This registration is a frozen, non-editable version of this project
Initial Formation of a Committee
Initial Formation of a Committee -------------------------------- The procedure for initially forming a committee is as follows: 1. Someone agrees to be the Chair. It is highly appropriate for an investigator to serve as Chair, since it is the responsibility of investigators to judge the work of the Committee (to determine whether the research should be reviewed by other committees) and the Chair has excellent awareness of the work of the Committee (see “**The Chair**”). 2. The Chair creates a publically accessible set of written procedures. One way to do this is to fork an Open Science Framework project that contains a complete set of procedures (see [OSF help]). The Chair should review all of the procedures, revise them as appropriate, and register the revised version. The US Department of Health and Human Services (HHS) has published a checklist of properties recommended in written procedures at [https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm512761.pdf] 3. The Chair creates and registers a “Committee Review Template” OSF project that includes instructions to investigators and templates for “Ethical Considerations”, “Exemption from Review”, “Committee Opinion”, “Research Consent Form”, and “Sponsors, Collaborators and Publishers”. One way to do this is to fork an existing “Committee Review Template” OSF project (see [OSF help]). The Chair should review the template and revise it as appropriate. 4. The Chair creates a publically accessible website for the Committee with a front page that specifies a regular meeting location, name and contact information for the Chair, and links to the registered written procedures and Committee Review Template. One way to do this is to fork an OSF project for a committee and edit the forked copy (see [OSF help]). 5. The Chair invites other people to become members. The invitation should include a link to the Committee website with the linked procedures, the candidate’s proposed representative capacity (e.g. scientist or non-scientist) and voting status (e.g. voting or alternate member-at-large), and should instruct the candidate that they must read the “**Expectations for Committee Members**” before accepting membership. 6. For each candidate that accepts the invitation, the Chair updates the front page of the Committee website, indicating the new member's name, public contact information, representative capacity, and voting status. The Chair also adds the new member to the to OSF projects as an Administrator (see [OSF help]). The new member is then responsible to maintain their contact information and sign-up for email notifications at his or her discretion. 7. When the Chair is finished adding members and they satisfy the criteria detailed in the “**Committee Membership**” section of these procedures, the Chair registers the Committee as an IRB with the US [Office of Human Research Protections] (OHRP) and adds the issued IRB identification number to the front page of the Committee website. As this point, any amendments to the procedures can be made only via the procedure titled “**Amendment of Committee Procedures**” and any additional members can be added only via the procedure titled “**Appointment of Members**”. : https://osf.io/support/ : https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm512761.pdf : https://osf.io/support/ : https://osf.io/support/ : https://osf.io/support/ : https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/new-irb-registration/index.html
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