As outlined in Standard Practice Guide 601.34, it is the policy of the University of Michigan to promote the health, wellness, safety, and security of minors who participate in university-sponsored activities. This policy applies to minors participating as subjects in university-sponsored research.

Study team members (including university employees, students and volunteers) who interact with minors participating as subjects in university-sponsored research are required to complete the Minors as Research Participants eLearning course, consent to a background check, and adhere to a Code of Conduct and reporting obligations. This policy applies to all university-sponsored research on and off all campuses (Ann Arbor, Michigan Medicine areas, UM-Flint, UM-Dearborn). Individuals who do not adhere to this policy will no longer be authorized by the university to interact with minors as research participants. A minor is defined as an individual under the age of 18 years.

Minors as Research Participants eLearning course

The required annual eLearning course explains the background check and outlines the university’s Code of Conduct and reporting obligations for interacting with minors as research participants. The 25-minute course must be completed within 30 days of Institutional Review Board (IRB) approval of the study and before interacting with minors as research participants. An optional module is available that provides more in-depth training about child abuse and neglect.

Code of Conduct

Study team members must adhere to the Code of Conduct. The Code of Conduct is reviewed in the required eLearning course. Included in the Code of Conduct is the Rule of Threes. Under the Rule of Threes, study team members are not permitted to have interactions with minors that cannot be witnessed by an adult third party. Examples of an adult third party include a parent, study team member or UM employee. The Rule of Threes applies to all interactions and interventions, including in-person, phone, email, videoconference (i.e., Zoom),text messages, social networking websites, internet chat rooms, multiplayer online games, or other forms of digital or social media. Some changes to study procedures may require an IRB amendment, and study teams are encouraged to consult with the IRB. IRB approval of study procedures that do not adhere to the Rule of Threes does not negate this university policy. Unique considerations in managing this requirement include:

• It is permissible to conduct research with minors without a witness when the research is being conducted by clinical care providers in the context of clinical care provision (e.g., delivering experimental therapeutics, obtaining an additional specimen nasal swab during a clinic visit). Study team members conducting research at Michigan Medicine are reminded to ensure that they are also compliant with the Michigan Medicine Chaperone Policy.

• Studies that involve texting minors must always include an additional individual in the texting conversation, or the texting conversation must be recorded and visible to the study team (e.g., on a study-specific texting account). Study team members are advised against texting minors using their personal device and/or personal contact information; a study-issued device and/or account is strongly recommended.

• Interactions with minors on social media should occur on professional accounts accessible to other study team members and not through private accounts.

• When the research necessitates that the study team member interact with the minor alone, there are several options:

  • An additional adult witnesses the interaction.

  • The interaction occurs in an open public setting where the interaction can be witnessed by others.

  • The interaction occurs in a room with the door open, or can be witnessed by others through a window.

  • The interaction is video- and/or audio-taped and the recording is stored in a secure location accessible to other study team members (this scenario is common when the interaction is already being recorded for research purposes).

The Office of Research Compliance Review will perform audits to confirm compliance with the Rule of Threes in study protocols and practices.

Obligation to Report Suspected Child Abuse or Neglect or a Violation of the Code of Conduct

Study team members may become aware of or suspect abuse or neglect of a minor through witnessing abuse or neglect, the minor disclosing information to a study team member, or observing signs or symptoms of abuse or neglect. Study team members may become aware of violation of the Code of Conduct by another member of the university community.

If you observe or suspect a violation of the Code of Conduct, or abuse or neglect of a minor, you must report it. The study Principal Investigator (or faculty advisor on student studies) must be notified immediately of any scenario involving reporting and is ultimately responsible for ensuring required reporting has been followed. A study Principal Investigator or other qualified individual with delegated authority must always be reachable immediately during periods of interaction with minors.

This document describes team members’ reporting obligations. The obligation to report suspected abuse or neglect or a violation of the Code of Conduct supersedes the expectation of confidentiality in research and any assurances of confidentiality outlined in the informed consent or assent, or approved IRB protocol. Certificates of Confidentiality do not prevent reporting, and do not eliminate the obligation to report. It is permissible, appropriate, and expected that study teams provide research participants’ contact information to Children’s Protective Services when necessary.

A copy of any report filed with Children’s Protective Services by a study team must be provided to Risk Management Services via a secure site.

