Submission Process
New Application - Determine the type of Application to Prepare
The Office for Human Research Protections (OHRP) provides to guide IRBs, investigators and others to decide if an activity is research involving human subjects that must be reviewed by an IRB. The charts address decisions on the following:
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
Chart 1: Is an Activity Research Involving Human Subjects?
Chart 2: Is the Human Subjects Research Eligible for Exemption?
Chart 3: Does the Exemption for Educational Settings [45 CFR 46.101(b)(1)] Apply?
Chart 4: Does the Exemption for Tests, Surveys, Interview, or Public Behavior Observation [45 CFR 46.101(b)(2) or (b)(3)] Apply?
Chart 5: Does the Exemption for Existing Data, Documents, Records and Specimens [45 CFR 46.101(b)(4)] Apply?
Chart 6: Does the Exemption for Public Benefit or Service Programs [45 CFR 46.101(b)(5)] Apply?
Chart 7: Does the Exemption for Food Taste and Acceptance Studies [45 CFR 46.101(b)(6)] Apply?
Chart 8: May the IRB Review Be Done by Expedited Procedures?
Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?
Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
New Application - select the link appropriate to the type of Application to be prepared
Not
Human Research
Exempt
Application
Expedited
Application
Full
Board Application
Approved Protocols - select the link appropriate to the type of activity to be communicated to the IRB
Continuing
Review
Amendment
Protocol Deviation  
Adverse
Event
Principal Investigator's Statement of Assurance
This
signature page is a separate document within the application. The Statement
of Assurance certifies that the PI will carry out the proposed research
in compliance with IRB policy.
Once the study application has been completed and submitted electronically,
the hardcopy of the Statement of Assurance is available for signatures. A study
application is not accepted for review until the IRB has received the signed
Statement of Assurance. The signed Statement of Assurance can
be delivered or faxed to the IRB to complete the application process.
If there is a change in PI of an approved study, then the
new PI must submit a signed Statement of Assurance.
By signing this statement, the PI's signature
will no longer be required on IRB forms with two exceptions:
1) the electronic Change in Personnel Amendment must be submitted by
the PI
2) the hard copy Conflict of Interest form requires the PI's
signature
Conflict of Interest - Human Research Conflict of Interest Disclosure
Completion of this form is required for all corporate/industry sponsored studies,
or if the investigator or any family member or other persons have any financial
interest or relationship with sponsor or agency that would appear to be a conflict
of interest.
Guidelines for Research Involving Cancer patients, The Hollings Cancer Center (HCC) or Any Research Addressing Cancer
In accordance with the operational guidelines involved with the NCI designation of the Hollings Cancer Center and the Hollings Cancer Center Protocol Review and Monitoring System, the following procedures must be followed for securing approval to perform human subject research.
Full Board and Expedited Protocols
All protocols addressing any of these areas of research to be considered for full board or expedited IRB review must be reviewed and approved by the HCC Protocol Review Committee before IRB approval may be released.
Exempt Protocols - All approved exempt protocols addressing any of these areas of research must be forwarded to the HCC protocol review committee when approved by the IRB.
Upon receipt of the approval of the exempt protocol, the Principal Investigator is to forward the approved protocol pdf file (received by email from the IRB) directly to the HCC Protocol Review Committee for their records. This is for informational purposes only and will not alter IRB approval.
IRB Fees - Effective August 2006, the
IRB charges the following fees:
Initial Protocol Review
Industry Sponsored Study........................................$2500
No Sponsor - MUSC Faculty*......................................$100
*NOTE: There are no fees for trainees, students or VA submissions.
Continuing Review (Annually)
Industry Sponsored Study..........................................$500
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