Research Process 2- Research Governance in clinical research Flashcards
1
Q
What are the strategies that researchers needs to be put in place ?
A
- Indemnity insurance approval
- Professional codes, standard and guidelines: will be specific to the researcher’s professional background and participant groups.
- The Research Governance Framework (DoH, 2005): provides guidance on the way in which research should be conducted.
- The law: The Human Rights Act 1998; the Data Protection Act 1998,2003; Freedom of Information Act 2000; The Human Tissue Act 2004; the Mental Capacity Act 2005, 2007.
- Health and safety and European Union regulations.
Researchers need to uphold all these strategies throughout the research.
2
Q
When undertaking research in the context of healthcare in the UK, what two approval are required ?
A
- Indemnity insurance
- Approval of an ethics committee
- Advice about where, when and how to make an application for these approvals are from research supervisors or employers.
3
Q
What is the indemnity insurance ?
A
- If necessary, compensation will be provided to anyone harmed by the study.
- This needs to be in place before a study begins
4
Q
How do you apply for the indemnity insurance ?
A
- Usually provided by the organisation that the chief or lead researcher works for, or the academic institution where a student is studying.
- They will have an application process which will probably include the requirements to complete specific documentation pertaining to the study.
- Decision of the provision of indemnity insurance are usually made by a committee on behalf of the organisation.
- If the application is approved the researcher will be issued with a letter of confirmation.
- No research can begin without the indemnity insurance
5
Q
What is the indemnity insurance committee looking for?
A
- The purpose of the application is to enable the committee to assess the level of risks: to participants, the researcher, the study site and the institution providing the approval.
- The committee wants to be reassured that any risks of the study, there are strategies put in place to minimise them.
6
Q
How to apply for an approach of the ethics committee
A
- Can be provided by an NHS or an academic institution’s ethics committee.
- However some studies decided that their approval is not required for some type of study.
- Most straightforward way that a researcher can find out if they require NHS ethics committee approval is to contact the research development office.
- Part of the application process includes the researcher assessing the level of risk
o Low risk studies are notified of the outcome after 14 days
o Higher risk studies are notified within 60 days - If the application is approved the researcher will be issued with a letter of confirmation.
- Researchers need to look at the websites to see which documentation needs to be provided.
7
Q
If an approval from the ethics committee is not required, what are the two things to look out for ?
A
- If the research is being undertaken by students or member of staff of an academic institution, they will need to acquire approval from the academic institution instead.
- Lack of NHS ethics committee approval may have implications on publication.
8
Q
What are the ethical committee looking for ?
A
- They want to be reassured that strategies have been put in place to promote the safety and wellbeing of research participants, researchers and the institution the research is taking place.
- The purpose of the ethics committee is to see if the risks out weight the benefit
9
Q
Which two of the criteria come first ?
A
- Usually indemnity insurance is acquired first and the ethical committee would like to see written evidence that this approval has been given.
- Very important that the research gets a confirmation letter for both before starting any research.
10
Q
What are the practical and logistical ethical issues to be addressed ?
A
- The documentation that a researcher is required to complete for ethics committee approval will indicate the sorts of issues that ethics committee will want to know.
- The sort of things that the researcher should consider:
- Do I need permission to access potential participants
- Can I guarantee participant anonymity and confidentiality?
- When and how I obtain informed consent?
- How do I obtain informed consent for research involving children?
- How do I address issues regarding mental capacity?
- Can I involve vulnerable adults in my research?
- Could power relationships impact on the research?
- Where will data collection take place?
- Where will the data be stored?
11
Q
Would you need permission to access potential participants ?
A
- Yes- written permission to access participants. The ethics committee will want to see the evidence.
- If a study is to undertaken in a clinical settings and the researcher doesn’t work there and honorary contract, research passport and DBS is needed. They may also have to complete the Good Clinical Practice (GCP).
- Written confirmation of permission to access the information for research purposes should be obtained.
12
Q
Can I guarantee participant anonymity and confidentiality?
A
- Wherever possible researchers should reassure participants that they will remain anonymous and confidential which needs to be stated in the participants leaflet and consent form.
- Being reassured can increase the likelihood that a potential participant will agree to take part.
- Number of strategies that the researcher can make sure that anonymity which include:
o Minimising the number of people who have access to participant identifiers such as names and addresses
o Securely storing information about participants names and contact details
o Using code to replace names and location
o Careful use of direct quotes and data extracts in presentation and publications to minimise knowing the participants and locations being recognised. - Can however be problematic, particularly when the study is small-scale.
- In terms of confidentiality, the researcher can feel that they have to breach it particularly in clinical studies- if they have concerns of safeguarding.
13
Q
When and how I obtain informed consent?
A
- Potential participants should be fully informed about:
o The study
o Why they have been identifies to take part
o What the study will involve
o Potential risks
o Their rights to withdraw
o Strategies to facilitate their anonymity and confidentiality - The information is usually provided in a participants information leaflet
- Consent will be taken by the lead researcher. Both participant and the person taking the consent should sign and a copy of the consent form should be given to the participant and the researcher.
14
Q
What are the three conditions that must be achieved when health care professional take consent ?
A
- Health care professionals taking consent for participation must not have any concerns about the research
- HCP taking consent must have an open and honest discussion with potential participants about the research
- Participants must make informed decisions about whether or not they participate in a study.
15
Q
How do I obtain informed consent for research involving children?
A
- Research involving babies and children under the age of 16, consent will be provided by their parents
- Good practice to provide age appropriate information in a range of formats.
- May not be easy to get parental consent- mother does not have the mental capacity to give consent and a father can only give consent if:
o He has the mental capacity to do so
o He is married to the child’s mother or he is registered as the child’s father on the birth certificate
o He has acquired parental responsibility
o He has obtained a residence order
- If the case if that one consents and the other doesn’t, the child should not be enrolled into the study.
- If the mother is under 16 years old, then the grandparents can be present when the consent is being given.
