Membership and quorum requirements for ethics committee (EC)

[Guest guest]

hello,

the most important challenge facing the proper functioning of an IEC is, the insttutions are not taking clinical research as seriously as they should. The meetings , the presentations by the PI , the objections if at all any, are very casually dealt with.The bigget hurdle is subsequent monitoring of the trials.

I had once presented a project for approval to our IEC. I was not even required to present my abstract of proposed project and it was approved. then later due to some unavoidable circumstances the project did not materialise. There was no follow up of my project by any member of the IEC.

kunda

From: chaitalib <chaitali_bajait@...>Subject: Membership and quorum requirements for ethics committee (EC)netrum Date: Thursday, 31 December, 2009, 8:19 AM

Dear members,

What are the challenges before constituting an IEC?

1) Inviting qualified members to join the EC:

While qualified members would be better suited for ethical review of proposals, there are various challenges in inviting such people to join the EC:

a) Time and availability

They may be very busy persons, and time may be a premium for them. They may not be in a position to spare time for a long duration, and on specified dates for the meetings.

Place of residence

Travel to place of meeting – only locally available persons can attend the meeting, not out station. If they reside in another city, they would not be able to attend the meeting

2) Having a representative of the concerned community

While it is desirable to include a member from specific patient groups in the EC, this may be difficult in the case of a stigmatized health condition such as HIV/AIDS.

3) Familiarity with local customs for organizations not having CAB

Normally, a Community Advisory Board serves as a link between the researcher and the community, and enables the researcher to get a better understanding of the community in which the research is proposed. When the institution does not have a CAB, not all qualified members would be familiar with the local customs, and this could be a drawback. Hence, familiarity with local customs is essential, in organizations where there is no Community Advisory Board.

Dear members, waiting for some more reasons..

Regards

Dr. Chaitali

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Dear members,

Some challenges after constituting an IEC:

a) Many of the time, constituency of an IEC doesn't follow standard guidelines and decision are taken without taking into consideration quorum requirement

While the EC members may be experts in their respective subject field, they may not be well acquainted with IRB processes and ethical guidelines, and what issues to address.

c) Their membership in the EC becomes a learning process to them; it requires time to get acquainted with the ethical issues to question, and to play a more crucial role in safeguarding the rights and welfare of the research participants.

d) Many of the members are reluctant to update their knowledge about recent development related to ethical guidelines for research in various biomedical areas.

e) Long absence in EC's meetings without any genuine reason

f) Non disclosure of conflict of interest

g) ECs do not report to an authority that is responsible for supervising these committees and ensuring their proper and competent functioning.

Thus they are, in reality, either self-sufficient private bodies obliged to the institutions or independent private entities charging for their services. There is no transparency of their functioning and no public scrutiny of their review and regulation of clinical trials. So, ECs remain an enigma still today.

Regards,

Dr. Chaitali

[Guest guest]

Hi,Very true....presentations by the PIs are not held...PIs are not even informed about the date for IEC/IRB. In case of a minor change or missing of some document or signature which can be changed at the same time is delayed till next meeting!I have one query...suppose for one project, clearance is given by IEC but due to some reason (funding agency could not give funds) project could not be started immediately. For how long (months or years) the same ethical clearance is valid? Can a part of the project submitted can be started?Thanks.Anita netrum From: gharpurekunda@...Date: Thu, 31 Dec 2009 09:58:12 +0530Subject: Re: Membership and quorum requirements for ethics committee (EC)

hello,

the most important challenge facing the proper functioning of an IEC is, the insttutions are not taking clinical research as seriously as they should. The meetings , the presentations by the PI , the objections if at all any, are very casually dealt with.The bigget hurdle is subsequent monitoring of the trials.

I had once presented a project for approval to our IEC. I was not even required to present my abstract of proposed project and it was approved. then later due to some unavoidable circumstances the project did not materialise. There was no follow up of my project by any member of the IEC.

kunda

From: chaitalib <chaitali_bajait >Subject: Membership and quorum requirements for ethics committee (EC)netrum Date: Thursday, 31 December, 2009, 8:19 AM

Dear members,

What are the challenges before constituting an IEC?

1) Inviting qualified members to join the EC:

While qualified members would be better suited for ethical review of proposals, there are various challenges in inviting such people to join the EC:

a) Time and availability

They may be very busy persons, and time may be a premium for them. They may not be in a position to spare time for a long duration, and on specified dates for the meetings.

Place of residence

Travel to place of meeting – only locally available persons can attend the meeting, not out station. If they reside in another city, they would not be able to attend the meeting

2) Having a representative of the concerned community

While it is desirable to include a member from specific patient groups in the EC, this may be difficult in the case of a stigmatized health condition such as HIV/AIDS.

3) Familiarity with local customs for organizations not having CAB

Normally, a Community Advisory Board serves as a link between the researcher and the community, and enables the researcher to get a better understanding of the community in which the research is proposed. When the institution does not have a CAB, not all qualified members would be familiar with the local customs, and this could be a drawback. Hence, familiarity with local customs is essential, in organizations where there is no Community Advisory Board.

Dear members, waiting for some more reasons..

Regards

Dr. Chaitali

The INTERNET now has a personality. YOURS! See your Homepage.

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