THE HML IRB PROCESS
THERE ARE THREE BASIC TYPES OF RESEARCH ETHICS REVIEW:
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.
Full Board Review
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.
For US domestic studies there are exemptions from ongoing IRB review described in the US Code of Federal Regulations 45CFR46.104(d). Exemptions under this CFR section may include research in educational settings, benign behavioral interventions, or document reviews.
To determine if your research qualifies for an exemption, we will need to review your study materials in a way that is similar to conducting an Expedited Review
To request an Exemption, complete the Request for Exemption from Ongoing IRB Review.
Once we have received your application, it will be assigned to reviewers. They will review the materials as quickly as possible – usually within one or two days for expedited reviews and exemptions. If more information or a Full Board Review is required, we will contact you promptly. Once we determine that the study protocols and protections are adequate or exempt, we will issue a letter.
All reviews and all review materials are strictly confidential.
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:
Your written protocols for the protection of human subjects’ identities;
Your written protocols for the protection of the data you collect; and
Your written Informed Consent forms and/or guidelines
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 email or call us.