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How to Obtain Consent
Consent Methods Based on Data Collection Method
Always default to written consent.
Alterations of consent are only allowed under certain considerations.*
|DATA COLLECTION METHOD||CONSENT COLLECTION METHOD||FACTORS AFFECTING WAIVER AND ALTERATION REQUESTS|
|In-Person Interview||Written hardcopy consent form collected at interview.||
Keep in mind that an in-person interview is by nature not anonymous.
See also Common Rule.*
|Online Video Interview (Zoom or other video conferencing method)||Written consent form can be electronic with secure acceptance or electronic signature or written and collected in hardcopy form or scanned copy.||
Keep in mind that an online video interview is by nature not anonymous unless extraordinary steps have been taken to create anonymity.
See also Common Rule.*
Written consent form can be obtained ahead of time through hardcopy mail, or electronically at time of interview through AdobeSign, email, or other secure acceptance or electronic signature or through scanned copy, or verbally. If verbal, the individual obtaining consent reads and explains a scripted version of the consent form with detailed information about the study, and then the study participant gives their verbal consent in place of written consent. Provide subjects with a copy of the study information and provide an opportunity for the participant to ask questions. Document the discussion and keep it in the research file.
Keep in mind that a telephone interview is by nature usually not anonymous unless extraordinary steps have been taken to create anonymity.
See also Common Rule.*
|Focus Groups||Written consent should fall under one of the interview methods listed above.||
Keep in mind that an interview is by nature usually not anonymous.
See also Common Rule.*
|Hard Copy Survey/Questionnaire||Written hardcopy consent form collected in advance or at the time the study participant completes the survey/questionnaire.||See also Common Rule.*|
|Online Survey/Questionnaire||Written consent form can be electronic with secure acceptance or electronic signature at the time the study participant completes the online survey/questionnaire. For example the consent form can be within the introductory pages of the online survey or questionnaire so that the participant can read and choose whether to proceed or can electronically sign. Written consent could also be collected in hardcopy form or a scanned copy collected in advance or at the time the study participant completes the online survey/questionnaire.||See also Common Rule.*|
|In-person oral survey/questionnaire||Written consent on a consent form should be obtained.||See also Common Rule.*|
|Existing Documents/Records||Written consent must be obtained or have been obtained prior to using personal, private, otherwise FERPA-protected, otherwise HIPPA-protected, or other identifiable non-anonymous existing documents and records.||
In rare cases data sets may be used without direct consent if the researcher did not already and will not have access to the data or information and the anonymous, de-identified data is obtained from another non-affiliated source that obtained consent previously.
See also Common Rule.*See also OHRP guidance on Private Information and Biospecimens.
|Interventions and Observations||
See methods listed above.
Interventions and observations would take place in conjunction with one of the data collection methods listed above.
|See also Common Rule.*|
In all cases the Post-2018 Common Rule requires written consent and only allows for waiver of consent or alteration of consent (for example, oral documented consent) in rare cases as described below by the Common Rule language:
“§46.117 Documentation of informed consent.
(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form.
(b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following:
(1) A written informed consent form that meets the requirements of §46.116. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.
(2) A short form written informed consent form stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject’s legally authorized representative, and that the key information required by §46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject’s legally authorized representative, in addition to a copy of the short form.
(c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
(Approved by the Office of Management and Budget under Control Number 0990-0260.)”