Regulatory Requirements

Office of Research Integrity

All applications, modifications, RNI and Continuing Review please submit via electronic submission. Log into the IRB Manager or copy and paste this link: https://irbmanager.becirb.com/?ClientID=spectrumhealth. 

Below you'll find more information about:

Pre-Submission Information
IBC
S.A.F.E. Program
What Does S.A.F.E. Stand For?
What Does an S.A.F.E On-Site Review Entail?
During the Site Visit, What Will the Reviewer Examine?

ORI Newsletters

2015 Summer Edition  (PDF)

2015 Winter Edition (PDF)

2016 Winter Edition (PDF)

2017 Spring Edition (PDF)

If you are participating in a research study and have questions, concerns or complaints, and you want to talk to someone besides the research team, please contact the IRB office at 616.486.2031 or irbassist@spectrumhealth.org.

Pre-Submission Information

The Spectrum Health IRB requires documented completion of the human subject research protection training prior to submission. If this is your first involvement with a research study being conducted at Spectrum Health and you have not completed the training, visit the research education page for further instruction. If you are unsure about the status of your training, contact the Spectrum Health IRB office at 616.486.2031.

Regardless of affiliation with Spectrum Health, when conducting any research activities at Spectrum Health involving human subjects and their data the Spectrum Health IRB must review and approve the research or verify exempt status before it can be initiated. This also applies when Spectrum Health has written agreement to serve as the IRB of record.

The first step in the submission process is assessing the project for category of review. There are three categories of IRB review.

  • Exempt status review (very little risk)
  • Expedited review (minimal risk)
  • Full board review (greater than minimal risk) 

If there are any questions about how your project fits into the category of review, consultation is available. Contact the Spectrum Health IRB office for additional guidance at 616.486.2031.

For further guidance on the categories of review and subsequent submission requirements, reference the Investigator Manual. All IRB submission forms are located at our IRB Forms  page. If you have any questions about the materials to be submitted, contact the Spectrum Health IRB office at 616.486.2031 or email irbassist@spectrumhealth.org for assistance.

Once the study has been reviewed and voted on at the convened IRB meeting, a letter indicating the outcome will be provided.

IBC

Meeting Notices:

June 10, 2015
October 22, 2014
July 9, 2014
June 11, 2014
March 24, 2014

S.A.F.E. Program

The Spectrum Health IRB is responsible for ensuring compliance with organizational policy, federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRB is expected to provide for post-approval monitoring of research. This Review is designed to meet this requirement through a pro-active and collaborative process with investigators.

The purpose of the Review is to provide information to investigators and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; to verify investigator adherence to the study design in the IRB-approved protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with research regulations. The review is meant to be a collaborative process whereby the on site reviewers assess compliance (regulatory, policy, approved protocol, etc.) and helps the investigator resolve/correct problems and discrepancies and provides recommendations for process improvements.

What Does S.A.F.E. Stand For?

The S.A.F.E Program stands for “Stop, Assess, provide Feedback, Evaluate."

What Does an S.A.F.E On-Site Review Entail?

The Review will entail a visit to your site. The full Review usually takes an entire day onsite; however, this may vary depending on the complexity of the study and the enrollment. It is usually a good idea for the PI and/or study coordinator to be there in the morning before the visit begins and at the end of the day when the review is over. The PI does not need to be present for the entire review. However, a staff member should be available to provide the reviewer with the necessary documents, files and binders, and answer any questions (or to contact the PI if there is an urgent question).

During the Site Visit, What Will the Reviewer Examine?

The scope of the review or investigation may vary depending on a number of factors, including if the review is random or for cause. All site reviews or investigations will be preceded by a notification letter from the Office of the IRB that includes specific details about the precise Scope of Review. The Scope of Review may include some, or all of the following items:
  • The reviewer will be looking to see documentation that the approved protocol and study procedures are being followed by the research team.
  • The review team will want to see all study related documents including:
    • Original Signed Informed Consent Forms
    • Subject Files
    • Inclusion/Exclusion Checklists
    • Experimental Drug/Device Accountability
    • Adverse Events/Serious Adverse Events
    • Regulatory Files (GCP Essential Documents): IRB Files and Correspondence, Sponsor Correspondence
    • FDA Files and Related Documents (if applicable)
    • Enrollment Logs
    • Staff Signature Logs (Delegation of Responsibility Logs)
    • Laboratory Certifications and Normal Reference Ranges
    • Investigator Brochure