The econsent project is a template to be used for those who have approval from the IRB to collect the consent and HIPAA documents for their study electronically. Currently, Palmetto Health only recognizes using REDCap as a way to collect research consents and HIPAA authorizations in situations where a qualified study team member is present with the person being consented. Other uses will be considered on a case-by-case basis. The database contains 3 data collection instruments, one to create a participant record, the second for the study consent, and the third one to create the study HIPAA/Notice of Privacy document. Note that since records are created in the project prior to obtaining consent, the possibility exists that the database will contain completed participant records as well as incomplete records for those cases where consent was not obtained. When using this template, please follow the steps below. If you are new to REDCap and unfamiliar with the basic terminology and features, there are short tutorial videos provided on the REDCap site under the Training Resources tab to help you (HSSC website). Detailed Overview, Data Entry Overview and Online Designer are 3 videos that cover much of the basics you will need.
Using the eregulatory Project Template STEP 1: Create a study folder in REDCap to group your study s databases/projects A. Create the study folder Once on the REDCap site, click My Projects Click the Organize button Enter the name of your study in the text field displayed Click Add Customize the folder and save B. Assign study projects to the folder To assign an existing project to this folder o From the My Projects page click the Organize button o Select the study s folder from the dropdown menu (Step 2: Assign Projects to Folders) o Place a check next to each project assigned to this study folder To assign a new econsent project to this folder check the box provided on the Create New Project screen (STEP 2A below) STEP 2: Access and customize the econsent database for your study A. Download the regulatory project template Click Create New Project Fill in the fields and assign the project to its study folder Enter the date it is being created to Project notes box Select Use a template Select econsent Project Template from the menu Click Create Project B. Review the pre-defined settings and set user rights Settings defined on the Project Setup page: Surveys are enabled Auto-numbering is enabled Settings defined on the Online Designer page: The Consent and HIPAA documents have been enabled as surveys The Survey Queue has been set up to display the HIPAA document when 2 conditions are met: (1) the consent document has been submitted as a survey; and (2) the answer to the HIPAA question in the first instrument is yes. The document will automatically appear once the consent survey is submitted. B. Review the pre-defined settings and set user rights (continued)
User Rights Survey Setting If someone other than the person consenting will be assisting the potential participant and the consenter will be at a separate location, the consenter will need to have Edit Survey Responses rights for the consent document. To enable this from their user rights page: Check the Edit survey responses box for the consent form Click Save Changes C. Customize the 3 data collection instruments From the Project Setup page, click on Online Designer to customize the data collection instruments Edit each of the 3 instruments as follows: For Instrument #1 - Participant Information This instrument consists of 2 required fields and contains a copy of the instructions for this project. Customize as follows: o Edit the eirb PRO# field by adding your study s # as the radio button choice o Return to the list of instruments For Instrument #2 MUSC Consent to be a Research Subject This instrument consists of descriptive text field placeholders for the consent document, 4 required fields to capture participant s first and last name, signature and date of signature, 3 fields to capture full name, signature and date of signature for the consenter, and conditional text that states that all signatures are associated with the PRO# provided in the first form. This statement must appear prior to printing any copies of the consent and will only appear when both signatures and date fields are completed. Customize as follows: o Save your stamped consent document as a JPEG o Make sure you have a descriptive text field in the consent instrument for each page of your consent document the template is set up for 6 pages If your consent has more than 6 pages, copy consent_p6 give the new field the variable field name of consent_p7. Repeat the process if you require more fields, i.e. copy the last descriptive field and give it a variable field name using the naming convention provided until you have one field per page If your consent has less than 6 pages, delete the excess descriptive text fields starting with consent_p6 o Upload the first page of the consent document into the first descriptive text field and select inline image for display type
C. Customize the 3 data collection instruments (continued) o Repeat the process for each subsequent page o When the entire document has been uploaded review the form to verify the pages are in correct sequence and each has the correct stamp o Return to the list of instruments For Instrument #3 Authorization to Use or Disclose (Release) Health Information that Identifies You for a Research Study (HIPAA) This instrument consists of descriptive text field placeholders for the HIPAA document including the Notice of Privacy Practices, 3 required fields to capture the participant s full name, signature and date of signature, 4 fields to capture legally authorized representative (LAR) information if applicable and text that states that the participant signature is associated with the PRO# provided in the first form. This statement must appear prior to printing any copies of the consent and will only appear when the participant