What is IRB?

IRB refers to Institutional Review Board. Any research conducted by American University affiliates involving the use of human subjects for keeping the assurance for rights and welfare of human subjects is undertaken by this board.

Mission

What is IRB?American University aims at undertaking ethical research for facilitating the staff, faculty and students to conduct researches in an efficient and timely way. The aim of IRB is to review and approve the research with the pre-defined protocols meant for regulating the products/services with human welfare terms. IRB has fixed rules and regulations for federal funded research for protection of human subjects and supporting the required reports. IRB strives to create awareness, respect and welfare of human rights with the subjects treated in a quality-based mode.

IRB approval

IRB gives approval with Human Subjects research. You need to get research through human subjects for completion of IRB process. IRB has many projects of pre-existent data and the collected information. There is proper process followed with the pre-defined steps for IRB approval.

Deadline and Schedule Meeting

The protocols are completed and reviewed with the receipt. There are some exemptions for the protocols pre-decided by the board. There are board reviews required to be received about 2 weeks ahead of the meeting. The meetings are usually take place on 2nd and 4th Wednesday of each month. IRB meeting includes all the protocols meant for rights and welfare of human beings. There are many non-compliance actions, which need to be excluded from the data.

The forms have to be submitted to IRB at least one month before the beginning of the research. It has become mandatory for getting IRB approval before floating any product/ service in the market. It is necessary to do so for avoiding any troubles later on. IRB approval is necessary for best results for the welfare of human rights.

Process of IRB submissions

The forms for IRB approvals have to be submitted for the beginning of research. You can check out the procedure and Process FAQs. The process is as follows:

  • There is IRB determination tool on the website to check if the project you want to get approved qualifies for human subjects’ research or not. If you are approved for the same, move to step 2.
  • If there is need for exemption from IRB approval, you can fill in the exemption form available. If your research is not in exempt category, you can complete IRB application with attached supplements and signatures. It is mailed to Research Compliance Office.

The alternative way is to attach .pdf files and scanned to the email ID mentioned on the website. The certification is needed to conduct human subjects’ research. Students are required to get supervision before reviewing the work for supervision.

Process of IRB submissions

 

  • Your application requires proper completion as incomplete ones will be rejected and returned to investigators. Only complete applications are considered in compliance with federal regulations.
  • Advance requests are reviewed by the Unit IRB Liaison/ IRB Coordinator/ Designated IRB Member. The investigator will be informed if there is exemption for application.
  • IRB will conduct meetings on monthly basis for review of applications. The approved applications are valid for the duration of 3 years. The research will be valid for annual basis and investigator are immediately sent information on the required decision.
  • Project can’t be extended beyond the dates approved by IRB. There is a special Termination/ Continuation request submitted to extend work beyond the date.
  • The tasks can’t be modified outside the approved protocols. There is modification request form meant to be submitted for even a minor change.
  • There can be no research conducted till the confirmation is attained from IRB coordinator for approval or exemption of any new case or renewal application.

GAO Sting on Coast IRB shuts the doors

Coast IRB could have worked in the best way and earned reputation in the industry, but it had to close the doors due to the GAO sting on pharmaceutical investigations on them. The US FDA announced that there will be halt in the activities of Coast IRB, LLC of Colorado due to the serious concerns originated from their false clinical trials. This step was taken in the month of April 2009 for the protection of human subjects and concerns of mankind.

GAO Sting on Coast IRB shuts the doorsCompany’s records revealed that there were investigating studies meant for these records and about 3000 clinical investigators made the report. However, it is a false statement as the reports had some false records. FDA had to issue warning letter to IRB with their concerns and immediately undertook the case for taking next actions. The restrictions came into effect after FDA finally found out the fakeness in the whole case and the negative impact for human research subjects.

There is approval of an IRB required for biological, medical devices and any new drugs. IRB constitutes a panel of doctors who make this research for the safety and rights of the subjects participating in the studies. There was undercover sting operation made by GAO in which fictitious research was involved. It was a matter of shock when FDA cleared the medical device without any actual implementation to any subjects. It was a successful sting operation by Government Accountability Office (GAO) of the United States and aimed at saving people from the hassles of fraud companies.

It was determined that Coast IRB committed violation of laws and rules intended for the rights of human research subjects. It failed to make the approval of the study and the actions were termed as precautionary. The research got an adequate review and progress reports were submitted by the officials acclaiming Coast IRB as non-trusted organization.

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Coast IRB got restricted by FDA for violations

It is the matter of April 2009, when FDA announced that Coast IRB has voluntarily halted some of the clinical operations with the resultants of serious concerns about the ability of the company for protecting the subjects participating in the trials related to clinical aspects. The company’s records suggest that there were about three hundred active studies conducted by investigators for checking out the researches.

Coast IRB got restricted by FDA for violationsCoast IRB made agreement to terminate the review of FDA regulated studies. It focused on direct clinical investigators for on-going studies being approved by Coast IRB for keeping a check on the enrollment in new subject. There was warning letter issued to Coast IRB by FDA with the concerns related to quality check and it also made a decision for actively monitoring the company by undertaking necessary actions by their own. These restrictions were bound to get effected till the time Coast IRB would have been taken the corrective actions bringing the regulations on the right track.

FDA regulated products were required to get reviewed properly to get approval from IRB. The main constituents of IRB were a panel of doctors, researchers, scientists and experts to protect the welfare and rights of the people. US GAO submitted the Coast IRB for reviewing the fiction based research. FDA concerns were about the ability of Coast IRB to give the right report, but it was a fiction based approach. There were absolutely no human subjects involved and it was a negative aspect for the rights and welfare of human research subjects.

FDA determined that Coast IRB committed different violations for regulations and laws and it was aimed at protecting the rights of human research. The actions of FDA were absolutely right as there can be potential risk involved in the life of people by untested false reports and products.

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Coast IRB Sting Operation

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.

Coast IRB Sting OperationThe 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.