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Philander Smith College currently does not have an Institutional Review Board, but I am currently trying to collaborate with the Unversity of Tennessee Health Science Center in Memphis, so I will post theirs.
 

 

Submissions to UTHSC IRB

a. Submissions to the UTHSC IRB will be transmitted electronically via iMedRIS. 

b. The IRB Chair or designee will determine whether submissions qualify for full board review, expedited review, or exempt status. Full board review will be required for all studies that involve more than minimal risk or do not otherwise qualify for expedited review or exempt status. 

c. For new studies requiring full board review, the principal investigator will submit to the UTHSC IRB the following documents 21 days prior to the scheduled IRB meeting: 

i. Form 1 application prepared according to the IRB instructions, including all required signatures, 

ii. Study protocol (if applicable) including amendments, 

iii. Informed consent document(s) prepared according to UTHSC IRB informed consent template, 

iv. Grant application (if applicable), 

v. Subject surveys or questionnaires (if applicable), 

vi. Copy of all proposed advertisement(s) / recruitment materials, 

 

vii. Investigator’s Drug Brochure and/or Package Insert(s) (if applicable), 

viii. For HHS-supported multicenter clinical trials, the complete HHS-approved protocol, and 

ix. For HHS-supported multicenter clinical trials, the HHS-approved sample informed consent document. 

d. For renewals of previously approved studies requiring full board review, see SOP: UTHSC IRB Continuing Review 

e. For revisions of previously approved studies requiring full board review, see SOP: UTHSC IRB Revisions in Approved Studies. 

2. Document Distribution

All materials are placed on the agenda and available to all IRB members on the iMedRIS website prior to the IRB meeting. Preparation of the agenda is the responsibility of the Director or designee. 

3. Review Process

a. Full Board review will be required of all new studies that involve more than minimal risk to human subjects or do not otherwise qualify for expedited or exempt review, as well as all continuations and revisions that do not qualify for expedited review. 

 

b. Reviewers will be assigned as appropriate to the subject matter of the application. For all new studies requiring full board review, a primary and secondary reviewer will be assigned.. No IRB member will participate in the review of research in which the member has a known conflict of interest. 

c. All applications for full board review are usually due in the iMedRIS system 21 days prior to the meeting at which they will be reviewed. 

d. Applications and all supporting documents are distributed to reviewers after an initial review is conducted by the assigned IRB analyst, 19 days prior to the meeting of the full Board. 

e. Reviewers must complete their review no more than 13 days prior to the Board meeting using the reviewer form available in the iMedRIS system. 

f. The assigned IRB analyst collates the comments of the reviewers and administrative staff and sends them to the investigator, study contact(s), and Research Administrative Specialist (RAS) (if appropriate) via iMedRIS as pre-review recommendations prior to the meeting. 

 

g. The principal investigator must respond to questions and recommendations using the PI Response Form within 5 days prior to the meeting, if possible. 

 

 

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1015.05 kB21:03, 23 Jun 2014rjwalkerActions
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Is any type of training required?
Posted 18:29, 23 Jul 2014
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