Review Process
To apply for HASRC approval, the principle investigator must submit the
appropriate completed application, Subject Informed Consent form(s), any
questionnaires to be distributed, and appropriate release forms for biological
or diagnostic specimens (if applicable). If you have questions regarding the
appropriate application, please refer to the
Office of Protection from Research
Risks (OPRR) Decision Chart. Applications are available below.
• Expedited review is allowed for research activities which involve no more than
minimal risk to the human subjects.
• The principal investigator is responsible for completion of the Human Subjects Protocol.
• The principal investigator has the responsibility of submitting a COMPLETE
application, and FINALIZED questionnaires/survey (not drafts) or other
appropriate materials (if applicable).
• An electronic copy of all documents, plus the FINALIZED Subject Informed
Consent form, along with any questionnaires, specimen release forms are to be submitted to the following e-mail
address: MooreJL@montevallo.edu .
• Materials will be reviewed online by appropriate members of HASRC. When review
is complete, the investigators will be notified to sign hard copies of their
research materials.
• Please allow at least 2 weeks from the time the application is submitted to
final approval. Applications have been approved within 2 weeks from the
submission date; approval time is dependent upon the application being complete, as well as a variety of other
factors.
• IF PROJECT IS CONDUCTED BY A STUDENT, the application materials are to be
reviewed by the faculty advisor who will ensure that the application is complete
and ready for review by HASRC.
• The IRB Chair will review each project by examining the application, Subject
Informed Consent form, questionnaires, and other appropriate materials. The
principal investigator may be contacted for clarification if needed.
• Upon completion of the review process, the IRB Chair may approve the
application at which time the finalized research materials will be marked as
approved in their current form.
• No changes to these forms will be allowed after the approval date unless
revisions are resubmitted for review with a complete packet of the newest
versions of all forms.
• All Subject Informed Consent forms must be kept by the principal investigator.
Those forms are subject to review by an IRB Committee member.
• In the event that the reviewers cannot approve a study as an expedited review,
the principal investigator will be asked to submit the study for full board
review.
• After the research project is completed, the principal investigator is
required to submit an Application Closure Form to the IRB Chair.
• The principal investigator has the responsibility of submitting a complete
application and finalized questionnaires /survey (not draft copies) or other
appropriate materials (if applicable) to the e-mail address listed below.
• An electronic copy of all documents, plus the FINALIZED Subject Informed
Consent form, along with any questionnaires or specimen release forms (if applicable) are to be submitted to the following e-mail
address: MooreJL@montevallo.edu .
• Materials will be reviewed online by appropriate members of HASRC prior
to meeting. When review
is complete, the investigators will be notified to sign hard copies of their
research materials. Changes to methodology or forms/questionnaires may be
required prior to approval.
• Should a board member have a question, she/he may contact the principal
investigator for clarification.
• The IRB Chair or designee will notify the primary investigator of the
scheduled committee meeting dates so that he/she may be present for any
discussion.
• After discussing the application materials with the primary investigator and
among the IRB members, a vote will then be taken. Approval requires a favorable
vote by the majority of members in attendance.
• Upon completion of the review process, the IRB Chair may approve the
application at which the finalized Subject Informed Consent form will be marked
approved, after which no changes to research materials will be allowed.
• All Subject Informed Consent forms must be retained by the principal
investigator. Those forms are subject to review by an IRB member.
• The principal investigator is responsible for reporting any subject adverse
events/effects that occur during the research project. These must be submitted
to the IRB Chair, even if the subject adverse events/effects may not be related
to the research protocol.
• After the research project is completed, the principal investigator is
required to submit an Application Closure Form to the IRB Chair.