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Human Research Protection Program

 

 

 

 

 

 

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Office Hours:
Monday - Friday
8am - 5pm

 

Mailing Address:
Michigan State University

207 Olds Hall
East Lansing, MI 48824

Phone: (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu

 

Office Location:
207 Olds Hall.
Olds Hall is located between the Administration Building and MSU Main Library. Campus Map

 

Frequently Asked Questions

 

Most questions can be answered by referring to the HRPP Manual. To submit a question not answered on our website, please use the Feedback Form.

 

Initial Application Approval

 

Will my study require IRB approval?
Where do I find the initial IRB application on the website? How do I apply for IRB approval?
When can I expect a final decision about my IRB application?
How will I be notified when my IRB application is approved?
When can I begin my research?
How long does my approval last?
My project was determined as exempt. What does it mean to be exempt?

 

Supporting Documents - Consent Forms, Advertisements, Interview Protocols, Survey Instruments, etc.

 

Are there any formatting requirements for consent documents submitted to the IRB office?
Where can I find information on informed consent?
What if my instruments (e.g., survey, questionnaire) are not yet finalized when I submit my application?

 

Revisions to Your IRB approved Study

 

What kinds of changes to my research study require the submission of a revision application?
How do I submit a change to an IRB approved research study to the IRB?

 

Renewal of IRB approval

 

How often must I renew my IRB approval?
How do I submit for renewed approval of my study?
I received a renewal reminder from the IRB office, but my project is complete (data collection, follow-up and analysis are complete). What should I do?

 

Closure of IRB Approval

 

Can I continue to work on my research study if I have received a Notice of Closure letter indicating that my approval has expired?
How do I close out my IRB project (funding was lost, my study never received funding, data collection and analysis is complete, etc.)?
I received an expiration notice from the IRB Office indicating my approval will soon expire. What should I do if I don't intend to renew my approval?

 

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Unanticipated Problems and Adverse Events

 

How do I report an adverse event/unanticipated problem?

 

Initial Application Approval

 

Will my study require IRB approval?

 

At MSU, all research involving human subjects must be reviewed and approved by an IRB before initiation. This is based on federal regulations, university policies, and accreditation standards. If you have any questions on whether an activity requires IRB review, contact the IRB office by phone: (517) 355-2180 or email: irb@msu.edu. For procedures in determining whether a study will require IRB approval, please visit section 4-3, “Determination of Human Subject Research” in the Human Research Protection Manual.

 

Where do I find the initial IRB application on the website? How do I apply for IRB approval?

 

All applications must be submitted via the online application system. To access the online initial application, click here.

 

An “Initial Application Reference Form” is provided on the Forms page as a reference document to assist in developing your IRB application. However, all initial applications must be submitted via the online application system. Initial applications submitted via e-mail, mail, or fax are no longer accepted.


When can I expect a final decision about my IRB application?

 

Because every IRB application is unique, a set amount of time is difficult to provide. The length of IRB review depends on the nature of the study. However, an estimated time frame may be provided based on the review category of the application. Please see the table below for the estimated time frame. If your application is time sensitive, please contact the IRB office.

 

Initial Application Time Frames

Exempt 7-10 Working Days
Expedited 3-5 Weeks
Full Review 6-8 Weeks

 

Please remember that the review category is determined by the IRB and not the investigator. An investigator can submit an application indicating the review category in which he/she feels that the application fits into, but the ultimate decision is made by the IRB. The IRB office will determine the category based on whether or not the application meets the federal criteria in that particular review category.

 

How will I be notified when my IRB application is approved? ( Updated)

 

The IRB office is excited to announce the transition to an electronic notification system for approval letters! Previously, approval documents were sent by campus mail to investigators. To expedite receipt of such documents, the IRB staff is now sending a notification email when the approval letter and consent document, when appropriate, is ready for the investigator to view in the online application system.

 

Investigators will then log into the online system to access the documents. The approval documents for each submission (e.g., initial approval, renewal, revision) will be associated with that particular submission and could be accessed at any time. Please remember that the approved consent form(s) with the IRB approval language in the footer must be used when obtaining consent from subjects.

-- 5/11/09 --

 

When can I begin my research?

 

A hard copy of the approval letter or determination letter is needed by the investigator before research can begin. The IRB approved consent form (if applicable) must be used when obtaining consent from human subjects. A copy of the the IRB approved consent form with the IRB expiration footer will be sent to the responsible project investigator and the secondary investigator (if applicable) along with the approval letter.


