ELEMENT III.2.B.

ELEMENT III.2.B.: Researchers maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions.

Researchers are ultimately responsible for the conduct of research. Although researchers may delegate certain responsibilities and functions of the research, they must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.

When researchers delegate responsibilities or functions, they should ensure that research staff are trained and able to perform the function and assume the responsibility for the delegated function.

Regulatory and guidance references

DOJ: 28 CFR 512.11(a)(7)
FDA: 21 CFR 312.53(c) (1), 21 CFR 312.60, 21 CFR 312.61, 21 CFR 312.62, 21 CFR 812.43(c) (4), 21 CFR 812.100, 21 CFR 812.140
ICH-GCP(E6)(R2): 2.7
ICH-GCP(E6)(R3): II.1.5, III.2.3.
VA: VHA Directive 1200.05, Section 5
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures indicate:
  1. Researchers ensure that they and their research staff are appropriately qualified and trained to conduct the research.
    1. This could include any delegated procedures to research staff, such as obtaining and documenting informed consent.
  2. Policies and procedures describe training requirements for researchers and research staff who conduct research procedures, including:
    1. training on any procedures they will perform.
    2. training on the protection of research participants.
  3. Policies and procedures indicate that:
    1. Researchers maintain active, ongoing oversight for research staff who conduct study procedures.
    2. Researchers retain responsibility for all delegated activities, even when performed by qualified staff.
    3. Researchers establish processes to:
      1. communicate regularly with research staff.
      2. update research staff regarding changes or modifications to the research.
    4. Researchers maintain documentation of any delegation of responsibilities.
When following DOJ requirements:
1. Policies and procedures indicate that for research conducted within the Bureau of Prisons, the researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
When following ICH-GCP(E6)(R2) guideline:
1. The medical care given to, and medical decisions made on behalf of, participants should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
When following the ICH-GCP(E6)(R3) guideline:
1. Policies and procedures describe responsibilities of researchers for supervising others, when relying on others to conduct the research:
  1. A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to and medical decisions made on behalf of participants. Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.
  2. The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor.
  3. The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.
  4. The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities. Documentation of delegation should be proportionate to the significance of the trial-related activities. In situations where the activities are performed as part of clinical practice, delegation documentation may not be required.
  5. The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.
When following VA requirements:
1. Policies and procedures specify If the investigator does not personally obtain informed consent, the researcher must delegate this responsibility in writing (e.g., by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective participants, and about the ethical basis of the informed consent process and protocol.
2. Policies and procedures specify that investigators and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.
3. If the investigator contracts with a firm (e.g., a survey research firm) to obtain consent from participants, collect private individually identifiable information from human participants, or be involved in activities that would institutionally engage the firm in human participants research, the firm must have its own IRB oversight of the activity.
  1. In addition, the Privacy Officer (PO) must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.
4. Policies and procedures specify that individuals working under a contract with VA cannot conduct research as VA Investigators under a without compensation appointment while simultaneously working as a contractor.
  1. Trainees can serve as a co- or sub-investigator but must have a VA PI sufficiently experienced in the area of the trainee’s research interest to serve as the PI.

Common types of materials that may be used to meet the element

Researcher manual

Outcomes

Researchers are actively engaged throughout all phases of the research.
Researchers hire, train, and verify that research staff possess appropriate education, relevant training, and competence for their assigned role.
Research Staff indicate that the researcher delegates responsibility to them commensurate with their training and qualifications.
Researchers are available and maintain contact with research staff.

Proceed To: ELEMENT III.2.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.2.B.