About Us
Authority of the IRB
Sterling Independent Services, Inc. established Sterling Institutional Review Board in 1991. Sterling IRB is duly constituted (fulfilling FDA requirements for diversity), has written procedures for initial and continuing review of clinical trials, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process, all in compliance with requirements defined in 21 CFR Parts 50, 56, 312 and 812 (Code of Federal Regulations) and ICH (International Conference on Harmonisation) guidance relating to GCP (Good Clinical Practice).
The Sterling Institutional Review Board is an appropriately constituted group that has been formally designated to review and monitor research involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research participants.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human research participants.
The IRB reviews research in accordance with current Department of Health and Human Services (DHHS) and U.S. Food and Drug Administration (FDA) regulations. The primary purpose of the IRB is to protect the rights and welfare of human participants who take part in research.
More specifically, the IRB assures that:
- Risks to participants are minimized. For example, the IRB determines that procedures to be performed on participants: a) are consistent with sound research design and do not unnecessarily expose participants to risk, and b) that they are already being performed for diagnostic or treatment purposes.
- Risks to participants are reasonable in relation to any benefits that might be expected from taking part in a research study and to the importance of the knowledge that may result.
- Selection of participants is fair and equitable. For example, the IRB seeks to determine that no eligible individuals are denied the opportunity to take part in any study, particularly those from which they may benefit, based on an arbitrary criterion such as gender or because they do not speak English.
- Participation is voluntary and informed consent is obtained from each prospective participant or where appropriate, from the participant's legally authorized representative.
- The research plan provides for monitoring the data collected to ensure the safety of participants.
- There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
Sterling IRB has the authority to perform the following functions:
- Conduct initial and continuing review of any research activities involving drug, device, biological, behavioral, psychosocial, and educational or other studies involving human participants.
- Report findings and actions to the investigator and sponsor, when applicable.
- Determine which studies need more than annual review.
- Determine which studies need verification from sources other than the investigator that no material changes have occurred since previous IRB review.
- Ensure prompt reporting to the IRB of changes in research activities.
- Ensure that changes in previously approved research are not initiated without IRB review and approval.
- Ensure prompt reporting to the IRB of unanticipated problems or scientific misconduct involving risks to participants or others.
To learn more or if you have any questions, call 1-888-636-1062 (toll-free) or email us.
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