Important Contact Information

Immediate Next Steps (September 14th, 2021)

For studies involving minors as participants that are already approved by the Institutional Review Board (existing studies):

• All study team members will receive an email from the Minors in Research team in the Office of Research Compliance Review. The email will contain a Qualtrics survey in which you will be asked to confirm that you will interact with minors as research participants, or attest that you will not do so. You will need to respond within 3 weeks. If you do not respond, you will be classified as a study team member who interacts with minors.

• By October 31, 2021, study team members who interact with minors as research participants must complete the required eLearning course and have consented to a background check by responding to the email they will receive from HireRight. Study team members who do not complete these requirements by October 31, 2021, will no longer be authorized by the university to interact with minors as research participants until the requirements are met.

For studies involving minors that are not yet approved by the Institutional Review Board (new studies) as of September 14, 2021:

• A question will be added to the eResearch Regulatory Management System (IRB application) to identify study team members who interact with participants. This will be a required question for all new studies and amendments submitted after the policy change.

• Within 30 days of Institutional Review Board approval and before interacting with minor participants, study team members must complete the required eLearning course and consent to the background check by responding to the email they will receive from HireRight approval. Study team members who do not complete these requirements will no longer be authorized by the university to interact with minors as research participants until the requirements are met.

All studies involving interactions with minors as research participants must have modified their study procedures to adhere to the Rule of Threes by December 31, 2021.

For assistance in becoming compliant with these changes email ResearchWithMinors@umich.edu.

FAQ

General

1. Does this policy apply to international research?

• Yes

2. Does this policy apply to research occurring off of university property?

• Yes. The policy applies to all human research under the direction and authority of the university.

3. My study takes place in the community, not on UM property, does this policy still apply?

• Yes. This policy applies if you are conducting university-sponsored research.

4. Does this policy apply to research that has been determined to be exempt from Institutional Review Board review?

• This policy applies to Exempt 1 studies. The policy does not apply to studies that have been determined to be exempt under other exemption categories.

5. Does this policy apply to research being conducted by study team members (including university employees, students and volunteers) on all campuses (Ann Arbor, Michigan Medicine areas, UM-Flint, UM-Dearborn)?

• Yes

6. Does this policy apply to minors as research participants who are also enrolled undergraduate students (i.e., first year undergraduate students who are not yet 18 years old).

• No

7. Does this policy apply to minors as research participants who are also dual enrolled (i.e., a high school student taking a U-M course).

• Yes.

8. A parent is in the room during my study. Does the parent being present meet the requirement for the Rule of Threes in the Code of Conduct?

• Yes.

9. A sibling of the study participant is in the room during my study. The sibling is younger than age 18 years. Does this sibling (who is a minor) being present meet the requirement for the Rule of Threes in the Code of Conduct?

• No.

10. What if one of my research study staff has a problem with their background check or refuses to have the background check done.

• HR is available to aid study staff in these rare cases. Study staff, faculty or students who refuse a background check will no longer be authorized by UM to interact with minors.

11. I am not sure if I will interact with minors as research participants, but I may. Should I complete the eLearning course and consent to the background check?

• Yes.

12. I am the Principal Investigator on the study. I do not have any interactions with minors as research participants but other members of my study team or those who I supervise (staff, students, volunteers) do. Do I need to complete the eLearning course and consent to the background check?

• Yes. All Principal Investigators on studies involving minors as research participants, even if the Principal Investigator does not have interaction with the minors, must adhere to the policy.

13. I am a Faculty Advisor on a student study. I do not have any interactions with minors but the student I am supervising does. Do I need to complete the eLearning course and consent to the background check?

• Yes. All Faculty Advisors on student studies involving minors as research participants, even if the Faculty Advisor does not have interaction with minors, must adhere to the policy.

14. I understand that supervisors of study team members who do or may have interaction with minors as research participants, even if the supervisor does not have interaction with minors, must adhere to the policy. What defines being a supervisor?

• In general, the individual responsible for oversight and training of the study team member is considered to be the supervisor. The individual who the study team member would contact for direction and guidance if difficulties were encountered during interaction with minors as research participants is considered a supervisor.

15. Does this policy apply to study team members listed in the eResearch application who do not have an affiliation with the University of Michigan (i.e., a site PI at another institution, or an international collaborator)?

1. The policy applies only to study team members (including faculty, staff, students, and volunteers) with an affiliation with the university.

16. For my study, I only send texts to minors, and often they never reply. Do I need to adhere to the policy?

• Yes. Interaction is defined as any of the following: in-person, phone, email, videoconference (i.e., Zoom),  text messages, social networking websites, internet chat rooms, multiplayer online games, or other forms of digital or social media.The communication can be bidirectional or it could be unidirectional, i.e., a study team member texting minors (who may not reply). Using a professional study account or service will meet the Rule of Threes requirement in the Code of Conduct.

