groups » Research Ethics » Forum for Ethics Committees & Regulators

We are planning to set up a new area of this site especially for members of ethics committees and regulatory bodies. The aim of this forum would be to provide straightforward information and explanation to members of bodies that provide scientific and ethical review of clinical research studies being proposed in the field of global health in resource limited settings. There would be opportunity for members to have secure discussions and seek advice from experts. The material would be relevant to the environment, promote sharing of best practice and be a single access point for reviewers to seek answers to the questions they have on protocols that they are reviewing or to explain an area of research. There could be a closed and open discussions, training and other resources - as well as access to everything else on this site. Please can you share your views on here and please tell us what would make this useful and support reviewers in their roles.

Reply

ethics committees regulatory bodies

  • rravinetto Raffaella Ravinetto 22 Nov 2011

    Hi, concerning the speakers in Atlanta, it was almost one year ago and I have to admit that I do not remember the details. Roughly, I would say that "substantial" was what brings a concrete improvement to the protocol (e.g., adding a lab test to monitor a safety parameter), or to the recruited patients (e.g., requests that some concomitant conditions are treated for free, or adapting the travel reimbursement to local conditions, or improve the information on risks in the informed consent), or to the community (e.g., asking for provisions for post trial access). On the other side, simple modifications of wording would be seen as "format".

    In the same line, concerns about the ability of the IRBs/ECs to actually protect patients appear from time to time in the literature, see for instance Grady, JAMA. 2010;304(10):1122-1123; or Menikoff in the NEJM. 2010; 10.1056/NEJMp1005101. There maybe of course episodes of poor efficiency, but it is important that they do not undermine the importance of having a full ethical review process (with both Northern and Southern actors incolved, in the case of North-South collaborative research). Best wishes,

    Raffaella

  • shahinazfaisal Shahinaz Faisal Bashir 21 Nov 2011

    IT WOULD BE VERY BENEFICIAL TO HAVE THIS AREA especially for members of ethics committees

  • tchantler Tracey Chantler 19 Nov 2011

    Hi Rafaella,

    I was just wondering how the speakers at the ASTMH differentiated between formal and substantative? Is formal just procedural issues, and substantive about risk analysis and ethical conduct?

    Thanks,
    TC

  • GHN_Editors The Editorial Team 1 Nov 2011

    Hello everyone, I just wanted to let you know that we're very pleased to announce that the website mentioned above, dedicated to the members of research review committees is now up and running - it's www.globalhealthreviewers.org. Like Global Health Trials, its ethos is to provide free, open-access resources to help members in their day-to-day lives. It has closed, private discussion groups in which you are free to discuss your protocols if you like without other members being able to view them. Please visit and join!

  • mamulla Moses 10 Dec 2010

    This would be helpful. Ethics committees have a hard job and there is so much jargon in research and different design and lots is technical. A site for answers would be good

  • Promero Palma Romero 26 Nov 2010

    This is a good idea. In South America our ethics committees are gaining capacity but if they could have somewhere to ask questions and get advice this would be welcome. It would need to be in Spanish, too for us.

  • rravinetto Raffaella Ravinetto 23 Nov 2010

    Hi, at the recent ASTHM Conference in Atlanta, at least a couple of speakers pointed at the fact that sometimes conflictive opinions issued from different IRB/EC may unnecessarily delay the researches. All the speakers agreed on the absolute relevance and need of ethical review, but they also found that sometimes the ethical bodies can focus on formal rather than substantial requirements.
    In this view, the new area of the website could be used by the researchers to share this kind of experience with ECs and IRBs, to work together to improve the communication lines between researchers and ethical bodies, and to improve the quality of the ethical review.
    Obviously, the effectiveness of such a website wil depend on a sufficient participation of researchers and reviewers from different countries and settings. Best wishes,

    Raffaella

  • phaikyeongcheah Phaik Yeong Cheah 22 Nov 2010

    This onlilne ethics/regulatory forum will be discussed at the 10th FERCAP International Conference, 22-25 November 2010.
    http://www.fercap-sidcer.org/index.php

  • GHN_Editors The Editorial Team 22 Nov 2010

    Please tell us what you think of this planned new area of this website - what do you think would help?

Please Sign in (or Register) to view further.