Frequently Asked Questions

• When can I submit a research proposal for IRB review?
• To whom do I submit IRB materials?
• How long does the review process take?
• Who and what determines whether my proposal will go through a full board review or an expedited review?
• When can I request a waiver of informed consent?
• What does it mean if my proposal is approved?
• What does it mean if my proposal is remanded with specific revisions?
• What does it mean if my proposal is disapproved?
• What if I decide to change something in my procedure after my proposal has already received approval?
• Do I need to do anything after I have completed my study?

Q. When can I submit a research proposal for IRB review?

A. You may submit a research proposal at any time.

Q. To whom do I submit IRB materials?

A. Submit all material (e.g., proposal/application, progress reports, change in procedure applications, etc.) to:

Maria Gokim
Chair, DHS IRB
DHS Decision Support Services
1237 West Divide Ave, STE. 1C
Bismarck, ND 58501-1208
Phone: (701) 328-8946

Q. How long does the review process take?

A. It depends whether your proposal will undergo a full board review or an expedited review. We have a policy of having a 30 workday review period for a full board review and a 14 workday period for an expedited review. The Chair may decide on a case-by-case basis to extend the review period.

Q. Who and what determines whether my proposal will go through a full board review or an expedited review?

A. Upon receipt of the application, the DHS IRB Chair will decide whether the proposal will require a full board review or will qualify for an expedited review. The decision of whether a proposal requires full board review or qualifies for an expedited review will be contingent upon whether the proposal meets the criteria for minimal risk as indicated in the Code of Federal Regulations.

Q. When can I request a waiver of informed consent?

A. An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

• The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
• The research could not practicably be carried out without the waiver or alteration.
• The research involves no more than minimal risk to the subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• The research could not be practicably conducted without access to and use of the protected health information;
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation;
• The privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to the anticipated benefits if any to the individuals, and to the importance of the knowledge that may reasonably be expected to result from the research.
• There is an adequate plan to protect the identifiers from improper use and disclosure;
• There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law;
• There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use of disclosure of protected health information would be permitted by this subpart.

Q. What does it mean if my proposal is approved?

A. As soon as you are given verbal or written approval, you may begin collecting data.

Q. What does it mean if my proposal is remanded with specific revisions?

A. Your proposal's approval is contingent on your implementing revisions suggested by the IRB. After the revisions are implemented, you may begin. The IRB may require that you submit the revised section for review before final approval.

Q. What does it mean if my proposal is disapproved?

A. Your research proposal was fully disapproved. You will be sent a list of the Reviewers' comments. You are encouraged to resubmit a new or revised proposal; however, you must go through a new application process before the IRB can review your proposal.

Q. What if I decide to change something in my procedure after my proposal has already received approval?

A. Before you implement any changes, you must submit the "Change in Procedure or Principal Investigator Application" along with any other applicable documents.

Q. Do I need to do anything after I have completed my study?

A. Yes. You need to submit a final Research Progress Report along with a copy of your completed study.

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