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IRB Application Procedure

The principal investigator needs to submit the completed application along with the research proposal, appropriate informed consent forms, the application fee or "Request for Waiver of Fee" form, the "Consent for Videotaping Form," if applicable, and any supporting documents.

Please submit materials to:

Maria Gokim
Chair DHS IRB
DHS Decision Support Services
1237 West Divide Ave, STE 1C
Bismarck, ND 58501-1208

If you have questions or if you would like paper copies of the IRB forms mailed to you, contact:

Maria Gokim
Chair DHS IRB
Phone: (701) 328-8946
mgokim@nd.gov

To request a waiver of informed consent, complete the appropriate request form, Requests for Waivers of Informed Consent (92kb pdf), and submit the form with the application. A waiver of informed consent may be granted, if the IRB decides that written informed consent is not needed (e.g., Internet or phone surveys). In this case, the investigator provides the informed consent form to the participant but no signature is required. The other instance in which a waiver of informed consent may be granted is when no informed consent is necessary (e.g., secondary data analysis). If you are requesting a waiver of informed consent, you cannot proceed with the study without using informed consent forms until you are notified by the IRB that the waiver has been approved.

To request a waiver of fee, complete the appropriate request form, "Request for Waiver of Fee", and submit the form with the application. A waiver of fee may be granted under certain circumstances. These circumstances include students, researchers employed or contracted by the Department of Human Services and performing research within their scope of duties at DHS, those claiming financial hardship, and others that may be determined eligible for a waiver of fees.

The principal investigator will be notified within 30 workdays, whether the proposal is approved, remanded with revisions, or rejected.

If at anytime after approval of your research project anything changes in your procedure, including a change in principal investigator, you must complete and submit the Change in Procedure or Principal Investigator Application (41kb pdf). If the consent form needs revision in order to correspond with the changes in the procedure, it must also be reviewed and approved before implementation. You cannot initiate any changes in your procedure until they have been approved.

The Research Progress Report (38kb pdf) must be submitted to the IRB Chair in time intervals that will be determined by the IRB (at least annually). The progress report must also be submitted at the completion of the study, accompanied by a report of the results. The progress report should also to be used if the study is terminated before completion.

Any adverse events that occur during the study must be reported directly to the DHS Risk Manager ((701) 328-2311) and on the appropriate Adverse Event Report form.

 

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