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RESEARCH & ETHICS
An Expedited IRB Review is permitted for studies where subjects face no more than minimal risk (or for minor changes to a previously approved study). Examples are survey research, focus group discussions, observational studies, etc. We have provided an Expedited IRB Review Checklist to help you decide if your study qualifies. USDHHS rules require just one member of the IRB for an expedited review (the Chair), although at Health Media Lab, we generally involve two or three IRB members. Research may not be disapproved by expedited review.
Your responses to the HML Expedited IRB Review Checklist will show you the type of review needed. In either case, we will quickly assign your study’s human protection design and protocols to reviewers. They will review the materials as fast as possible – usually within one or two days for expedited reviews, and a day or two more for full board reviews. If more information is required to determine protections, we will ask you for that right away.
For either type, reviewers will pay particular attention to three elements of your request:
Once we have determined that your protocols and consents are adequate, we will provide you with an IRB Letter of Approval.
For more information, please call or email us.
There are two basic types of IRB review:
Full Board IRB
A Full Board IRB Review is for studies that do not qualify for expedited review. The full IRB meets when the research poses greater than minimal risk typically encountered in daily life such as clinical trials, maximal exercise, stressful psychological tests, questions about illegal activities, blood or tissue removal, or when the research involves a vulnerable population such as children, the elderly, prisoners, pregnant women, students, handicapped or mentally disabled persons. USDHHS rules require participation of a majority of IRB members.
Data collection and subject safety monitoring protocols are critical and required components in protecting human subjects in research. Researchers should integrate these protocols into their research design and methods, and IRBs should review and approve them -- and when necessary require changes -- to protect participants.
Regulatory criteria for IRB approval of research, from the Department of Health & Human Services, stipulate that a study’s research plan includes protocols for data collection and storage to ensure the safety of human subjects. Protocols must indicate the method and degree of data collection and monitoring commensurate with subjects’ risks. The IRB must approve these protocols before the research may begin.
In general, data and safety monitoring protocols are required for research that involves greater than minimal risk. However, in some instances the IRB may find written protocols necessary for a particular research project where it may be argued that there is no greater than minimal risk.
For the HML IRB process, investigators should develop and submit data collection and safety monitoring protocols for IRB review. The Principal Investigator should also submit an annual update of protocols to the IRB annually, and inform the IRB of any changes to protocols as they occur. All research team members should read data and safety monitoring protocols and be prepared to follow them.
HML IRB has the responsibility to review data collection and safety monitoring protocols and the authorization to determine if they are adequate for the proposed research. Data collection and safety monitoring protocols should include an analysis of risks and potential benefits. Protocols should also indicate who is responsibile for subjects’ protections (usually the PI), protection measures that will be monitored, methods and frequency of analysis, and who will carry out these activities. Sometimes it is appropriate for data collection and safety monitoring to be independent of the research team to ensure an unbiased analysis. If so, data and safety monitoring personnel should meet periodically to consider what conditions would trigger suspension or termination of the study, and what precautions need to be taken to ensure the validity and integrity of the data. Protocols should also include mechanisms for reporting routine data collection and safety monitoring status and emerging issues. These data collection and safety monitoring reports should be sent to the IRB.
If necessary or appropriate, IRB members may question data collection and safety monitoring protocols if they perceive the need for more information. Furthermore, IRB members may need to review and consider data collection and safety monitoring reports when granting continuing approval of research.
Basic Criteria for IRB Approval
USDHHS, FDA, & VA regulations all state that the following must be in place for an IRB to approve research protocols that involve human subjects:
If your study’s protocols do not meet these criteria, HML IRB will work with you to comply.
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