Remote and Online Consent
The increase of remote and online research tools has increased the need for methods of collecting consent that extend beyond pen and paper. This guide will introduce and detail the following:
- Requirements for all types of consent
- Methods to gain online or verbal consent
- Sample language for online/remote consent, parent permission, and assent
- considerations forremote consent
When engaging in the consenting process, researchers will present participants with consent, permission, or assent forms. If appropriate, researchers and participants will discuss the study activities, and throughout the study and between activities, the researcher will ask the participant if they are willing to continue. The researcher can remind the participant that the study is voluntary, that they can skip any questions, and that they are free to stop participating at any time.
Teachers College Institutional Review Board (TC IRB) has provided the following templates to aid researchers in developing consent materials:
- Informed Consent Form Template
- Assent Form Template
- Parental Permission Form Template
- Verbal Informed Consent Template
Researchers should use TC IRB-approved consent, parent permission, and assent form templates for all studies involving human subjects. Where appropriate, researchers can adapt TC IRB templates for online data collection. When preparing consent (permission or assent) documents for online studies, the consent process must be:
Authenticated: Researchers must be sure that the person receiving the consent, parent permission, or assent form is the intended individual. Authentication can occur by linking Qualtrics surveys to specific email addresses, verballyover the phone, or face-to-face through Teachers College Information Technologies (TC IT) approved video (teleconference) platforms (e.g., Zoom). If a face-to-face interaction is not possible, the researcher must take additional steps to ensure confirmation that the person signing (or acknowledging) the consent form is the intended individual. Qualtrics has aguide for linking surveys to specific email addresses. Researchers may also use voice (Zoom or telephone) confirmation or identity verification methods (e.g., TC UNI) to confirm the identity of the individual wishing to engage in the study.
Documented: Researchers must have confirmation that the intended individual provided their consent, permission, or assent on a specific date. Documentation can occur through an automated date stamp record, an electronic tracking system that verifies that the event occurred, or a manual entry from the participant. For verbal consenting (or assenting) processes, the researcher can sign and date the “researcher verification” section to confirm that they described the study in a clear and understandable way to the individual being recruited.Researchers must provide subjects with a version of the consent (permission or assent) form that they can retain for their records, whether it is a hard copy or an electronic version. In an online survey, the researcher can provide a PDF downloadable version of the consent form for the participant to access (review our for a sample).
Retrievable: The researcher must be able to retrieve the consent, permission, or assent form when asked by the research participants, an IRB official, or a fellow research staff member. Retrieval can occur digitally or through aphysical, signed document. An example of a digitally retrieved consent form may include a scanned copy of the consent form or an electronic tracking system (like an acknowledgment online through Qualtrics). Consent (assent or permission) documents must be stored in readily accessible locations that are secure, monitored, and well-managed.
Gaining Consent Online or Verbally
In some online contexts, researchers may elect to use a survey platform to gain consent. TC Information Technologies (IT) has a guideon how tocreate a consent form using Qualtrics' survey platform.Depending on the nature of the study,researchers may replace signature lines with clickable “I agree” options, such as checkboxes. Researchers can adapt the standard TC IRB template and replace the signature line at the end of the document with text explaining the online consent process (review the section below for sample language). If researchers choose to use a survey platform to obtain consent, they must provide participants with the option to download a copy of the TC IRBstamped informed consent. Researchers can provide this option at the bottom of the consent page.
If researchers choose to use a survey platform to obtain consent, they must provide participants with the option todownload a copyof theTC IRBstampedinformed consent.
Researchers engaged in low-risk exempt studies may consider using verbal consent forms or verbal assent processes when engaging in online settings (e.g., Exempt Verbal Consent template). For example, a researcher may email the parent or guardian of a child and ask them to review the parent permission form via email. The researcher may ask the parent or guardian to have a discussion with their child about their interest in participating in a study. Then, if the parent and child are interested in proceeding, the researcher can schedule a Zoom meeting. At this point, the researcher can summarize the content of the verbal consent form and gain verbal permission (from the parent/guardian) and verbal assent (from the child).
TC IRB will review each study submission on a case-by-case basis and work with researchers to determine the best course of action for protecting participants and engaging in the consenting process. The IRB will consider:
- The risk level of the study and how to best engage in consent (permission or assent).