How long does my approval last?

Most IRB approvals expire one year from the date of approval (exceptions may occur). Your project’s expiration date will be located on your project’s approval letter. However, research studies considered EXEMPT from federal regulations do not require continuing IRB review and thus, do not require a renewal application on an annual basis. Please visit section 8-1, “Exemptions" in the Human Research Protection Manual for additional information on exempt research studies.

 

My project was determined as exempt. What does it mean to be exempt?

 

The federal regulations state that if a project meets the specific exemption criteria, the project is exempt from this policy (45 CFR 46.101). Projects determined to meet the exempt criteria by the IRB Staff are exempt from initial and continuing review by the IRB, as long as the project maintains the properties that make it exempt.
This means:

  • You do not need to renew your application annually.
  • You do not need to submit a revision application to make changes in your project unless the modification will cause the research to change from Exempt to Expedited or Full Review Status.

Please visit section 8-1, “Exemptions" in the Human Research Protection Manual for additional information on exempt research studies.

 

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Supporting Documents - Consent Forms, Advertisements, Interview Protocols, Survey Instruments, etc.

 

Are there any formatting requirements for consent documents submitted to the IRB office?

 

The MSU IRBs have developed a system of electronic consent forms with an IRB expiration footer.  When approved, the files are converted to a PDF format and are placed on line with the file associated with your project.  The PDF will be print only.  This system allows you instant access to the latest approved consent form whenever you want it. 

Please adhere to the following when submitting your consent document:

  • Submit document in Microsoft Word format (xxx.doc).
  • Do not use text boxes in the consent form.  They will not transform when converted to PDF.
  • Do not place a footer in your consent document or place any text within one inch of the bottom.
  • Leave a 1-inch margin at the bottom so the IRB office can place the approval footer.

If you cannot simply use PDF printouts (e.g. mail merge), let the IRB staff know and they can work with you to get the approval footer on your document.  The current approved IRB consent form with the IRB expiration footer must be used.


*If your study is EXEMPT from federal regulations, an IRB expiration footer will NOT be inserted onto your consent form.

 

--11/25/2009--

 

Where can I find information on informed consent?

 

Information regarding the informed consent process can be found in various sections of our website.
Background: Informed consent is one of the most basic and important principles in the protection of human subjects in research.  The approach of the researchers toward the informed consent process is very important in ensuring its effectiveness.  The consent process should be transmitted as an informative and empowering process which gives potential participants the information they need to make a voluntary decision whether to participate or not (being completely voluntary is another basic principle of human subject protection).

 

Also, please remember that the consent form itself is only a part of the consent process.  How you inform the subjects, present and review the consent form with them, and answer any questions, are all important parts of the process and should be built into your research design.  If subjects are non-English speaking, the consent process and form should be provided in that language. If your study involves vulnerable populations such as prisoners, children, or subjects with diminished capacity, there are additional consent issues associated with these populations. Please refer to the corresponding policies in the Human Research Protection Manual for further information.

 

Templates: Templates geared towards the Biomedical and Health and the Social Science/Behavioral/Education disciplines are available under the “Form Instructions” section of our website.

 

MSU HRPP Policies: Please visit the following policies in the Human Research Protection Manual specifically regarding informed consent. Section 6-4, Informed ConsentSection 6-4A, Documentation of Informed Consent, Section 6-4B, Waiver or Alteration of Informed Consent, Section 6-4C, Parental Consent and Child Assent

 

What if my instruments (e.g., survey, questionnaire) are not yet finalized when I submit my application?

 

In most cases, all instruments should be submitted in their final version when applying for initial approval. Any change to an approved instrument requires IRB review and approval.

However, if for some reason an instrument is not finalized, indicate and explain this in the “Procedures” section of your initial application, including a description of your intended methodology. Be sure to submit the draft documents. Once the instruments are finalized, a revision application must be submitted to the IRB for review and approval before the finalized instruments may be implemented.

 

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Revisions to Your IRB Approved Research Study

 

What kinds of changes to my research study require the submission of a revision application?

