In order to move to any of the other tabs, you must complete information on the Protocol tab first. Once you have completed all required fields, you can save the information and move to the next tab.
Required Fields for Saving Document
- Protocol Type: Expedited or Full Board
- Title: Enter the title of your study.
- Principal Investigator: Identify the Principal Investigator (PI) by:
- Entering the user Id in the box and pressing <tab>, which will populate the PI Name and Lead Unit; OR
- Click the spyglass button, which will bring up a search window. Enter the PIs Last Name in the appropriate field and click search. Helpful Tip, using the “*” before or after a person’s name is helpful in ensuring the correct person is found. For example, “Johnson*”.
- Click “return value” next to the appropriate person. This will populate the PI name and lead unit on the Protocol tab.
- Additional Information: N/A
- Organizations: Add IU affiliated organizations (locations) that are engaged in the research, i.e., any organization where subject records will be accessed, or where research related interactions and/or interventions occur. For more information on IU affiliated organizations, go to: IU-affiliated research personnel.
- Select the magnifying glass icon to take you to an organization lookup for a list of frequently used organizations. From the list, check the box or boxes for the organization(s) engaged in the research.
- If the organization you are searching for isn’t listed, change the value in the Organization Type field to select and click search to return all organizations included in the KC Organizations database.
- To narrow your search, enter part of the organization’s name in the Organization Name text box (e.g., *health*).
- Check the box or boxes for the organization(s) engaged in the research.
- Click the “return selected” button. All organizations checked will populate onto the Organizations panel on the Protocol tab.
- Funding Sources: All studies must have some kind of funding source listed. If your study is not funded, select “Unfunded” from the dropdown and click the “add” button. For additional information about how to add funding sources, refer to the Quick Guide: Adding Funding.
- Participant Types: All Protocols must list a total in this section. Other available Participant Types include children (subjects under the age of 18), subjects lacking consent capacity, prisoners and students. A selection or count of these Participant types is not required; however, if you wish to list either type:
- Enter the total number of subjects to be enrolled in the research and click the “add” button.
- Select any necessary vulnerable populations from the dropdown menu, and click the “add” button to finalize your entry (you do not need to enter a count).
Once all required information has been entered on the Protocol tab, click save and navigate to the next tab.
For information regarding who should be listed on this tab, please refer to Quick guide: Research Personnel.
- The Principal Investigator identified on the Protocol tab will display in the first folder in the Personnel tab.
- For additional information on how to add Personnel, refer to the Quick Guide: Adding and Removing Personnel.
- Conflict of Interest Questionnaire: Once all personnel have been added and all personnel are green and/or black, the Conflict of Interest Questionnaire should be completed below.
Study personnel are automatically assigned certain permissions based on the protocol role assigned to them on the Personnel tab. For more information about automatic permissions, please see the Quick Guide: Permissions.
If individuals who are not a part of the study team need to view protocol information, make submissions or request IRB actions, or receive protocol notifications, they must be designated as a Study Manager/Correspondent on the Permissions tab.
The KC Questionnaire is a smart form, which works on how you, the user, complete questions. The update button at the bottom of the Questionnaire will help to ensure that the Questionnaire displays all applicable questions.
Click ►show next to each panel reveal the questions in that specific section.
Depending on the specific question and your answer, additional questions may appear. Be sure to select “update” to ensure that you get all questions as you answer questions in the questionnaire.
Once this panel has turned green and notes “(Complete)”, you are ready to move on to the next panel.
Click Save and continue.
- Level of Review Assessment: This appears for both Expedited and Full board Studies
- Expedited questionnaires provide categories for the user to check, along with additional questions regarding risk level.
- Full Board questionnaires provide for a confirmation that the study is more than minimal risk.
- Lay Summary and Research Design: This section appears for both Expedited and Full Board Studies. There are no differences in this part of the questionnaire between levels of review. This area is designed to capture information about the purpose of the research and what subjects will undergo.
