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IRB Handbook

Appendix B

Children and Other Vulnerable Populations

 

  Vulnerable Populations

  • If any vulnerable group participates in research, you must provide specific safeguards for that group to prevent coercion and added risk
  • If the adult participant is unable to consent, additional safeguards to protect their rights and welfare must be considered
  • All consent and assent must be provided in the participants’ primary language
  • The IRB committee may ask you to elaborate on how you will engage adults with cognitive impairments (e.g., adult assent, verbal script, etc.)

     

    Assents and Parental Consent forms are in the Center for Graduate Studies Lounge
    Click Content -> find Institutional Review Board (IRB) Process.
    If you cannot locate a form, please contact IRB@Aspen.edu


    Assents (Children and Mentally Impaired Adults)

  • Assents are required for children in research (when developmentally appropriate)
  • Assents are required for adults who are mentally impaired, including participants with head injuries
  • You must obtain parental/guardian permission prior to obtaining the child’s assent or the mentally impaired individual’s assent
  • A written assent should be used for children between the ages of 13 and 17
  • An oral assent should be conducted for children between 7 and 12
  • For mentally impaired adults, written consent should be the first choice; if this is not possible, then oral assent and a written approval from the guardian is needed
  • Submit a script for the oral assent to make sure it is developmentally appropriate for the age of the child or mentally impaired adult
  • If an assent form is missing from a proposal and the IRB committee feels it is appropriate to use, the protocol cannot be approved and will be postponed

     

    Parental/Legal Guardian Permission

  • Signed parental permission is required for most studies involving minors
  • Best practice is for both parents to sign the parental permission for a child’s involvement in research (assuming that both parents are alive, not incarcerated, and in the geographical area)
  • Legal guardian permission is required for studies involving mentally impaired adults, if the adult has a legal guardian

Consent of Non English-Speaking Participants

If you are planning to enroll non‐English speaking participants, then both of the following must be done:

1. A translated version of the consent form, any questionnaires, or materials given to participants. This must be reviewed and approved by the IRB prior to their use according to 45 CFR 46. 116 & 117.

  • Documents can be translated via a certified translation service with their stamp on the consent form, and any other documents that require translation; or
  • You can have the English version translated into language of choice, and a back translation into English done by an independent person. You must make sure that the original English and translated version are the same and include a note with the submission that this process was completed

And

2. This requires that a person fluent (i.e., can read and speak the language) be present as a witness to the consent process to verify that the consent was understood.

  • Person obtaining consent can speak the language of choice, but a witness who is independent of the study and is fluent in the language must be present to verify that it was informed and not coerced
  • The person obtaining consent cannot serve as the witness