Frequently Asked Questions related to restart of research
On June 1, 2020, IU began the process of restarting research which had been paused due to the COVID-19 pandemic. Detailed information, resources, and FAQs regarding the restart of research are available on the Vice President for Research’s Coronavirus website. Answers to most questions regarding process and protections can be found on the Research Restart site.
In-person research activities that were designated as “essential” may continue but must comply with the protection procedures described in the Research Restart Checklist and must complete the Return to On-Campus Research Form no later than July 1, 2020.
Yes. If your research (or parts of your research) can be conducted remotely, you should continue to conduct it remotely. This change to remote conduct of the research should have been submitted to the IRB as an Amendment. If you did not previously obtain approval, submit an Amendment requesting approval as soon as possible. If you have approval to conduct procedures remotely “during the COVID-19 pandemic” (or similar), this approval is still valid and remote procedures can and should continue.
You do not need to notify the IRB, or obtain IRB approval, prior to restarting human subjects research paused due to the COVID pandemic. However, as described in the Research Restart Guidelines, you must obtain approval of your department chair, school dean, or other official and complete the Return to On-Campus Research Form prior to restarting research. Additionally, carefully review the FAQs below to determine whether any planned changes to the conduct of your research may require an Amendment.
No. Screening for symptoms and risk factors prior to a research visit is not considered a research procedure and, therefore, does not require an Amendment. Screening questionnaires and symptom checks (e.g., temperature screenings upon arrival) can be implemented without IRB approval. However, the results of such screenings should not be kept as part of your research files or used for research purposes. If you do want to use this information as research data, an Amendment is required.
No, as long as subjects will still sign the consent form. Flexibility to the consent process is allowed without an amendment. However, you still need to obtain a signature documenting consent (unless the IRB previously approved a waiver of documentation of consent). The subject can return the signed consent to you at an in-person visit, electronically via fax or e-mail, or via mail. Study procedures cannot begin until you receive a copy of the signed consent.
If you would like to request a waiver of documentation of consent (verbal consent only with no signature from the subject), this will require an Amendment. Additional information regarding flexible consent procedures and the proper processes for obtaining consent over the phone are described in our Informed Consent Guidance.
Yes. RedCap’s e-Consent Framework can be used to obtain signatures electronically for non-FDA regulated studies. More information regarding electronic signatures for FDA-regulated studies can be found at the bottom of this FAQ. The remaining information regarding RedCap applies only to non-FDA regulated studies. If subjects will be signing the informed consent using an electronic system, this should be indicated in your IRB submission; this will require submission of an Amendment if not previously approved by the IRB.
Obtaining signatures electronically in RedCap requires you to build the consent form directly in RedCap. Therefore, you will not be able to use the stamped informed consent document. As long as the format and content of the consent form are consistent with the IRB-approved version, use of an unstamped version is acceptable when the IRB has approved the use of an electronic signature system. Unless the IRB grants an exception, the individual conducting the consent process (the “person obtaining consent”) will also need to provide a signature electronically in RedCap. Additionally, if HIPAA Authorization is required for your study, be sure to build the Authorization form into RedCap (unless you plan to separately obtain an ink signature on the Authorization).
The IU RedCap support team has provided the following information regarding use of RedCap to document consent. If you have additional questions regarding RedCap functionality, contact Catherine Bauer-Martinez at catbauer@iu.edu.
How the e-Consent Framework works: The 'Auto-Archiver + e-Consent Framework' survey option adds two things to the typical survey-taking process. 1) Before a participant completes the survey, an extra certification page is added to the end of the survey that displays an in-line PDF copy of their survey responses in which they will be asked to confirm that all information in the document is correct. Once they confirm all is correct, the survey will then be marked as complete. The survey will not be considered complete until they fulfill the certification step. 2) Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository. The consent-specific PDF will have the values of the e-Consent Framework Options inserted at the bottom of each page in the PDF. These values (i.e., name, date of birth, etc.) are added to the PDF as extra documentation of the identity of the consenting person.
Why is this called a 'framework'? The 'e-Consent Framework' is referred to as a 'framework' because enabling this option alone does not provide an e-Consent process but merely provides the general framework or mechanism to allow you to provide e-Consent to patients/subjects. As a research team member, you must still create your e-Consent survey and all the questions in it, including name, address (if you are using RedCap to document HIPAA authorization in addition to informed consent), and how you wish to capture the signature. This framework allows you to implement your e-Consent process by providing standardized tools (certification screen + automatic storage of consent form as a 'hard-copy' PDF) while still providing the ability to customize your survey how you wish.
How can the 'signature' process be handled for e-Consent? Subjects can 'sign' their consents by typing in their name or by utilizing REDCap's 'Signature' field type (i.e., 'wet signature') on the survey. One might also assign PINs to prospective participants to aid in the signature process. Please note that the signature process will NOT be implemented by REDCap automatically, so it is your responsibility as a research team member to construct your survey using one of the methods above for the signature to get captured appropriately. Coordinators or research team members can also sign the e-consents after the participant has consented if remotely or at the same time if consent is completed in person. If the person obtaining consent will be signing at a later time, e.g., because the consent process is conducted remotely, this may require an additional document since the e-Consent Framework cannot be edited once it is completed by the subject.
