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IRB Requirements for Approval

With every developed biomedical product, companies perform the necessary research to assure the product will be safe to market to the society. Biomedical companies will obtain human research participants to study the effects of these products. But before such research can occur, an Institutional Review Board must evaluate the risks and benefits of the research before giving approval. An IRB insures the rights and welfare of participating subjects under the U.S. Food and Drug Administration guidelines.

  1. Evaluating Risks and Benefits

    • IRB will approve the research of biomedical companies only after investigating the risks and benefits. Requirements for obtaining IRB approval involve using sound research procedures that will not expose dangerous risks to participants. If some risks may accompany the research, IRB will examine that risks will not outweigh the anticipated benefits and whether any research knowledge will be gained from such testing.

    Participant Selection

    • IRB will assess the purposes of the research and how it is conducted. Before IRB will give approval, it will evaluate for any special problems with the research when it involves certain vulnerable groups of population such as children, pregnant mothers, mentally or physically disabled persons, prisoners and economically disadvantaged persons. The IRB will also examine the setting where the research the setting where the biomedical company will perform its research to assure the safety of all participants.

    Informed Consent

    • For IRB approval, the biomedical company must provide each prospective participant or legally authorized representative all information regarding the research plan. This information will include what provisions are taken to protect the participant's privacy, how the company will collect the data and how it will maintain confidentiality concerning this data in every format -- electronically or written. Each prospective participant must give documented informed consent to be included in the research.

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