Subject had an accident during the visits to the hospital.Who should bear the treatment cost if the patient require the surgery? Sponsor or the Investigator or the Institution?
The question is brought from Linkedin GCP group.
Fiona Waddell. If this is a routine visit at which trial information will be collected ie the patient is not attending hospital purely for trial reasons then the patient bears the cost. If the patient is attending hospital purely for the trial and the hospital is arranging transport then I imagine that the hospital will be responsible for medical costs as the patient was under their care when the accident happened. If the patient is attending hospital purely for trial reasons and the patient has arranged his/her own transport then the patient bears the costs. The sponsor may agree to assist with cost but I don't think they have any legal responsibility.If the accident happened within the hospital or hospital grounds due to any negligence on the part of the hospital (eg water on the floor, broken floor tile etc) then the hospital bears the cost. If there is no negligence then neither the sponsor nor the hospital have any liability and the risk and the cost belong to the patient.
Jim Sheets • This should be defined in your informed consent, as per ICH E6 4.8.10(j) and (q) and possibly 21CFR50.25(a)(6). Fiona's points are also pertinent. There are other considerations, though. For example, is the drug you are studying a psychoactive substance that can possibly impair driving ability? I also encourage you to see FDAs "Information Sheet Guidance - A Guide to Informed Consent" http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm It states: "Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. If specific statements cannot be made (e.g., each case is likely to require a different response), the subjects should be informed where further information may be obtained. The consent should also indicate whether subjects will be billed for the cost of such medical treatments. When costs will be billed, statements such as "will be billed to you or your insurer in the ordinary manner," "the sponsor has set some funds aside for medical costs related to.... Here's how to apply for reimbursement if you think you might be eligible" or "no funds have been set aside..." are preferred. Statements such as: "will be the responsibility of you or your insurance company" or "compensation is not available," could appear to relieve the sponsor or investigator of liability for negligence, see 21 CFR 50.20."
Lynda Cedar • Hello Guruprakash, - Can you describe please the accident happened: what, where and when? - Is there a relationship between the visit to the hospital and the study?
Dominique Chesnais • It is an event that happened during the participation of the subject to a trial; it is an adverse event. As it requires surgery, it might need hospitalization, therefore it could also be serious.Investigations should also be made why and how the incident occurred: was the accident the result of a sub-latent medical problem, e.g. heart (arrhythmia) or neurological problems, which could have been induced by the investigational drug or by the subject's participation to the trial. In other words, what Lynda has just asked above.Unless an obvious cause is found, e.g. injury induced in a car crash by another driver, incident at the hospital /institution due to work, professional error at the site, it is difficult to claim a responsibility of the hospital or physician.That subject would not have had that accident during the visit to hospital, if he or she would have not participated. S/he should not bare any cost and any issue with the insurance imbroglio.
Guruprakash Manohar • HI Lynda, Subject had an accident on the way to hospital for the scheduled protocol visits. He was riding back on a motor-vehicle. He had an accident in a road and diagnosed Fracture in Left leg.The visit to the hospital is scheduled protocol visit. Thanks for responding!
Lynda Cedar • Hi Guruprakash, Thank you for the information and clarification. Dominique brought good points. - The visit was scheduled by the protocol and the subject filled his duty and made it. - As the vent needs a surgery and hospitalisation it has therefor to be documented and classified as SAE. - Since no institution (hospital nor the site) are involved in the happening of the event, therefor the insurance would not cover the event as an error or omission made by the clinical/medical staff. - If the subject is under medication effect and was aware by the ICF that the medication may affect his alertness and was not allowed to drive but he did, he has therefor his part of responsibility in the happening of the incident. However as Dominique argued above, if the subject did not have to go to the hospital for a visit scheduled by the protocol the event would not happen.... That was exactly what a lawyer told us when one of our study subjects had a shoulder dislocation (skating on ice) while he was participating in a study. - If there is no possibility of relationship between the medication effect and the event happening therefore, the sponsor is not responsible to pay for the surgery nor for the hospitalisation. In Canada all people are covered by the medical system, the surgery of shoulder dislocation of our subject was not an issue for the study, the subject was covered by his medical card .... which means the government paid for. The event was documented and reported as SAE in the study. For sure, as clearly stated by Dominique '' the subject should not bare any cost and any issue with the insurance imbroglio''. You should look at the local policies (government or insurance coverage) and also maybe the sponsor and the investigator find an arrangement to cover the fee.
Rajendra Bhaktha • The patient on his way to hospital was riding back on a motor-vehicle. He had an accident in a road and diagnosed Fracture in Left leg. ---->Makes it fit for a motor vehical insurance claim as all the motor vehicals are suppose to have a compulsory third party damage cover (which is mandatory).
Dennis McHugh • Any consideration for personal responsibility. On the back of a motor cycle? I hope he has an organ donor card.
