HSC Procedures

HSC Procedures

Human Subjects Research Procedures Relating to Policy 2-11

HSC Authority and Investigator Responsibility

UCAR has established a Human Studies Committee (HSC) as its Institutional Review Board (IRB) to review, approve, authorize and act on behalf of UCAR in every manner required by the federal regulations, guidelines and procedures to protect the interests of human subjects.

UCAR has adopted a comprehensive Human Subjects Research Manual which provides UCAR researchers with the background, processes and procedures that must be followed. All researchers involved in human subjects research are expected to have reviewed the HSC Manual and participated in training for Human Subjects Research. In addition, the following procedures apply.

HSC Review and Communication

The HSC uses the following procedures in reviewing research, as outlined in Chapter 2 of the Manual.

In conducting its initial review of research, the HSC has an "on-call" member who reviews the research and determines initially if it is exempt; can be reviewed under an expedited procedure; requires a "pending review,"; or needs a full review under the Human Subjects Research regulations. The on-call schedule is posted on the HSC web site. 

The HSC will require oversight and continuing review of the research or more frequent than annual review, where:

  • there are multiple phases to research;
  • a federal agency has determined that the research needs specific monitoring;
  • review of the research at more frequent intervals is appropriate based on the risk involved; or
  • the HSC, in its judgment, determines that the research needs more frequent review.

 

During its review process, the HSC will communicate directly with the researcher via email and phone, and will issue a final written memo to the researcher. The researcher is responsible for completing all documentation required by any funding agency with regard to human subjects research. The HSC will keep its approval documentation along with all information provided by the researcher as part of the HSC's formal institutional records for a period of five years. 

In projects that are controlled outside of UCAR, for which other institutions or IRBs have given approval as set for in 45 CFR Part 690.114, or for which there may be extraordinary circumstances or issues of risk, the HSC may request project verification from a source other than the researcher, particularly to confirm that no material changes have occurred since the previous HSC review.

Unanticipated Problems in Research & Notification

Researchers may not make any changes in the approved research that concerns human subjects without formal HSC approval, except when necessary to eliminate apparent immediate hazards to the subject. Researchers must promptly report to the HSC any proposed changes in the research activity, and must seek approval.

Researchers and anyone involved in the research are required to report to the HSC any:

  1. unanticipated problems involving risks to subjects or others; and
  2. serious or continuing noncompliance with the federal regulations or the requirements or determinations of the HSC.

In any instance where (1) or (2) outlined above occurs, the HSC has authority to suspend or terminate approval of the research, and will issue a written statement to the researcher setting forth the reasons for the HSC's actions. In cases where the HSC suspends or terminates its approval, the HSC will promptly notify the appropriate member of President's Council (the NCAR or UOP Director) and UCAR's President, and the cognizant official at the National Science Foundation and any other funding agencies, as necessary.