Bioequivalence and Bioavailability Forum

Varsha ★ 2011-11-21 15:11 (5331 d 10:26 ago) Posting: # 7684 Views: 5,807	ethics [Regulatives / Guidelines] Post reply
	Dear All, Can I have your views regarding....a person working for a pharmaceutical company can he be a member for ethics committee for a BABE organization? Thanks and regards, Varsha

Helmut
★★★

Vienna, Austria,
2011-11-21 17:47
(5331 d 07:51 ago)

@ Varsha
Posting: # 7685
Views: 5,232

Conflict of interest

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Dear Varsha!

❝ […] a person working for a pharmaceutical company can he be a member for ethics committee for a BABE organization?

This member easily will run into a conflict of interest. See Ethical Guidelines for Biomedical Research on Human Participants (published by the Indian Council of Medical Research in 2006):

The decision must be taken by a broad consensus after the quorum requirements are fulfilled to recommend / reject / suggest modification for a repeat review or advice appropriate steps. The Member Secretary should communicate the decision in writing to the PI.
If a member has conflict-of-interest (COI) involving a project then s/he should submit this in writing to the chairperson before the review meeting, and it should also be recorded in the minutes,
If one of the members has her/his own proposal for review or has any COI then s/he should withdraw from the IEC while the project is being discussed
A negative decision should always be supported by clearly defined reason
An IEC may decide to reverse its positive decision on a study if it receives information that may adversely affect the risk/ benefit ratio.
The discontinuation of a trial should be ordered if the IEC finds that the goals of the trial have already been achieved midway or unequivocal results
are obtained.
In case of premature termination of study, notification should include the reasons for termination along with the summary of results conducted till date.
The following circumstances require the matter to be brought to the attention of IEC:
1. any amendment to the protocol from the originally approved protocol with proper justification;
2. serious and unexpected adverse events and remedial steps taken to tackle them;
3. any new information that may influence the conduct of the study.
If necessary, the applicant/investigator may be invited to present the protocol or offer clarifications in the meeting. Representative of the patient groups or interest groups can be invited during deliberations to offer their viewpoint.
Subject experts may be invited to offer their views, but should not take part in the decision making process. However, her / his opinion must be recorded.
Meetings are to be minuted which should be approved and signed by the Chairperson/ alternate Chairperson/ designated member of the committee.

IMHO this member will have a COI all the time: either the IMP is of his/her own company or of a competitor.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Varsha ★ 2011-11-21 19:41 (5331 d 05:57 ago) @ Helmut Posting: # 7692 Views: 5,126	Conflict of interest Post reply
	Dear HS, Thanks a lot. Regards, Varsha.

ElMaestro
★★★

Denmark,
2011-11-21 17:48
(5331 d 07:49 ago)

@ Varsha
Posting: # 7686
Views: 5,179

ethics

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Hi Varsha,

❝ Can I have your views regarding....a person working for a pharmaceutical company can he be a member for ethics committee for a BABE organization?

this comes down to concrete interpretation.
My interpretation is: Yes, I think this is possible, but ways to ensure independence and no conflict of interest need to be implemented and documented. For example by having SOPs in place which describe how a voting member can declare a CoI and refrain from voting (perhaps even be replaced?) for a specific task.

Here is a link for information, check obs. #4.

Let me also add: What it ethically and esp. legally means to be "working for" a pharmaceutical company is pretty unclear.

Best regards,
EM.

Varsha ★ 2011-11-21 18:25 (5331 d 07:13 ago) @ ElMaestro Posting: # 7687 Views: 5,152	ethics Post reply
	Hi EM, Thanks a lot. One small query: Will the Conflict of Interest be applicable if he reviews and vote for the protocols which are related to the person's organization/ Pharma company? Or will it be applicable irrespective of the person's organization/ Pharma company? Regards, Varsha.

ElMaestro
★★★

Denmark,
2011-11-21 18:57
(5331 d 06:41 ago)

@ Varsha
Posting: # 7688
Views: 5,127

ethics

Post reply

Hi Varsha,

❝ One small query: Will the Conflict of Interest be applicable if he reviews and vote for the protocols which are related to the person's organization/ Pharma company?

I don't know, but here's what I think: Apply common sense. Does the FDA or any other relevant authority have a reason (regardless of whether you or the member consider said reason good or bad) to challenge that members lack of CoI? If yes, game over. Voting for or against to something that relates to the member's employer is -in my opinion- clearly beyond the reasonable limit.
The burden of proof of presence/absence of CoI is not on the authority but on the IEC/IRB.

❝ Or will it be applicable irrespective of the person's organization/ Pharma company?

