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If an ongoing study was approved for a period of one year, and they are required to apply for the protocol review and renewal after the expiry of the approval period. The site has submitted the protocol for annual review and approval with no amendments. Can the site continue enrolling participants before they receive annual renewal or favourable opinion from IRB/IEC, in regard to epidemiological study, where no investigational product is been administered to study participants?

  • dralinn ALI Innocent 18 Aug 2010

    There seem to be a divergence in what happens elsewhere and the experience in resource poor settings like sub saharan Africa. I agree with Moses that ECs should have an annual report but not a review. It should be clear what role the DSMB play and how this relates to reviews imposed by ECs. Could it also be that annual review required by some ECs include a review fee to help strengthen the financial capacity of these ECs, which fee must come pretty often and against a background of a great need to improve EC capacity to review increasingly complex trials taking place in developing countries. I think that annual reviews are not necessary in this situation. Raffaella, what do you think if the intervention involved the administration of a new product?

  • Waweru Waweru 14 Jul 2010

    I totally concur with Roma on this. The study coordinator need to have a system that reminds them of important dates. He/she should also have knowledge of local regulatory requirements and time lines, and submit their requests for approval renewal on time. The site PI should also take responsibility and should be aware of such dates and liaise with the coordinator to ensure they have the annual approval.
    I however think that the site should continue recruiting, and the time lapse should be documented.

  • HMM HMM 1 Jul 2010

    i really agree with Raffaella, the ECs really delay with the protocol not considering that this might bring protocol approval lapse. and again turn back and accuse you of the lapse!! what are you supposed to do if you submit your protocol on time but they delay and the sponsor is on your neck to recruit!!! research Dilemmas?

  • rravinetto Raffaella Ravinetto 30 Jun 2010

    Hi everybody, on the specific point, I agree with those who recommended not to enroll new patients while waiting for the renewal of the ethical approval.

    In general, I am not surprised by the procedure of annual renewal: the TDR Guidelines for EC (2000), for instance, recommend in chapter 9 that "ECs should establish a follow-up procedure for following the progress of all studies for which a positive decision has been reached, from the time the decision was taken until the termination of the research". Note that art. 9.2 says that "the follow-up review intervals should be determined by the nature and the events of research projects, though each protocol should undergo a follow-up review at least once
    a year".

    However, the Guideline also says that "the ongoing lines of communication between the EC and the applicant should be clearly specified", and in my experience this may fail to happen: sometimes, ECs do not have guidelines clearly stating minimal and maximal deadline for answering submission (either in case of first submission or renewal), and sometimes such deadlines exist but are not respected, making the life of researchers very hard due to persisting incertainty.

    So, I would tend to say that the principle of annual review is absolutely correct, but also that there is a need to improve the efficiency of the ECs (in terms of respect of pre-defined timelines); and, maybe, it could also be suggested to adapt the level of follow-up to the nature of trials, according to a kind of risk-based approach, in order to maximize efforts on follow-up of those researches that involve more risks to the participants and the community.

  • mamulla Moses 18 Jun 2010

    In my view Roma's view is sensible and appropriate. We are seeing more often that ethics committees are asking for an annual review. I is difficult for many ethics committees to have capacity to really manage this. If the protocol clearly states that the study is running for several years then that is what should be approved. Introducing annual review i a concern - they are not set up to be DSMB's! They cannot have blinds broken and any decision needs to be made carefully and responsbily based on all the data. What if it is a multicentre trial? they cannot review all the data and this is really going beyond the scope, resources and training level of most committees. Is this common practice in Europe and the US? I think it is appropriate for EC to have a report every year but a review is a very different and more worrying. I think you should keep recruiting and write to the chair and explain. There is no safety issue here - let us all be sesnsible and logical!

  • Roma Roma Chilengi 18 Jun 2010

    Hi, This is Roma again.
    May i add that although international regulations are critically important; it is ultimately important that the local applicable regulatory/ethical requirements rule in the situation.

    Roma

  • Roma Roma Chilengi 18 Jun 2010

    Let me add a view to this scenario.

    I think the study team made a mistake in note keeping track of the IRB requirements. This is why coordinators should particularly keep a calendar of key dates and raise the issue of renewals in time.

    I think that the study should continue, but immediately you must submit a protocol deviation or suitable documentation to explain the problem.

    The essence of IRB review is protection of participant safety. And since the protocol has not changed, it is reasonable to assume that the risk benefit balance is probably the same. Therefore, stopping the study would be counter productive. However, the team must honour up their failure to renew and should proactively report their deviation to the IRB.

    I am assuming that this is an investigator led type study with no formal industry sponsor? If there is a sponsor, then the sponsor must of course be notified and should approved the wording of the report. But that would also mean the sponsor was sleeping as well.

    I recommend the coordinators to be using some Project Management software that is extremely helpful for keeping such dates.

    Roma

  • jmueller Jenny Mueller 17 Jun 2010

    I think you have to wait for approval before you can continue recruitment under the given circumstances, although it is not clear in 46.109 e) of Title 45 CFR Part 46 whether annual approval needs to be in writing (as for initial approval and modifications as stated in 46.109 d) or whether it is an 'implicit approval', meaning a 'go ahaed' if the IRB has no objections. It seems that an IRB can only approve a project for a maximum period of one year (see 46.110 b2). However, as the EU Directive does not require annual approval I am not familiar how to interprete this CRF.

  • NKisengese Nicodemus (Nick) Kisengese 17 Jun 2010

    yes - the protocol says the study will run for atleast 3 years, but the ethics committee only approves the protocol for one year, then the site PI is required to request for annual review and contuing approval, including an annual progress report even if no amendments to approved protocol have been included.

  • tlang Trudie Lang 17 Jun 2010

    Nick in the protocol that was approved did it say that the study was to run beyond one year, and the ethics committee only gave a years approval? Is that a standard practice with your committee?