Cynthia J. Robinson • Is the hospital visit in relation to the study visit when the accident occurred? If so, the hospital should bear the cost because the subject is under their care. Otherwise, the subject should bear the cost. If the subject took study drug while visiting the hospital; impairment occurred from study drug. Then the sponsor would bear the cost. Who bears the cost should be noted in the informed consent. The event should be noted as an adverse event, if subject was hospitalized then as a serious adverse event.
Dr Nitin Nagrecha • Indemnity agreement and insurance agreement both covers clauses under which subject will be paid. Here the main Question is that whether accident occured because of influence of study drug on the person ? Critical questions may be what was his behavior before drug. His state of mind. Now there can be no person who can judge this except if someone was accompanying him. Now everything becomes legal and be couteracted by both parties viz subject and sponsors and at times investigator. Unless there is no conclusion of study drug's involvement., sponsor may not be liable for loss. Once it is proved then it is their responsiblity to pay subject. That are my thoughts.
Michael A. Swit • @Lynda: why is this an AE? The accident was not related to the the investigational product in any way.
Felix Schaller • An AE doesn't have to be related to the investigational product. If it were related, it would be referred to as an AR (adverese reaction).
Sergio Goldfeld • @Michael: ICH-GCP definition for adverse event: "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment." Although this is not an ADR (Adverse Drug Reaction), this is an Adverse Event.
Richard A.M. de Rooij, MD • this is an interesting discussion but should not be about if this is an AE or not, nor about the cognitive affect of the drug. If the subject didn't particpate in the trial the accident wouldn't have happened A court can judge it is protocol related and by this the hospital and the sponsor could be held (co) responsible.
Lynda Cedar, Ph.D. • Dear Michael. You got excellent answers and great input from the other members, I don't have an additional comment. I also agree with Richard regarding the legal issues. If the subject was not involved in the study, this discussion would not even exist.... therefore an AE is not related to the medication intake only but all the happenings during the study to the subject and other aspects of the study. Each event must be documented and recorded to be tracked even years after a study has been finished and archived ..... Thalidomide is one of the best examples, the QA samples at CROs is another one, etc., etc. I learned from my experience that a study is a global event that starts one day and continues years later (even after archives). The industry is going to face this issue more and more for biologics and biosimilars for example.... The monitoring is fundamental, it has to be achieved by well trained and experienced monitors. I d not mean only the clinical operations side but the entire aspects of the study. Study must be conducted in respect of GCP/GLP/GMP, Ethics and standards. It also deserves to look at the legal aspects carefully (subjects and staff injury, medication quality, patents, contracts and everything). The role of the regulatory affairs should be broad, and not limited to the reg. submissions and inspections. Before starting a study we should be able to gauge how trial protocols manifest in real life, consequently, the sponsor and investigator can plan and budget based on real-world projections...they have to be prepared as much as their knowledge enables them to be. Thank you all for sharing your thoughts on this platform, I look forward to interacting further with all of you. Lynda.
Finaly Lopez Rasquin • I agree with Sergio, and thanks for reminding everyone the definition of AE, I was already concerned with those who doubted it was an adverse event, of course it is!!The discussion here is who should pay if the hospital, the subject or the sponsor.Of course it should pay anyone but the patient; would be very easy for him/her to show that is participating in a clinical study and take legal actions against the sponsor, so that's why they are insurance policies that protect both the subject and the investigator for these cases.Is easier and cheaper for the sponsor be responsible.
Sudeshna Lama • We all know bout AE,SAE ....However I feel you should read over the liabilty and indemnity part of the Trial protocol,also referring the Contract Agreement could clearly outline the parties responsible for handling such a case
Liping Zhou • I agree with the comments that an investigation should be performed to evaluate the relationship of the event(i.e. AE/SAE) with the study drug and/or the study procedure. After the causality is confirmed, the responsible person/party should bear the treatment cost as well as other related cost/compensation as defined in corresponding agreement or regulations (e.g.Insurance agreement, clinical trial agreement, informed consent form...). If needed, IEC and/or legal should be involved. And sometime, we have to take local common practice, ethical concerns into account.
Susana Navarro • Dear Richard, in Argentina, and in real life acontesimientos, an AE was expected or not, provided I believe and also according to the regulations of this country, the sponsor would be able to afford the costs. Sometimes agreed in the Bach, some directly sponsor not want to carry the expense. Then the regulatory bodies and ethics committees, requires the PI to have a prior inpatient services and care for these contingencies, the cost of running them. Which is an opinion and personally I think is not ethical and fair. For GCP standards one can not a priori in this situation so precarious. In Argentina we have a major health system which never leaves the patient unattended, until the parties decide who carries the costs, thankfully, but exposes patients to the national protocols of Health, or recharging prepaid system. It should be borne in mind that when a patient is exposed to an investigational drug, we do not know for sure, to be exposed, although EA is expected, there is also a gap that do not always have all the information.Thank Susan
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