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Undergraduate's Guide to Creating & Communicating Research

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Erin Owens
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eowens@shsu.edu
NGL 223D
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IRB Application Walk-Through for Students

What is the Institutional Review Board (IRB)?

IRB is a committee of faculty who review proposals for human subjects research to ensure that studies are safe, ethical, and in compliance with relevant laws. At SHSU, the IRB is a division of the Office of Research and Sponsored Programs (ORSP).

What research must be approved by the IRB?

Most research involving living humans cannot begin until the IRB approves it. Depending on how high-risk or low-risk the research is, more or less detail may be required, and IRB review may be more in-depth or more expedited.

If our research only involves compiling existing data, or studying inanimate objects (like literature), then IRB approval is not required.

If our research involves living animals, then we will instead need approval from Institutional Animal Care and Use Committee (IACUC).

What steps should I complete before I request IRB review?

Before you request IRB review of a research study, you must complete CITI training with scores of 80% or greater in each module. If multiple people will collaborate on a research project, every one of them must complete CITI training. The ORSP Compliance website provides a link to the training and instructions for registering on the CITI site.

You should discuss your project with your faculty advisor before you begin your IRB application. You may also want to consult them along the way if you are not sure of the best way to answer a certain question. Be aware that IRB applications take time to review—this may be faster or slower depending on the complexity of the project and the risks involved, as well as how many other applications are waiting for review—so start your application as early as you can. ORSP provides some additional information about student-led and class projects and things to take into account concerning application timing.

You should have some general notes about your planned project before you begin, but it’s ok if you aren’t ready to complete every part of the application in one sitting. You can begin an IRB application, save it, and come back to it at a future time to add or edit information.

How do I submit my research for IRB review?

IRB review processes are done online in a special software program, Cayuse Human Ethics. To access Cayuse Human Ethics:

  1. Start at the SHSU IRB homepage.
  2. Click the blue “Submit IRB” button at the top of the page.

 

The tabbed pages of information below will offer detailed guidance through a student IRB application.


1. Click on Products

Click on Products

2. Click on Human Ethics

Click on Human Ethics

3. Click on the New Study button

Click on the New Study button

4. Enter a clear and concise title describing your project

Enter a clear and concise title describing your project

5. Click on the blue checkmark to confirm

Click on the blue checkmark to confirm

6. Click on the "New Submission" button

Click on the "New Submission" button

7. Click on Initial

Click on Initial

8. Click on Edit this submission

Click on Edit this submission

9. Here is where you will begin entering details about your study (see the walk-through on the next tab for details). You can always save a draft and come back to work on it another time.

Here is where you will begin entering details about your study (see the next walkthrough). You can always save a draft and come back to work on it another time.

10. When you revisit Cayuse Human Ethics in the future, you will see a list of "My Studies" where you can click on the title to resume editing your draft study.

When you revisit Cayuse Human Ethics in the future, you will see a list of "My Studies" where you can click on the title to resume editing your draft study.

11. After you choose the study title, you will have to click on the Submissions tab...

After you choose the study title, you will have to click on the Submissions tab...

12. ...and click to open the "Initial" submission that you had begun drafting.

...and click to open the "Initial" submission that you had begun drafting.

13. Click on Edit this submission to resume entering details about your study

Click on Edit this submission to resume entering details about your study

 


 

Creating a New Study or Accessing a Draft Study

Creation Date: August 30, 2023
Created By: Erin Owens

1. Read all details on the Application Information page CAREFULLY, including (but not limited to) the fact that all project personnel must have completed the appropriate CITI human ethics training.

If you (or any collaborators) have not completed CITI, you will need to do so BEFORE you complete this submission.

Read all details on the Application Information page CAREFULLY, including (but not limited to) the fact that all project personnel must have completed the appropriate CITI human ethics training.

2. The application details explain to look for a white checkmark beside each application section in the blue menu.

If a section does not yet have a checkmark, you have an incomplete item somewhere in that section.

The application details explain to look for a white checkmark beside each application section in the blue menu.

3. After you have read all details CAREFULLY, click the button to certify your understanding.

After you have read all details CAREFULLY, click the button to certify your understanding.

4. Click on the arrow at the lower right to go to Section 1.

Click on the arrow at the lower right to go to Section 1.

5. The first field asks for the Primary Contact and likely already lists you as the creator of the submission. Verify that this is correct for this project -- that you want all IRB communication to come to you.

The first field asks for the Primary Contact and likely already lists you as the creator of the submission. Verify that this is correct for this project -- that you want all IRB communication to come to you.

6. The next question asks who the actual Primary Investigator (PI, or head researcher) will be. Click the "Find People" button to select the appropriate person.

This might be you! Or it might be your faculty advisor, or even another student collaborator. Think carefully about your situation and "who is ultimately responsible for the conduct and oversight." If you are unsure who to enter, ask your faculty advisor.

