E-Consent
Consent by Phone
Short Form
COVID-19 Guidance
FINAL Jeopardy FUN
100
How does the Colorado State Law define electronic signature?
Colorado state law defines an “electronic signature” as 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.
Bonus info: This definition is also used in the federal E-SIGN Act. For purposes of human subjects research, COMIRB requires that subjects type or sign (e.g., with a stylus or their finger) their name and date on the eConsent form
100
What tools has the University formally approved to use for confidential HIPAA data.
The University has formally approved the following audio/video applications for use with highly confidential/HIPAA data: Zoom, Skype for Business, Microsoft Teams.
Bonus info: In addition, our affiliate health care systems each have telehealth systems (e.g., Vidyo) which may be used for patientfacing encounters. If you are using a telehealth system with one of our affiliate health care systems, be sure this use is in compliance with health system policies.
100
What are the 4 parties generally involved in the short form consent?
Enrolling a non-English speaking participant with a Short Form generally involves four parties:
1. The participant
2. The person obtaining consent
3. An interpreter (might not be needed if the person obtaining consent is fluent in the language)
4. A witness to the oral presentation
Bonus info: The approved English version of the consent form is used by the person obtaining consent and the interpreter to obtain consent and to make sure all the elements of informed consent have been presented orally to the participant or participant’s legally authorized representative (LAR).
100
Is IRB approval sufficient for research to proceed?
NO, IRB approval alone is not sufficient for research to proceed. The COVID-19 pandemic has necessitated a site approval process to ensure necessary resources are in place to support the conduct of research in compliance with University and affiliate screening, space, distancing and PPE requirements.
100
Name the green Character from Guardian's of the Galazy
WHY Is GAMORA
200
Daily Meme Double!
Who is the Gentleman that became meme famous for sitting in a chair during President Biden's inauguration?
Bernie!
200
Do we need COMIRB approval to permanently move study visits from in-person to over videoconferencing?
: Yes, COMIRB approval would be required before implementing these changes to make sure risks are minimized. Carefully consider any changes before implementing them. For example, moving study visits from a clinic to the subject’s home, in the current environment, would need to involve new screening procedures for the subjects, the household members, and for your research staff. Such a change may also require additional staff training and protective gear, which is in very short supply at this time. Moving study visits from clinical locations to campus non-clinical locations is not advisable. Contact COMIRB if you wish to discuss whether some study procedures could be moved to new locations.
200
If the participant agrees to be in the study who signs what?
If the participant agrees to be in the study:
1. The English version of the consent form is signed by the person obtaining consent and the witness.
2. The short form is signed by the participant and the witness.
3. The stand-alone HIPAA Authorization is signed by the participant.
200
Do Federal regulations and COMIRB policies allow researchers to make changes to eliminate apparent immediate hazards to subjects without IRB approval?
Yes! Federal regulations and COMIRB policies allow researchers to make changes to eliminate apparent immediate hazards to subjects without IRB approval. If the state, county or University implements new restrictions to mitigate a public health emergency, researchers are obligated to respond but those actions do not need to be reported to or approved by COMIRB
300
The website for an eConsent application I want to use states it is fully complaint with 21 CFR Part 11. Is that all that is needed for 21 CFR Part 11 compliance?
No, an eConsent application is not complaint with 21 CFR Part 11 on its own. The application must be licensed by the University or one of our affiliate health care systems and then certified as 21 CFR Part 11 complian
300
The website for a videoconference application the PI wants to use says on its website that it is HIPAA compliant. Can’t we use it?
No, a videoconference application is not HIPAA-compliant alone. In particular, it is not HIPAA-compliant without a legally-binding Business Associate Agreement (BAA) with the University or with one of our affiliate health care systems. Contact the OIT for an assessment
300
What should be indicated in the research records and on the English consent form?
A statement in the research records (and on the English consent form) should indicate that the participant did not speak English and identify the interpreter
300
If a research subject acquires COVID and it is not directly related to research does it need to be reported?
NO! If a research subject acquires SARS-CoV-2 infection and is not directly related to the research, it does not require reporting to COMIRB, within 5 days or at time of continuing review. An example of when SARS-CoV-2 infection would need to be reported is if a research subject becomes infected specifically because a research team did not follow if campus policies and space plans for COVID-19
400
Can eConsent be used for a proxy or Legally Authorized Representative (LAR)?
Yes. COMIRB must first approve the use of a proxy or LAR for consent and the process for obtaining eConsent. As a reminder, under Colorado State law, a proxy may only be used for consent for research for studies which might provide direct benefit to the subject. State law, University and health system policies must also be followed for properly identifying a proxy or a LAR.
400
Our protocol currently requires written consent, how can I obtain consent during a telehealth session?
Contact COMIRB if you wish to discuss whether conducting a consent process over telehealth is feasible. COMIRB approval would be required before implementing the new consent procedure.
400
Daily Meme Double
In the middle of the Vice Presidential debate what landed on Mike Pence Head?
In the middle of the Vice Presidential debate, a fly landed on the Malfoy-white head of Vice President Mike Pence.
400
The study site is requiring all research subjects be tested for SARS-CoV-2 before the study visit. Do I need COMIRB approval for this testing?
It depends. If the SARS-CoV-2 testing is charged to the subject as a clinical test, COMIRB approval is not needed. If the cost of the SARS-CoV-2 testing is covered by research funding, the testing is a research activity and should be described in the protocol and consent form, and requires COMIRB approval.
500
Can eConsent be used for documenting assent?
Yes, although documentation of assent can be accomplished through other means. For example, for clinical research the study team may be required by the hospital to document assent in the medical record. Describe your plan in the COMIRB application, as COMIRB must approve the assent process.
500
Which section of the IRB application needs to be updated in order to obtain consent by phone or video?
The COMIRB application, Section L
Bonus info: it should address these issues: • The prospective subject must have a written copy of the approved consent form “in-hand” at the time of the informed consent discussion. • The discussion should begin with identification of who is participating on the call/video, and an inquiry to confirm that the potential subject has a copy of the consent form. • For FDA-regulated research, an impartial witness must be involved in the phone consent process. If the subject agrees to participate, the witness should sign their copy of the consent form. Include the following under the signature line for the witness: “The subject’s questions were answered, and the subject agreed to participate.” The additional language must be approved by COMIRB. • A copy of the signed consent form (and HIPAA Authorization) must be received by the study before any research procedures are conducted on the subject. The IRB application must address how this will be ensured. • If the research involves one of our affiliate health care systems, hospital policies regarding uploading the signed consent form to the medical record must still be followed.
500
What if the protocol is not approved for enrollment of non-english speaking participants?
If your protocol is not approved for the enrollment of non-English speaking participants and there is insufficient time to obtain such approval prior to enrolling a participant, and there is appropriate justification for using the short form without approval, you must submit an Unanticipated Problem form to report the use of the short form without COMIRB approval. Additionally, you should submit a concurrent amendment to request approval for any future enrollment of non-English speaking participants
500
Is it a deviation if we deviate from the approved protocol to eliminate hazards to subjects?
Yes! Protocol deviations: If researchers deviate from their approved protocol to eliminate apparent immediate hazards to subjects, that does not require COMIRB approval and does not fall under COMIRB 5-day reporting requirements assuming the deviations are considered temporary and are relatively minor. Researchers should document these deviations in their research records