Minors Participating in Imaging Studies

Purpose

This page details the procedures to be followed when using minors in human imaging studies

Introduction

Special precautions must be taken when enrolling children in Magnetic Resonance Imaging (MRI) studies. Some important considerations are listed below. Researchers may, on a study-by-study basis, choose to utilize other procedures. Those situations will require consultation with Imaging Research Center (IRC) staff. The standard operating procedures outlined below represent study procedures that present no more than minimal risk to the research subjects – that is, the risk of participation will be no greater than that of everyday life or routine medical imaging procedures.

• Reports of Pregnancy.  Any female research subject past the age of menarche and less than 18 years of age will be asked to self-report pregnancy. As with adult subjects, these individuals should be prompted to report in written form (through the MRI Screening Form) and verbally. This process should take place in private, away from the parent or guardian. Under no circumstances should the researcher convey the response to the parent or guardian of the research subject. The fact that this information will not be shared should be conveyed clearly in the assent form and in the parental permission form. This information should also be clearly conveyed in the verbal component of the informed consent process.

  If the subject indicates that she is or might be pregnant, researchers should not enroll the subject in the study.  All research subjects that self-report possible pregnancy should be provided with a resource list, included in the next section of this document. Researchers are strongly encouraged to use these resources when speaking with the research subject. For instance, researchers may use a speakerphone or conference phone to call the Texas Youth Hotline with the research subject in order to ensure the subject has the opportunity to speak with a trained professional about the options available to them.

• Resource List for Pregnant Adolescents.  This list of resources shall be provided to adolescents who identify themselves as pregnant under the procedures described in the section above.

  Texas Youth Hotline: 800-98-YOUTH (800-989-6884)

  The Texas Youth Hotline is answered 24 hours a day, seven days a week and provides prevention services to youths, parents, siblings, and other family members who are in need of a caring voice and listening ear. The Hotline counselors have many state and local resources for teens who have become pregnant, including pro-life and pro-choice alternatives.

  Planned Parenthood: 800-230-PLAN (7526)

  http://www.plannedparenthood.org/

  Planned Parenthood has information about options for teens who have discovered they are pregnant.  On their website, you can go to “Info for Teens” (menu on the right screen) - > “Pregnancy”  -> “I’m Pregnant. Now What?” for more information.  You can also call 800-230-PLAN (7526) or go to a Planned Parenthood clinic (there are three in Austin) for pregnancy testing and information.

  Life Care Pregnancy Services: 512-374-0055

  http://www.austinlifecare.com/pservices/index.htm

  LifeCare is a faith-based organization that has options counseling and support services.  On their website, you can click on “What Are My Options?” or clicking on “Choices” on the top. You can also their hotline at 800-374-0055 or go to their location at 1215 West Anderson Lane Austin, TX 78757.

• Reporting Abuse.  Please note, these policies are not intended to provide an exhaustive list of legal or ethical responsibilities to report suspected cases of abuse.  It is the explicit and individual responsibility of each researcher working with children to familiarize themselves with the relevant legal requirements involved.  The IRC can in no way be expected to provide legal advice or interpretations, and herein lists only information provided by state government agencies it considers to be reliable resources on the matter – the State of Texas Department of Family and Protective Services (DFPS) and the State of Texas Office of the Attorney General (OAG).

  If a minor provides information indicating a pregnancy as a result of sexual abuse or indicates a sexual relationship that is abusive, the researcher has an obligation to make a report to the DFPS through the Texas Abuse Hotline (1-800-252-5400).

  • Any pregnancy in a child under the age of 14 years should prompt a report to the DFPS.
  • In any other situation, the researcher should use their judgment to determine if the situation represents a reportable situation. Pregnancy does not in and of itself establish that sexual abuse has occurred. To require reporting, the sexual contact must be considered "sexual conduct harmful to a child."

   

  It is not the responsibility of the researcher to do ANY investigation into any allegations or suspicions of abuse, but if a minor spontaneously provides information about potential sexual abuse or does so in response to standard research or screening questions, the researcher has an obligation to report this spontaneous outcry to the DFPS. This is a legal obligation for each individual who hears this information from the minor; it is that individual researcher’s responsibility to report to DFPS and this obligation cannot be satisfied by reporting to more senior research staff, IRC staff, faculty mentors, or any other individual.

  In any situation in which a minor self-reports pregnancy or possible pregnancy, the researcher has a continuing obligation to protect the privacy and confidentiality of that disclosure except where the law requires otherwise. Operationally, this requires the researcher to only convey information to DFPS and other law enforcement agencies. Researchers should not inform the parents/guardians or the potential father of the possible pregnancy.

• Resource List for Reporting Abuse.  This list of resources regarding the reporting of abuse is provided help prepare researchers for issues they may encounter.

  Frequently Asked Questions About Reporting Abuse, DFPS:  http://www.dfps.state.tx.us/Contact_Us/report_abuse_faqs.asp

  When You Suspect Child Abuse or Neglect: A General Guide, OAG:   https://texasattorneygeneral.gov/cvs/when-you-suspect-child-abuse-or-neglect-a-general-guide

  What We Can Do About Child Abuse, OAG: https://www.texasattorneygeneral.gov/cvs/what-can-we-do-about-child-abuse

  The last document in the above list of resources contains detailed and more specific information about recognizing abuse and abuse reporting that are found in most other guides cited. Below is information specifically about sexual abuse and STDs/pregnancy (emphasis added).

