Dear All,

 

Thank you, Dr. Isabelle, for raising this discussion point. Actually, A somewhat similar issue was discussed during our last workshop in Alexandria (29th-30th of Oct. ) and I shared the group in the discussion ( email on 2nd of Nov. ) . Responses from our colleagues agreed that REC approval is essentially prospective and is never retrospective but because of the problem of promotion in Egypt and lack of established RECs at the time of initiation of the studies, each REC developed its own regulations regarding such particular cases as Dr. Maged, Dr. Diaa, Dr. Abdullah mentioned. In addition the chair of our REC asked the researchers to bring an official letter signed by the head of the department that states that the research was done in accordance with international and local regulations and informed consents were obtained from the research subjects and if these consents are present, he can submit them to the REC to support him.

 

 I understand that your question is somewhat different i.e., you mean that despite the presence of a functioning REC  at the institution, the investigators didn't submit their protocol to the REC prior to initiation of study-related procedures. As you mentioned this is completely unethical and in my openion there should be some additional risks  to the subjects that made the investigators afraid of disapproval of their protocol.In this case the high risk-benefit ratio will add further to the issue of unethical research.What if some subjects had been already harmed by the risky procedures used ??? How can this kind of research be published ????

 

On the other hand, as Noha mentioned, if all other requirements for ethical research were really met ( remember Heba's lecture on what makes clinical research ethical) and the only missing point is the independent review by the REC ( although it is hard to accept ), there may be some suggestions to help for publications. In my personal openion the investigators should submit the protocol and their results together with the ICFs ( assumed to be present ) and probably official letters from the heads of their departments documenting that all study procedures were done in an ethical way and explaining why the investigators didn't seak for ethical clearance before initiation of the study e.g., because the meeting of the REC was postponed and the research subjects that could meet inclusion & exclusion criteria are rare and potential subjects would have been lost if the investigators wait for REC review........Then, a full-board REC in addition to a scientific committee will review the data and decide if the scientific and social validity of the results could justify publication in order not to lose useful data esp. that the subjects were willing to participate in the research and they all signed ICFs prior to the research. Also, the REC shall notify those PIs that this situation should not be repeated and they will never have future approvals for publication of research that was not submitted to REC for prior review.

 

The last situation is what if , in addition to not having independent review, the researchers didn't obtain valid informed consent i.e., the subjects were not informed that they were involved in research. Here, I think- whatever the scientific and social values of this research- it is completely unethical to publish those data without obtaining approval ( can I call it consent ?or may be post- consent ) of those subjects. If the investigator can re-approach them and apologize in a written form for not taking their prior consent and if they accept to publish their data ( all this should be documented and signed by the investigator, the subject or his authorized representative and an impartial witness), then these documents together with the same documents mentioned above should be submitted to REC as well as a scientific committee to decide whether to publish or not.

However. if the PI fails to re- contact the subjects or he is afraid to do that or the subjects refuse the publication, then data should not be published.

 

I'm sorry, but those are my thoughts,,,

 

 

Best regards to all of you..

 

Nadia

 

 

--- On Wed, 12/17/08, inakhla1 <inakhla@...> wrote: