IRB Policies, Complaint Procedures, and Other Event Reporting Policies
Reporting of Concerns or Complaints for Human Subjects Research
Anyone with a concern about any aspect of research involving human subjects at Austin College or who wants to report a violation of these Policies and Procedures may contact the Institutional Official (the Vice President for Academic Affairs or the College President), the IRB Chair, or any IRB member. Concerns may also be emailed to IRBChair@austincollege.edu or submitted using the report form on the IRB Forms webpage.
No adverse action will be taken against anyone making a good-faith report. No college employee, committee member, student, or another person shall be discriminated against or be subject to any reprisal for reporting, in good faith, concerns or violations of regulations or standards under Title 45 Code of Federal Regulations Part 46 or Title 21 Code of Federal Regulations, Parts 50, 56, 312 or 812. Persons with no formal relationship with the Austin College are also encouraged to an Institutional Official, the IRB Chair or an IRB committee member with and concerns, also without fear of reprisal or future discrimination.
Noncompliance with Austin College IRB Guidelines or Committee Decisions
Any research project involving human subjects that is carried out without IRB approval constitutes noncompliance. The IRB cannot approve any project if the student or faculty investigator has begun data collection prior to receipt of the IRB approval. Projects cannot be retroactively approved.
Investigators may not begin a project until they receive official approval of their project from the IRB. No actions involving engagement of participants or potential participants (including recruitment or prescreening of participants) may begin until the investigator receives final approval of the project from the IRB Committee.
For IRB approved research projects, any significant protocol deviation by an investigator or protocol change without prior IRB approval also constitutes noncompliance. A IRB Modification Extension Renewal Form that includes relevant supporting materials needed to evaluate proposed changes must submitted to and approved by the IRB Committee before the investigator can implement any changes to a project.
In the case of student projects, the faculty supervisor is responsible for providing oversight to ensure that the student complies with IRB Committee guidelines and follows ethical guidelines for all activities involving human subjects.
All incidences of noncompliance shall be promptly reported to the Institutional Official. For sponsored projects or significant violations noncompliance may also be reported to the Secretary of the Department of Health and Human Services or the sponsoring agency. Actions resulting from noncompliance may range from additional humans subjects education requirements or increased oversight to suspension or termination of research activities.
A data security breach (e.g., a stolen laptop, misplaced thumb drive, unauthorized access of a data file by internal or external entities) almost always constitutes an unanticipated problem.
Definition: An unanticipated problem is any event, experience, issue, instance, situation, problem, or outcome that meets all 3 of the following criteria:
- Is unexpected in terms of the nature, severity, or frequency given the research procedures that are described in the IRB application/protocol-related documents AND in the characteristics of the population under study.
- Is related or possibly related to participation in research. This means that there is a reasonable possibility that the incident may have been caused by the procedures or activities involved in the research study.
- The incident suggests that the research places the subject or others at greater risk of harm (physical, psychological, economic, social, etc.) than was previously known or recognized OR results in actual harm of the subject or others. An unanticipated problem usually will require a change in policy or procedure, consideration of substantive changes to the protocol/consent materials, or other immediate corrective actions in order to reduce the risk or eliminate immediate hazard.
Reporting of Unanticipated Problems, Protocol Violations/Noncompliance, or a Data Breach
If an unanticipated problem, protocol violation/noncompliance, or data breach should occur during the conduct of any study under the jurisdiction of the IRB, the primary or faculty investigator should notify the IRB within 10 days from the time the PI/Study team receive knowledge of the event and complete the report form. The Austin College has a single reporting for reporting Unanticipated Problems, Protocol Violations/Noncompliance, or a Data Breach. For student projects the supervising faculty member should work with the student to complete the report. The faculty member should be the person who notifies the IRB and submits the reporting form and any other relevant documentation.
Unanticipated Problems: Per federal regulations the IRB must report unanticipated problem to OHRP and other sponsoring agency (if applicable). Per IRB policy these reports are copied to institutional officials involved in research oversight. The primary or faculty investigator will also receive a copy of this letter.
Protocol Violations/Noncompliance: For addressing protocol related violations the committee will have to determine if this also constitutes an unanticipated problem. Minor violations that the IRB determines to involve no risk or not more than minimal risk to participants will be addresses with the researchers and will be reported to Institutional Officials in the IRB committee’s end of year report. Any problem that is deemed to present more than minimal risk will be reported to Institutional Officials within 10 of the IRB committee review of the event.
Data Breach: Since data breaches will typically meet the definition of an unanticipated problem or involve more than minimal risk to participants they will be reported to Institutional Officials within 1o days. When a data breach occurs, the PI should immediately contact the Austin College IT director and in the case of stolen equipment or illegal access of a database contact campus police.
For a data security breach that involves protected health information under HIPAA or FERPA protected educational records the IRB will notify the Institutional official within 10 days.
All student-initiated research must have a faculty sponsor. The faculty sponsor is responsible for reading and editing the IRB application and all related materials before submitted the application to the IRB. All IRB applications must be submitted by a faculty member, students may not submit applications directly to the IRB. In the case that a student is to work on a faculty’s project that already has IRB approval, the faculty investigator shall submit an amendment to the IRB to name the student as a co-investigator. Note this only applies to students who are collaborating as an investigator. Student research assistants who work on projects to complete specific, delegated tasks do not need to be added as an investigator.
The faculty principal investigator or the faculty supervisor shall maintain all documents pertaining to each research project. Project documents and any signed consent forms must be kept for a minimum of three (3) years following termination of the study and be made available for internal reviews or external audits as necessary.
HHS regulations at 45 CFR 46.115(b) require that IRB records be retained for at least 3 years, and records relating to research which is conducted be retained for at least 3 years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner.
Conflict of Interest Policy for Researchers
Faculty and staff should have a conflict of interest form on file with the business office. The Austin College policy on Conflict of Interest can be found on the intranet.
For grant or other funded projects Austin College prohibits real or apparent conflicts of interest related to award and prohibit acceptance of gratuities, favors, or anything of monetary value from collaborators, contractors, or parties to sub-agreements.
Before a project begins investigators must disclose: anything that could be considered a significant financial interest or that could reasonably appear to be affected by research (this includes influencing the outcomes of the research or receiving undisclosed personal benefits from research).
One a project begins investigators must disclose if a significant financial interest is acquired to the IRB, institutional official, and funding agency. Such disclosures should happen within 30 days of a significant financial interest arising during the project.
Researchers are also expected to follow the disclosure policies of the granting agency and to following agency reporting guidelines.
Whenever PI faces decision potentially benefiting family, partner or business which employs family or partner using sponsored research funds, PI must report the situation to the institutional official before proceeding.
PI must disclose proposed purchase of goods or services from entity in which s/he or an immediate family member has financial interest. PI must submit a completed employee-vendor disclosure form (see business office). The purchase should not be completed until the institutional official and the business office have reviewed and approved the purchase.
Conflict of Interest Management Plan
Where relationships are deemed appropriate by the institutional official and the business office, but the potential for a conflict of interest exists a conflict of interest management plan should be developed and implemented.
See the NSF conflict of interest guidelines.