MRI Research Safety and Ethics: Points to Consider - NIMH

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issue. Considerations for screening should take into account whether to screen the minor privately or withthe parent or guardian present and whether to inform parents or guardians of the results of suchscreenings. As part of the assent process, the adolescent should be informed of what will be done with theresults of the screening, including any interview data and/or pregnancy testing (consistent with state andlocal statutes). Sites testing for pregnancy should consider in advance how participants and/or parents willbe informed of results, and whether there are personnel on site who are adequately trained to providecounseling. Such considerations should be discussed with the local IRB(s) in advance.Special consideration is warranted for vulnerable populations, whose members may be less accurate inreporting the possibility of pregnancy, e.g., minors, or potential participants with psychosis or majordepression. Added safeguards should be considered for such participants. Leaving decisions aboutwhether to participate up to potentially pregnant adolescents and/or people with severe mentalimpairments may be unacceptable to IRBs.Note that the issue of when a minor's health information, including pregnancy screening results, may ormust be disclosed to parents or guardians is governed by the Department of Health and Human Service'sHealth Insurance Portability and Accountability Act (HIPAA) and/or other applicable privacy and statelaws. The application of HIPAA would depend upon whether the screening is performed by a HIPAAcoveredentity (such as a healthcare provider that conducts certain transactions electronically). HIPAAmay also interact with other applicable privacy and state laws. With some exceptions, HIPAA generallyrequires covered entities to treat parents and guardians of un-emancipated minors as "personalrepresentatives" to whom the minor's records must be disclosed upon request, if the parent or guardian hasauthority under applicable law (e.g., state law) to act on behalf of the minor with respect to health caredecisions. However, where a state law permits a minor to consent to pregnancy treatment without a parentor guardian's consent and the minor does so without parental involvement, this HIPAA requirement maynot apply. Note further that state laws may govern mandatory reporting of pregnancy to Child ProtectiveServices, depending on the age of the adolescent, the age of the sexual partner who fathered the child, andthe difference in their ages. HIPAA would permit HIPAA-covered entities to disclose patient healthinformation as required by other laws. Researchers should consult their institutional legal counsel forguidance on the parental and other disclosure requirements, if any, that apply to a particular researchsetting, and the applicable requirements for reporting should be made clear to the adolescent.Providing the results of a pregnancy test to participants or parents implicates the federal ClinicalLaboratories Improvement Act (CLIA) and state laws regulating laboratory testing.Researchers should consult with legal counsel to ensure that screening involving pregnancy testing isperformed in compliance with applicable law.A-9. Are there approaches in place for screening for repeat scans?The question of screening for repeated scanning arises most commonly in cognitive neuroscience researchinvolving normal volunteers, some of whom may be scanned daily or weekly for some period of time.
The Workgroup discussed whether participants should complete a full screening questionnaire andinterview for each scanning session. The Workgroup recognized the value of completing the fullscreening, i.e., full standard written questionnaire and interview, with appropriate signatures for each scan.B. Training, Operating, and Emergency ProceduresAre training, operating and emergency procedures in place to help ensure participant safety?B-1. Are specific policies and procedures for training personnel associated with the MRI facilitydeveloped and documented?Given that the MRI environment presents many potential dangers to untrained or improperly screenedindividuals, the Workgroup recognized the need for appropriate levels of training for all individuals whooperate the scanner and/or have routine access to the MRI suite and for a clearly specified scheme fortraining and certifying individuals for each level of authorization. A range of options was mentioned forcertification, including didactic training, mastery of written materials, and terms of apprenticeship, as wellas written and/or practical tests.The following was discussed as one example of a multi-level training and certification scheme:Level I personnel are defined as those who are authorized to have unsupervised access to the MRI suite,but who lack authority to screen other individuals or to bring other individuals into the scanner facility.Certification at Level I requires training in how to screen oneself, a clear understanding of what is and isnot safe in the MRI environment, and knowledge of safety procedures for entering the MRI suite and verybasic emergency procedures, e.g., knowledge of whom to call and how to rapidly access appropriatephone numbers. Level I may include cleaning, transportation, security, and anesthesia staff, and anyothers who may have legitimate reasons to enter the MRI suite unsupervised and thus need to beappropriately trained in safety and emergency procedures.Level II personnel are those who, in addition to Level I certification, are also certified to operate the MRequipment, as well as to screen others for entry into the MRI suite and oversee their presence in the suiteand during scanning. They would have more in depth knowledge of MR safety issues including the safetyof different materials for the particular environment, the safety guidelines of the applicable IRBs, andwhere to get additional information if needed.Level III personnel are faculty or senior staff who, in addition to having achieved levels I and IIcertification, are also certified to train and certify Level I and Level II personnel and are authorized by thefacility director to do so. These individuals would have knowledge of the requirements needed to run asafe MRI environment and would be responsible for keeping these requirements updated.It was felt that researchers should adhere to an accepted national standard of care consistent with safetyprovisions, such as those of the ACR. Personnel should be trained on all elements relevant to theirresearch practices. In the terms of the ACR guidelines, those operating the scanner should be trained to
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Page 4 and 5: The Workgroup agreed on the need fo
Page 6 and 7: As an alternative to two full inter
Page 10 and 11: Level II status insofar as the guid
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Page 18 and 19: clinical scan. This might be addres
Page 20 and 21: which may, albeit infrequently and
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Page 26 and 27: AcknowledgmentsThe NIMH wishes to a
Page 28 and 29: P. Ellen Grant, M.D.Division Head,

MRI Research Safety and Ethics: Points to Consider - NIMH

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