Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-10

Title 10:

Research Participant Withdrawals, Inquiries and Concerns

Effective Date:

09-24-14

Revision History:

12-06-04; 06-21-06; 02-05-08; 06-01-08

Objective

To describe VCU's policy for handling inquiries and/or concerns reported by research participants and others.

Description

  1. Withdrawal from Clinical Trials:
    1. When a participant withdraws from a clinical trial regulated by the FDA, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.
    2. A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.
    3. The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.
    4. If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
  2. Inquiries / Concerns Addressed to Investigators:

    Principal investigators must provide an environment that welcomes inquiry, comment, and concerns from human research participants, the community, and others. The following guidance is provided:

    1. All inquiries and/or concerns presented by human research participants must be documented as part of the study file, addressed using all reasonable measures, and presented to the IRB if any concerns about potential increased risk (to the research subject or others) have been raised.
    2. Special efforts must be taken to protect the interests of persons who raise concerns. Whistleblower protection laws are enforced at VCU. Any issue raised must be heard as a valid concern and addressed/researched by the investigator and folly documented in writing. A valid, efficient, and careful inquiry is always warranted.
    3. Every effort must be made to ensure that the matter is addressed or brought to the attention of the IRB (if unable to address/resolve or additional risk might be posed). The principal investigator should reinforce to all persons, who raise concerns or inquire about human subject protections, that reports and inquiries can also be made to the VCU Office for Research Subject Protections (ORSP) and other authorities at VCU.
    4. All reports of complaints or concerns should be evaluated by the person handling the complaint to determine if the complaint might represent non-compliance or an unanticipated problem involving risk to research participants or others.
    5. Any research participant who raises an issue about their safety or unwillingness to participate in further research must be reminded of their right to report their concerns and discontinue their involvement in the research, without penalty.
    6. For concerns regarding potential non-compliance with VCU IRB approval, federal, state, or local laws, or other serious concerns, investigators must immediately report the issue to the ORSP and respond verbally and in writing. The ORSP may be consulted by the Principal Investigator (and/or staff) and will provide assistance, as appropriate.
    7. At the time of continuing review, the VCU IRB will request a summary of all inquiries and/or concerns.
  3. Inquiries / Concerns Addressed to the IRB, ORSP:

    To report possible areas or incidences of research non-compliance with federal, state, or local regulations which involve VCU faculty, staff, students, or research subjects, please contact the Office for Education and Compliance Oversight at the contact below.

    Reports or allegations are forwarded to the convened IRB Panel (accompanied by investigative materials, as available) for review and determination of serious or continuing noncompliance and/or whether the report constitutes an unanticipated problem involving risks to subjects or others. Such determinations are required reporting to federal agencies and sponsors – see IRB WPP VI-3 “Determination and Reporting of Serious or Continuing Noncompliance, Unanticipated Problems Involving Risk to Subjects or Others, Suspensions, and Terminations”

    If the report or allegation is determined to not represent non-compliance, the convened IRB will consider if it is an unanticipated problem involving risks to subjects or others (and designate reporting as such). If the report or allegation does not represent an unanticipated problem, the recommendation will be made to handle the issue as a complaint and/or concern that may or may not be considered general noncompliance to be addressed by the IRB, but not federally reportable (see WPP VI-3 “Investigations and Reporting of Unanticipated Problems, Serious or Continuing Non-Compliance, Suspensions, and Terminations,” – Section B1.

    VCU makes every effort to encourage investigators to bring all incidences of non-compliance forward for assistance in developing remedies. VCU also encourages non-investigators to feel free to report concerns about research and makes every effort to ensure that the identity of persons reporting non-compliance are kept confidential. ALL reports of possible areas of research non-compliance are taken seriously and reviewed.

    Every effort is made to ensure that the identity of persons reporting non-compliance is kept confidential. ALL reports of possible areas of research non-compliance are taken seriously and reviewed.

    Please submit compliance concerns to:

    Office of Research Subjects Protection – Human Research Protection Program
    828-0868 or ORSP@vcu.edu
    800 East Leigh Street, Suite 3000
    BioTech One Building
    Box 980568
    Richmond, VA 23298

    General information for research participants may be accessed on the VCU IRB website.

Responsibility

It is the responsibility of all VCU faculty, staff, and other personnel to ensure that all inquires and or reports of concerns regarding human research protections are handled swiftly and efficiently, with appropriate reporting to the VCU IRB and documentation, in writing.

References

None listed