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Ethical issues within health research > Research Ethics Committees > Flashcards

Research Ethics Committees Flashcards

1
Q

some people see ethics committees as

A

hurdles

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2
Q

however should be seen as

A

gateways to high quality research

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3
Q

ethics committees prevent researchers from becoming

A

complacent

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4
Q

Main aspects research Ethics Committee

A

1) design and conduct of research

2) Participant protection

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5
Q

design and conduct of research

A
  • consideration of the rights and welfare of research subjects and those whom the research will impact
  • research which involves others as participants creates the possibility of an invasion of the participants interests or rights
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6
Q

participant protection

A

‘medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights.. considerations related to well-being of the human subject should take precedence over the interests of science and society’- Helsinki

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7
Q

Henry Beecher

A

1996

  • NEJM article- Ethics and Clinical research
  • 22 examples bad research practices
  • from mainstream researcher
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8
Q

Maurice Pappworth

A

human guinea pos 1967
- details over 200 cases in the US and UK infants, children, the elderly, people in institutions often without their knowledge and consent

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9
Q

Alder Hays organ retention

A

1988-95- liverpool

-removal, storage and disposal of human tissue, from dad patients, including organs from children, without knowledge or consent
-2000 relative brought a suitcase against the NHS 2004
-

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10
Q

Human Tissue Act

A

2004

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11
Q

principles

A
  • respect for persons autonomy- consent
  • respect peoples privacy
  • to ensure confidentiality of the peoples information
  • social justice
  • not to cause undue physical or mental arm
  • ases risk/benefit
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12
Q

quote

A

ethical practice requires that participants, at a min, be fully informed, are to volunteer without inducement, free to opt out without redress, and be fully protected in regard to safety to the limits of best practice

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13
Q

also important to consider

A

safeguarding researchers

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14
Q

informed consent

A

is the decision,w which must be written, dated and signed, to take part in a research project freely after being duly informed of its nature, significance, implications and risk and appropriately documented

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15
Q

for some situations

A

ongoing consent and sensitivity to non-verbal cues may be required

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16
Q

participants must always be

A

free to ask questions at any time and can withdraw from the project whenever without any prejudice to service or care they may be receiving

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17
Q

a good technique used in informed consent

A

allowing a cooling off period to consider their participation- time between reading the info sheet and actually agreeing to take part

-also testing comprehension

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18
Q

what information must be provided to participants to ensure informed consent

A
  • what their participation involves
  • risks and benefits
  • what the research is about
  • what data is being collected and what will be done with it
  • wehere the data will be stored, who has access to it, how long it will be kept
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19
Q

must also be informed

A

what happens if things go wrong: provide info about safeguarding, contact details of researchers and ethics committee chair

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20
Q

Recruitment issues to be considered

A

Who is in your sample?
- are there vulnerable groups involved?
Recruitment:
-how will you recruit? are you offering expenses or payment? Beware of inducement. Is there a gatekeeper? Power imbalances
Is there a pre-existing sample
- if so was consent given for proposed study?

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21
Q

Data protection act

A

1998

-research must comply

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22
Q

groups

A

focus groups discussions: Chatham House rules

23
Q

Chatham House rules

A
  • participants are free to discuss what happened in the meeting
  • but not to disclose who took part or ascribe particular statements or experiences to individuals
24
Q

when is an ethical review required

A
  • when it involves people as participants
  • their data or tissue or body fluid
  • data about them collected for other purposes (secondary analysis)

UNLESS THE PROJECT CAN BE DEFINED AS AUDIT OR EVALUATION

25
Q

audit

A

routinely collected data e.g. age or smoking used to make changes in GP setting

26
Q

evaluation

A

not to be published

27
Q

if data will be published

A

need ethical revieq

28
Q

what happens at the meetings

A

-discussion on each submission
- decided if there are :
Major ethical issues, minor issues, no issues

29
Q

in the case of major ethical issues

A

may be rejected or asked to respond to comments and come to the next meeting

30
Q

in the case of minor ethical issues

A

respond to comments and submit for chairs action

31
Q

in the case ono issues

A

go ahead

32
Q

who is in UEMS REC

A

-researchers with experience of diff research methods
-clinicians - wide specialities
-early career researchers
-PhD students
Members of the public
-administrator

