SOP100: Consenting Subjects

  1. Summary

    Informed consent must be obtained from all subjects prior to participation in research MRI experiments. This SOP establishes procedures for obtaining informed consent.

  2. Scope

    These policies apply to all investigators, research assistants, and MRI operators who conduct studies at the BIAC research scanners. Only individuals who are listed on an particular IRB protocol can obtain consent for that protocol.

  3. Definitions

    • Subject - An individual who is participating in an experimental protocol at BIAC and has not taken the BIAC safety course.

    • Minor Subject - A subject below the age of eighteen is considered a minor.

    • Experimenter - The investigator, research assistant, or MRI operator who is responsible for the subject and conducting the experiment.

  4. Policies and Procedures

    No individual may be run in any experiment on the BIAC scanners without that experiment being part of an IRB approved protocol. Signed informed consent must be obtained prior to study.

    1. Adult Subjects (ages eighteen or higher)

      1. The Experimenter must provide the Subject with an IRB approved consent form that is appropriate for the protocol in which the Subject is participating. The Experimenter must answer all questions posed by the Subject, and the Experimenter must be certain that the Subject understands the procedures.

      2. The Experimenter must be certain that the Subject has signed and/or initialed in all appropriate places on the consent form, and has supplied contact information if stipulated on the form. The Subject must date the form.

      3. The Experimenter must emphasize to the Subject that they can stop the scanning at any time without penalty and withdraw from the study.

      4. The Experimenter must sign the consent form to signify that consent was properly obtained and all Subject's questions were thoroughly discussed.

      5. The Subject must be offered a copy of a blank consent form to take with him or her.

      6. The Experimenter must remove the consent form from the MRI suite. A Subject's participation in an experimental study is confidential, and a Subject's privacy must be protected. BIAC investigators must turn consent forms into the BIAC office for filing. Other investigators should file their forms wherever is appropriate.

    2. Minor Subjects

      1. A parent or legal guardian must provide consent for Minor Subjects. Subjects between the ages of twelve and eighteen must provide assent, indicated by their co-signing the consent form after their parent or legal guardian has provided informed consent. Please note that minors can only participate in protocols for which IRB permission to run minors has been specifically requested and approved, and an appropriate consent form for minors has been approved.

      2. In some situations, adult Subjects who are capacitated may not be able to provide informed consent. If specifically approved by the IRB, a parent or legal guardian may provide consent for such Subjects.

      3. The Experimenter must provide the Subject's parent or legal guardian with an IRB approved consent form that is appropriate for the protocol in which the Subject is participating. If the Subject is over the age of six, they must also be included in the consent process.

      4. The Experimenter must answer all questions posed by the parent or guardian and Minor Subject (if age six or older).

      5. The Experimenter must be certain that the parent or legal guardian has signed and/or initialed in all appropriate places on the consent form, and has supplied contact information if stipulated on the form. The parent or legal guardian must date the form.

      6. Subjects over the age of twelve must co-sign the consent form to signify their assent to participate in the procedures. A Subject's assent is not sufficient if the parent or legal guardian does not provide informed consent. Similarly, informed consent provided by the parent or legal guardian is not sufficient if the Subject over twelve does not provide assent.

      7. The Experimenter must emphasize to the parent or legal guardian and to the Subject (if six or older) that they can stop the scanning at any time without penalty and withdraw from the study.

      8. The Experimenter must sign the consent form to signify that consent was properly obtained and all questions were thoroughly discussed.

      9. The parent or legal guardian must be offered a copy of a blank consent form to take with him or her.

      10. The Experimenter must remove the consent form from the MRI. Participation in an experimental study is confidential, and a Subject's privacy must be protected. BIAC investigators must turn consent forms into the BIAC office for filing. Other investigators should file their forms wherever is appropriate.

      11. The Experimenter is cautioned that improperly executed consent forms (e.g., not signed or dated by parent or legal guardian, Subjects over twelve, or investigator) may not be considered valid by federal oversight bodies.

    3. Incapacitated Subjects who cannot provide consent

      1. The Experimenter must have specific approval from the IRB regarding protocols in which adult Subjects cannot provide informed consent. If the IRB permits the Experimenter to obtain consent from a parent or legal guardian, then the procedures described above for Minor Subjects should be followed.

SOP