- How the electronic signature (telephone or verbal affirmation) is communicated to potential participants.
- Whether the consent (permission or assent) process is clear and understandable.
- If the electronic signature can be shown to be legitimate, such as with an authenticated timestamp.
- How the researcher plans to provide a version of the consent (permission or assent) form to the potential subject for their review and retention.
Below are samples of language that could be used for obtaining consent online, based on the medium of consent:
Using Qualtrics to Obtain Adult Consent (18+) for an Online Survey (No Identifiers):
- “By checking the “I agree” box, you agree to participate in this study. You also confirm you are 18 years or older and [list inclusion criteria]. To agree: Check the “I agree” box below and then click next to participate in the study. If you do not wish to participate in this study, simply close out of this browser window.”
Using Qualtrics to Obtain Adult Consent (18+) for an Online Survey (With Identifiers):
- “By checking the “I agree” box and typing your name, you are electronically signing this consent form to participate in this study. You affirm that an electronic signature has the same effect as a written signature. You also confirm you are 18 years or older and [list inclusion criteria]. To agree: Check the “I agree” box and click NEXT to participate in the study. If you do not wish to participate in this study, simply close out of this browser window.”
Using Telephone, Email, or United States Postal Service (USPS):
- "An Informed Consent form will be emailed to each participant in the study.If the study participant is not able to scan and email back the form, a form will be mailed with a self-addressed and stamped envelope. Participant addresses will not be kept. Informed Consent forms will be scanned or placed and put in a password-protected file on the researcher's private computer."
- Studies that pose more than minimal risk, or that involve the transmission of sensitive information, may consider implementing a process by which the researcher confirms identities using authentication that relies upon multiple factors, liketelephone, email, or USPS.
When research involves minors, research teams will have to take theChildren’s Online Privacy and Protection Act (COPPA) into account. The IRB application should describe how the research team will ensure compliance with COPPA. For example, the research team could first obtain parental permission via Qualtrics, Zoom, mail, or in a telephone call. Each option must ensure that the parent or guardian can be authenticated.
Using Qualtrics to Obtain Parent/Guardian Permission for Child Participation in an Online Study:
- “By checking this box and typing your name and your child’s name below, you are electronically signing this permission form for your child to participate in this study. You affirm that an electronic signature has the same effect as a written signature. You also confirm you are the parent or guardian of a child who qualifies to participate in this study and that you agree to allow your child to participate in this study. To agree: Check the “I agree” box. Type in your first and last name, your child’s name, and then, click NEXT. If you do not want your child to participate in this study, simply close out of this browser window.”
- Next page: “The following screen will give you instructions on how your child can participate in this study. Your child will be asked to review and give their assent for their participation in the study on an Assent Form.”
Using Qualtrics to Obtain Child Participation Assent (In Age-Appropriate Language):
- Use this statement below if the childcan read and write. Signing an assent is for children between the ages of 8 to 17: "Your parent or guardian has informed the researcher that it is okay for you to be in this study. It is important that you understand what we will ask you to do. If you have any questions, you can ask the researcher [email, text, or call the researcher]. You can also quit this study whenever you want to and that will be OK. It will not be a problem for anyone if you decide to quit at any time. [Do you have any questions?] Do you agree to be in this study? To agree: Check the “I agree” box. Type in your first and last name and click NEXT. The next screen will give more instructions so you can get started. If you do not want to be in this study, just close this browser window.”
- Use this statement if the childcannotread and write: "The child is not capable of reading the assent form, but the information was verbally explained to the child in age-appropriate language. The child had an opportunity to ask questions and indicated assent. The child has been informed that the child can quit this study whenever the child wants to and it is perfectly OK to do so. The child's parent or guardian was present during the verbal assenting process. [The researcher would then sign aResearcher’s Verification of Explanation, with the "Signature of Person Obtaining Assent," "Name of Child, "Age of Child," and "Date."]
Considerations forRemote Consent
Researchers should note the following items when using online means to collect consent (permission and assent):
- Qualtrics has an electronic signature option (for signing with a finger or a mouse, for example on an iPad or a laptop trackpad) if typing a name is not sufficient for documenting consent. Please review this tutorial provided by Qualtrics.
