Remote Study Activities Guidance
Even as limited in-person study activities are beginning to be allowed back on campus, the pandemic demands that if study teams can perform research activities remotely, they should do so. Therefore, many studies are thinking creatively on how to accomplish their research without in-person interactions. For existing studies, these changes must be approved in advance by the IRB as a change of protocol, unless they are necessary to eliminate apparent immediate hazards to participants. This page is intended to assemble IRB guidance to help study teams plan for how recruitment, research interventions, and data collection will occur remotely.
- Recruitment by phone or mail: If a study team is identifying potential subjects based on information within their electronic health care record, the initial contact about the research study should come from someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information. Please review Initial Recruitment Contact and Screening Guidance for more information.
- Recruitment by email: If you will be recruiting subjects through email, please review Use of Email for Research Purposes Guidance.
- HIPAA permission-to-contact: Study teams whose members are not part of UW-Madison Health Care Component (HCC) or the Affiliated Covered Entity (ACE) but who need to recruit clinical patients for a study must use a specific HIPAA authorization form to obtain permission to contact these patients when the initial contact with the patients occurs in person. Please see What if my study team is not affiliated with a clinical department or unit but we need to recruit patients for our study? for more information. That process remains in place for remote recruitment if PHI will be transferred from the HCC/ACE to a study team outside the HCC/ACE. If it is not feasible to get a signed permission-to-contact form remotely, consider whether you could alter your recruitment process to avoid that data transfer, e.g. subjects opt-in to your study (their clinician refers the patient to your study website, where the patient can enter their information if they want to learn more). If remote permission-to-contact is required, you may justify altering HIPAA authorization to waive the signature on the permission-to-contact form. Contact your HIPAA Privacy Coordinator with questions.
- Emailing consent/authorization forms to subjects: If you will be emailing subjects, please review Use of Email for Research Purposes Guidance. Note that privacy protections mandate that because email is not considered secure, you must obtain permission from the recipient prior to emailing attachments that contain health information – such as informed consent forms and information sheets. Study teams could get verbal permission over the phone, or build in electronic permission if your recruitment process has the subject filling out an online form to request more information. Once you have that permission, you can email a consent form or information sheet to subjects. Even with subject permission, the email should contain as little health information as is necessary to convey the intended message.
Remote Consent and HIPAA authorization
- Waiver of signed consent: If your study is minimal risk then you could likely get approval for a waiver of documentation (also called a waiver of signed consent, see Waiver of Signed Consent), so that you do not have to obtain signatures on your consent form. This means that consent could be obtained over the phone, through the mail (e.g. a consent form without signature lines mailed to subjects along with a questionnaire or other study collection tools), through an online form, or any other method that obtains consent from subjects without needing to obtain a signature on the consent form. For more examples, see the FAQ How do I obtain informed consent remotely?.
- Alteration of HIPAA authorization: If your study falls under HIPAA and you plan to waive signed consent, you also must request an Alteration of HIPAA Authorization to waive the signature from your consent/HIPAA authorization form.
- Receiving signed consent/authorization forms by email: If you will be communicating with subjects by email, you must have language in your consent form about the risks of email communication. If your study must obtain signed consent and you would like subjects to return the consent form by email and the form may reveal information about the potential subject’s health (e.g., “You have been invited to participate in this study because you have [disease/condition],”), then the subject should not email the signed form to the study team unless you get their prior permission to communicate with each other through email for research purposes (see “Emailing consent/authorization forms to subjects”, above). If the subjects are unable to attach a scanned copy of the signed form, emailing a picture of the form is permissible. It is best practice for the subject to email a picture of the entire consent form, because then the study team has a record of what information the subject received, and the full document that was signed. If it is not possible to send back the entire form, the subject should email the signature page(s) as well as any pages requiring subject responses, such as checkboxes or initials. In cases where the entire form is not provided, study teams should confirm that the version date and IRB stamp is visible on the page(s) received, in order to document that the subject signed the correct version. The email from the subject can also provide documentation of timing of receipt and should be retained in the research records. For more information, please see FAQ How do I obtain informed consent remotely?.
- Electronic signatures guidance:
- If your study requires signed consent (i.e. cannot justify a waiver of signed consent) and you intend to use electronic (digital) signatures rather than handwritten signatures, best practice is to obtain electronic signatures using a method that complies with FDA Part 11 requirements, such as the Part 11 version of DocuSign through the UW-Madison licensed version.
- If your study requires signed consent (i.e. cannot justify a waiver of signed consent) but the study is not FDA regulated, then you have more flexibility about the possible software or system. Per the US Office of Human Research Protections (OHRP), this could include “the use of a secure system for electronic or digital signature that provides an encrypted identifiable ‘signature.’ If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of recordkeeping.” In other words, it would satisfy requirements in case of an audit. DocuSign may be an option, but you would not need the Part 11 module and DocuSign is not the only option.
- For more information about electronic signatures please see the recent FAQ, How do I obtain informed consent remotely? and Documenting Consent Electronically or for Remote Subjects Guidance.
Remote study activities
- Impact on risks to subjects: Please consider whether the risks of any study activities may change with the shift to remote activities. E.g. physical interventions, like exercise, that used to occur in a clinical space and now are occurring in subjects’ homes. What protections can you add to address the added risk of being remote?
- Software for remote visits: Please see the FAQ What software platforms can I use to conduct remote visits or procedures?
- HIPAA-compliant data transfer and storage:If your study falls under HIPAA, all remote activities must be completed via one of the permitted and approved tools for exchanging and/or storing Protected Health Information in accordance with HIPAA, noted in guidance posted on this HIPAA page.
Additional guidance for ongoing research projects
- If you are new to submitting changes of protocol in ARROW, please review the Guidance on Presenting Changes of Protocol to IRB .
- A minor change in previously approved research may be expedited, which means that the change is reviewed by one IRB Member instead of the entire Board. Please see Expedited Change of Protocol Guidance for information on what constitutes “minor”, including a table of examples.
- For exempt studies, a change does NOT need to be submitted to remove study activities as a result of COVID-19.
- When submitting a COVID-19-related change, please note this in the submit activity form so we can prioritize these changes appropriately.
- Implementing Changes to Eliminate Immediate Hazards to Subjects Guidance can be done prior to receiving IRB approval.
- Other changes to study visits NOT intended to eliminate an apparent immediate hazard to subjects, must be by approved by the IRB before being implemented.