U9D1-60 S1 - Ethics: Protection of Human Participants - See Detail Questions.

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IRB QUICK GUIDE

INTRODUCTION TO THE IRB QUICK GUIDE The Institutional Review Board (IRB) reviews research that involves human participants in order to ensure that it is conducted ethically and that the rights of participants are protected. The IRB process is intended to ensure that researchers comply with federal, state, and international regulations as well as ethical principles and responsible practices. The IRB supports research by partnering with the researcher to promote research integrity, while also working to maintain public trust in research. Nevertheless, the IRB process, like many processes that are subject to regulatory oversight, may sometimes appear bureaucratic and even daunting. This guide is intended to answer questions using IRBManager. Beginning Q4 2013, the IRB is implementing a new submission system, IRBManager. This system replaces IRBNet. IRBManager works in a very different manner than IRBNet. Therefore, it is essential that you consult these resources to help you with your IRB submission. The IRB will not accept submission through IRBNet after December 13, 2013. Studies not approved by December 31, 2013 will have to transition into IRBManager. As a reminder, you may not begin recruiting potential participants or collecting data until after you have obtained IRB approval. You will know you are approved when your study status has changed to ‘Approved’ and you have received an IRB Approval letter.

Note on completing the IRB Application

The IRB application in IRBManager is a webform. Webforms in IRBManager are called xforms. You will need to be logged into IRBManager to complete the form. This form is intended to collect information about your study and required additional documents. Read each question carefully before responding. You are required to answer questions on the application before you can move forward. Once you’ve answered a question, you may view previous pages, but you cannot move ahead until a question is answered. You will attaching supporting documents onto the application. Read the Preparing to Complete the IRB Application for more information on what questions/information you should be prepared to answer/provide before beginning the application. Before submitting your application, you should look through your responses to ensure that you completely answered the question. You are not able to save the xform locally, complete it, and then upload it again. However, you may create a pdf of the form, if need be.

Preparing for IRB Review

Understand and apply key ethical concerns in research by completing an interactive media piece

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IRB QUICK GUIDE

http://media.capella.edu/NonCourseMedia/Research/EthicalResearch/conflict_of_interest.as p

Frequently asked recruitment questions

http://capella.libanswers.com/doctoralsupport/faq/132845

Frequently asked informed consent questions

http://capella.libanswers.com/doctoralsupport/faq/132846

Frequently asked site permission questions

http://capella.libanswers.com/doctoralsupport/faq/132841

Locating and Completing IRB Forms

How do I know what forms to submit to the IRB?

http://capella.libanswers.com/doctoralsupport/faq/132864

Where do I locate the IRB Forms?

http://capella.libanswers.com/doctoralsupport/faq/132851

Why am I unable to add more information to a question in the IRB Application?

http://capella.libanswers.com/doctoralsupport/faq/132926

My site requires Capella IRB approval prior to providing site permission. What do I do?

http://capella.libanswers.com/doctoralsupport/faq/132837

The IRB submission and review process

How do I share my study with my mentor? (My mentor can’t view of find my study)

http://capella.libanswers.com/doctoralsupport/faq/132927

How do I submit to the IRB?

http://capella.libanswers.com/doctoralsupport/faq/132839

How long will the IRB review process take?

http://capella.libanswers.com/doctoralsupport/faq/132838

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IRB QUICK GUIDE

How do I submit revisions?

http://capella.libanswers.com/doctoralsupport/faq/132840 Why can’t I make changes to my application?

http://capella.libanswers.com/doctoralsupport/faq/132955

After IRB Approval

When am I able to start recruiting, consenting, and collecting data?

http://capella.libanswers.com/doctoralsupport/faq/132932

I need to modify my study, what do I do?

http://capella.libanswers.com/doctoralsupport/faq/132931

I received an email stating that my IRB approval was about to expire. What do I need to do?

http://capella.libanswers.com/doctoralsupport/faq/132859