THE HML IRB PROCESS

THERE ARE THREE BASIC TYPES OF RESEARCH ETHICS REVIEW:

Expedited 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.

Exemptions

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.

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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

PROCESS

To determine if you qualify for an Expedited Review, complete the HML Expedited IRB Review Checklist and submit it along with the other IRB application materials.

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To request an Exemption, complete the Request for Exemption from Ongoing IRB Review.

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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.

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Please email all materials to Dr. D. Michael Anderson, IRB Chair at dma@hmlirb.com, & Penelope Lantz, General Counsel at plantz@hmlus.com.

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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.

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For either type, reviewers will pay particular attention to three elements of your request:

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  • 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

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Once we have determined that your protocols and consents are adequate, we will provide you with an IRB Letter of Approval.

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For more information, please email or call us.

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.