- Qualtrics has the option to allow participants to download a copy of the TC IRB stamped informed consent. Researchersmust providethis option at the bottom of the consent page.
- Teachers College Information Technology department also offers suggestions on how to maximize the use of Qualtrics features. To get help from TCIT, please create an “incident report” and describe your technology questions or concerns about online platforms.
- Researchers cansend Qualtrics links directly to specific email addresses to ensure that the person clicking the link is the person associated with the email address. This helps maintain security when consenting online because the link is not general or open-access. This process also meets the “Authenticated” requirement for online consent (permission or assent).
- Researchers may want to send the Qualtrics link with the consent, parent permission, and/or assent form, and follow-up with a Zoom meeting to conduct a verbal affirmation of participation. This would also support the “Authenticated” requirement.
- Some research studies may include options for future contact, audio recording, or access to existing data (e.g., class curriculum). If your study has specific additional components that require individual acknowledgments, you can add checkboxes at the end of the consent form. For example, your consent (permission or assent) form might include language such as: “By checking “I agree,” you agree to participate in this study. You also confirm that you are 18 years or older and [list inclusion criteria]. To agree: Check the “I agree” box below, and also check to indicate whether you agree to be audio recorded for this study. Then, click NEXT to participate in the study.”
Researchers should always remember that consent, permission, and assent are not just forms but also processes.
Researchers are responsible for ensuring that any individual interested in participating in a study is informed and provided with study-related information in a clear and understandable way.
Consenting online provides an opportunity for researchers to engage in study activities when in-person data collection is not possible. Researchers should design the consent process with considerations for the best protection of participants in online environments. This may mean ensuring that participants are fully informed about the research activities, can easily obtain answers to questions, and know that participation is voluntary.
An easier way to get patient consent online is to create a consent form through a provider like JotForm. With online forms, your patients can fill out their information, electronically sign the form, and send it back to you securely, even from their mobile devices.How do I get informed consent from IRB? ›
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.What are the two exceptions to informed consent? ›
Exceptions to Informed Consent
Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.
Remote consent (sometimes referred to as “teleconsent”) is a method of obtaining informed consent using a paper or electronic consent form where the study team and participant are not in the same physical location during the consent process.How do I upload informed consent to simple practice? ›
- Navigate to Settings > Client Portal > Shared Documents and Files.
- Click + Consent Document.
Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy of the signed and dated consent form must be given to the person signing the form.How do I prepare for an IRB submission? ›
To prepare for a submission to the IRB, the investigator must generally develop a protocol (not required for studies that meet the criteria for exemption), any relevant consent form(s), recruitment materials (written or printed in alternative media, as applicable), and complete the IRB's electronic application in eIRB.How do I submit a protocol amendment to the IRB? ›
To request a change in your protocol or consent form, please submit the Request to Amend an IRB Protocol form. Answer all questions. The revised protocol, consent form, and/or survey instruments should be sent electronically to irb ( at ) olemiss ( dot ) edu, with changes highlighted.How do you mention IRB approval in paper? ›
Some journals may request a standard statement disclosing that the study received the IRB approval and appropriate guidelines were followed. While others would mandate IRB details (Board name and approval number) in the Methods section.What are the 4 principles of informed consent? ›
There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.
The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.Who Cannot give informed consent? ›
We cannot give informed consent when we are very young or very ill, mentally impaired, demented or unconscious, or merely frail or confused. Often people cannot give informed consent to emergency treatment.Can informed consent be digital? ›
with informed consent documents, be obtained electronically? Yes. HIPAA authorizations may be obtained electronically, provided that the signature of the subject (or the subject's personal representative) is a valid electronic signature under applicable laws and regulations.What is an example of electronic informed consent? ›
Examples of how this could be accomplished include: Having the potential study participant write their signature on a digital screen when in the presence of a member of the study team (either physically present or remote via a video conferencing platform).What are examples of remote research? ›
- Online Interviews with Interactive Elements.
- Remote Contextual Inquiry (Diary Studies and In-Home Video)
- Online Usability Testing for Digital Products.
