PRO-U4520.08 Protecting Human Subjects In Research

Action By:

Vice Provost for Research

  1. Selects, interviews, and appoints members of Institutional Review Board (IRB)

Investigator

  1. Submits application packet to Research and Sponsored Programs (RSP) utilizing the human subject research form on the RSP webpage.

  2. Includes the following in the submission:

    • A completed application form, including:
    • Investigator’s name, department, and title of protocol,
    • (Optional) the research category,
    • Description of study purpose, procedures, research participants,research risks and benefits,
    • Description of the recruitment methods,
    • Description of the consent process, and
    • Description of the type and sensitivity of data and the data management plan, (unless the research is exempt).
    • Include all applicable attachments, including:
    • Recruitment text(s),
    • Informed consent document(s) or a consent wavier supplement,
    • Copies of all survey instruments or tests,
      questionnaires, interview questions,
    • Other attachments as needed, including
      supplements, debriefing form, assent
      form, K-12 clearance letter, Tribal IRB or
      leadership approval, etc., and
    • Signature of investigator and department
      chair as well as faculty advisor if
      investigator is a student.
  3. Completes CITI Social & Behavioral Basic/Renewal Ethics Training or an IRB approved alternative.
    • All researchers recruiting subjects, collecting data, designing the research method, or analyzing identified data must complete ethics training.
    • Does not submit certificates with their applications but Investigator is responsible for maintaining all records of research team.
    • Renews ethics training every five years.
  4. Cannot recruit until IRB approval is secured. However, researcher may contact a community or organization representative to obtain permission to conduct research with the participant population.
  5. Reviews protocol and determines whether the application is complete.
  6. Determines review category.
  7. Notifies Investigator with any needed revisions or missing elements.
  8. Reviews protocol to determine if risk to human subjects is minimal and falls within the exempt categories and protocol is complete.
  9. Sends approval memo to Investigator if protocol complies with federal regulations.
  10. Reviews to determine whether the protocol meets the expedited categories if the protocol does not fall within the exempt category.
  11. Designates primary and secondary reviewers and sends the protocol to the reviewers for expedited category review. The RCO can serve as one of the designated reviewers.

Primary/Secondary Reviewers

  1. Review protocol to assess whether it complies with federal regulations. Sends any change requests or missing document requests to RCO.

RCO

  1. Sends revision requests to Investigator.

Primary/Secondary Reviewers

  1. Contact RCO if request full review.
  2. Contacts RCO with revisions request.

RCO

  1. Contacts Investigator with revisions request.

Investigator

  1. Revises and resubmits protocol if changes were requested.

RCO

  1. Sends revised protocol to designated reviewers.

Primary/Secondary Reviewers

  1. Review and communicate approval to RCO if the protocol complies with all federal regulations.

RCO

  1. Sends approval memo to Investigator if approved.
  2. Sends protocol to full IRB committee for review if protocol does not qualify for exempt or expedited review or is not approved by the expedited reviewers.
  3. Sets meeting date and notifies all IRB of the meeting time and date.

IRB

  1. Meets and votes whether protocol is approved or disapproved. Approval requires a majority vote of a quorum of the committee.

RCO

  1. Sends approval memo to the investigator if the protocol is approved.

Investigator

  1. May appeal IRB non-approval to the Vice Provost for Research explaining the regulatory basis for the appeal.

Vice Provost for Research

  1. Determines whether research protocol is approved or not approved. This decision is final.

Investigator

  1. Submits protocol modification to RCO if any changes are made to protocol including:
    • The subject population
    • The maximum number of subjects
    • Recruitment plan or materials
    • Study instruments
    • The lead investigator or any investigators working with human subjects or their identifiable data.

RCO

  1. Reviews modification and send it for expedited review to a primary and secondary reviewer.
  2. Review and notify RCO if protocol complies with federal requirements.
  3. Sends approval if modifications comply with federal requirements.

Investigator

  1. Submits status report (full board applications only) describing any adverse events, and whether the protocol should be closed.
  2. Reports any unanticipated problems, possible non-compliance, and other Information and incidents that might affect its approval of the protocol or the subjects’ willingness to continue participation.

RCO

  1. Orders discontinuation of research if there are unanticipated problems, possible non-compliance and other information or incidents that might affect approval of the protocol or the subjects’ willingness to continue participation.

Investigator

  1. Retains all signed informed consents and data for six years following the completion of the research unless the protocol specifies otherwise. These may be retained in electronic format.

Procedure Information

Approved By:

Vice Provost, RSP

Effective Date:

May 27, 2021

Authority:

Related Forms

No forms apply to this procedure.

Procedure Contact

Research and Sponsored Programs

Phone: (360) 650-3220

Research and Sponsored Programs website