THE HML IRB PROCESS

THERE ARE THREE BASIC TYPES OF RESEARCH ETHICS REVIEW:

Expedited Review

An Expedited Research Ethics 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, interviews, focus group discussions, observational studies, etc. If you believe your study qualifies for an expedited review, make sure to select Expedited Review as the review type when you create your request for ethical review in the online system. You will also be asked what category or categories your study is eligible under. 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 Research Ethics Review is for studies that do not qualify for expedited review.  The full IRB meets when the research poses greater than minimal risk to subjects. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests. In assessing risk we look at the type of research being conducted as well as the type of subjects involved. USDHHS rules require participation of a majority of IRB members and usually takes longer than either expedited or exemption reviews.

Exemptions

For US domestic studies there are exemptions from ongoing Research Ethics Review described in the US Code of Federal Regulations 45CFR46.104(d). Exemptions under this section may include research in educational settings, benign behavioral interventions, or document reviews. If you want to request an exemption, select Exemption Determination as the review type when you create your request for ethical review in the online system. You will be asked what category your study is eligible under and some additional questions about your selection to clarify study eligibility. In making our exemption determination, we will review your study protocols, data collection tools and informed consent in a process similar to an expedited review.

PROCESS

 

When you submit your application through the IRB Online Portal, we will receive an email notification and it will be assigned to reviewers. They will review the materials as quickly as possible – usually within two or three days for expedited reviews and exemptions. If a Full Board Review is requested, it will take five to ten business days for us to return our comments to you.

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If a different type of review is required than the one you selected in the online application, we will contact you promptly. Once we determine that the study protocols and protections are adequate or exempt, we will approve your study and a letter of approval with be issued to you.

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If you have any questions about the process or how to apply, please contact Dr. D. Michael Anderson, IRB Chair at dma@hmlirb.com, & Penelope Lantz, General Counsel at plantz@hmlus.com. Once you have submitted an application through the IRB Portal, please submit all correspondence about that study through the IRB Portal using the Messages feature.

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All reviews and all review materials are strictly confidential.

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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:

 

  • The IRB must find that risks to subjects are minimized.

  • Risks are reasonable in relation to any anticipated benefits to subjects and to the importance of the knowledge that may reasonably be expected to result from the research.

  • Selection of subjects is equitable.

  • Informed Consent will be sought and documented from each prospective subject or the subject's legally authorized representative.

  • Research plans make adequate provision for monitoring the data collected to ensure subject safety.

  • There are adequate provisions to protect the privacy of subjects and to maintain their confidentiality.

  • When some or all of the subjects may be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons), additional safeguards have been included in the study to protect the rights and welfare of these subjects.

 

If your study’s protocols do not meet these criteria, HML IRB will work with you to comply.