17. What is the timeline for completing these policy requirements for studies that are newly approved by the Institutional Review Board after September 14, 2021?

• Within 30 days of Institutional Review Board approval, study team members must complete the required eLearning course and consent to the background check by responding to the email they will receive from HireRight approval. Study team members who do not complete these requirements will no longer be authorized by the university to interact with minors as research participants until the requirements are met.

18. I am a study team member on a study that received approval from the Institutional Review Board before this policy change occurred on September 14, 2021. Does this policy apply to me?

• Yes. You will receive an email from the Minors in Research team in the Office of Research Compliance Review. The email will contain a Qualtrics survey in which you will be asked to confirm that you will interact with minors as research participants, or attest that you will not do so. You will need to respond within 3 weeks. By October 31, 2021, study team members that interact with minors as research participants must complete the required eLearning course and have consented to a background check by responding to the email they will receive from HireRight. Study team members who do not complete these requirements by October 31, 2021, will no longer be authorized by the university to interact with minors as research participants until the requirements are met. Your study procedures will need to be in compliance with the Rule of Threes by 12/31/2021.

19. Does the policy apply to all study team members listed in eResearch on studies involving interactions with minors as research participants?

• No. The policy only applies to study team members who interact with minors as research participants. Interaction is defined as any of the following: in-person, phone, email, videoconference (i.e., Zoom), text messages, social networking websites, internet chat rooms, multiplayer online games, or other forms of digital or social media Study team members who do not interact with minors as research participants are not subject to the policy. All study team members on studies that received Institutional Review Board approval before the policy took effect on September 14, 2021, will receive an email from the Minors in Research team in the Office of Research Compliance Review. The email will contain a Qualtrics survey in which you will be asked to confirm that you will interact with minors as research participants, or attest that you will not do so. You will need to respond within 3 weeks. If you do not respond, you will be classified as a study team member who interacts with minors.

20. I am still confused as to how I can have my study be compliant with this new policy. Who can I talk to find a solution so that I can continue interacting with minors in my study and continue the research?

• Email ResearchWithMinors@umich.edu for assistance.

21. I plan to modify my study procedures to adhere to the Rule of Threes. Do I need to submit an IRB amendment to modify the study protocol?

• Generally, studies that have been IRB approved before this policy change are not required to submit an amendment to reflect changes in study procedures related to the Rule of Threes, unless the change impacts storage of sensitive identifiable data that is not addressed in the IRB approved protocol or permits access to sensitive information by individuals other than study team members. Examples of modifications that do not require an amendment are: “we’ll leave the door open”, “we’ll text from the research study account instead of a personal account”, or “we’ll copy the lab email on any email”. Examples of modifications that do require an amendment are: “We will audiotape the interview”, or “We will retain a recording or a transcript with identifiable data for a longer period than what the protocol describes”.

22. These changes would cause such a disruption to my study that I don’t think I can comply, what do I do?

• For guidance or assistance on how to handle these changes, contact researchwithminors@umich.edu

23. Is it permissible to conduct research with minors without a witness when the research is being conducted in the context of clinical care provision?

• Yes, if the study team members conducting the research in the context of clinical care provision are also the clinical care providers. Study team members conducting research at Michigan Medicine are reminded to ensure that they are also compliant with the Michigan Medicine Chaperone Policy.

24. I am no longer engaged in a research study that is subject to this policy but have been contacted indicating I must complete the steps required by the policy. How do I ensure that this information is corrected? 

• Contact the Principal Investigator(s) or study team leader of the research study on which you were previously a study team member. The Principal Investigator will need to ensure that you are removed as a study team member from the active IRB application. 

25. My study is now complete. Am I still subject to the Minors in Research Policy?

• If you have completed all research activities related to a specific study, submit a termination report in eResearch Regulatory Management System (IRB application). Once the report is finalized, the application will be terminated. For step-by-step instructions on this process please click here.   

26. The link to the eLearning course is not working. Where can I access the course? 

• If the link provided is not working, you can access the MyLinc course through Wolverine Access and search ‘UMOR_MRP101’, select the course, click register, and then click start. If you continue to have technical difficulties, please contact the HelpDesk (764-HELP). 

27. I thought I had already completed my required research trainings. Is this a new training? 

• The Minors in Research eLearning course is new and specific to studies that include minors as research participants. The course takes about 25 minutes to complete. You can find the course in MyLinc (search ‘UMOR_MRP101’) or through this link. 

