Feedback for this assignment
“Only clinical research that is ethical is acceptable to support the marketing of medicines. How do we know that this clinical research is ethical?”
Assessor 1: "Too little information regarding the elements of ethical review. "
Assessor 2 (Assessor comments are "[NCx]". I have tried to copy across the relevant parts of the text which are being commented on:
"The use of placebo, when a standard of care can be provided, is not permitted by recent DoH (WMA, 2018) and GCP (EMA, 2016) updates but, is not proscribed in earlier revisions (Wolinsky, 2006). GCP states the standard of care should be relative to what is ordinarily locally available. If the primary decision[NC1] of sponsor to run trials in less economically developed countries is not to address specific health needs of that population, there is an ethical dilemma, despite its legislative acceptability under the guidelines (Weigmann, 2015).
[NC1]This was a core to the discussion, and it needed to be expanded. Why is there this tension?
Authorisation to conduct clinical trials may be [NC1] required from the regulator, who will request evidence of REC approval and may have further stipulations such as, the social value of the research and evidence of patient risk have been mitigated, managed and minimised before they will provide approval for the clinical trial to proceed. The role of RECs differs internationally. In the USA and UK, RECs are independent from the FDA. [NC2] While in Holland, the REC can be a part of the national regulator (CCMO, n.d.). Despite these structural differences, the requirement for ethics approval and review is common amongst jurisdictions.
REC opinions are subjective and can differ from committee to committee, which is not a new complication (Downie, 1963). [NC3] RECs deliberate and decisions are made by consensus. The specific make-up of each REC can determine what practices are considered acceptable or not. This is beneficial when decisions are made within the context of local considerations, however, it raises an issue that a common ethical standard may not always be maintained (Edwards, Ashcroft and Kirchin, 2004). Further questions are raised when considering the range of expertise and experience within an REC (Sayers, 2007). The volume of ethics legislation means that nuances are not always picked-up and considered.[NC4] RECs are criticised as stifling innovative methods in research, especially in vulnerable and at-risk patient groups (Edwards, Ashcroft and Kirchin, 2004). However, this is due to their risk-averse nature in wishing to safeguard participants (Fistein and Quilligan, 2011).
[NC1]Does this mean not always? [NC2]Independent of the regulator [NC3]How does Downie come in here? Did Downie make this comment then? Are you using an old reference to claim the currency of your assertion? [NC4]What does this mean, and do you have an example? A DSMB is advisory and can only suggest changes, the EMA explains that as the sponsor is the ultimately responsible entity, they are not mandated to comply with DSMB recommendations however, any digressions from the DSMB must be justified and documented. The sponsor is also strongly advised to inform both the REC and the regulator if the DSMB recommends the early end of a trial. Any changes made are done through ‘Protocol Amendments’ and will require ethics committee and regulatory approval (CHMP, 2004[NC1] ).
[NC1]Ok, but where is this point going?
This declaration of ethical practice is made both from the sponsor and from an independent REC and with inputs from DSMBs
[NC1]. Ultimately RECs determine if the proposed research is socially,
[NC1]What about researchers (investigators)?