- Quantitative and Qualitative Surveys.
- Navigate to the Help Center.
- Scroll down to the bottom and click Get more help.
In most cases, the federal regulations require that informed consent be documented, but they also provide some important exceptions. See Verbal, Electronic or Implied Consent for more information.What is the difference between simple and informed consent? ›
In simple consent, a professional simply asks for permission to perform a procedure and explains the procedure as needed. For written informed consent, the patient must be educated at length about risks, benefits and treatment alternatives.What is the difference between consent and informed consent? ›
While implied consent is informal, informed consent is a legal term that requires seven elements to be valid: The individual is competent and can understand what they're consenting to. For example, a patient with dementia may not give informed consent.What are the five elements of informed consent? ›
- A statement that the study involves research.
- An explanation of the purposes of the research.
- The expected duration of the subject's participation.
- A description of the procedures to be followed.
- Identification of any procedures which are experimental.
- Title of the Study.
- Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the student's information first.
- Purpose of the Study. ...
- Subject Selection Criteria. ...
- Study Procedures. ...
- Potential Risks and Discomforts. ...
- Potential Benefits. ...
- Cost and Compensation.
- Consent Document(s)
- Recruitment Materials.
- Study Instrument(s)
- Permission Letters (if applicable)
- Certificate of Education (if not already on file)
- Grant proposal narrative (if applicable)
- The application materials have been made into one PDF.
Effective September 1, 2021, NEW clinical research protocols partially or fully supported by industry sponsors will be charged a ONE-TIME fee at the time of UCI or sIRB approval. The ONE-TIME fee will be $1,568.00. There will be no fee for renewals.What is the IRB process of submission and approval? ›
Under this system, studies are assigned to one or more IRB members for a full review of all materials. Then, at the convened IRB meeting the study is presented by the primary reviewer(s) and, after discussion by IRB members, a vote for an action is taken.Who is responsible for submitting IRB protocols for review? ›
Investigators are responsible for providing the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents) so that the IRB can fulfill its regulatory obligations, including making the required determinations under 45 CFR 46.111 and, ...Who submits protocol to IRB? ›
The Principal Investigator will submit modifications and/or changes to the IRB as necessary, in the form of an amendment, to ensure these are consistent.When must a sponsor submit a protocol amendment according to 21 CFR 312.30 B )( 1? ›
A sponsor shall submit a protocol amendment for a new protocol or a change in protocol before its implementation. Protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals.Where do you put IRB approval in a research paper? ›
Avoid nontechnical uses of technical terms in Page 8 statistics, such as random or significant. All recent clinical studies should be performed with Institutional Review Board (IRB) approval, and confirmation of IRB approval should be given in this section.What to do after IRB approval? ›
After IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population.Where do you put IRB approval in manuscript? ›
A statement should be included in the Materials and Methods section of your manuscript, regarding the IRB decision.
An electronic signature can be used as legally effective documentation of consent. To be legally effective, the electronic signature needs to be attributable to a verified identity.What is informed consent in Internet? ›
Informed consent is the term given to the agreement between researcher and participant.What is the remote consent process? ›
Remote Consent procedures are defined as follows: The participant or their legally-authorized representative (LAR) receives a copy of the informed consent document (e.g., via mail, fax or email) in advance of discussion regarding the study.What are examples of digital consent? ›
Digital consent is about asking, seeking and receiving permission online. Examples of digital consent include asking for permission before sharing someone else's images, videos, posts or text messages online.Does written consent include email? ›
Written Consent means a signed form with the customer's signature received by the Company through mail, facsimile, or email. A customer may also digitally sign a form that is transmitted to the Company.What regulations apply to electronic consent in the US? ›
The E-Sign Act allows the use of electronic records to satisfy any statute, regulation, or rule of law requiring that such information be provided in writing, if the consumer has affirmatively consented to such use and has not withdrawn such consent.How should consent forms be written? ›
Informed consent language should be written in the second person (“you”), not in the first person (“I”). Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”What are the 4 types of consent? ›
- Implied Consent. Participation in a certain situation is sometimes considered proof of consent. ...
- Explicit Consent. ...
- Active Consent. ...
- Passive Consent. ...
- Opt-Out Consent.