Salem Institutional Review Board

The Institutional Review Board (IRB) considers human subject research proposals involving Salem faculty, students, and staff as researchers or research subjects. “Research” means a systematic investigation designed to develop or contribute to generalizable knowledge (Final Common Rule, section 102L). Salem College requires that proposals for research activities involving human subjects be submitted for review and approval or exemption by the IRB prior to initiation of research.



 

Scope of IRB Review

The Salem College IRB considers three principal issues when evaluating a proposal:

Levels of IRB Review

To Apply for IRB Approval or Exemption

To apply for exemption without limited review:

To apply for exemption with limited review or approval:

If you are unsure whether you should submit the long proposal form or the short proposal form, please read the flow chart linked here.

The submitted proposal will undergo an initial review by the IRB Chair to determine whether (1) it requires review and approval from the full committee, (2) it requires limited review and exemption by a single IRB member, or (3) it is exempt without requiring a limited review. If your project is not eligible for exemption but involves only minimal risk to the participants, then it might be eligible for an expedited review. Projects that are neither eligible for exemption nor eligible for expedited review can only be reviewed in the next convened IRB meeting after they are submitted, and therefore these proposals should be submitted well in advance of the anticipated start date of the project.

You are not required to complete CITI Program training prior to submitting your proposal, but you are strongly encouraged to do so. Approval or exemption cannot be granted until the training is complete.

Projects that Do Not Require IRB Approval or Exemption

Not all projects that involve human subjects qualify as research. Some examples of projects that are not considered research (and hence do not require IRB review of any kind unless it is required by your faculty supervisor or program of study) are listed below (Final Common Rule, section 102L).

If you are unsure whether your project fits into any of the categories above, you should email the IRB Chair with a description of your project to receive assistance in determining if your project qualifies as research.

Projects that Require IRB Exemption WITHOUT Limited Review

Projects that qualify for this level of review commonly come from the following two categories, as described from section 104 of the Final Common Rule:

Projects that Require IRB Exemption WITH Limited Review

Projects that qualify for this level of review commonly come from the following category, as described in section 104 of the Final Common Rule:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) such that both of the following criteria are met:

Projects that Require IRB Approval

Human subject research projects that do not qualify for exemption must undergo review and approval by the full IRB. These are projects that do not fit into any of the exemption categories mentioned above or otherwise outlined in section 104 of the Final Common Rule.

Renewing or Revising Research Proposals

Approval from the IRB for a research proposal is valid for one year from the date on which it is issued. To renew IRB approval of a project past its original end date, the researcher should make a request to the Chair of the IRB at least one month before the expiration date.

If a researcher wishes to substantively change a project after it has received IRB approval or exemption, then the researcher should explain the necessary changes in an email to the IRB and submit a revised proposal form indicating the changes. Substantive changes may not be initiated without IRB review and approval or exemption except when necessary to eliminate apparent immediate hazards to research participants.