28. Does the Minors in Research eLearning course and background check affect my study’s IRB approval or study team member’s IRB approval? 

• No. Approval of studies by the IRB is independent of this process. Approval of individual study team members to interact with minors as research participants is independent of the IRB. Within 30 days of IRB approval and before interacting with minor participants, study team members must complete the required eLearning course and consent to the background check by responding to the email they will receive from HireRight. Study team members who do not complete these requirements will no longer be authorized by the university to interact with minors as research participants until the requirements are met. 

29. Will IRB protocols remind me to confirm that I am interacting with minors as research participants? 

• Yes. A new question has been added to the IRB application, under Interaction with Minors to identify study team members who interact with minor participants. This is a required question for all new studies and amendments submitted after 9/20/2021. Study team members, on qualifying studies, who answer ‘yes’ to the Interaction with Minors question will receive a system-generated message reminding them to complete the eLearning course and will receive an email from HireRight asking them to consent to the background check. The Office of Research Compliance Review will be monitoring for compliance and will send reminders for study team members, as needed. 

30. Am I subject to the Minors in Research policy if I am alone with minors on campus who are not research participants? 

• Although the children are not research participants, you must still adhere to university policies related to children. Specifically, individuals who are involved in any children-related U-M activities, whether they are held on campus, virtually, or at an off-site location are subject to the Children on Campus Standard Practice Guide 601.34. Please reach out to Risk Management (RiskMgmt.General@umich.edu) if you have questions regarding this policy. The Minors in Research policy is the application of the broader Children on Campus policy to research. 

31. Does this policy apply to individuals who are administrative staff in clinics who may interact with research participants but are not members of the research study team? 

• No. If the individual is not engaged in the study and therefore is not listed as a study team member on the IRB application, then they are not subject to the policy. Individuals will know that they are included in an IRB application because they will have accepted their role in eResearch in the past. If you are uncertain if you are included in an IRB application, you may login to eResearch to see which studies (if any) you are currently listed on.

Background Checks

1. What does the background check include?

• The background check consists of a review of criminal records for the past seven years in counties where credit was established (limited to a total of seven counties), Social Security verification and the National Sex Offender Registry. Foreign nationals undergo a check through the Visa screening process conducted by the State Department.

2. Do I need to arrange for background checks for members of my study team?

• No. Each member of a study team who may interact with minors as research participants will be contacted automatically, based on the information in the IRB application submitted to eResearch. Study team members will receive an email from HireRight for consent to the background check and must respond to the email within seven days.

3. How are the background checks administered, and what is the notification process?

• When study team members respond to the email from HireRight, they will be asked to submit their information on a secure website. Risk Management Services will review the background check. The estimated turnaround time is five to seven business days but this is dependent upon the responsiveness of the jurisdictions contacted. We recommend allowing up to 60 days for processing requests.

4. What types of findings in a background check would exclude someone from being authorized to interact with minors as research participants?

• Serious offenses that would potentially put minors’’ safety at risk.

5. Who will know the results of my background check?

• Risk Management Services will review the background check and will contact you to gather additional information before any other members of the university are contacted. Findings on background checks are confidential and are not shared outside of Risk Management Services and the Office of General Counsel without the study team member’s knowledge. If any events of concern are identified in your background check, the first step is for you to be contacted by Risk Management Services to discuss the event in more detail. Depending on the results of this discussion, if the event raises concerns about the appropriateness of interacting with minors as research participants, and you still wish to be approved to do this work, this will lead to a discussion with supervisors in your unit to determine the best next steps.

6. I think the policy requirements apply to my role in research, but I did not receive an email from HireRight asking me to consent to a background check. What should I do?

• Check the spam folder in your email. If you still don’t find an email from HireRight, contact ResearchWithMinors@umich.edu.

7. Is there a fee or cost associated with background checks? 

• No. 

8. I interact with minors as research participants and completed the eLearning course but have not been contacted for my background check. What should I do? 

• Study team members on new studies will receive an email from HireRight within two weeks of IRB approval asking you to consent to a background check. If you did not receive such email, please check your spam folder before emailing ResearchwithMinors@umich.edu for assistance. 

9. Do I need to alert or work with my local HR office to complete my background check?

• No. This process is managed centrally by the Office of Research Compliance Review and the Shared Services Center. If you are subject to the policy, you will receive an email from HireRight asking you to consent to a background check. 

10. I recently received a background check for my new position at the University. Do I need to complete another background check? 

