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.
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.