33
Q

Public and patient involvement

A
  • where groups of patients or members of the public work with a research team on the project:
  • discussing issues
  • refining question
34
Q

what will PPI comment on

A
  • info sheets
  • consent forms
  • plain language summary
  • other material aimed at the public
35
Q

PPI are involved at

A

at every part the research cycle

36
Q

what is a research ethics committee

A

a group of people who discuss applications to check that ethics issues have been identified and planned for appropriately

37
Q

you must

A

inform committee when the study has finished and submit report- thank participants and if they sign up for it, inform them of study results

38
Q

main types of ethical commitites

A

NHS research ethics approval

HRA approval

EMS

39
Q

NHS research ethicss approval

A

research involving the NHS e.g. patients or service users, relatives or careers of patients within the NHS or a health and social care organisation

40
Q

what do you apply through for NHS research ethics approval

A

Integrated Research Application System (IRAS)

41
Q

HRA stands for

A

Health research authority

42
Q

Health research authority

A

introduced in 2016 for managing approval for all project based research in the NHS. TheHRA brings together the assessment of governance and legal compliance with the independent REC opinion provided through Research Ethics Service.

It replaces the need for local checks of legal compliance and related matter by each participating NHS organisation.

_Applications are made through IRAS also

43
Q

HRA approval is required for

A

all project based research which involves NHS organisation in England

44
Q

NHS REC approval required for any research involving

A

= patients, carers and users of NHS
= access to data, organs or other bodily material of past and present NHS patients
=foetal material and IVF involving NHS patients

45
Q

studies requiring NHS REC approval

A

1) clinical trials
2) trials of a new service
3) studies recruiting people through the NHS or because they are a patient
4) patients identified as potential research participants because of their status as relative or carers of patients
5) access to data, organs or other bodily material of past and present NHS patients
6) foetal material and IVF involving NHS patients

46
Q

HRA approval needed for

A
  • the use or potential access to NHS premises or facilities

- NHS staff recruited as research participants by virtue of their profession

47
Q

UEMS research ethics committee needed if

A
  • UEMS students staff
  • members of the public
  • participants recruited other tan through NHS
  • secondary data analysis
48
Q

Use of human tissue (as defined in the Human Tissue Act 2004)

A

requires additional clearnace

49
Q

what do you need to do if you intend on using human tissue

A

if you wish to store any human samples you must inform relevant designated individual and you will need to complete an application to Store Human Samples form.
- you will also be required to read the UofE Human tissue act management handbook

50
Q

Human Tissue Act 2004

A

-consent required for research on human tissue in connection with disorder or functioning of the human tissue

51
Q

Human Tissue Act makes it an offence

A

to have human tissue, including hair, nails, gametes in this context, with the intention of it DNA being analysed without the consent of the individuals from whom the tissue came, or those close to them if they have died. This provision applies UK-wide. Penalties for not obtaining consent are provided

52
Q

13 terms of reference used by EUMS

A

1) safeguarding rights, safety and well being of participants
2) ensure staff and students are supported in and held accountable for the ethical conduct of research
3) to be satisfied that proposed research is worthwhile in itself and have beneficial effects that outweigh the risks
4) to make sure research is in accordance with the principles of expressed relevant bodies
5) to monitor appropriateness and effectiveness of procedures for granting or withholding the ethical approval of research- this is transparent
6) To consider the qualification and expertise of the investigator and research team involved in the proposed study
7) operate a system of appeals for rejected research
8) refer to the University Ethics Committee ases which cannot be resolved
9) to inform UEC of any changes in ethical codes of professional bodies in relevant discipline areas in order that the procedures remain valid
10) to advise staff and students on policy issues related to research ethics as determined by the UEC
11) to ensure effective liaison with appropriate university and school committees
12) to encourage staff development in the areas of research ethics
13) to regulate the burden of research studies that use students as participants

53
Q

to regulate the burden of research studies that use students as participants

A

to make sure that not too much pressure is being put ons students - distracting them from other studies

Ethical issues within health research (11 decks)

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