The next question asks who the actual Primary Investigator (PI, or head researcher) will be. Click the "Find People" button to select the appropriate person.

7. Enter a name (yours or another) to search for.

Enter a name (yours or another) to search for.

8. Press Enter or click the magnifying glass to search.

Press Enter or click the magnifying glass to search.

9. Click to select the correct name from those listed.

Click to select the correct name from those listed.

10. Click on SAVE

Click on SAVE

11. Based on who you selected above as the PI, click the correct button to describe that PI's role at SHSU. If you are the PI, you will choose Student.

Based on who you selected above as the PI, click the correct button to describe that PI's role at SHSU. If you are the PI, you will choose Student.

12. A note will inform you that student PIs must have a faculty sponsor, who must be identified in this IRB submission.

A note will inform you that student PIs must have a faculty sponsor, who must be identified in this IRB submission.

13. Click on FIND PEOPLE…

Click on FIND PEOPLE…

14. Enter a name to search for.

Enter a name to search for.

15. Press Enter or click the magnifying glass to search.

Press Enter or click the magnifying glass to search.

16. Click to select the correct name from those listed.

Click to select the correct name from those listed.

17. Click on SAVE

Click on SAVE

18. Indicate whether your faculty sponsor has up-to-date CITI training on record with SHSU's Office of Research. If you aren't sure, ask your sponsor!

Indicate whether your faculty sponsor has up-to-date CITI training on record with SHSU's Office of Research. If you aren't sure, ask your sponsor!

19. Select whether this is a class project that will only last for a semester...

Select whether this is a class project that will only last for a semester...

20. ...Or whether this project will be longer-term, towards your thesis or dissertation.

...Or whether this project will be longer-term, towards your thesis or dissertation.

21. If you have other collaborators INSIDE of SHSU, such as other student researchers, click Yes and identify them here.

Anyone who was already identified in Section 1 does NOT need to be added again here.

If you have other collaborators INSIDE of SHSU, such as other student researchers, click Yes and identify them here.

22. If you are collaborating with any other researchers OUTSIDE of SHSU, click Yes and identify them here. This will not be common for most student projects.

If you are collaborating with any other researchers OUTSIDE of SHSU, click Yes and identify them here. This will not be common for most student projects.

23. If this is the first time this project has been proposed to any IRB (at or outside of SHSU), click No. If this project has been proposed before AND BEEN REJECTED, select Yes.

For past disapprovals, you will need to provide details and documentation.

If this is the first time this project has been proposed to any IRB (at or outside of SHSU), click No. If this project has been proposed before AND BEEN REJECTED, select Yes.

24. If you have secured grant funding, or intend to apply for funding, indicate that here. This DOES include grants from within SHSU, such as a EURECA or ORSP grant.

Note that if a funding application is pending but not yet decided, you will mark Pending, but then you will also eventually need to send the IRB an update when that funding application is either received or rejected.

If you have secured grant funding, or intend to apply for funding, indicate that here. This DOES include grants from within SHSU, such as a EURECA or ORSP grant.

25. Enter the date AT LEAST two weeks in the future (or further) when you expect to start collecting data for this project, if it is approved.

Enter the date AT LEAST two weeks in the future (or further) when you expect to start collecting data for this project, if it is approved.

26. Click on the arrow at the lower right to go to Section 2.

Click on the arrow at the lower right to go to Section 2.

27. In this field, enter your research question(s), hypothesis, or a clear, concise statement of the research purpose. If you are completing a thesis or dissertation, the purpose/questions here should match those in your thesis or dissertation.

Note: Do NOT include explanatory background of the problem or literature in this field. Just state clearly and concisely the overall question or phenomenon you are studying and what you hope to learn about it.

In this field, enter your research question(s), hypothesis, or a clear, concise statement of the research purpose. If you are completing a thesis or dissertation, the purpose/questions here should match those in your thesis or dissertation.

28. Your project summary in this field will SUMMARIZE what would be the introduction/background and literature review in your complete paper. This is where you should briefly explain the context and importance of your research question for someone who is not yet familiar with it.

Do not cut and paste full sections from your thesis or dissertation; this should be a very short summary. Cite only the 3-4 most crucial publications to support what you will be doing and why.

Your project summary in this field will SUMMARIZE what would be the introduction/background and literature review in your complete paper. This is where you should briefly explain the context and importance of your research question for someone who is not yet familiar with it.

29. Are you deliberately seeking to collect data from outside the U.S.? If so, additional regulations may apply.

If the answer to this question is Yes, be prepared to provide additional details about what country or countries your data will come from and whether you have identified their equivalent of an IRB for approval of your research.

Are you deliberately seeking to collect data from outside the U.S.? If so, additional regulations may apply.

30. If this research will be applied to support a thesis, dissertation, presentation, publication, or similar, select YES for this question.

