What if you have problems or need to make changes?


What if you need to make changes?

If substantial changes are planned, the investigator should submit a new IRB application. For minor changes (e.g., a change in principal  investigator, minimal changes in wording of a survey instrument, or increasing the sample size from the same sample pool), the investigator  must fill out a Change Request Form (Form B) outlining the modifications. Prior to making any changes that will affect the information given on a previously  approved application, the investigator must have approval from the IRB Chair. The IRB Chair will contact the investigator by email if the changes outlined on the application are not acceptable.

What is a minor vs. a major change?

Minor project changes have no impact upon the original goals and protocols outlined in the original application. Minor changes include those  that do not adversely alter the overall harm-benefit profile of the study or would not potentially affect the willingness of current subjects  to remain or enroll in the study. Examples include: change of project title, minimal changes in wording of a survey instrument, minor  grammatical changes to an informed consent and/or child's assent form, addition or deletion of collaborators and/or co-investigators, change  in student advisor, adding additional sites for data collection (include a letter from the authorized individual for a new location).

Major changes involve substantial changes to the research protocol including changes in the purpose or process of the research project.  Examples might include changes in: sampling population, survey instruments, interview protocols, administration of a treatment of any kind,  and/or the informed consent process. Any research, by definition, that increases the level of risk to the participant relative to the initial  application MUST assume that the changes are major.

The initial evaluation as to whether an addendum/modification is major or minor starts with the principal investigator, who should assess  the degree of change in procedures and risks. The IRB Chair or committee reviewers may change the status of that designation if they deem the  designation inappropriate. The investigator must receive a letter from the IRB Chair stating that the proposed changes to the research are  approved before any modifications may proceed. There is no such thing as an emergency approval and no university official other than the IRB  Chair may grant approval for changes in projects.

What happens if you forget to submit an annual review?

The investigator must receive a letter from the IRB Chair stating that the research is renewed prior to the anniversary date or the research  must be suspended pending an approved renewal notice. Projects which are found to be continuing without IRB approval are in non-compliance with  UTC policy and federal regulations. In these circumstances a non-compliance report may be sent to the Provost for further action.

What happens if there are problems that result from your study (e.g., injuries to a subject, breach of  confidentiality, failure to follow protocol/research design)?

All investigators conducting research on human subjects must report any injuries or adverse events associated with the study procedures  and/or problems involving the conduct of individuals associated with the study which occur during the course of their research project. This  is called an adverse event and requires a report be submitted to the IRB. More information is available in the policy statement.  Failure to report is a breach of the conditions under which IRB approval is given, and could result in suspension or revocation of approval.  Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish.

What happens if you know that research is being conducted in violation of IRB policy?

Researchers are required to report any possible violations of IRB policy. The IRB will conduct an inquiry following any report of possible  misconduct related to human research activities that may come from subjects, study personnel, staff, students, or faculty. If, for instance, a  research project is being conducted without IRB approval, or an improper method of recruiting subjects is being used, or undue influence is  being placed upon prospective subjects to participate in a study, the IRB has no means of learning about such situations and rectifying them  unless it is informed that they are taking place. Thus, in order to fulfill its obligation to protect human subjects in research, the  institution depends upon concerned individuals, including investigators, to inform the IRB of any possible misconduct related to research  activities of which they become aware.

Such incidents are usually reported by telephone or in writing to the Provost or to the Chair of the IRB Committee. An inquiry is made to  the investigator conducting the research activity, maintaining requested anonymity of the individual submitting the report whenever possible.  Depending upon the outcome of the IRB's initial inquiry, information about the incident may be forwarded to the Institution Signatory, the  Provost, or the Chancellor for appropriate resolution.