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The IRB Page

The IRB, or Institutional Review Board, oversees human subjects research to ensure that researchers are minimizing risk appropriately during research activities. Risk is always involved in research for both the participants and the researcher(s).  

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Before conducting any research with humans, you must get approval from the IRB to do so. That process requires you to submit a protocol that describes your research project in detail so that the IRB can judge the level of risk and ensure that you are taking appropriate steps to reduce that risk.  

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Gwynedd Mercy University has a standard protocol that you must complete and submit. The protocol can be found in the Investigator's Handbook. You can find the Handbook on the GMercyU portal under the Institutional Review Board community. 

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Access the Handbook and review it. Then email myself (smith.t@gmercyu.edu) and Dr. Oksana Mykhed (mykhed.o@gmercyu.edu) to let us know you are ready to start the IRB protocol. We will send you step-by-step instructions on how to complete the protocol.  

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Dr. Mykhed and myself will review your protocol as you draft it. When you have a final draft ready to go, we will forward it for the necessary electronic signatures and send it to the IRB. 

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This is the required process for all EdD students at Gwynedd who are submitting to the IRB to help reduce the possibility of your protocol being rejected by the IRB and needing to be resubmitted. Because of the accelerated timeline, it is best if we can get the protocol approved the first time. 

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Process: 

  1. Access the Investigator Handbook on the GMercyU portal under the Institutional Review Board community.

  2. Review the Handbook.

  3. Email Dr. Smith (smith.t@gmercyu.edu) and Dr. Mykhed (mykhed.o@gmercyu.edu) and let us know you are ready to start the protocol.

  4. We will send you step-by-step instructions.

  5. Share versions of your draft with us as you are completing the protocol.

  6. When ready, submit the final protocol to Dr. Mykhed (mykhed.o@gmercyu.edu). 

  7. We will send the protocol for necessary signatures and submit it to the IRB.

  8. It will take about two weeks to get a response from the IRB.

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What If Your Protocol Is Rejected?

 

You will need to do a revision of the protocol to add any additional information that the IRB needs, and clarify any concerns. You will also complete form IRB-008 and include it as a cover sheet for the revised protocol. Importantly, on form IRB-008 you will list each concern raised by the IRB and respond to it.  This can be placed in the section asking for "Sections with Modifications" on the IRB-008 form. 

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The IRB will have sent you a review sheet that lists any questions or concerns they have. This will have been attached to the email they sent saying the protocol was rejected.  Open that sheet and use it to create a list of each item that you need to respond to. 

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Contact Dr. Mykhed (mykhed.o@gmercyu.edu) and myself (smith.t@gmercyu.edu) to review the list and get direction on how to respond to each item.  The sooner you submit the responses, the better, but this needs to be done under supervision.  

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Process:

  1. Review the sheet attached to the email the IRB sent you.

  2. Make a list in a new document of each concern on that sheet that was raised by the IRB.

  3. Email that list, the original protocol and the review sheet from the IRB to Dr. Smith (smith.t@gmercyu.edu) and Dr. Mykhed (mykhed.o@gmercyu.edu).

  4. Work with us to develop appropriate responses and to make appropriate edits to the protocol.

  5. Highlight all changes you make to the protocol in yellow.

  6. On your list, record your response and/or where you made any relevant changes for each item. 

  7. Copy this into the IRB-008 form under the section "Section with Modifications".

  8. Merge the IRB-008 form and your edited protocol together.

  9. Send your final version to Dr. Smith (smith.t@gmercyu.edu) and Dr. Mykhed (mykhed.o@gmercyu.edu) for review.  

  10. We will send it for the appropriate signatures and submit it to the IRB.

I Need to Change My Research Methods

 

There are many situations in which you may need to revise your research methods. If this happens, it means the protocol you sent to the IRB is no longer being followed. As such, you need to send an update to the IRB with the changed methods and get their approval before implementing those changes. 

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To update the IRB on what your changes are, you need to complete the form IRB-007, which can be found on the GMercyU portal under the Institutional Review Board community.  The IRB-007 form is one page in length and includes several multiple choice questions. Choose the appropriate responses for your study. Then, it will ask you for a description and explanation of the changes. For example, if you are expanding your recruitment to include participants at another location or from an online source, you need to describe to the IRB what this new location is, why you are expanding to include it, and how many participants you expect to recruit. Be sure to get a letter of permission to recruit from this location and include a copy for the IRB. If you are adding a survey or changing an interview protocol, describe the new survey/questions, why you are making the change, and provide a copy.

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When you have completed the form, you can have myself (smith.t@gmercyu.edu) or Dr. Mykhed (mykhed.o@gmercyu.edu) review it.  After this, we can have it sent for electronic signatures and submit it to the IRB. 

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Here are other pieces of information that may pertain to your changes and should be included in the description of changes:

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Are you changing who the participants are or adding new participants? 

  • Let the IRB know who you will be accessing as participants.

  • Who is giving you access to the participants? Who will give you the emails, phone numbers, or permission to post on a Facebook group? Be sure to include a letter from that person saying they are giving you the contact info/permission to post.

  • Do you need to update the consent form? If yes, make the appropriate change, describe the changes for the IRB and include a copy of the new consent form for the IRB.

 

Are you changing the data collection method? Maybe you are switching to online or changing to paper/pencil surveys.  

  • If switching to online, what platform are you using (e.g., Google or SurveyMonkey)?

  • Who has access to the account (best if it’s only you)?

  • State that it is password protected.

  • How you will distribute the link for the survey? 

  • If switching to paper/pencil, when and where will you distribute it? 

  • Where will you keep the paper copies so that only you can access them?

 

Are you using a new survey, data, or interview protocol? 

  • Include a copy of any new survey or interview questions. Describe why the change is needed.

  • Did you create the questions or obtain them from someone? If they were authored by someone else, are they publicly available? If not, did you get permission to use them?

  • Is someone giving you access to new data? Who? Include a letter of permission to access that data.

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I Need to Switch to Virtual Data Collection

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Be sure to talk this through with your advisor. I have created a table that can help you determine ways to switch to virtual data collection. Feel free to book a time to talk with me to discuss options more. 

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After you have determined the new virtual process, you will need to complete IRB-007 (see directions above under "I Need to Change My Research Methods"). If you would like an extra set of eyes on it, please feel free to send the completed form to me (smith.t@gmercyu.edu) or Oksana Mykhed (mykhed.o@gmercyu.edu) for review. If there are any details missing that the IRB will need, we will let you know. If you feel good with what you have, you can skip that step and simply send it to Kelly Doyle (doyle.k@gmercyu.edu) to circulate for signatures and forward it to the IRB.

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