The College of Medicine Office of Research (COMOR) Research Volunteer Program (RVP) is being restructured to ensure compliance with applicable law and policy.

Please note the below changes to the RVP effective August 10, 2021:

  1. The following are not considered Research Volunteers (RV):
    1. Persons under the age of 18 who are enrolled for academic credit or have been accepted for enrollment at Ohio State
    2. Current Ohio State students and employees
    3. Non-Ohio State-affiliated researchers collaborating on Ohio State research with or without an Individual Investigator Agreement (IIA), IRB Authorization Agreement (IAA), or Memorandum of Understanding (MOU)

      The term RV must not be misinterpreted to mean Research Subject or Research Participant.
  2. Any individuals befitting the description in 1. a., b., or c., may require access (as applicable to their involvement in research) to areas and systems. It is the responsibility of the Principal Investigator (PI) to determine what access is appropriate, and to work with their department administrator to ensure that access is obtained.
  3. Additionally, non-Ohio State-affiliated researchers collaborating on Ohio State research may also be required to complete a background check, fingerprinting, and badging in accordance with (IAW) Human Resources (HR) policy, similar to the onboarding of a new employee. It is the responsibility of the PI or designee to ensure that the individual completes a background check, fingerprinting, and badging IAW HR policy. As such, it is also the responsibility of the PI or designee to ensure that removal of access to areas, systems, and return of ID badge (as applicable) occurs after the individual is no longer participating on the research project.

PI RESPONSIBILITIES

PIs are ultimately responsible for:

  • The ethical and humane conduct of research, and compliance with federal regulations, applicable state and local law, and university policies;
  • Knowing when proposed activities are defined as “research involving human subjects” in accordance with (IAW) Human Research Protection Program (HRPP) policy [Research Involving Human Subjects] or for seeking guidance, as appropriate;
  • Delegating study-related tasks to appropriately qualified and trained study personnel and maintaining oversight of and retaining ultimate responsibility for the conduct of those who perform delegated functions;
  • Ensuring that all researchers assisting in the conduct of the study are informed of their obligations for following the IRB-approved, IACUC-approved, or IBC-approved protocol, and applicable regulations, laws, and policies; and
  • Ensuring sufficient time to properly conduct and/or supervise proposed research and study personnel

OTHER INVESTIGATOR AND STUDY PERSONNEL RESPONSIBILITIES

Other investigators and study personnel are responsible for:

  • Adhering to the principles outlined in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (“Belmont Report”) when conducting research involving human subjects;
  • Adhering to the statutes of the Animal Welfare Act and the guidelines of the Public Health Service (PHS) as outlined in the Guide for the Care and Use of Laboratory Animals when conducting research involving animal subjects; and
  • Conducting research IAW all applicable university, and Office of Responsible Research Practices (ORPP) policies, as well as federal, state, and local laws and guidance for the protection of human and animal subjects in research

PROCEDURE

  1. For an existing IRB-approved, IACUC-approved, or IBC-approved study: Submit a personnel change request via Buck-IRB (IRB) or e-Protocol (IACUC or IBC) to add an individual befitting the description in 1. a., b., or c.
  2. For a new IRB, IACUC or IBC study: Add the individual befitting the description in 1. a.,b., or c. to the application in Buck-IRB or e-Protocol. If there is an associated study (e.g., Human Gene Transfer [HGT] studies are typically performed under an IRB-approved study and an IBC-approved study), follow the same procedure for each study.
  3. After approval is obtained, the PI or designee will work with their department administrator to ensure that the individual befitting the description in 1. a., b., or c. obtains access (as applicable to their involvement in the project) to areas and systems, and that any individual befitting the description in 1.b. or c. completes a background check, fingerprinting, and badging IAW HR policy, similar to the onboarding of a new employee.
  4. For any individual befitting the description in 1. a., b., or c. who will work on a project not under the oversight of the IRB, IACUC, or IBC, (e.g., basic lab science):
    1. The PI of the project is ultimately responsible for:
      1. The ethical conduct of the study and for compliance with federal regulations, applicable state and local law, and university policies;
      2. Delegating study-related tasks to appropriately qualified and trained study personnel and maintaining oversight of and retaining ultimate responsibility for the conduct of those who perform delegated functions; and
      3. Ensuring sufficient time to properly conduct and/or supervise study personnel

Additional information with regard to youth is forthcoming.

Contact Us

Please contact ResearchVolunteers@osumc.edu with any questions.

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