Restarting Research and Conducting Research Under Current Conditions July 21, 2020 Please use “chat” to ask questions This session is being recorded Human Research Protection Office of Research Protections
Welcome! • Restart considerations and process • Role of other University offices • Consent processes • Consenting options • Conducting visits remotely • Q&A Human Research Protection Office of Research Protections
Let’s first take a look back High Direct Benefit to Research Participants or May Tier 1 Have a High Public Health Priority • IRB petition to enroll subjects Moderate Direct Benefit to Research Participants • Tier 2 IRB petition to enroll subjects or continue face‐to‐ face interactions Low Direct Benefit to Research Participants and Other Impacts to Research Tier 3 • Can only conduct activities that do not require face‐ to‐face interactions Remote Studies that can be carried out entirely remotely with Studies no face‐to‐face interactions Human Research Protection Office of Research Protections
Can I apply to start? Should I apply to Yes, anyone can start? apply for the restart • Risk/Benefit of study process • Study population • Is a subject best served by participation? • Availability of resources • Availability of personnel Human Research Protection Office of Research Protections
Elements of Restart Process IRB Restart Survey School / Unit Restart Plan Lifts COVID-19 Restrictions All studies (including those recently Executed by Dean or Associate Dean approved) must complete survey for Research, Institute Directors, and/or except: Regional Campus Presidents -Documented prior permission from IRB -Final authority to approve the restart -No face-to-face contact required activities of their faculty -Data analysis only or long term follow- up Each study must have a survey entry. Different studies may have different outcomes
Survey Access Human Research Protection Office of Research Protections
Petitioning through Reportable New Information (RNI) Necessary in cases where “petition the IRB” is the outcome of the survey: usually sites other than Pitt/UPMC • Where is the site? • Are these high risk setting/populations (e.g. nursing homes)? • How is pre-screening of subjects and staff occurring prior to the visit? • What PPE and infection control precautions are being taken during visits? Human Research Protection Office of Research Protections
Elements of Restart Process IRB Restart Survey School / Unit Restart Plan Lifts COVID-19 Restrictions All studies must complete survey Executed by Dean or Associate except: Dean for Research, Institute Directors, and/or Regional Campus -Documented prior permission from Presidents IRB -Final authority to approve the -No face-to-face contact required restart activities of their faculty -Data analysis only or long term follow-up Each study must have a survey entry. Different studies may have different outcomes
Research Restart Governance Process From https://www.svcresearch.pitt.edu/pitt-researchers/research-restart, Research Restart for PIs and Faculty Slide Deck
Environmental Health and Safety Health and Safety Related Information for Research Restart https://www.ehs.pitt.edu/ehs-covid-19-resources • Guidelines for Human Subject Research Restart • Research Participant COVID-19 Screening Questions • Cleaning Information • Laboratory Management • Non-Laboratory Workspace management • PPE Guidance Questions? safety@ehs.pitt.edu Human Research Protection Office of Research Protections
Human Resources www.hr.pitt.edu/covid-19 • University operating postures • Personnel concerns • Symptomatic individuals • Remote work • Return to campus
https://www.policy.pitt.edu/university-policies-and-procedures/covid-19-standards-and-guidelines
Consent Considerations Human Research Protection Office of Research Protections
Do I need to add COVID-19 Risks to consent forms?
Think About the Consent Process Traditional consent form Written Informed • Must obtain the written informed consent of the subject or Consent the subject’s legally authorized representative Written informed consent is not obtained • Verbal consent process takes place Waiver to Document • May include scripts or other visual aids Consent • Researcher documents subject’s willingness in research record • Meet regulatory criteria Full Waiver of Consent is not obtained from any subjects in the study • Researcher must justify criteria Informed Consent Human Research Protection Office of Research Protections
Remote Accommodations: Exception, Modification or Nothing at All? A change only for the duration of COVID‐19 restrictions, currently restricted by the protocol Exception • My protocol says study procedures will be completed in person but I want to do it by phone during restrictions A change that will be permanent, regardless of COVID‐19 restrictions or a change that requires regulatory determinations • I’d like to add the option of eConsent for the duration of my protocol Modification • I’d like to request a waiver to document consent instead of obtaining written informed consent • My protocol is exempt • My protocol isn’t specific on in‐person vs other modes and I need no Nothing at All other changes
E-Consent Examples • Signature on tablet • Validated “signature” through online format • Exchange of traditional consent form through electronic means • REDCap or Qualtrics consent process • “click” to participate
Regulatory Questions No Waiver Waiver to Document Use of an e-signature that is an electronic sound, symbol or If you agree to participate in this process attached to or logically study, please click the box below associated with a record and executed or adopted by a person with the intent to sign the record Human Research Protection Office of Research Protections
Let’s think about HIPAA • Use of PHI requires written authorization • Absence of written authorization requires alteration justification • PHI is rarely exchanged during consent process (i.e. platform does not need to be HIPAA compliant) Human Research Protection Office of Research Protections
OHRP eConsent Guidance Electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent • Method for providing copy to participant (does not have to be signed) • Consistent for parental permission and assent • Emphasis on process over form https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html
21 CFR 11: Electronic Records; Electronic Signatures • Generally applies to electronic records created, modified, maintained, archived, retrieved, or transmitted under an FDA regulated study • For electronic signatures and their associated electronic records that meet this part, FDA will consider the electronic signatures equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations • Printed name of signer, date and time, responsibility Human Research Protection Office of Research Protections
21 CFR 11: Electronic Records; Electronic Signatures An electronic signature based upon cryptographic methods of originator Digital authentication, computed by using a set of rules and a set of parameters Signature such that the identity of the signer and the integrity of the data can be §11.3(b)(5) verified Scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a Handwritten writing in a permanent form. The act of signing with a writing or marking Signature instrument such as a pen or stylus is preserved. The scripted name or legal §11.3(b)(8) mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark A computer data compilation of any symbol or series of symbols executed, Electronic adopted, or authorized by an individual to be the legally binding equivalent Signature of the individual's handwritten signature §11.3(b)(6)
FDA COVID-19 Recommendations • Obtain electronically if technology is available • When electronic is not possible: • Have care provider already in contact provide unsigned consent form • Investigator can discuss over the phone or video conference with subject, witness and any others necessary or wanted • ID who is on the call, review consent information, confirmation by the witness that questions have been answered • Confirm willingness to participate • Verbal confirmation by the subject that they would like to participate and have the signed & dated consent form in their possession • Photographs are also acceptable https://www.fda.gov/media/136238/download Human Research Protection Office of Research Protections
Remember… • Regardless of medium, consent MUST include the required elements • Engagement still needs to occur, process happens, memorialization of the process is different • If assent is required, be sure to include that process
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