That would be too difficult in practice, I think. Usually the member works somewhere, right?

Try and give some more details, please.

Best regards,
EM.

Varsha
★

2011-11-22 07:46
(5330 d 17:51 ago)

@ ElMaestro
Posting: # 7697
Views: 5,131

ethics

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Dear EM,
Thanks a lot. The person works for a Innovator Pharma company and have a prior experience to BABE studies (was a PI for many of the studies). This is the reason why the Ethics committee want's him to be in the committee, to use his prior knowledge in reviewing protocols plus his experience in handling the regulatory queries. Kindly let me know for any further clarification.
Regards,
Varsha

Varsha ★ 2011-11-24 06:48 (5328 d 18:50 ago) @ Varsha Posting: # 7705 Views: 5,088	ethics Post reply
	Dear EM, Will you like to add more after knowing that the person have previous exposure to BABE as well as Health authority. Do you think if the Ethics committee have proper SOPs to serve the situation can tackle the situation? Regards, Varsha

ElMaestro
★★★

Denmark,
2011-11-24 09:30
(5328 d 16:08 ago)

@ Varsha
Posting: # 7707
Views: 5,069

ethics

Post reply

Hi Varsha,

❝ Will you like to add more after knowing that the person have previous exposure to BABE as well as Health authority. Do you think if the Ethics committee have proper SOPs to serve the situation can tackle the situation?

I don't know. You have not said anything that send my alarm bells ringing, but on the other hand I am not an autority and the info is at best patchy. Why don't you ask the local authority?
Having proper SOPs in difficult. There should be a way for members to declare CoI's and remove themselves from specific cases, and the FDA also expects a way for the board to check that the volunteered info is accurate and complete. But that's kind of difficult isn't it? Depends a lot on information infrastructures and such.

Best regards,
EM.

Ohlbe
★★★

France,
2011-11-21 19:07
(5331 d 06:31 ago)

@ Varsha
Posting: # 7689
Views: 5,230

ethics

Post reply

Dear Varsha,

❝ Will the Conflict of Interest be applicable if he reviews and vote for the protocols which are related to the person's organization/ Pharma company?

Yes, no discussion about that.

❝ Or will it be applicable irrespective of the person's organization/ Pharma company?

There you can have some tricky situations:
- the member works for a company which is a competitor of the sponsor, or develops a similar product: he will gain access to confidential technical, commercial or medical information from the sponsor (and even with a confidentiality agreement, the sponsor is not going to like it);
- the member votes for a company which is a competitor of the sponsor, or develops a similar product: he may give a negative vote, or argue against the trial, or try to delay it, to delay the sponsor's product;
- the member works for a company which is preparing a clinical trial similar to the one being submitted by another sponsor: he may wish to give a positive opinion, and hope that the Ethics Committee will later adopt the same opinion for his own trial;
- and quite a few others...

Regards
Ohlbe

—
Regards
Ohlbe

Varsha ★ 2011-11-21 19:39 (5331 d 05:59 ago) @ Ohlbe Posting: # 7691 Views: 5,156	ethics Post reply
	Dear Ohlbe, Thanks a lot. Regards, Varsha.

Dr_Dan
★★

Germany,
2011-11-24 10:45
(5328 d 14:52 ago)

@ Ohlbe
Posting: # 7709
Views: 4,995

ethics

Post reply

Dear all
I think you should distinguish between a general BE/BA study and a real clinical trial. A BE/BA study is just an in vivo quality testing, ethical implications are limited. I guess this is what ElMaestro meant when he talked about common sense.
For a general BE/BA study the ethics committee has to answer the following questions:
Is the study design reasonable?
Is the burdon for the subjects acceptable?
Is the subject information sufficient?
There is not much room to sabotage a study of a competitor, right?
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Varsha ★ 2011-11-24 15:30 (5328 d 10:07 ago) @ Dr_Dan Posting: # 7713 Views: 5,042	ethics Post reply
	Dear Dr. Dan, Totally agreed with your comments. If I understood correctly (from all the comments), IEC should have proper justification/procedure to take the person into the board in order to avoid further queries from the HAs. Hope you all agree with my conclusion. Thanks a lot to all the members again. Regards, Varsha

Helmut
★★★

Vienna, Austria,
2011-11-24 16:41
(5328 d 08:56 ago)

@ Dr_Dan
Posting: # 7715
Views: 5,112

“Sabotage”

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Dear Dan!

❝ A BE/BA study is just an in vivo quality testing, ethical implications are limited. […] There is not much room to sabotage a study of a competitor, right?

Not right, IMHO. See Ohlbe’s comments.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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