Research governance, ethics and permissions (for dummies!) Part 2

This piece is again modified from a section written by me as a resource supporting the Edinburgh Surgical Sciences Qualification (ESSQ) MSc Masters in Surgical Sciences. It is not meant to be an exhaustive guide more an outline. Similar regulatory processes exist in most countries but I have only included links for the UK. Finally as always opinions are my own.

Local Research Ethics Committees

These committees are made up of medical professionals and lay people and they have a responsibility to review applications to conduct medical research using human subjects or samples derived from human subjects. In USA these committees are known as Institutional Review Boards (IRB’s). The ethics committee will ask the following questions about a research project.

Is there a benefit to patients? research should have some benefit if not to the subjects actually participating to the wider society. There should be a balance of risk and benefit and looking at this objectively this should be appropriate to the problem being addressed.  

Is there a potential harm to patients? Are there any harmful and unnecessary procedures or investigations? Untested drugs for example may be considered to be hazardous and so the committee will require reassurance that appropriate safety measures are built in like starting with a small dose and increasing it, monitoring for side effects and cessation of therapy if a serious adverse event appears etc. 

How are patients recruited to the study and what information are they given? Recruitment of patients or subjects to clinical trials should be voluntary and patients must be given adequate information upon which to base a decision to participate or not. Individuals should be told the options available to them if they choose not to participate that is the trials should not be presented as the only option they have. Trials for example commercial studies can offer financial recompense for expenses but this must be transparent and subjects should have the right to withdraw if they feel this is their wish.

Are they in a dependent relationship with the researcher? People often get confused over this issue. A surgeon who is in charge of your medical care is in a dependent relationship with the patient and it would be inappropriate for them to inform and obtain consent from the patient. They may be involved in the research project but the actual consent process should be conducted by an independent individual. 

Are they allowed to change their mind or withdraw from the study? No one should be compelled to participate in clinical research and it is every participants right to withdraw their involvement if it is their wish. Having said that many patients get great satisfaction from participating in research and see it as a personal contribution to changing medical practice and improving peoples lives not only their own.

What information is given to their family doctor? Imagine you are a family doctor and one of your patients is in a clinical trial. You would need to know this and so you would need to know what the study is about who is running it and more importantly who to contact in an emergency of your patient should become unwell. If it is a randomised and blinded trial knowing which arm the patient is in may be important and in an emergency the code can be broken for the safety of the individual.

What samples will be collected and how will they be used? Samples collected from clinical research need to be accounted for. In the UK human tissue is subject to regulation through the Human Tissue Act 2004 and the Human Tissue Act (Scotland) 2006. Both of these acts describe the way in which tissue including blood and other fluids may be used and stored. Particular note should be given to DNA and there is a specific section in both acts dealing with DNA theft and misuse. There may well be a time limit imposed on the storage of samples. Samples collected in one research project cannot automatically be used for any other research project.

What data will be collected, how will it be anonymised and what security will be used to prevent release of data to the public domain? Protection of the security of data is considered to be extremely important and guidance on this is provided by the Data Protection Act.  Data should be securely stored, it should be encrypted or password protected and it should be anonymised. Although all of these principles are well known data breaches are common in health and medical research and can result in disciplinary action for those responsible for failing to protect data. 

Is the study adequately resourced / supported? You might well ask what this has to do with an ethics committee, but it is more about firstly ensuring that planned treatments will continue to the end of the study period and secondly ensuring that the research itself can go ahead and will have resource to monitor outcomes, report results and generally be worthwhile participating in. 

Probity and conduct of research

It is expected that individuals who are undertaking medical research will be honest in their pursuance of research and in their presentation of research. Research fraud can have very damaging effects on public confidence and is taken extremely seriously. In addition, deliberate publication of misleading or false results is dishonest and wrong. For example read about the MMR research fraud or the case of the famous Korean cloning scientist Hwang Woo-suk .

I will be devoting a blog or two to probity and conduct of research.


© 2012 SJ Wigmore

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