Submissions Requiring Full Review

Initial Review
A protocol will require full review if the risks to the subjects are more than minimal, if the study involves activities that are not listed in the criteria for exemption or expedited review, and when the study involves deception.

Continuing Review
With some exceptions, if the initial review of protocol was conducted by the full IRB, so are its continuing reviews.

Amendments Involving Major Changes to an Approved Protocol
As a general guideline, major changes would affect the experience of the subjects in some way, for example:

1. Introducing a new procedure or instrument
2. Revising the consent process
3. Changing the risk/benefit analysis
4. Adding a new subject population
5. Changing the investigator

Review Procedures for Initial Review

• A Request for Protocol Approval must be completed and submitted to the IRB two weeks before IRB meetings. IRB staff will conduct a pre-review of the request and offer feedback and suggestions to facilitate the review process.
  
• Full reviewed is conducted by the convened IRB. Decisions are made by a majority vote of a quorum of the IRB.
  
• The IRB may request that an investigator attend a meeting in order to respond to questions about a protocol, although the investigator may not be present for the discussion and vote.

Basics of an IRB Review

Basic review, as described in the federal regulations, will ask the following questions:

• Have the risks to subjects been minimized?
  
• Are the risks reasonable in relation to anticipated benefits?
  
• Is the selection of subjects equitable?
  
• Are adequate procedures in place to ensure privacy and confidentiality?
  
• Has informed consent been sought and appropriately documented?
  
• Are safeguards in place to protect vulnerable populations?
  
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  
• If the research is externally funded, is the protocol consistent with the grant application?
  

Furthermore, because so much campus research involves students as subjects, the IRB will consider two additional issues:

• Do the protocol materials include a debriefing with enough concrete information to provide an educational experience for the student subject?
  
• Are appropriate mechanisms in place for responding when student problems, such as serious depression, are identified?

Notifying Investigators about Review Results

The IRB will notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.