Restarting Research and Conducting Research Under Current - - PowerPoint PPT Presentation

Human Research Protection Office of Research Protections

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

Tier 1 High Direct Benefit to Research Participants or May Have a High Public Health Priority

• IRB petition to enroll subjects

Tier 2 Moderate Direct Benefit to Research Participants

• IRB petition to enroll subjects or continue face‐to‐

face interactions Tier 3 Low Direct Benefit to Research Participants and Other Impacts to Research

• Can only conduct activities that do not require face‐

to‐face interactions Remote Studies Studies that can be carried out entirely remotely with no face‐to‐face interactions

Human Research Protection Office of Research Protections

Can I apply to start? Yes, anyone can apply for the restart process Should I apply to start?

• Risk/Benefit of study
• Study population
• Is a subject best served

by participation?

• Availability of resources
• Availability of personnel

Elements of Restart Process

IRB Restart Survey

Lifts COVID-19 Restrictions All studies (including those recently approved) must complete survey except:

• Documented prior permission from IRB
• No face-to-face contact required
• Data analysis only or long term follow-

up

School / Unit Restart Plan

Executed by Dean or Associate Dean for Research, Institute Directors, and/or Regional Campus Presidents

• Final authority to approve the restart

activities of their faculty

Each study must have a survey entry. Different studies may have different outcomes

Human Research Protection Office of Research Protections

Survey Access

Human Research Protection Office of Research Protections

Petitioning through Reportable New Information (RNI)

• 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?

Necessary in cases where “petition the IRB” is the outcome of the survey: usually sites other than Pitt/UPMC

Elements of Restart Process

IRB Restart Survey

Lifts COVID-19 Restrictions All studies must complete survey except:

• Documented prior permission from

IRB

• No face-to-face contact required
• Data analysis only or long term

follow-up

School / Unit Restart Plan

Executed by Dean or Associate Dean for Research, Institute Directors, and/or Regional Campus Presidents

• Final authority to approve the

restart activities of their faculty

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

Human Research Protection Office of Research Protections

Environmental Health and Safety

• Guidelines for Human Subject Research Restart
• Research Participant COVID-19 Screening Questions
• Cleaning Information
• Laboratory Management
• Non-Laboratory Workspace management
• PPE Guidance

Health and Safety Related Information for Research Restart

https://www.ehs.pitt.edu/ehs-covid-19-resources

Questions? safety@ehs.pitt.edu

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

Human Research Protection Office of Research Protections

Consent Considerations

Do I need to add COVID-19 Risks to consent forms?

Human Research Protection Office of Research Protections

Think About the Consent Process

Written Informed Consent Traditional consent form

• Must obtain the written informed consent of the subject or

the subject’s legally authorized representative Waiver to Document Consent Written informed consent is not obtained

• Verbal consent process takes place
• May include scripts or other visual aids
• Researcher documents subject’s willingness in research record
• Meet regulatory criteria

Full Waiver of Informed Consent Consent is not obtained from any subjects in the study

• Researcher must justify criteria

Remote Accommodations:

Exception, Modification or Nothing at All?

Exception A change only for the duration of COVID‐19 restrictions, currently restricted by the protocol

• My protocol says study procedures will be completed in person but I

want to do it by phone during restrictions Modification 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
• I’d like to request a waiver to document consent instead of obtaining

written informed consent Nothing at All

• My protocol is exempt
• My protocol isn’t specific on in‐person vs other modes and I need no
• ther 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

Human Research Protection Office of Research Protections

Regulatory Questions

No Waiver

Use of an e-signature that is an electronic sound, symbol or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record

Waiver to Document If you agree to participate in this study, please click the box below

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)

OHRP eConsent Guidance

• Method for providing copy to participant (does not have to be

signed)

• Consistent for parental permission and assent
• Emphasis on process over form

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

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html

Human Research Protection Office of Research Protections

• 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

21 CFR 11: Electronic Records; Electronic Signatures

21 CFR 11: Electronic Records; Electronic Signatures

Digital Signature

§11.3(b)(5)

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified Handwritten Signature

§11.3(b)(8)

Scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark Electronic Signature

§11.3(b)(6)

A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent

• f the individual's handwritten signature

Human Research Protection Office of Research Protections

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

Remember…

• Regardless of medium,

consent MUST include the required elements

• Engagement still needs to
• ccur, process happens,

memorialization of the process is different

• If assent is required, be

sure to include that process

Human Research Protection Office of Research Protections

PA Supreme Court Decision

“A physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed

• consent. Informed consent requires direct communication between

physician and patient, and contemplates a back-and-forth, face-to- face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent.”

Shinal v. Toms, 31 MAP 2016, 2017 Pa. LEXIS 1385, at *52 (Pa. 2017) (emphasis added). All prior decisions holding otherwise are overruled. Id. at 53.”

Human Research Protection Office of Research Protections

What falls under the ruling?

• 1. Performing surgery, including the related administration of

anesthesia.

• 2. Administering radiation or chemotherapy.
• 3. Administering a blood transfusion.
• 4. Inserting a surgical device or appliance.
• 5. Administering an experimental medication, using an

experimental device or using an approved medication or device in an experimental manner.

University of Pittsburgh Policy

Studies involving drug, device or surgical procedure: PI or Co‐I who is a licensed physician must obtain consent Greater than Minimal Risk Study

(does not involve drug, device or surgical procedure) :

PI or listed Co‐I must

• btain consent

Minimal Risk Study: Listed investigator must obtain consent

Can request and justify a licensed health care professional in lieu

• f physician

Can request and justify an exception to a listed investigator

Individual must sign Investigator’s Certification at time of involvement

Human Research Protection Office of Research Protections

Conducting visits remotely

Pitt licensed versions:

• Skype for Business
• MS Teams
• Zoom (request HIPAA

compliant version )

• Vidyo (UPMC)

Method depends on the sensitivity of the information to be disclosed during the visit and if it will be recorded

Data Security:

• Recording storage
• Up-to-date anti-virus protection
• Storage in Pitt/UPMC cloud or

University-managed server NOT one size fits all approach!

Human Research Protection Office of Research Protections

Q& A

Please use chat function to ask questions