Polaris

SOP# IRB-005.0CompanyEffective Date: DD/MMM/YYC. Criteria for IRB Approval of ResearchThe IRB may approve research only after it has determined that all of the followingrequirements are satisfied:1. Risks to subjects are minimized by using procedures that are consistent withsound research design, and that do not unnecessarily expose subjects to risk.Whenever appropriate, researchers should employ procedures that are beingperformed on subjects for diagnostic or treatment purposes.2. Risks to subjects are reasonable relative to:a. anticipated benefits, if any, to subjects, andb. the importance of the knowledge that may reasonably be expected to result.3. The selection of subjects is equitable. In making this assessment the IRB musttake into account the purposes of the research and the setting in which it will beconducted. The IRB must be particularly attentive to the special problems thatmay arise when research involves vulnerable populations, such as children,pregnant women, prisoners, mentally disabled persons, or economically oreducationally disadvantaged persons. If any of the subjects is likely to besusceptible to undue influence or coercion, the IRB may require additionalsafeguards in the study to protect such subjects.4. Informed consent will be sought from each prospective subject, or the subject'slegally authorized representative, generally by means of a written consentdocument. The IRB will carefully review these documents to assure that theycontain the required elements of informed consent and that they areunderstandable to a lay person.5. The research plan makes adequate provisions for ensuring the safety of subjects.6. There are adequate provisions to protect the privacy of subjects and to maintainthe confidentiality of data.7. The investigator is appropriately qualified and has the facilities to ensure allaspects of the research will be conducted with regard for the safety and well-beingof the subjects.When some or all of the subjects are likely to be vulnerable to coercion, the IRBshould add additional safeguards in the review of the research to ensure the rights andwelfare of these subjects are protected.D. Notification to the InvestigatorThe Board will provide the Investigator with written notification of its decision toapprove, disapprove, defer, or modify the research proposal (Attachment C – IRBReview Results Form). If a proposal is disapproved, the reasons for such disapprovalwill be documented. The Investigator will also be notified of the duration of theBoard’s approval, which will never exceed one year. The decisions of the Board willbe included in the files maintained by the Secretary.IRB-005.0.doc© 2004 by CRC Press LLC