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Biomedical Engineering > Research Ethics > Flashcards

Research Ethics Flashcards

1
Q

What is research ethics?

A

Research ethics govern the standards of conduct for scientific research

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2
Q

Why is it important to adhere to ethical principles?

A

It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of researchers and participants.

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3
Q

What does research ethics provide?

A

Research ethics provides a framework and sets boundaries for people conducting scientific research.

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4
Q

Is it a crime to cross the ethical boundary?

A

No, ethical boundaries are not laws, they are agreements. There are/maybe consequences for breaching ethical boundaries.

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5
Q

You should have the right to stop the experiment…

A

without having to give a reason.

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6
Q

What are the three categories that explain why research ethics is needed?

A
  • Preparation
  • Experiment
  • Dissemination
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7
Q

Why are research ethics needed in preparation for biomedical engineering?

A
  • Is it a good research question to ask?
  • Is it for the good of society? For the good of the research field? Only good for you as an individual?
  • Think through the methodologies and the ethical implications of each stage.
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8
Q

Why are research ethics needed in experimentation for biomedical engineering?

A
  • Privacy and respect for the participant
  • Safety and welfare of both participant and researcher
  • Justice for the participant-don’t manipulate the data for scientific gain
  • May not want to comprise the identity of the person.
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9
Q

Why are research ethics needed in dissemination for biomedical engineering?

A
  • Data protection for participant, can communicate more details if given permission.
  • Encourage knowledge exchange.
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10
Q

When did Research Ethics start?

A

Nuremburg Code 1947

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11
Q

When were the research ethics updated after the Nuremburg code?

A

1964: Declaration of Helsinki

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12
Q

How many times has the declaration of Helsinki been revised?

A

Seven times

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13
Q

When is the most recent revision of the declaration of Helsinki?

A

October 2013.

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14
Q

How many paragraphs were in the original declaration of Helsinki, and how many now?

A

It has grown from the original 11 paragraphs to 37 in 2013. This shows how peoples opinions change over time.

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15
Q

What are the different sections to the declaration of Helsinki?

A
  • Risks, Burdens and Benefits
  • Informed Consent
  • Research Ethics Committees
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16
Q

You can’t consent if…

A

You can’t consent if your not fully informed.

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17
Q

In order to consent you need…

A

You need a signature and date from everyone involved.

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18
Q

What are the four guiding principles of research ethics?

A
  • Autonomy
  • Non-maleficence
  • Beneficence
  • Justice
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19
Q

Autonomy is one of the guiding principles of research ethics, what does autonomy mean?

A

Autonomy: Respect decision making capabilities of autonomous people. May have to ask carer/guardian/government to make decision if they are incapable, if they can’t answer, then must stop

20
Q

Non-maleficence is one of the guiding principles of research ethics, what does non-maleficence mean?

A

Non-maleficence: Obligation to avoid harm. People who run experiment may be first aid trained in case something goes wrong.

21
Q

Beneficence is one of the guiding principles of research ethics, what does beneficence mean?

A

Beneficence: Obligation to provide benefits and to balance benefits against risk. Need to be prepared for all levels of risk.

22
Q

Justice is one of the guiding principles of research ethics, what does this mean?

A

Justice: Obligation of fairness in the distribution of benefits and risks.

23
Q

An ethical application must be submitted, what does it include?

A

Explain whats going to happen, what steps will be taken, what the potential results are, any benefit of the results. Very long document.

24
Q

At Newcastle University, who is first given the ethical application?

A

Newcastle Joint Research Office (NJRO)

25
Q

Who are NJRO?

A

Newcastle Joint Research Office, they sit between the NHS and Newcastle University, and organise all research applications.

26
Q

If NJRO are happy with the ethical application, who does it get passed to?

A

If NJRO are happy with the application, they will pass it on to the NHS HRA.

27
Q

Who are the NHS HRA?

A

NHS Health Research Authority, they look at the application alongside another department called MHRA and ensure everything is justifiably certified.

28
Q

Who are the MHRA?

A

Medicines & Healthcare products Regulatory Agency. They are an executive agency of the department of health.

29
Q

Who can give recommendations to health, public health and social care professionals to gain MHRA approval?

A

NICE

30
Q

Where would you look for ethical guidelines?

A

WMA and Guiding principles

31
Q

What is WMA?

A

World Medicine Association

32
Q

What organisations are in charge of governance of ethical research?

A

NJRO, NHS HRA, MHRA, NICE, NU

33
Q

Ethical applications need to be quantified well, why?

A

Need to ensure it is a financially sensible idea.

34
Q

What can be used as evidence on an ethical application?

A

Could use evidence from other countries, but need to make sure the experiment has a new aspect, as repeating an experiment is unethical. Need enough evidence to prove it is different.

35
Q

Can you start research before getting ethics approval?

A

Cannot start research before getting an approval.

36
Q

How long after getting the ethics approval must the research start?

A

Must have started within 12 months of receiving the approval.

37
Q

How do the Biomed team at Newcastle suggest doing the ethics application?

A

The Biomed team at Newcastle Uni took more time over the application, letting them become more familiar with the process. It helped to engage all members of the team, and aided in defining the study collaboratively. They were also able to create supporting documents. They could gain sign off from the team, and react quickly to HRA requests.

38
Q

How long did Newcastle Uni take to fill in application for ethics?

A

It took them 7-8 months to complete, and got approval within 4 weeks.

39
Q

It is important to view the experiment from the participants point of view, and consider what?

A
  • Thinking
  • Seeing
  • Saying
  • Hearing
  • Feeling
40
Q

What must the communication on the ethics application be like?

A
  • Jargon free
  • Clear English
  • Easy to read
  • Visual language
  • Factual
  • Descriptive
  • Consistent
41
Q

What did Newcastle Uni do to their posters as advertisements for the trials to make them more friendly?

A

They put photos of the clinicians on the poster to make it easier for people to find and talk to them about the study.

42
Q

How many members usually make up an ethics committee in the North East?

A

Usually made up of 18 members

43
Q

What people make up the ethics committee in the North East?

A

Officers, experts and lay members

44
Q

What are lay members?

A

Lay members are independent and do not come from a technical background, they may be patients, family members or cares. They may have no higher education.

45
Q

How many members of the ethics committee is made up of lay members?

A

They make up atleast 1/3 of the committee.

46
Q

What type of officers make up the ethics committee?

A

Chair, vice chair, alternative chair.

Biomedical Engineering (13 decks)

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