  “Other physical indicators of sexual abuse include symptoms of sexually transmitted disease (STD) as well as pregnancy. STD and pregnancy are by themselves indicators that a child is sexually active; they do not by themselves establish abuse or assault. In a preteen child, abuse is strongly indicated by STD (except that infants may contract some STDs from their mothers at birth). In a teenager, further information is needed about the circumstances and the child's sexual partner, who might have been another minor about the same age, an older minor, or an adult. The sexual contact may have been assaultive or may otherwise qualify as "sexual conduct harmful to a child." Reasonable suspicions of this nature must be reported and may be investigated, depending on circumstances.”

• Training: Requesting information from adolescents about pregnancy status requires that researchers are aware of their legal and ethical obligations as mandatory reporters of child sexual abuse. As such, all researchers who enroll minor females of childbearing potential will be required to have specific training regarding those obligations. Any researcher (faculty, staff, or student) that interacts with research participants in these studies is required to watch the OAG’s video “What Can We Do About Child Abuse,” available online at https://www.oag.state.tx.us/media/videos/play.php?image=childabuse&id=105 or available on DVD from IRC staff.

  Documentation of Training:

  1)       Training: Documentation of training by watching the OAG video should be maintained by the senior faculty member on each research project that involves imaging minors at the IRC. That information should include:

  1. Date of the training
  2. Names and UT EID’s of individuals who completed the training
  3. Title of the video
  4. Signatures for each individual who has completed training

  2)       Test Results in Study Data: An indication that a participant did not meet inclusion/exclusion criteria for a study is acceptable, but specific information about a positive self-report of possible pregnancy result should not be included in study data sets.

  3)       Reporting: Each individual who reports suspected child abuse should maintain a record of that report. The Texas Abuse Hotline will provide the reporter with a Call ID. It is the responsibility of each individual to maintain this information. This record should comply with the data security provisions as outlined in the IRB approved proposal. If the research proposal approved by the IRB states that information will not be stored with the research subject’s name, then the individual reporter has an obligation not to create a record with the subject’s identifying information, even if that record is maintained for the researcher’s personal use. 

• Motion Control.  As with adults, it is important that minors remain still during the imaging process. For younger minors, this can be more difficult than for adolescents and adults. Researchers who use younger children in the research process must take special care to ensure that children are not distressed by the process of participation in a study that uses imaging tools and to ensure that children are provided with ample opportunity to withdraw from participation.

  Required Procedures:

  1)       All minors should be given the opportunity to use the mock scanner located in the Sarah M. and Charles E. Seay building. This may occur on either a preliminary visit or immediately prior to utilizing the actual scanner at the same visit. For subjects under the age of 10 years, the IRC very strongly encourages the use of this resource. Researchers are encouraged to use this resource with older participants on a case-by-case situation as well.

  2)       Research subjects under the age of 10 years must be scanned with a handheld metal detector specifically designed as a pre-screening detection tool for MRI scans and provided by the IRC in order to ensure the child has not swallowed any metal/magnetic items. Researchers are strongly encouraged to use this resource with older participants as well.

  3)       Minors who are unable to remain still to a degree that produces scans of acceptable image quality after two tries will be given the opportunity to take a break or to discuss the problem with the researcher. For example, the researcher may conduct a more detailed “check-in” with the child, inquiring whether they think they can hold still or not.

  1. If the child cannot continue after the check-in or break because of discomfort, the scan session should cease, with no negative comments or consequences towards the child at all. For example, the researcher may use phrases like, “We’re so glad you gave it a try! You were so brave and tried so hard!”
  2. If the child cannot remain still but expresses no discomfort or desire to cease participation, the scans may be continued at the discretion of the researcher, with prompts to remind the children to hold still. Some post-hoc analysis methods may allow for the development of usable data from these scans.

  4)       If at any time during scanning the child expresses the wish to stop or take a break, this will be arranged immediately.  If the child expresses discomfort verbally or indicates discomfort with external cues, the researcher will respond immediately to create a more comfortable environment for the child and ensure that the child still wishes to participate.

   

  Suggested Procedures/Practices:

  Researchers working with children may try a variety of methods to overcome barriers to a child remaining still during scans. Some examples of best practices are listed below. These are not required by all researchers as each study, age-group, and individual child may benefit from different practices.  

• Explanation of Procedures and Equipment.  All researchers should explain what an MRI is and what will be done in age-appropriate language.  For example, children can be introduced to the MRI environment by using an analogy with a camera.  In the same way that people moving when a picture is taken make the picture look blurry, people moving while the MRI machine takes pictures results in blurry brain pictures (like a cottonball).  It will be explained that to help them hold still, researchers will do four things:

  1)       Have them lie down on a bed with pads and sheets to make them comfortable (Explain that staying still is easier lying down than holding really still standing on one foot, or sitting in a chair with wheels.);

  2)       Use headphones and pads to restrain their head movements (Explain that this is also how they will hear the researcher’s voice and hear the movie and/or game sounds);

  3)       Give them games and movies to play and watch (Explain to the parent or child that it is easiest to hold still when distracted.); and

  4)       Talk to them in-between each scan and ‘checking-in’ to make sure they are comfortable and doing ok (Explain that the researchers can hear them at all times, and will stop whenever they need or want to do so). 

  The various components of an MRI scan may also be introduced progressively to prevent overwhelming the child. For example, they may first be shown the mock scanner and allowed to explore, then asked to lie down and be moved into the mock scanner bore. This can be followed by introducing the use of the pediatric coils necessary for the study outside the scanner, then using the coils inside the mock scanner. Researchers may also introduce each part of the study procedures by having the parent or stuffed animal go through them in the mock scanner first, then having the child undergo the same procedures.