- Sites and Collaborations: Both the Expedited and Full Board questionnaire contain this section. The purpose of this section is to collect information about multi-site studies and/or non-IU affiliated Investigators. For more information regarding non-affiliated investigators, please see IU IRB Review for Non-Affiliated Investigators or External Sites.
- Recruitment Methods: Identical questions exist in the recruitment section of the questionnaire for Expedited and Full Board submissions. The goal of the Recruitment Methods section is to help articulate the story of how subjects will be identified and determined to be possibly eligible for a study.
- Risks, Benefits and Protections: Both Expedited and Full Board questionnaires request this information. Information in this section is related to subjects in the study, science and society.
- Data Safety Monitoring: This section will appear for both Expedited and Full Board questionnaires, however questions differ in length and details.
- Expedited Studies are considered minimal risk research and are expected to provide a description of how data will be monitored to ensure safety of subjects as applicable.
- Full Board Studies are considered greater than minimal risk and are expected to provide a more robust data safety monitoring plan.
- Questionnaires that will appear if selected as a population on the Protocol tab:
- Children: Please see additional information on Research with Children.
- Individuals Lacking Consent Capacity: Please see additional information on Individuals Lacking Consent Capacity.
- Pregnant Women/Fetuses/Neonates: Please see additional information on Pregnant Women/Fetuses/Neonates.
- Transnational Research: Please see additional information on Transnational Research.
- For more information about including vulnerable populations in human subjects research, please be sure to review the IU HRPP Policies.
- Informed Consent Process: Both the Expedited and Full Board questionnaire contain this section. Additional questions will appear based on information from the Protocol Tab (vulnerable subjects selected), as well as other previous answers. This section should describe how (if any) informed consent will be sought from subjects after they have been recruited for the study.
- Child Assent & Parental Consent Process: Will appear for either type of study which chooses Children as a subject population.
- HIPAA: The HIPAA section will appear for Expedited and Full Board questionnaires. If you are unsure about whether your study is subject to HIPAA please refer to: https://research.iu.edu/compliance/human-subjects/guidance/hipaa.html
- ClinicalTrials.gov: All Expedited and Full Board Studies are required to complete this portion. For questions regarding ClinicalTrials.gov or your specific study, please contact the IU ClinicalTrials.gov Office.
Uploading to the Notes and Attachments Tab: A Full Board study is required to provide and upload a protocol document, an expedited study is not required to provide a protocol. Additional documents that are necessary to upload will be dependent on the study.
- Click on the Notes & Attachments
- Click►show on Protocol Attachments folder to attach any required study documents
- Select an Attachment Type from the drop-down list.
- Assent Form
- Data Collection Instrument (Required for Expedited Studies that answered “yes,” to the use of a data collection form)
- Drug or Biological Product Form
- HIPAA Authorization Form
- Informed Consent Statement (Form)
- Investigator Brochure
- Medical Device Form
- Protocol (Required for Full Board Studies)
- Recruitment Materials (includes flyers, emails, letters, call script)
- Study Information Sheet
- VA HIPAA Authorization Form
- VA Healthy Subjects Authorization
- VA Informed Consent Statement
- VA Security/Privacy Checklist
- Enter a Description that will help you identify the document, e.g. “Protocol.” Other fields that can be completed if needed, though not required for saving, are Contact Name, Email, Phone, and Comments.
- To add an attachment, click Browse for File Name
- Locate the file and click Open to attach. Note: all commonly used file types should be compatible except for “.msg” (Outlook messages).
- When file returns, click add.
- When all documents have been added, select Save.
When the item is ready for review, it must be submitted in the KC system via the Protocol Actions tab.
- Expedited Studies
- Click ►show on the Request an Action
- Click ►show next to Submit for Review.
- Click submit.
- Full Board Studies
- Click ►show on the Request an Action
- Click ►show next to Submit for Review .
- Click submit.