adequate lab and adequate animal experimentation.

Question 5

What is being referred to in the informed consent section of the declaration of Helsinki?

Answer 5

After ensuring the patient has understood the information, the subject must give freely given informed consent. For patients incapable of giving informed consent, it must be from their legally authorised representative. For subjects that are physically or mentally incapable of giving consent (unconscious), may participate only if their physical/mental condition is a required characteristic of the research group. Also require consent for the collection, storage and reuse of human material/ data.

Question 6

What is being referred to in the post-trial provisions section of the declaration of Helsinki?

Answer 6

After a trials completion; sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.

Question 7

What is being referred to in the research registration and publication and dissemination of results section of the declaration of Helsinki?

Answer 7

Every study must be registered in a publicly accessible database before recruitment of the first subject. The results must be published and made publicly available, especially if it is negative, as these have previously had a tendency to remain unreported, leading to unnecessary risk to patients.

Question 8

what are the 13 core principles of ICH GCP?

Answer 8

1. Ethical principles
2. Risks and benefits - before initiation, weigh up risk Vs benefit. Trial should only be initiated or continued if the anticipated benefits outweigh the risks
3. Patient rights - Safety and well-being of subjects prevails over the interest of science and society
4. Relevant drug information - Nonclinical and clinical information on an intervention should be adequate
5. Scientific basis - It should be scientifically sound and described in a clear, detailed protocol
6. Ethics approval - Trial should comply with the protocol that received prior ethics committee approval/favourable opinion
7. Responsible doctor
8. Education
9. Consent
10. Data - stored in a way that allows for accurate reporting, interpretation and verification
11. Confidentiality
12. Manufacturing
13. Quality

Question 9

What declaration of Helsinki was not adhered to and resulted in the results of the TGN1412 results?

Answer 9

research registration and publication and dissemination of results (publication of negative results) adverse events seen in a similar case study of an CD28 agonist antibody.

Question 10

What is the goal based approach to a morally acceptable action?

Answer 10

Utilitarian/ consequentialism - Jeremy Bentham. The action is good if the goal or outcome is good
In Clinical trials, there must be scientific validity. The problem is that initially it isn’t known if the outcome will be good.

Question 11

What is the duty based approach of a morally acceptable action?

Answer 11

Kantianism - does the action accord with the principles like cheating or lying. Welfare of the research subject in clinical trials is paramount. Are the risks necessary and justifiable? How do we protect vulnerable participants?

Question 12

What is the rights based approach of a morally acceptable action?

Answer 12

Individual protected in society by human rights.
Individual Vs collective ethics.
Individual: patient receives therapy that gives them the most benefit
Collective: Achieving medical progress so that all will benefit

Question 13

How is it ensured that patient harm is minimised (as an ethical consideration)?

Answer 13

experienced sites and investigators are selected, data monitoring committees and stopping rules are in place, trials are reported to competent authorities.

Question 14

What are the three most important aspects of consent?

Answer 14

1) Only valid if the person giving it is competent to do so
2) Person is properly informed and competent to understand consequences
3) Given voluntarily

Question 15

Why do patients volunteer for trials?

Answer 15

1) Noble altruism
2) Fear of refusal
3) Pleasing the doctor
4) Self interested optimism

Question 16

Why don’t patients enter trials?

Answer 16

Not asked, guinea pig effect, time available, issue with randomisation, fear of the unknown, resignation to the disease, practical issues.

Question 17

What kind of patients are more likely to volunteer for clinical trials?

Answer 17

Women, English speaking, middle class (also more likely to adhere for treatments and have better outcomes), higher education

Question 18

What GCP principles are not in the DoH?

Answer 18

Manufacturing requirements and quality assurance

It also expands on the investigator brochure and the requirements for data.

Question 19

What principles are in the the DoH but not in the GCP?

Answer 19

Harm to the environment, Equity of access to research, animal welfare, patients informed of study results, use of human tissue, scientific basis for placebo, post trial provision, trial registration, obligation to publish the results, compassionate use.

Question 20

What are the responsibilities of the sponsor?

Answer 20

Initiation, management and financing (or arranging financing) of the research. A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them.

Question 21

What are the responsibilities of the chief investigator?

Answer 21

Individual that is responsible for the conduct of the whole project in the UK. They’re able to supervise the research effectively. They’re readily available to communicate with the research ethics committee and other review bodies during the application process and where necessary during the conduct of the research

Question 22

What main issues are ethics committees concerned with?

Answer 22

Risks and benefits, inclusion of minors or adults lacking capacity, approach to potential participants, information sheets and consent forms, the consent process.

Question 23

What trial procedures do ethics committees review?

Answer 23

Frequency of blood tests/imaging
Type of sampling - repeat biopsies might increase the risk of bleeding
How invasive is the procedure
Information/consent issues

Question 24

What are the main headings of the DoH

Answer 24

Risks, burdens and benefits - Do the benefits outweigh the risks?
Vulnerable groups and individuals - Some groups and individuals are particularly vulnerable and have an increased likelihood of being wronged or of incurring harm
Scientific requirements and research protocols - trial must be based off accepted scientific principles
Research ethics committee
Privacy and confidentiality
Informed consent
Use of placebo
Post trial provisions
Research registration, publication and dissemination of results