Regulating medical research and clinical trials in South Africa – Too much red tape to handle?
Dr. Harriet Etheredge
Posted on June 9, 2017
My post this week is delayed because it’s been a mad spin setting up ethics and regulatory protocols for a number of new, exciting research projects. We’ve had to jump through hoops, negotiate hard and make some real compromises in order to get these studies to the point where we can submit them to our Human Research Ethics Committee (Medical) [HREC] and seek approval. In full disclosure, I am a member of our HREC so this post may be a bit partisan….
Do we over-regulate medical research?
The events of the week got me wondering about the extent to which we regulate medical research in SA. Not for the first time – I asked myself whether we are taking it too far. I’ve had so many conversations with frustrated clinicians, who are just trying to do projects that will improve the lot of patients, and feel like the regulatory red-tape is stifling research.
I understand these frustrations – and sometimes I agree. But I also don’t think clinicians understand why research regulation is necessary. It’s because research involves people. Directly – when people take part in drug trials, for instance, often at some risk to themselves. Or indirectly – where medical data about people is accessed, or where stored samples like blood and tissue are analysed. The main objective of research regulation is to protect these people.
How do we protect research participants?
Amongst many checks and balances: We ask researchers to inform people about the study before they decide to participate. We insist that this information is delivered in a manner sensitive to the language and literacy capabilities of the individual in question. We usually insist on some kind of written consent from all people taking part in research. We make sure that people aren’t getting paid to take part in research, because money could incentivise them to take risks they wouldn’t normally consider (especially applicable in SA where people aren’t wealthy). We carefully scrutinise how samples like blood and tissue are stored, and what will be done with them in future.
Yes, it is necessary – examples from history
‘But clinicians and researchers are wonderful people’, they are all in the business of saving lives and making the world a better place, they don’t need such regulation! Sadly not. Throughout history there have been instances of medical “research” (in inverted commas because of questionable scientific and methodological rigor) performed on people without their consent. Historically, the work of Nazi war doctor Josef Mengele is often cited as one of the most disturbing examples. In SA, too, we have not been free from scandal, with Wouter Basson and later Wits Professor Werner Bezwoda.
My feelings, in conclusion, are these. Yes, we need regulation, in spite of the fact that the majority of researchers (at least those who I am privileged to work with) maintain consistently high ethical standards. We need it because there are one or two who don’t – and this can endanger patients. We need it because it sets a standard and thus improves the quality of our science.
 I say ‘usually’ here because there are some cases where we don’t get written consent. For instance, in the case of a child who is still very young, and cannot read or write, we get written consent from the parent or legal guardian. When we have patient records that date back a long way, but the patients are no longer in the hospital system getting treatment, we don’t require informed consent from each patient as long as the project has been approved by the HREC.
The views published in this blog are entirely my own (informed) opinions. They are open to debate, discussion and disagreement.