Investigator-Initiated/Sponsored Research

In investigator-initiated/sponsored research, the principal investigator is responsible for all aspects of initiating and conducting the research. Thus, the principal investigator must comply with applicable investigator and sponsor regulations (e.g., Good Clinical Practice), in addition to adhering to the appropriate standards of their discipline.

Why Salus

When Salus IRB reviews investigator-initiated/sponsored research, it aims to foster a consultative relationship with investigators. During the pre-review process, an experienced, CIP-certified Client Services Manager (CSM) guides the investigator/sponsor through the submission and review process, assisting with protocol and informed consent form development when needed.

IRB of Record

Salus IRB may serve as your IRB of record. By submitting an application, you grant Salus the authority to be your IRB of record for the study submitted.

Protocol Review

The board evaluates protocols by ensuring they are scientifically sound so that the results may likely develop or contribute to generalizable knowledge. The board considers the adequacy of the following in evaluating whether research design and conduct are sound and will meet the stated objectives of the protocol:

• Dosage of investigational drug or the use of an investigational device
• Type(s) of procedure(s), length of enrollment, and number of participants
• Sufficiency of study design
• Safeguarding of sensitive information collected

Monitoring

The principal investigator must develop a data safety monitoring plan or comply with the existing data safety monitoring plan of the study. Such plans must be disclosed to Salus IRB. Monitoring may be conducted by the principal investigator, the sponsor, or an independent monitoring board. In studies where the Sponsor has a plan to monitor the research, the board requires the sponsor or investigator to report, directly to Salus IRB, any findings detected during the monitoring process that could directly affect participant safety, rights, or welfare, or alter the board’s approval of the study.

Template Study Documents

For your convenience and to facilitate IRB review, Salus IRB has developed template study documents that may be used to assist in the development of the protocol and informed consent documents.

Final IRB Approval

Research cannot begin until Salus IRB has granted final approval in writing. The Salus IRB-approved informed consent document(s) must be used when consenting research participants.

For more information, contact Client Services.

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