Problems Involving Risk/Noncompliance
Guidelines for Defining Problems to be Reported:
Unanticipated problems involving risks to participants or others and adverse effects need to be reported to the IRB. Adverse effects may be directly or indirectly related to the research and may be expected or unexpected.
The following examples illustrate what needs to be reported:
Unanticipated problem involving risk to participants: The laptop computer which has identifying information about research participants is stolen.
Unanticipated problem involving risk to others: The research assistant involved in the project is inadvertently exposed to a low level of radiation.
Expected adverse effect: Subject A becomes upset when asked about feelings regarding prior sexual abuse. The subject is referred for counseling.
Unexpected adverse effect: Subject B becomes agitated and angry when asked general non-invasive questions about the appropriateness of corporal punishment of children. The subject is referred for counseling.
Reports of adverse events must be reported immediately via phone, email, or in person to the IRB Chair and to the Office of Sponsored & Academic Programs Support. A written report of the adverse event must then be submitted to the IRB Chair and Office of Sponsored Programs, within 5 working days after first awareness of the problem
Defining Noncompliance
Guidelines for Defining Noncompliance:
- Misuse or nonuse of approved informed consent procedures
- Failure to submit protocols in a timely manner
- Breaking confidentiality, unless required by law (e.g., child abuse)
- Unapproved subject recruitment activities
- Failure to secure confidential records in the required manner
- Failure to report problems involving physical or psychological injury to participants or others
- Failure to report risks to participants or others that exceed the protocol as approved
- Report from a subject of abuse by the PI or research staff
- Conducting research involving human participants that has never been approved by the IRB
- Initiating changes to research protocols involving human participants without prior IRB approval
- Continuing research activities beyond the IRB approved end date
Even though these types of events must be reported, the PI is encouraged to contact the IRB Chairperson and OSRP if anything occurs that causes concern regarding the protection of human participants.
Reporting of Problems or Noncompliance by the PI:
The PI must contact the IRB Chairperson via phone and/or e-mail immediately following an incident of injury, increase in risk, unanticipated risk, other adverse effects experienced by participants or others involved in research, or incident(s) of noncompliance. Additionally, the PI must submit a written report of the incident to the Office of Sponsored Programs, care of the IRB Chairperson, as soon as possible thereafter, but no later than 5 working days after first awareness of the problem. If the incident is severe or increases the risk to participants or others, the PI may be asked to suspend research activities pending further review by the IRB and/or OSRP.
Investigation of Problems/Noncompliance
Investigation of Problems and Noncompliance:
If any member of the IRB receives information about injuries to participants, unanticipated problems involving risk to participants or others, or serious noncompliance, through a source other than the PI or co-PI, he or she will immediately inform the IRB Chairperson and OSRP. The IRB Chairperson may temporarily suspend IRB approval for a study, pending investigation by the Office of Sponsored Programs and further IRB review, after learning of the problem, adverse effect, or noncompliance.
A subcommittee of the IRB consisting of the IRB Chairperson, an IRB member or alternate who is the community representative, and another IRB member, who holds tenure and is outside the PI’s department, will investigate the allegation of a problem involving risk to participants or others, an adverse effect, or noncompliance. The IRB Chairperson will request an interview with the individual(s) alleging the problem, adverse effect, or noncompliance. The IRB Chairperson will share the results of this interview or written correspondence with the other members of the ad hoc committee, and they will decide how to proceed. The IRB Chairperson will notify the PI in writing within 5 working days that an allegation of problem, adverse effect, or noncompliance was received. Following the interview or upon receipt of a written allegation, the IRB Chairperson will request an interview with the PI and any other researchers involved, in order to assess the situation, require changes in the protocol, if necessary, and resolve the issues without further official action. The committee members will decide if both need to be present at the interview with the PI and other researchers involved. If the ad hoc committee members are not satisfied with the results of the initial interview with the PI, they may expand the investigation. The ad hoc committee members may interview the research staff and any other persons who have relevant information, including research participants. The committee will produce written summaries to the interviewed parties for comments, and written comments received will be included in the record of the investigation.
The committee will prepare a report which includes a description of the investigative activities, how and from whom information was obtained about the problem(s), a list of those interviewed, a summary of records obtained, findings, basis of findings, and actions taken. Before the report is shared with the IRB, identifying information which may put the individual making the allegation at risk may be removed. The final report, which contains all identifying information, will be filled with confidential project records.
The PI’s Department Head, other appropriate University Administrative officials, OHRP, and funding agency (if applicable) officials will be notified if problems are confirmed by the ad hoc committee.
Suspensions/Terminations
Suspension or Termination of Approval of Research Activities:
The IRB Chairperson may suspend a study at any point after receiving information regarding unacceptable and uncorrectable levels of risk or harm to the participants or others or serious disregard on the part of the researcher to the policy and requirements of the IRB. The Chairperson will promptly notify the PI(s), as well as the Office of Sponsored Programs, in writing of this decision and the reason(s) for suspension of approval. The Office of Sponsored Programs will notify OHRP and funding agency (if applicable) of the suspension or termination of approval.
Furthermore, the IRB Chairperson will convene a meeting of the IRB to discuss the suspension of IRB approval and the IRB will decide whether (1) IRB approval should be reinstated with or without modifications, (2) suspension of IRB approval should be continued, or (3) IRB approval should be terminated. The PI will be informed, in writing, of the outcome of the IRB meeting.
Reporting of Problems or Noncompliance:
The IRB Chairperson will keep the OSRP informed of reports by PIs or others of unanticipated problems involving risk to participants or others, adverse effects, serious or continuing noncompliance, and suspension or termination of IRB approval. The Office of Sponsored Programs will notify appropriate PIs Department Head, University Administrative officials, OHRP, and funding agency (if applicable) of unanticipated problems involving risk to participants or others, unanticipated adverse effects, serious adverse effects that may have been expected, serious or continuing noncompliance, and the IRB suspension or termination of approval for research activities.