What is the e-Consent version and type? e-Consent version and type are both free-form text fields whose value will be inserted at the footer of each page in the PDF. Versioning of a form is a concept whereby you may give it a number or alpha-numeric designation to represent the current version or state of the form. So if the form is modified AFTER data collection begins, then it is recommended that a new version be applied. For example, the first version might simply be '1', and after collecting the consent of a few participants, a question is modified or added, which represents a new version of the form, so you might increment the version to '2' (and so forth). The e-Consent 'type' is optional
Electronic consent signatures for FDA-regulated research
Use of electronic signatures for FDA-regulated research implicates 21 CFR 11 (Part 11). RedCap’s signature functionality is not certified as being Part 11 compliant, so it should not be used for FDA-regulated studies. For FDA-regulated studies, you may be able to utilize Adobe’s electronic signature capabilities. IU does not, at this time, provide any policies, procedures, or compliance support around Part 11 compliance for FDA-regulated studies utilizing electronic signatures for consent. Additional information regarding Part 11 compliance can be found on the FDA’s website.
It depends. Changes such as those described above – implementation of screening protocols and remote consent processes – do not require an Amendment. However, changes to research procedures – such as changing an in-person visit to a telephone visit, combining study visits, eliminating procedures, or reducing the overall duration of subject participation – do require review and approval by the IRB prior to implementation of the change.
If restarting your research safely requires such a change, you must submit an Amendment and obtain IRB approval prior to restarting your research. If you have any questions regarding whether the particular change you are planning would require an Amendment, please contact the HRPP at irb@iu.edu for assistance.
Usually not. The protection procedures described in detail in the Research Restart Guidelines and summarized in the Research Restart Checklist have been designed to minimize the risk of transmission of the virus while allowing research to resume. Provided the research is conducted in full compliance with these protection procedures, the IRB does not consider the risk of contracting coronavirus to be a risk that is specific to participation in the research. Therefore, the IRB does not require the risk language in Informed Consent Statements to be updated in order to restart research.
Yes. A general information sheet about what you are doing to protect subjects can be used. You do not need to obtain IRB approval to provide this to subjects. However, any such information sheet should be carefully drafted to ensure they do not function as informed consent documents or recruitment materials which would require IRB approval. We recommend focusing on protection procedures you are implementing and how the subject’s visit may change. For example, you could inform them you will call them the day before their visit to screen them for any symptoms, that they will be asked to call when they arrive for the visit to ensure individuals are not waiting together in a waiting room, that research staff will wear masks and that they will need to as well (including that you will provide one if appropriate), etc.
While not required, if you would like HRPP staff to review your proposed information sheet to ensure it includes only appropriate information, please send a copy to Beth Johnson via email at bwinnie@iu.edu.
No. Requesting subjects to sign such a form is not permitted without IRB review and approval. Additionally, it is likely the IRB would discourage the use of such a form. While providing information to subjects regarding protection procedures and safe conduct of the research is encouraged, requiring them to sign a document related to these practices is not recommended.
Please email the Biosafety Office at ibc@iu.edu to obtain:
A list of alternate risk group 2 viruses, to assess if any of these can be used in place of the SARS-CoV-2 risk group 3 virus and;
The SARS-CoV-2 BL3 request form for review by the BL3 subcommittee.
Be sure to include on the request form why the risk group 2 alternatives could not work for your experiments.
Please email the Biosafety Office at ibc@iu.edu to obtain the SARS-CoV-2 BL3 Request Form to have your experiments completed in the IUPUI BL3 facility.
At the top of the request form, be sure to include funding which is already secured as well as proposals you have submitted to request additional funding.
At the bottom of the form be sure to state when you would like to start the experiments (i.e. September 2020) and how long you expect those experiments to run (e.g. four months).
At this time only IUPUI has a BL3 space. If you are at IUB or a regional campus, contact the Biosafety Office at ibc@iu.edu to discuss what alternatives may be available.
Your IBC protocol will need to be updated to include this work. The samples can be worked at BL2, but you cannot culture these samples unless the work is done in a BL3 space.
Be sure to submit an IBC amendment to cover all new work you are proposing for your lab.
Research Integrity
IU Bloomington Responsible Conduct of Research Seminar Series has moved online due to the COVID-19 pandemic and sinceflexibilities have been provided by NIH during this time.
Undergraduate, graduate students, postdoctoral fellows, trainees, and any other research personnel may complete training requirement for responsible conduct of research (RCR) by completing Collaborative Institutional Training Initiative (CITI) RCR modules.
CITI’s RCR modules vary per discipline to include Research Misconduct, Data Management, Authorship, Peer Review, Mentoring, Conflicts of Interest, Collaborative Research, Financial Responsibility, Using Animal Subjects in Research, Research Involving Human Subjects.
CITI Program will store/record completion reports, view or print for your records.
If you have questions about this requirement, please contact our office at rio@iu.edu.
The NSF requirements during the COVID-19 pandemic have not changed.
As a reminder, the NSF requires that each institution submitting a proposal certify that it has a plan to provide appropriate training and oversight in the ethical conduct of research to all undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.
This policy requires that Institutions are responsible for verifying training has been received.
To meet the NSF RCR training requirement, undergraduates, graduate students, and postdoctoral researches receiving NSF funding need to successfully complete IU’s two-part program:
Complete online CITI module in Responsible Conduct of Research (RCR) and
Discipline-specific mentoring by the principal investigator and lead investigators during the course of the grant.
The Office of Research Compliance will conduct audits of online completion of CITI RCR training and will notify individuals when they are non-compliant.