• Background checks for the Minors in Research policy are required every two years. You will only be required to consent to a background check if it’s needed or out-of-date. Individuals who have had a background check completed by the university at hire within the last 2 years will not be contact for a background check until it has been at least 2 years from the date of hire.

11. I have some data security concerns. Is it safe to consent to the background check?

• Yes. The University’s background check vendor has a highly secure system. You may refer to the HireRight data security materials on the HireRight website for additional information.   

Code of Conduct

1. My study involves a study team member meeting alone in a room with a minor one-on-one. This policy requires that my study team adhere to the Rule of Threes. How do I meet this requirement?

• It is permissible to conduct research with minors without a witness when the research is being conducted by clinical care providers in the context of clinical care provision (e.g., delivering experimental therapeutics, the clinical care provider obtaining an additional specimen nasal swab during a clinic visit). When the research necessitates that the study team member who is not also the clinical care provider interact with the minor alone, there are several options: an additional adult witnesses the interaction; the interaction occurs in an open public setting where the interaction can be witnessed by others; the interaction occurs in a room with the door open, or can be witnessed by others through a window; or the interaction is video- and/or audio-taped and the recording is stored in a secure location accessible to other study team members (this scenario is common when the interaction is already being recorded for research purposes).

2. My study involves a study team member interacting with minors via text and on social media What can I do to adhere to the Rule of Threes?

• Studies that involve texting minors must always include an additional individual in the texting conversation, or the texting conversation must be recorded and visible to the study team (e.g., on a study-specific texting account). Study team members are advised against texting minors using their personal device and/or personal contact information; a study-issued device and/or account is strongly recommended. Interactions with minors on social media should occur on professional accounts accessible to other study team members and not through private accounts.

1. Is it permissible for clinical research coordinators to conduct research with minors without a witness when the research is being conducted in a clinical care setting? 

• No. Clinical research coordinators are not clinical care providers therefore the Rule of Threes must be implemented. 

Reporting Obligations

1. I am not confident in my ability to correctly carry out my reporting obligations for child abuse and neglect. What can I do?

• Review the optional eLearning module that provides greater detail regarding child abuse and neglect available here. (link). If the study team is uncertain, the Child Protection Team at Michigan Medicine is available for consultation 24-7. Some study teams may want to consider including on their team a study team member with experience as a Mandated Reporter who can be responsible for addressing these issues as they arise for the study.

2. The policy states that when research involving interaction with minors is occurring, that the Study PI or their delegate must be immediately available. What does that mean?

• Because of the reporting obligations, a senior study team member must be available immediately by phone or text if a study team member becomes aware of abuse or neglect. In some cases, reporting the information to Children’s Protective Services is time sensitive. Therefore, a senior member of the study team (generally the Study PI), must be available by phone or text to the study team. If the Study PI cannot be available (i.e., travel, being on leave), a delegate must be identified.

3. The instructions state that I must file a report with Children’s Protective Services within 24 hours. Why is this time frame important?

• It is important for the safety of the minor. In addition, in some cases, the observation being reported may involve an injury. It is important for Children’s Protective Services to evaluate any injuries before they heal (i.e.,. bruises fading).

4. If a minor discloses abuse or neglect to me, I would like to explain to the parent that I will be calling Children’s Protective Services in order to preserve the relationship with the family. Preserving these relationships is important to the integrity of my study. Why do the instructions indicate that I cannot disclose to the parent what the minor privately reported to me, and that I will be calling Children’s Protective Services?

• By sharing with the parent what the minor has disclosed to you, and then sending the minor home with the parent, the minor may be placed at risk and/or the parent may direct the minor not to disclose the information to Children’s Protective Services.

5. A minor made a comment that I couldn’t quite hear or understand, but might indicate abuse or neglect. Can I ask the minor more questions to clarify?

• It is permissible to ask the minor to simply repeat what they said if it was difficult to hear. It is common that minors report information that can be difficult to understand or vague. It is important that the study team not query the minor for more detail, as this can be leading and invalidate the minor’s reporting. It is important to leave interviewing of the minor to trained professionals.

6. Am I still obligated to file a report with Children’s Protective Services if I am not certain that abuse or neglect has occurred?

• Your obligation is to file if there is suspected abuse or neglect. This obligation is not limited to confirmed abuse or neglect. Evaluating the situation is the role of Children’s Protective Services.

7. If I call Children’s Protective Services, will this result in the minor being removed from the family and placed in foster care?

• This is a very uncommon outcome. The main goal of Children’s Protective Services is to preserve families, and the approach is primarily to provide families services and support.