Law And Ethics- Research

Question 0

What does “R&D approval” mean for the NHS?

Answer 0

The NHS requires research to be approved before it is undertaken within the NHS

Researchers wishing to conduct research in the NHS must obtain NHS management permission (R&D approval) for each NHS research site where the study will take place.

Question 1

What is research governance all to do with?

Answer 1

The good conduct of research for patient benefit

It’s to do with regulations, principles and standards that all act to achieve and improve research quality across all aspects of healthcare.

Question 2

What happens if the research involved undertaking research on the premises of an NHS organisation (eg a hospital) with NHS patients or with NHS staff?

Answer 2

The local R&D office needs to grant permission



Question 3

What are research ETHICS?

Answer 3

The ethics of experimenting on human subjects 

Research on health, illness and cure can be particularly sensitive

Question 4

Why is research in humans for healthcare matters ethical?

Answer 4

We are basically asking patients to allow themselves to be experimented on to establish which options of care are best.
Taking part may not even benefit the patient themselves, may only benefit future patients (eg if it all goes wroooong)

The issue that healthcare research is NOT clinical care.
We’re in a state of equipoise where we don’t know what options best so we experiment.
Like guinea pigs 

Question 5

How do capacity and consent relate to research ethics?

Answer 5

The patient has to be able to make a free and informed decision on participation in the research. Does the patient have the mental capacity to make this decision?
Need to inform the patient as much as possible: risks, benefits, long term, short term

Question 6

What legal frameworks must be considered when thinking about doing healthcare research?

Answer 6

EU clinical trials directive 2004
Data protection Act 1998
Human tissue act 2005

Question 7

How can ethical issues in research be prevented, minimised and managed?

Answer 7

Plan and design the study carefully
Trained and competent researchers
Appropriate support for the research such as funds, analysis etc
Appropriate information provided for participants so they know everything
Visible exit routes provided for patients so that they can drop out if they want, and also for the study itself incase a disaster happens!

Question 8

In the UK there is a system whereby research that meets a certain criteria must be approved by a RESEARCH ETHICS COMITEE Before it can be conducted.
Sometimes this is a legal requirement, sometimes an ethical.
What is it’s purpose?

Answer 8

This safeguards both the public and the researcher, as once it’s been approved it’s been seen as safe and acceptable,
so the researcher is less likely to be stopped mid experiment and the patients are less likely to be harmed.

Researchers should see the ethical review process as PART of the research process to help them out, not just a barrier to slow them down!! 

The study design may be modified in this ethical review, which may bring IMPROVEMENTS

Question 9

What is the application system for approval for health and social care research studies?

Answer 9

IRAS

Integrated research application system

Question 10

How do you know if ethical approval is needed, and what type?

Answer 10

“Governance arrangements for Research Ethics Comitees” document..
This states when review by a Research Ethics Committee is needed both ethically and legally

In the NHS, the NHS Health Research Authority cover Research Ethics Reviews!!

Researchers creating a study should identify if ethical approval is needed for research to go ahead and factor this into their plan!

Question 11

What authority in the NHS oversees research ethics reviews for NHS research, nationally?

Answer 11

NHS Health Research Authority 

Question 12

What must researchers provide when telling the NHS Research Authority about their study?

Answer 12

Application form
Protocol
PIS (patient information sheet)
Consent form
Peer review
Indemnity (insurance) and sponsor(who it's funded by)

Question 13

What is the difference between overt and covert research?

Answer 13

Overt: everybody involved understands what the research is and how it’s to be conducted
Covert: where the research study is Disguised, people don’t know what’s going on “under cover”= covert

Question 14

What are “gate keepers”?

Answer 14

Individuals you may need to ask permission to collect the data or gain access to potential participants

Question 15

What’s the difference between quantitative and qualitative research methods?

Answer 15

Quantitative= numbers
More to Do with “How many” questions, it’s used to test theories we analyse the data using statistics

Qualitative=
What and why questions
Data is in text or quotations rather than numbers
We can classify quotes of a similar theme in different categories

Question 16

What are focus groups?

Answer 16

Carefully planned series of discussions to pertain perception in a permissive and non threatening environment
Usually where 6-8 people are all invited to sit and discuss a particular topic naturally
Involved with Qualitative research

Question 17

What is the definition of a service evaluation?

Answer 17

A set of procedures to judge a service by providing a systematic assessment of its aims, objectives, activities, outputs outcomes and costs

I.e it will measure a current service without reference to a standard
Analyses existing data, adminstaration of interview or questionnaire
It does not require a REC review

Example: evaluating MUR services in community pharmacy

Question 18

What’s a REC review?

Answer 18

Review by Research ethics committee

Question 19

WHat does Pilot mean?

Answer 19

Using a sample of people not included in the study but with the same characteristics to ensure study procedures/ data collection methods are workable and acceptable to participants and
researchers

Question 20

What is cross-sectional research?

Answer 20

Data collected from sample on a single occasion

It’s a snap shot of data

Question 21

What is longitudinal research?

Answer 21

Data collected from a sample on more than 1 occasion

Question 22

Quantitative research provides ________ results.

Qualitative research provides _________ results.

Answer 22

Quantitative: reliable results
Qualitative: valid results

Question 23

Which method, qualitative or quantitative, involves sample size calculations?

Answer 23

Quantitative involves sample size calculations

Qualitative has no sample size calculations

Question 24

Quantitative data collecting involves stratified or cluster sampling. What does this mean?

Answer 24

Stratified: population divided into categories and a random individual selected from each catergory

Question 25

Qualitative methods involve convenience sampling. What does this mean?

Answer 25

Ask people because you know them / they are easily accessible to you.

Question 26

What is purposive sampling? (Part of qualitative sampling)

Answer 26

Purposively select a group of people.

Particularly interested in this group of people as they have particular interests.

Question 27

SNOWBALL collection of people for a qualitative study?

Answer 27

Recruiting some people then asking them if they know people who are interested, repeat over and over till your sample grows

Question 28

What’s the difference between internal and external validity?

Answer 28

Internal: does the data collection form you’re using measure what is intended to be measured?

External: are the research findings generalisable to the wider population of interest?

Question 29

Triangulation, what is this?

Answer 29

Using different researchers, types of data and research methods to test the same findings.