s signature and date of signature fields are completed. Customize as follows: o Save your stamped HIPAA and stamped Notice of Privacy Practices documents in JPEG format o Make sure you have a descriptive text field for: Each page of your HIPAA document to appear before signatures (3 fields are provided); and for Each page of the Notice of Privacy Practices to appear after signatures (3 fields are provided) (See consent instrument instructions above to add or delete descriptive text fields) o Upload the first page of the HIPAA document into the first descriptive text field and select inline image for display type o Repeat the process for each subsequent page including the Notice of Privacy Practices o When the entire document has been uploaded review the form to verify the pages are in correct sequence and each has the correct stamp o Delete LAR-related fields if not appropriate for your study o Return to the list of instruments D. When set-up and testing are done, move project to production status STEP 3: Using the template to consent a participant A. Create the participant record Select Add/Edit Records Click Add new record to open the first instrument
Select the radio button for the Study PRO# A. Create the participant record (continued) Select response for Will a HIPAA document need to be signed along with this consent? Select Complete for form status Click Save Record if you are setting up the record prior to consenting the participant and log out or add the next record. Click Save and go to next form if you are setting up the record at the time of consent, and continue on to part B below B. Access record-specific consent form as a survey and submit From the consent form of the participant record created above: Click on the Survey Options menu in the upper right corner Note: You must enter the consent form from the Participant Information form to trigger the Survey Options feature. Select Open Survey and open the survey in a new window Once the form opens as a survey: o Log out of the database o Close out of the browser o Ensure that only the survey remains open Review the consent document with the prospective participant Complete and submit the consent survey following either B1 (participant and consenter are in the same location) or B2 (participant and consenter are in different locations) below: B1: If the prospective participant elects to be a subject for the study and the person consenting is in the same location: o The participant will: Type first and last name in each text box provided o The consenter will Type their name in the text box provided o The statement The above signatures are in association with study: [your study PRO# displays here] will appear at the bottom of the form o Click Submit at the bottom of the consent survey to register the consent document into the record and trigger the HIPAA survey if survey queue logic is met for this record
B. Access record-specific consent form as a survey and submit (continued) B2: If the prospective participant elects to be a subject for the study and the person consenting is in another location: o The participant will: Type first and last name in each text box provide Click Today in the date field o Click Submit at the bottom of the consent survey to register the consent document into the record and trigger the HIPAA survey if survey queue logic is met for this record o Once the consent is received, the consenter will Enter the consent form of participant s record Click Edit survey responses Type their name in the text box provided o The statement The above signatures are in association with study: [your study PRO# displays here] will appear at the bottom of the form o The consenter will save the record C. Complete the HIPAA/Notice of Privacy Practices document By default the HIPAA survey is queued to open automatically once the consent is submitted as a survey and the logic is satisfied Review the HIPAA and Notice of Privacy Practices documents o The participant will: Type first and last name in the text box provided o If a LAR is required, complete the appropriate fields o The statement The participant signature above is in association with study: [your study PRO# displays here] will appear at the bottom of the form o Click Submit at the bottom of the HIPAA survey to register the HIPAA document into the record
STEP 4: Printing a PDF version of a signed document from a single record (OPTIONAL) STEP 5: Handling amendments Click Add/Edit Records Select the record of interest from the dropdown menu Select the form of interest from the left side of the screen Click Download PDF of instruments(s) at top of page Select this data entry form with saved data to create the PDF Print the document Note: you can also download all the documents associated with a record from the PDF dropdown menu A. Create a new econsent database Follow the process outlined above in STEP 2 to create a new econsent database Make sure to append the study name with the amendment tag from eirb B. Extract and store data from existing database Export the data captured in the consent status report The database template contains a consent status report that captures: (1) record ID; (2) consent form status; (3) first and last name of person being consented; and (4) date of signature. It is sorted by name and then date but also contains a live filter based on consent status. From Data Exports, Reports and Stats>My Reports and Exports>Edit o Rename the consent status report with the name of the database and date created o Export the data and save on secure server Download a PDF of all records with data From Data Exports, Reports and Stats>Other Export Options>PDF o Download the PDFs with data for all records o Save with report data on secure server C. Archive the existing database From the Project Home page of the completed econsent database, select the Other Functionality tab Click Archive the Project to remove it from the My Projects list and take it offline Click Archive the Project on the popup screen