Policy: Reporting Unanticipated Problems/Adverse Events to the IRB

Policy Statement 

This policy describes the policy and procedures for reporting unanticipated problems and/or adverse events in IRB approved/exempt human subjects research projects to the Lehigh University IRB. 

Who Should Read This Policy 

• Faculty, staff, and students of the university conducting human subjects research subject to IRB review and oversight
• New and re-appointed IRB committee members
• New and re-appointed IRB committee co-chairs
• Research Integrity office staff 

Reason for Policy

This policy addresses the university’s commitment to maintaining an effective, well-functioning, and compliant human research protections program. Federal regulations require institutions engaged in human subjects research to have written procedures for ensuring prompt reporting to the IRB of “unanticipated problems involving risks to subjects or others”. In order to ensure that participants are afforded the highest level of protection, the institution applies these reporting requirements to all human subject’s research that is the purview of the IRB, regardless of source of funding or applicability of federal regulations. 

Entities Affected By This Policy

This policy applies to all faculty, staff, and students of the university conducting human subjects research; the IRB committee members and chairs; the Institutional Official (IO); Research Integrity office staff.  

Responsibilities

Principles

Unanticipated problems are any information that is (1) unanticipated and (2) related or possibly related to participation in research, and (3) indicates that subjects or others are at increased risk of harm. Investigators are required to report the following:

1. Any information that meets all of the following criteria:
   1. Unanticipated or unexpected, in terms of nature, severity, or frequency, given the research procedures that are described in the protocol-related documents (e.g. the IRB-approved research protocol and informed consent document) and the characteristics of the subject population.
   2. Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
   3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
2. Information that indicates a new or increased risk, or a safety issue. For example:
   1. New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) that indicates an increase in the frequency or magnitude of a previously known risk or uncovers a new risk. 
   2. Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol. 
   3. Protocol violation that harmed subjects or others and indicates that subjects or others might be at increased risk of harm. 
   4. Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm. 
   5. Any changes significantly affecting the conduct of the research. 
3. Noncompliance with federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such noncompliance. 
4. Audit, inspection, or inquiry by a federal agency. 
5. Written reports of external/sponsor study monitors to the investigator; data safety monitoring board reports; or written reports of sponsors to investigators. 
6. Failure to follow the protocol due to the action or inaction of the investigator or research staff. 
7. Breach of confidentiality. 
8. Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to the subject. 
9. Incarceration of a subject in a study not approved by the IRB to involve prisoners. 
10. Complaint of a subject that cannot be resolved by the research team. 
11. Premature suspension or termination of the research by the sponsor, investigator, this institution, or another institution.

Procedures

1. Principal Investigators with IRB-approved/exempt protocols are required to report any of the 11 items above, or information that otherwise qualifies as (1) unanticipated (inconsistent with information previously reviewed by the IRB), (2) related or possibly related to participation in research, and (3) indicates that subjects or others are at increased risk of harm.
2. Other members of the research team, as well as faculty, staff, or students, are responsible for reporting to the Office of Research Integrity suspected or actual noncompliance with the provisions of an IRB-approved study as well as with any applicable human research regulations, University policies, and state and local laws when conducting human subjects research.
3. Research participants, participants’ family members, and others external to the University may also report suspected noncompliance to the Office of Research Integrity or to the IRB. These reports may be in the form of complaints and may also be made anonymously.
4. Self-Reports by Principal Investigator: Initial reports may be made by phone or email and must be made to the IRB within five business days of the Principal Investigator learning of the information. Initial reports must be followed by formal written reports. An Unanticipated Problem Report Form must be submitted as an Unanticipated Problem package in the existing IRBNet project. The report must be submitted within fourteen business days of the investigator learning of the information.
5. Reports made to the Office of Research Integrity and/or the IRB: Reports that are not made by the Principal Investigator are prepared by Research Integrity Staff.
6. The report is reviewed by the Office of Research Integrity and assigned to the committee co-chairs as described in the Procedure for Reporting New Information to the IRB.
7. If the reported information is determined to be an unanticipated problem involving risks to subjects or others, the IRB also determines the potential effect on the risks, benefits, and alternatives for subjects as well as whether any additional action is needed. The IRB may require one or more of the following actions:
   1. Require modifications to the protocol. 
   2. Require more frequent IRB review of the protocol.
   3.  Require modification of the consent process or documents.
   4. Requiring the investigator to provide additional information to current and/or past participants or re-consent to participation.
   5. Requiring additional training of the investigator and/or study staff.
   6. Reconsideration of IRB approval.
   7. Implementation of monitoring of the research.
   8. Implementation of monitoring of the consent process.
   9. Recommendation to the Institutional Official to suspend the privileges of an investigator or study team member to conduct human subjects research.
   10. Suspension of the research.
   11. Termination of the research.
   12. Refer the report to the full committee.
8. If the reported information is determined not to be an unanticipated problem involving risks to subjects or others, the IRB will not require any further action.