Too often, an IRB protocol is difficult to read, convoluted, inconsistent, or has too many grammatical or spelling errors. When an IRB protocol is poorly written, research compliance administrators may not understand what is happening in study, much less the potential risks. A common conversation uttered in the IRB office is, “the study is likely low risk, but I cannot understand what the researcher is asking of the study participant to make a confident assessment of the risk.”  

Researchers should utilize TC IRB resources on how to write for the IRB. For student researchers, they can visit the Writing Center and consult with a Research Writing & Ethics intern on how to write an IRB protocol. 

Writing for an IRB Review

The 5 Types of IRB Writers

A master’s student expressed interest in topics involving suicide ideation among youth. In assessing the student researcher qualifications for this study, the research compliance administrator discovered that the student had no prior mental health training and had never conducted a study of this type before. The student referenced on multiple occasions, that if a potential adverse event occurred or if the study participant exhibited discomfort or distress she would contact her faculty sponsor, who did have expertise in this study area. But it was uncertain how the student would handle the situation in the moment, how readily the faculty sponsor would respond to a call, and whether it was best that the student have direct supervision when engaging with a study participant, given her lack of qualifications on this topic. 

The Importance of a Faculty Sponsor for Student Researchers

A faculty researcher mentored a large research team and delivered the same training materials during convened meetings. However, one recently added research team member was unable to attend a training meeting but verbally affirmed he had the necessary skills to do the study tasks. The faculty member later discovered that this new staff member had inadvertently mislabeled participant data making it difficult to relabel the data to match the study participant. The faculty researcher reported the incident to the IRB office, as it was a data management concern, and in conversation with a research compliance administrator agreed to restrict research staff members from accessing data until they all went through the same training, even if they expressed previous knowledge of the task. Data is more secure when there is consistency of training, dependability on research staff to adhere to training procedures, and individuals engage in quality assessment.

Best Practices for Securing Research Data Across Teachers College, Columbia University Information Security Standard Procedures & Policies

Research compliance is a joint effort. 

The IRB will review investigator qualifications and must be assured that:  

1. The investigator has the appropriate qualifications and licensure to carry out the  procedures involving human subjects with an acceptable degree of risk,

2. The investigator has adequate facilities and equipment to conduct the research with  an acceptable degree of risk.

Accessible Research Design for Online Studies

The prospective subject population must be appropriate with respect to the nature and  goals of the research. In addition, the investigator should be guided by the principles  which lead to an equitable selection of subjects about the potential risks and benefits of  the research.  

The IRB, therefore, will carefully examine the characteristics of the subject population.  IRB reviewers will consider factors such as the required number of subjects, age range, sex,  ethnic background, and health status. The utilization of any vulnerable classes of subjects  such as sick persons, fetuses, prisoners, children, elderly persons, mentally disabled persons,  and persons who are educationally or economically disadvantaged must be clearly justified.

A research compliance administrator will also assess that a researcher can balance study activity administrator with participant protection expectations--in other words, can a researcher give due attention to the tasks proposed?

A Lens into Working with Vulnerable and Marginalized Populations Blog Series

Fostering Ethical Research in Contexts with Nuanced Vulnerability

The IRB will review the study design to be assured that the potential risks to  the subjects are minimized and the potential benefits maximized by using procedures  consistent with sound research design. 

In a math study where activities were administered through an iPad two students fought and in the tussle one youth released the device and struck the other youth in the face resulting in a bloody nose. No one could have predicted a math study might involve a bloody nose, but the researcher’s quick action prevented further injury and the proper school officials were notified to settle the situation. Researchers cannot predict every incident that may occur during the course of their study, but they should have a clear safety plan, easily accessible contact numbers, and emergency response resources, as applicable. 

In a major grant funded project two researchers had a falling out. Despite their better judgment, a disgruntled researcher reorganized the data filing and reset several digital passwords. While this is a serious ethical matter, it happened and the ramifications were detrimental and long-term. 

Staff turnover happens and while unfortunate events can occur, researchers can safeguard data during peaceful times, and manage data to keep it secure.  

When to Submit an Adverse Event

Emergencies (human-made or natural) can disrupt study activities. Researchers should have a research ramp-down and ramp-up plan.

In-Person Research Requirements

Adapting Research in an Emergency

A risk is a potential harm (injury) associated with the research that a reasonable person  would be likely to consider significant in deciding whether to participate in the research.  The concept of risk includes, but is not limited to, discomfort, burden, or inconvenience a  subject may experience because of the research procedures. Underlying the consideration  of risk is the implicit moral guideline that all investigators have a duty not to harm their  subjects and must minimize potential risk to the greatest extent possible.

A primary researcher may need assistance or supervision to mitigate risk factors. For example, when working with individuals at risk for falling due to a physical disability, the primary research may include a research assistant as a monitor to intervene if a study subject appears unbalanced. 

Ways for Researchers to Prepare for an Emergency

Research Compliance and Safety