There were many discussions made about Coast IRB and closure of the company. The revenue of the company in 2008 was recorded as $9.3 million US dollars. The major concern for its closure was the irresponsibility of people at Coast IRB and their duping. The monitoring of profit ethics boards require to be more vigilant. After the duping cases, the members aid that they weren’t sure about the ethical working of Coast IRB. These things have no use, if the statements come after the wrong actions have taken place.
The ethics review board couldn’t have made out such results as found by the sting operation. The homework and availability of ethics review boards are strong enough to decide about the negative aspects of these review boards. Coast failed to note that the company products and associated researchers actually didn’t exist. The review board failed to ask about the risks involved in the studies involved.
The sting operation was involved in Coast IRB private review panel and it approved as a false protocol to test for fictitious product to be included in the woman stomach after any surgical procedure. Coast IRB termed this procedure as probably safe. However it was rejected by the private boards by terming it as junk and the risky thing.
It was mandatory to make distinction for the things which could have been done and the regularly happening activities. There were many things which were mandatory to be recorded and done, but went undone due to carelessness.
The major failure of Coast IRB was to make identification of the researcher and their office. There are a few ethics boards, which don’t focus on direct meeting and involve only electronic research and review. The researchers could also do it through phone communication and hard copies of documents. However, it is not ethical and doesn’t involve any full fledge research for the company. Coast IRB was a failure to know about the researcher. Most of the companies don’t see actual products and check only brochures, monographs or documents from any other regulatory body. If these are fine, they don’t focus on the other aspects.
Coast IRB case also didn’t pay any heed to the fictitious medical license of the researcher, which got expired 18 years ago. This was the biggest mistake from Coast IRB and physicians were actually not actually asked to submit the license as research protocol. The system had issues in taking the ethics review in the safest way.
Coast IRB meetings didn’t ask questions for significant risk and trusted the researchers too much. These risks were so obvious that the other private ethics review boards out rightly rejected it. In case of risk, there should be more reviewers assigned for the work and scrutiny level should be encouraged. Ethics board should see for the full spectrum of side effects documented and communicated to the other side. Monitoring is mandatory by the safety board as the level of risk should be justifiable in all the terms. The balance between risk and benefit are important to be understood by the reviewers and Coast IRB missed it.