Volunteers and Human Research Conduct


Research volunteers (including all undergraduates) involved in the conduct of research with humans participants must be processed through the UCLA Hospital Volunteer Office on-boarding before undergoing BMC safety training.  Please complete the below BMC Version form and submit it to Lily Zhang, LilyZhang@mednet.ucla.edu and cc BMCTechs@mednet.ucla.edu.  If working with ONLY with TMS cc DarinWilliams@mednet.ucla.edu instead of BMCTechs. 

 

Clinical Research Volunteer Scope of Duties Form - BMC Version

 

CRVSOD Forms (How to Complete)

 

Additional Volunteer Forms:

CRV IRB Listing Template7.13.18

CRV Personal Device Form7.13.18

 

More information about the direct referral volunteer program can be found here: https://www.uclahealth.org/Volunteer/direct-referral-program

 

To reflect the new requirements related to undergraduates and other volunteers, the following BMC policies are now in effect:

 

1. No undergraduate or volunteer who has not completed the required School of Medicine onboarding process should be present when human subject research is being conducted in the BMC. This is true even if the individual has previously been BMC safety certified. 

 

2. If an undergraduate or other volunteer has completed the School of Medicine onboarding process, they must be under the direct supervision of a paid UCLA employee who is also a member of your staff at all times.  BMC technologists can never be designated as the supervisor of your undergraduates or volunteers. 

 

3. It is the PI's responsibility to assure that the volunteer's supervisor is a paid UCLA employee who has a current and valid UCLA employee ID number. It is also the PI's responsibility to assure that the supervisor is aware that he or she is responsible for the volunteer's actions and that the supervisor is qualified and authorized (e.g., by his or her own direct supervisor) to provide supervision to undergraduates and other volunteers. 

 

4. We will continue to safety train and certify undergraduates and volunteers, but reserve the right to prioritize non-volunteers when offering training slots. For MRI training, volunteers may attend the initial orientation and take the written quiz while their onboarding process is underway (the referral for onboarding should be submitted before any safety training). However, undergraduates and volunteers will not be advanced to in-person orientations or final walkthroughs until the BMC has received documentation of their successful completion of the onboarding process. The criteria for successful completion of MR safety training will not be modified, so if a volunteer later transitions to non-volunteer status, MR safety certification will remain valid after this transition. A detailed flowsheet for MRI safety training that has been updated to include specific instructions regarding volunteers is available at  http://bmap.ucla.edu/services/safety_training/mri_safety/

 

For the neuromodulation laboratory, full safety certification may in some instances be deemed incompatible with the constraints placed on volunteers, and a two-tiered certification approach may be necessary.  A flowsheet for safety training in the Neuromodulation laboratory that includes the special steps needed for volunteers is at http://bmap.ucla.edu/services/safety_training/tms_safety/

 

5. Undergraduates and other volunteers are no longer eligible to have personal biometric access to the laboratories and other rooms where human research is conducted. Existing access to those areas will be revoked. We will continue to offer biometric access to the building. This policy helps assure that volunteers cannot conduct research without a supervisor being present.

 

6. BMC staff are not responsible for assuring that your staff and volunteers conform to the approved job descriptions for volunteers. However, we reserve the rights to:

            a) bring violations to the attention of the supervisor and/or the PI

            b) eject unsupervised volunteers and/or revoke their safety certifications

            c) respond to failures to adequately supervise volunteers by prohibiting the supervisor from future supervision and/or by revoking the      

                supervisor's safety certification

            d) notify the Direct Referral program of actions taken under b) and c) above

 

7. Volunteers who work exclusively with non-human subjects (e.g. phantoms) fall outside the jurisdiction of the Direct  Referral Program and are not eligible to be onboarded by them. The onboarding requirement can therefore be waived by the BMC Director on a case-by-case basis for such volunteers working in the 3T Prisma or Neuromodulation laboratories, but the requirements for direct supervision by a paid UCLA employee will still apply. Other restrictions comparable to those for human studies may be applicable, to be determined on a case-by-case basis. 

 

8. No special BMC policies are currently in effect for undergraduates or other volunteers working in the Bruker laboratory. Bruker safety training and access requirements and privileges for volunteers are the same as for non-volunteers. However, PI's of Bruker projects are encouraged to carefully consider the roles of volunteers and to assure that these roles are consistent with University policies.

 

9. Undergraduates and other volunteers working in the PET laboratory are subject to the same general requirements as those working in the MRI laboratory. Additional constraints may apply since non-employees would be subject to the more stringent radiation dose limits that apply to members of the general public. Please contact BMC PET staff to discuss BEFORE submitting a Direct Referral request.

 

10. In the event that an undergraduate also has a paid position with the University (e.g., a work-study student) and their involvement in the conduct of human research studies in the BMC is entirely encompassed by their paid UCLA job description, they are not considered a volunteer and are not subject to the volunteer restrictions. However, any additional or subsequent unpaid work in the BMC would be subject to the volunteer restrictions.

 

11. PI's are responsible for assuring that the undergraduates and other volunteers who work on their projects have been onboarded specifically for their laboratory. If a volunteer changes laboratories (or volunteers independently in a second laboratory), a new Direct Referral form must be submitted, approved and provided to the BMC before working on projects conducted by the new laboratory. PI's should check with the Direct Referral program for guidance in complex situations where the supervisory chain between the volunteer and the designated BMC PI is amibiguous or uncertain (e.g., collaborations between two different laboratories, etc.). 

 

12. None of the policies above are meant to apply to volunteers who are in the BMC as IRB consented research subjects.

 

13. None of the policies above apply to graduate students, except that a graduate student who is not also a paid UCLA employee (i.e. does not have a current valid UCLA employee number) cannot supervise a volunteer.

 

14. No exceptions to the above policies will be made for situations where the Direct Referal program declines to review a volunteer referral (e.g., because the PI is not affiliated with UCLA). Being an official volunteer at another institution is not an acceptable substitute.

 

15. Current and/or previously paid full/part time UCLA employees are not allowed to volunteer within the SAME department and will not qualify to be onboarded. 

 “Per policy, previous/current UCLA employees are not permitted to volunteer (not UCLA SRP) in the same department or supervisor (conflict of interest and per labor relations) regardless of location and duties.”