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IRB PROCESSES

- REVIEW BY CONVENED IRB

When the research study does not fit within an exemption or an expedited review

category, it must be reviewed and approved by a convened IRB.

The Institutional Review Board convenes monthly as needed to review applications.

Convened IRB decisions are generally made by consensus; where needed, however, a

formal vote should be taken with the majority ruling. Subgroups of IRB may on behalf of

the full body act on applications. However, such subgroups cannot consist of fewer than 5

members, with the IRB Chair presiding over the monthly review.

All applications requesting IRB approval must be complete with attachments and

submitted to the Office of Research & Sponsored Programs both electronically and in

print with appropriate signatures.

- IRB CONCERNS TO BE ADDRESSED

RISK Factor – An application must identify all risks involved (personal or professional,

psychological, physical or sociological; from low, such as discomfort to high, such as a

dangerous situation), and rate them as low, moderate or high. If no risks are anticipated

beyond the risks encountered in normal daily life, then the application and the documents

shared with the subject must state that the risks are minimal and are not expected to

surpass normal risks encountered daily. Otherwise, the nature of the risk must be

disclosed and specific strategies for minimizing the risks must be explicitly described.

PRIVACY Factor – One of the risks in all studies involving human subjects is the

infringement of privacy. Except for special studies where subjects are tied to results (and

in which written permission to identify the subject must be sought), and for studies that

are anonymous (i.e., no pairing of subject and results is possible) studies with human

subjects must maintain confidentiality. Every possible step should be taken so that there

are no links between the identity of the subject, and the results of the works and results

must be presented in aggregate forms. Furthermore, raw data, along with signed consent

forms (and any other data that may reveal identify information) must be stored safely

under key for 5 years before being shredded.

KNOWLEDGE Factor – The human subject has the right, ethically and legally, to be

informed about the research study and should provide his or her consent to participate in

the study. As such, it is important for the researcher to discuss with the subjects where

possible (not only interacting through a piece of paper) the nature of the research, its

methods and sought outcomes, along with most importantly the anticipated risks and

benefits. The subject must know that his/her participation is completely voluntary (under

no coercion or duress), he/she can refuse to participate or withdraw any time from the

study without any penalty or loss of benefits to which he/she is otherwise entitled. When

the subject is too young to understand his or her involvement, a parent of a legally

authorized representative must be informed and sign the consent form permitting the

child to participate in the study.

- IRB APPLICATION PROCESS

The IRB Application (see Appendix) must be comprehensive to allow the members of

IRB to render informed judgment based on Criteria a-e above and make meaningful

suggestions to help protect human subjects and enhance the proposed study. As such, the

application must describe in detail the context and purpose of the study, the methods

planned, in particular the way subjects will be recruited and data accrued, and the validity

and reliability of instruments or protocols used, as it should discuss the anticipated risks

and benefits of the study.

Attachments

Consent forms and debriefing forms must be included with the IRB Application form,

you may view some samples here. Please attach all other relevant documents, including

surveys, and letters that accompany surveys etc. where appropriate.

Researchers are required to share with the subject consent forms describing the research

as detailed below. In most cases, especially when the anticipated risk posed by the

research study is more than minimum; a written informed consent must be shared and

signed by the participating subject.

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Your project will probably be of exempt status so it will not have to be reviewed at a convened IRB meeting.
Posted 14:16, 13 Jul 2011
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