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Opinion

Saturday, 13 January 2018 | MYT 12:00 AM

Calling the shots in research

I REFER to the letters, “Improper attack on study” (The Star, Dec 25) and “Talking about science and ethics” (Dec 28).

In principle, it does not matter who funds a study – government, private, donations or crowd-funding. It does not even matter if the researcher is on the payroll (directly or indirectly) of a commercial enterprise or someone with a vested interest. All that is required is that the funding source, affiliations and payments are disclosed.

This is because the quality and accuracy of clinical studies (involving human subjects) are fully the responsibility of the research institution, which discharges its duty primarily via the all-powerful Medical Ethics Committee (MEC).

The MEC ensures the integrity of both scientific and bio-ethics components of a study, among others.

Good research institutions, in addition, provide multiple layers of peer-review of a study before it lands on the desk of the MEC.

It is the MEC’s job to ensure that the study answers a clinically useful question, is scientific in its design and conducted by researchers with the right training. The MEC is also supposed to check on all changes to study design and the final analysis and results.

Its duties are enshrined in documents like the Declaration of Helsinki, which came about due to previous unethical behaviour by research physicians.

It is the MEC’s job to ensure that the study does not spread misinformation or disinformation when published.

In theory, every study is finally “signed-off” by the MEC before it leaves the institutional premises for public dissemination.

The MEC’s role is all powerful because, often, there is pretty much nothing that can be done to remedy a poorly-designed study after it has ended other than to re-analyse the data.

The MEC is independent in its functioning. However, the research institution has a role in constituting the MEC panel. Often, the first “fail” occurs at this stage. It is very difficult to find clinical researchers with the right qualifications to sit in these panels as the “core” scientific experts. The MEC then degenerates into a quasi-scientific panel. Without a strong core of experts, the MEC will not be able to fulfil its obligations.

In addition, a national Appellate MEC is needed. Sometimes, institutional MECs may be too conservative and hamper important clinical questions that need answers. This can be referred to a national body for a wider consensus.

After a study is published, doctors and patient groups may object to the way it was done, the type of research methodology used or the way data was interpreted, as seen in the UK PACE (Chronic Fatigue Syndrome) clinical trial that landed in a legal tribunal.

Further, doctors may point out additional caveats or amendments that need to be added to an already published study. An Appellate MEC can be helpful here.

So, there seems to be a lacuna in the laws and regulations pertaining to the conduct of clinical research and patient protection in its entirety. This lacuna can be, and often is, exploited by those with vested interests. The public and patients then become the victims of “bad medicine”.

Lawmakers and Parliament should step in to provide urgent remedy and relief for patients and the public.

CONCERNED DOCTOR

Kuala Lumpur