I would like to hear if you are aware of any guidelines of other documents guiding in the choice and negotiations of no-fault policy insurance for clinical trials. To our knowledge, there are no international guidelines helping to build a risk-based approach for such policies, so that for each and every trial we have to negotiate with the insurance company, without any authorative references (and the impact of the insurance may be quite heavy on the budget of non commercial trials). If it is confirmed that such guidelines do not exist, we could advocate for them, through our platform and òaybe through major Donors like the EDCTP.
A second, even more practical question is: are you aware of any insurance companies based in sub-Saharan Africa and available to make no-fault policies for clinical trials? Geographical and linguistic proximity between the insurer and the study site would improve the actual level of patients' protection.
You raise an important problematic issue in our setting.Our experience has been just like yours, negotiating directly with insurance companies.
I am not sure however that i understand exactly what you mean by "no-fault" policy.
ICH GCP refers to two distinct policy covers i.e. as per section 5.8 sponsor indemnity which covers for trial related events (3 categorical ones); and also the professional malpractice which is the responsibility of investigators/their institutions.
I have so far worked with two different companies; one in Tanzania and another in Kenya who have provided insurance for local studies.
For both experiences, we had to talk the company into the risk as they had never done it before. So you may have to negotiate your way into a policy, if you are based in Africa.
hi Raffaella, I would also like to know what you mean by a no- fault insurance policy?
From my experience I am more familiar with the situation that Roma has mentioned. But I am keen to learn what you mean by a No fault insurance policy.
by "no fault" we need the insurance policy covering for trial related events, even if they are not related to medical mistakes/professional malpractice.
In the (remote!) past, I worked with a commercial sponsor, and we had a kind of umbrella agreement(you "just" had to add a new study to it) and the financial impact of the overall study budget was very limited. Now, from the point of view of a commercial sponsor with externally-funded project, the impact of such policies can be very significant!
But as I was saying, another major concern is that so far we have taken such policies in Europe, so that the insurer is geopraphically and linguistically far from the patient. It is a good news that at least in Kenya and Tanzania you have managed to find insurance companies for this, even if you had to "guide" them into a new topic. Maybe this "coaching" of the company would become easier, if there were some international guidelines?
You are bringing up a very important topic. I worked on USA government funded clinical trials in Africa and the insurance was issued by a US firm. The practical question is, if there was a claim, how would the whole process work? There is the issue of laws cross borders, the issue of procedure and the issue of time from claim placing to payment. You know most of these details are never discussed. It's like it is wished that things never come to that level where a claim has to be made. I think you are right in that the insurance be closure 'home' and 'feel' real. As such, a regulatory framework will move implementation from a sentence or two in the ICH-GCP to a more serious agreement.
Is there really a need for insurance? are we being led by the insurance culture in other states and we are putting these policies in place simply because they are an industry norm and commericial requirement in some countries. If we all just follow and put these policies in place with out thinking through the rationale then we are creating a market and the requirement potentially needlessly. For example in many developing countries medical doctors do not have professional insurance. This is covered simply by the government who pay for any legals costs if and when cases occur. This I am sure is common practice in very many countries and I would be interested to hear from many people to confirm that this is the case. In the west clinical trial indemnity policies cover the none-neglegent harm cases outside of professional indemnity insurance and have a requirement in their small print that says the policy is only valid if there is professional liability cover in place. What does that mean? A policy? I might be opening a can of worms here but I have to agree with Peter that I suspect that many of these policies are probably meaningless and a really high amount of money is being spent on them. We need to explore this important issues openly and comprehensively. I call on the WHO to investigate and resolve this issue. Please others to comment.
This is something I had not considered but you raise an important point and a concerning one. What are the absolute regulations on this, does this depend on the country?
Hi, I think it depends on countries' legislation: in some settings, the insurance is explicitly requested.
Concerning the question "Is there really a need for insurance?", I would say that what is absolutely needed is a system (a regulatory framework, as suggested by Peter, stating clear, explicit and realistic rules) to guarantee that all patients partecipating in medical research are protected, and indemnified in case of harm caused by the research, irrespecively of the region, of the nature of the sponsor etc.
The current insurance-based system has clear limitations, and it seems sometimes to protect the sponsor or the investigator rather than the patient. So, the question is: can we improve the insurance system, for instance by issuing international (WHO) guidelines giving guidance on it (including, for instance, on a risk-based approach for fees, on what to do when the doctors have no professional insurance etc?). Or do we have to move to a totally different system? On this last point, I have really no suggestions, it is too far from my background and experience....
Well done all for bringing this important point up. I am pleased as I can now confess this has always been one area of clinical research I have not quite understood and does concern me. I really don't know what the legal situation is in my country and I am not even sure how to find out. I think that it is likely that there is often not the correct insurances in place for many studies, but I am please with our colleague from India's point that perhaps we are over-legalising clinical research and we should not put these policies in place unless they are needed - and think about by who and who they stand to benefit. Most of our clinical research studies are academic and I don't think we should be rushing to take out policies we probably don't need. Yes I agree with the call for more certainty and an international agreement on what really is needed - as long as it is realistic and focussing on the needs of academic researchers.
Thansk for bringing these new useful in the discussion! Th key question should not be "Do we have an insurance in place?", but rather "Do we have mechanisms in place that ensure that a patient who has been damaged by the participation in a trial will receive appropriate indemnity/compensation?".
Today, the only way we know is insurance. However, it is only the presence of the insurance at the start of the study which is verified: but how many patients use it, in either commercial or non commercial trials? How effective is this tool in providing indemnity or compensation, in different contexts and countries? How should a fair fee be calculated? How should an effective contract be written?
As long as all these points are not clarified, including through regulatory guidance, I am afraid we will remain unsure whether we are really protecting patients with policy insurances, in academic or commercial research.....
This topic has helped me but I am left not knowing how to proceed. We conduct trials with sponsors and they provide this so called indemnity that comes with paragraphs and paragraphs of details on the information sheet. In our country there is no professional liability for our medically qualified staff and I do not think we should be introducing this as a means to maintaining the income of overseas insurance firms. However does this mean that our trials are not properly insured? Now what if I wish to conduct my own trial? On the trials registration websites they ask who is sponsor. Am I right that it is the sponsor who provides insurance for the trial? What international body is regulating this? Is this needed or will that just make trials even more expensive and out of reach for academic researchers in less wealthy countries?
We too have haad discussions on this topic. it is not normal to have professional insurance in our area and this is true for clinical officers. We find the matter of being a trial sponsor very difficult and insurance and indemnity is one of the problems and it answer is not clear. I agree with others that we need to find our own regional solution and not follow what happens in places like the US without working out what is best and would work here
I am a student in my final semester of MS clinical research. Currently I am working on my dissertation/thesis on different insurance policies in clinical research(tentative title)The topics i though would include are, types, comparison between guidelines, duration of insurance, shortcomings..etc. I have started working on it but it would be great if you all give me a bit of idea as to which topic being crucial and important..Thank you for your expertise. I am a fresher in CR but have hands on training in the CROs as part of my course curriculum so i understand most part of it though it may only be a bookish knowledge.