Chapter 9 – Researchers' Obligations

9.A. Required Approvals
9.B. Required Reporting
9.C. Continued, Modified, and Delayed Studies
9.D. Unanticipated and Adverse Events
9.E. Notification of Unapproved or Harmful Research Activities

 

Chapter 9 – Researchers’ Obligations

Researchers are obligated to submit an IRB application and research proposal for IRB review and approval before conducting a study involving human subjects. They may begin their research projects after they have received official notification of IRB approval. Researchers are obligated to adhere to the ethical standards applicable to their profession, their field of study, and researchers in general. As members of the university community, researchers are obligated to abide by applicable institutional and college or departmental policies and procedures. Researchers are also obligated to ensure the safety and well-being of human participants in their studies and to abide by the policies and procedures established by the IRB and all they entail.

9.A. Required Approvals

Researchers are required to obtain all necessary approvals to conduct their research projects in their selected facilities and locations. For example, researchers planning to conduct research projects in public and private school systems often are required by the central administration of the school systems to obtain approval on a district level as well for specific school locations (e.g., from principals or school heads). Approval to conduct research projects in classrooms may also require approval from individual teachers.

Researchers employed at institutions of higher learning will need to verify whether their institutions have an IRB, ethics committee, or other research-approval process that must approve their research projects in addition to UI&U’s IRB. Some higher learning institutions require UI&U’s IRB to approve a research study before their research committee will approve the study for their employee.

Researchers employed in government agencies, hospitals, clinics, business organizations, and other professions need also to inform their employers of any planned research projects and obtain appropriate approvals if they plan to conduct any portion of their research projects at their places of employment.

Which approval should be obtained first may depend on the researcher’s employer. Approval letters from employers may be submitted after UI&U’s IRB approves a research project. Employer approvals must be submitted to the IRB prior to the initiation of any portion of a research project.

9.B. Required Reporting

The official notification of approval letter from the IRB may stipulate requirements for a progress report and/or a final report on a study. Researchers are responsible for submitting required reports by the date stipulated. The IRB may suspend or terminate IRB approval of a study if the required reports are not submitted as required.

The IRB may also require unscheduled reports on studies in progress. Researchers who receive a notice from the IRB Director requiring such a report should respond by the stated submission deadline, or the IRB may suspend or terminate approval of the study.

9.C. Continued, Modified, and Delayed Studies

Researchers are required to supply information to the IRB, at least two months in advance, to renew IRB approval for continuation of previously approved research and for any proposed, substantive modifications to previously approved research. (See “Renewal (Extension) of IRB Approval” and “Modifications to Previously Approved Research.”) Researchers should also notify the IRB if they need to change the start and/or end dates of their studies. Changes to study dates may be approved by the IRB Director. Substantive modifications must be reviewed and approved through applicable IRB processes. Renewal of IRB approval for studies approved under the expedited review process may be approved by the IRB Director. Studies approved by the full IRB may be granted continued approval by the full IRB if they do not meet the expedited review criteria for continuing review.

Because research studies may not continue beyond the end/ expiration date of IRB approval, and substantive changes may not be instituted without approval, requests for approval of modifications should be submitted to the IRB Director well in advance of implementation of substantive changes. Researchers should submit these requests on the Modification Request form.

Researchers are required to submit the Continuing IRB Review / Request to Renew IRB Approval form if their studies are not completed by the expiration date of the original IRB approval. If IRB approval has expired, the researcher is required to suspend the study until obtaining IRB re-approval. All IRB forms are available in MSWord format in the UI&U forms directory.

9.D. Unanticipated and Adverse Events

An unanticipated or unexpected event that occurs during a research study may result in a delay or interruption of the completion of the study. Examples of unanticipated or unexpected events that may occur during the course of a research study include the loss or theft of a laptop or file folder containing study data that contain subjects’ personal identifiers; a participant, or the researcher, is injured as a result of an accident; a participant, or researcher, contracts a serious illness; or the researcher’s or research assistant’s computer hard drive containing all study data crashes. Such incidents must be reported to the IRB Director within 48 hours of their occurrence. The researcher needs to submit a plan for overcoming the delay caused by the event, especially when participants’ personally identifying information is no longer secure.

An adverse event is any substantive, undesirable, or unintended experience resulting from research that does or is likely to have a harmful effect on an individual subject or group of subjects. An adverse event may be an experience that the researcher anticipated as a risk but that has occurred more frequently or is more serious than the researcher thought likely.

Regardless of whether the harmful experience is physical, psychological, social, legal, economic, or other, it must be substantive / serious. Quite often the harm is a matter of degree. In a study that includes subject interviews, an unanticipated, unexpected, or adverse event has not occurred if a subject becomes angry about one or more questions. An adverse event has occurred if that anger is great enough to result in a harmful physical or emotional response such as a heart attack, severe asthmatic episode, or clinical depression. Researchers are required to suspend their research if they see or hear of an adverse event or events during the course of their studies. Researchers must report the event(s) to the IRB Director, in writing, as soon as possible, but no later than 48 hours. An Adverse Event Report should include the following:

  • A description of the event, including the researcher’s immediate response (such as removal of the participant, referral of the participant to counseling, etc.)
  • A description of the process used to suspend the study, including copies of communications about the suspension to participants in the study
  • A description of any action that the researcher will take to resume the study, if possible

An adverse event may necessitate changes in a study to prevent re-occurrences. If the changes are substantive, they should, of course, be submitted to the IRB for review and approval. All requests for IRB approval of changes submitted as a result of an adverse event will require full review because the event constitutes evidence that the study poses potential risk to participants.

If a subject dies, even if the death does not appear related to the subject’s participation in a study, the researcher must immediately suspend the study, and he/she must report the death to the IRB Director, by telephone or e-mail, within 48 hours. The researcher must follow that report with a written report within ten (10) working days. If the death is clearly unrelated to participation in the study, the Director will reinstate approval.

9.E. Notification of Unapproved or Harmful Research Activities

As a member of the university community, researchers are obligated to notify the IRB Director immediately if they have a concern about the conduct of any university-sponsored research involving human subjects and/or the safety of participants in a study. (See “Suspension or Termination of IRB Approval.”)

The IRB has the authority to suspend or terminate IRB approval of research with human subjects conducted by a UI&U student, faculty, staff member, or consultant for any of the reasons listed below. The IRB’s decision to suspend or terminate approval of a study may result from notification of concern about the study by someone other than the researcher. In such cases, the researcher will be advised of the concerns and have the opportunity to respond to them. The IRB is under no obligation to identify the individual who notified the IRB.

A researcher is obligated to immediately halt the research if he/she receives notice of suspension or termination of IRB approval. The IRB will inform appropriate academic and administrative personnel, including the university’s chief academic officer, whenever the IRB suspends or terminates IRB approval of a research study.

A decision to suspend or terminate IRB approval of a study is mandated by the IRB’s charge from the university’s Board of Trustees, by its responsibilities to human subjects, and by its obligations as an OHRP-registered IRB. The IRB is required to and will suspend or terminate IRB approval of research in all of the following cases:

  • Research began and under way without IRB approval
  • Research continuing beyond the end / expiration date of IRB approval
  • The research study is substantively different from what was approved by the IRB
  • A study in which a subject or subjects have been harmed as a result of their participation
  • A study in which a subject dies