If your project will not be applied in ANY way that contributes to generalizable knowledge, then it may not qualify as "research" as defined by federal regulations, and you may not need IRB approval. You are encouraged to call the SHSU IRB office and ask for clarification or guidance.

If this research will be applied to support a thesis, dissertation, presentation, publication, or similar, select YES for this question.

31. In most disciplines, student projects are unlikely to involve deception -- not being truthful with your research participants -- but if that applies to your study, you must indicate it here. This will trigger a more rigorous review of your proposal.

In most disciplines, student projects are unlikely to involve deception -- not being truthful with your research participants -- but if that applies to your study, you must indicate it here. This will trigger a more rigorous review of your proposal.

32. Indicate whether you will be working with vulnerable populations such as those listed. Again, answering Yes to this question will trigger a more rigorous review to ensure participant safety.

Indicate whether you will be working with vulnerable populations such as those listed. Again, answering Yes to this question will trigger a more rigorous review to ensure participant safety.

33. A Certificate of Confidentiality will most often NOT apply to student research projects. If this applies to you, it is likely something that you and your faculty advisor have already discussed.

If you are uncertain, speak with your advisor or the SHSU IRB for clarification. Answering yes here will trigger a more rigorous review of your proposal.

A Certificate of Confidentiality will most often NOT apply to student research projects. If this applies to you, it is likely something that you and your faculty advisor have already discussed.

34. Unless your methods involve a DEXA scan, select NO for this question. Answering yes here will trigger a more rigorous review of your proposal.

Unless your methods involve a DEXA scan, select NO for this question. Answering yes here will trigger a more rigorous review of your proposal.

35. If you will be interacting with your human participants in some way -- whether through face to face conversation, email, online survey, syringe, blood pressure cuff, etc. -- you will answer NO to this question.

You should also answer NO if you will be observing participants, with or without interaction, in a PRIVATE place. Note that a "public school" is a "private place" for the purposes of this question.

 

If you will be sitting in a PUBLIC place like a park and watching people without interaction, you may need to choose YES here. You will likely not need to enter any more information about your project or receive IRB approval, if you are not actually interacting with human participants.

If you will be interacting with your human participants in some way -- whether through face to face conversation, email, online survey, syringe, blood pressure cuff, etc. -- you will answer NO to this question.

36. Most research projects that require IRB approval involve interacting with human participants in some way -- whether through face to face conversation, email, online survey, syringe, blood pressure cuff, etc. If that's your case, choose YES here.

There are some exceptions to this, for example if you are conducting secondary research with identifiable private information or biospecimens whose collection was unrelated to this project. If your research falls under one of these exceptions, and you are truly NOT interacting with human participants, then choose NO here. You will then answer accordingly to the question 4 regarding secondary research, and you will need to complete an additional application section detailing the secondary data source and the original purpose for its collection.

Most research projects that require IRB approval involve interacting with human participants in some way -- whether through face to face conversation, email, online survey, syringe, blood pressure cuff, etc. If that's your case, choose YES here.

37. If your research only involves analyzing a public dataset in which participants are unidentifiable, you will not require IRB approval; select Yes here. Otherwise, select NO to continue pursuing IRB approval.

If your research only involves analyzing a public dataset in which participants are unidentifiable, you will not require IRB approval; select Yes here. Otherwise, select NO to continue pursuing IRB approval.

38. As discussed above, if you are doing secondary research with identifiable information or specimens, select Yes here. Otherwise, select NO.

As discussed above, if you are doing secondary research with identifiable information or specimens, select Yes here. Otherwise, select NO.

39. If you are conducting ONLY an anonymous online survey, choose Yes here. This will trigger creation of a new section in the application that will ask you more detailed questions to ensure anonymity of the survey.

If you are NOT conducting an online survey, or it is not online and anonymous, select No instead.

 

Note: For logical consistency, if you select Yes here, you also should have selected Yes above for "interaction or intervention."

If you are conducting ONLY an anonymous online survey, choose Yes here. This will trigger creation of a new section in the application that will ask you more detailed questions to ensure anonymity of the survey.

40. If you are not conducting interviews at all, your answer to question 6 will be NO. If you are: Ask yourself whether the data could be traced to a participant, and answer Yes or No accordingly.

If you answer Yes:

 

You will be asked further whether or not you consider this activity "benign" (brief, painless, not invasive or embarrassing). If you are unsure, definitely click on the question mark icon to read more details about benign interventions. Check with your faculty advisor if you find you still need clarification.

 

You will also be asked again whether your study involves deception, or being untruthful with participants.

If you are not conducting interviews at all, your answer to question 6 will be NO. If you are: Ask yourself whether the data could be traced to a participant, and answer Yes or No accordingly.

41. Click the arrow at the lower right to on go to Section 3.

Click the arrow at the lower right to on go to Section 3.

 


 

Completing the Application Information Page and Application Sections 1 and 2

Creation Date: August 30, 2023
Created By: Erin Owens

 

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