Any proposed change or revision to an approved project that affects human subjects (with certain limited exceptions) must be reviewed and approved by the Institutional Review Board prior to implementation of the change. These changes can be minor or non-minor changes.
This includes, but is not limited to:

  • Alteration of study design, methodology, or recruitment methods
  • Changes to any instruments, including surveys and questionnaires
  • Changes to consent documents
  • Changes to the study population
  • Changes in funding
  • Addition/Deletion of investigators
  • Alteration of Project Title
  • Addition/Deletion of research performance sites

Please visit section 8-6, “Revisions to an Approved Project” in the Human Research Protection Manual for additional information. Please contact the IRB office with any questions.

 

How do I submit a change to an IRB approved research study to the IRB?

 

To apply for approval of a revision, the responsible project investigator must complete and submit a revision application and any new and/or revised documents via the MSU IRBs online application system.

 

A "Revision Application Reference Document" is available in the Download Forms section of the website. This document is provided as a reference document to assist in developing your revision application. However, all revision applications must be submitted via the MSU IRBs online application system. Revision applications submitted via email, mail, or fax are no longer accepted.

 

Revision approvals do not change the approval or expiration date of the project.  The approval simply approves the modification or revision to the project and allows investigators to begin using the modified or new documents, procedures, etc.   The responsible project investigators must receive a letter from the IRB approving the proposed revisions before the changes are implemented.

 

-- 11/25/2009 --

 

 

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Renewal of IRB Approval

 

How often must I renew my IRB approval?

 

Under federal regulations, IRB approval is valid for a maximum period of one year. Project investigators wishing to continue research activities, including data collection and analysis, beyond the expiration of IRB approval must submit and receive approval for updated renewal prior to the expiration.  The approval period will be listed on approval letters sent to investigators, including both the approval date and the expiration date.

 

Like initial approval, renewed approval is for a maximum of one year.  If the assessment of risk warrants it, however, the IRB may require additional review at more frequent intervals.  Furthermore, approval may be withdrawn by the IRB at any time if the IRB concludes that the risk to subjects has become unacceptable.

Please visit section 8-7, Renewed Approval in the Human Research Protection Manual for additional information.

 

How do I submit for renewed approval of my study?

 

To apply for renewed approval, the responsible project investigator must complete and submit a renewal application and the current consent form(s), if applicable, via the MSU IRBs online application system.

 

A "Renewal Application Reference Document" is available in the Download Forms section of the website. This document is provided as a reference document to assist in developing your renewal application. However, all renewal applications must be submitted via the MSU IRBs online application system. Renewal applications submitted via email, mail, or fax are no longer accepted.

 

-- 11/25/2009 --

 

I received a renewal reminder from the IRB office, but my project is complete (data collection, follow-up and analysis are complete). What should I do?

 

At any time prior to the expiration date, responsible project investigators may request closure if research activities including data collection and analysis are complete.  If all data collection and analysis are complete, a closure application must be submitted to the IRB office before the expiration date.

 

Closure of IRB Approval

 

Can I continue to work on my research study if I have received a Notice of Closure letter indicating that my approval has expired?

 

No – as of the expiration date, you may no longer continue to work on the study, including collection and analysis of data. The IRB office sends three renewal reminders as a courtesy to the Responsible Project Investigator and Secondary Investigator (if applicable) before closing the IRB approval of a research study upon expiration. If you have received a Notice of Closure letter and your project is not complete, contact the IRB office to discuss your situation.

 

How do I close out my IRB project (funding was lost, my study never received funding, data collection and analysis is complete, etc.)?

 

The responsible project investigator must complete and submit a closure application indicating the reason for closure. The closure application is available in the Download Forms section of the website.

 

I received an expiration notice from the IRB Office indicating my approval will soon expire. What should I do if I don't intend to renew my approval?

 

The responsible project investigator must complete and submit a closure application indicating the reason for closure. The closure application is available in the Download Forms section of the website.

 

Unanticipated Problems and Adverse Events

 

How do I report an adverse event/unanticipated problem?

 

The responsible project investigator must complete and submit the appropriate form (local adverse event, non-local adverse event or an unanticipated problems form) available in the Download Forms section of the website. In urgent situations, please visit www.humanresearch.msu.edu/contacts for multiple contacts if an urgent situation arises.

 

Please visit section 9-1, Unanticipated Problems and Adverse Events in the Human Research Protection Manual for specific reporting information.

 

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Quick Links

 

Biomedical and Health Institutional Review Board (BIRB)

 

Community Research Institutional Review Board (CRIRB)

 

Social Science/Behavioral/Education Institutional Review Board (SIRB)

 

MSU Privacy Board