Bypassing the IRB
When a graduate student in psychology proposes a novel approach for conducting an experiment for his dissertation, he decides that he does not have time to submit his proposal to his university's institutional review board before he needs to get the pilot experiment finished. This case explores when experiments need IRB approval.
Joshua, a third-year graduate student in psychology, studies decision making. He has devised an experiment for his dissertation. Although the method he plans to employ is commonly used in his field, he will be the first member of his lab to do so. He needs to convince his dissertation committee that it is an appropriate method for the study. The task is a hypothetical gambling task in which participants’ play a card game with losses and gains associated with certain cards. Playing styles are thought to be associated with personality traits such as dis-inhibition and risk seeking. Participants do not play for money; they play for points.
Joshua is meeting with his dissertation committee in one week to propose the study. Although he thinks the methodology has real advantages, he is concerned about proposing a technique that is new to his lab. He knows his dissertation committee would be more open to the idea if he had promising pilot data to submit. As luck would have it, a health fair is scheduled for the weekend. He decides to sign up for a booth and ask attendees to complete his experiment on a laptop. He plans to give them a university bumper sticker as a token thank you gift for their participation. Health fair attendees will provide the pilot data he needs to evaluate the methodology, and all in time for his committee meeting. However, he does not have enough time to submit a proposal to the Institutional Review Board and wait for their decision. When a friend asks about his decision to bypass the board, he explains: “Well, I don’t plan to publish this pilot data so I don’t need approval. Besides, the experiment is relatively innocuous. There doesn’t seem to be much risk to the subjects, and my gift is too small to be coercive.”
- Is this an experiment that needs to go before an IRB for approval? If not, might submission be nonetheless desirable?
- Should the experimenter ever be the sole person to make this sort of decision?
- In this case, does Joshua have responsibilities beyond the institutional/IRB requirements? How should responsible research be defined? Is it defined solely by institutional requirements or might the underlying ethical considerations apply even if the IRB need not have an official role?
After his friend expresses doubts about Joshua’s reasoning, he decides to consult with Dr. Johanson, a member of his committee. Dr. Johanson is very excited about the gambling task and believes that the rest of the committee will be swayed if Joshua presents new data. After thinking about it, Dr. Johanson tells him that he has had “a lot of experience with IRB decisions, and this experiment seems fine. There is no need to submit in my opinion.”
- Can Joshua take this as a green light to proceed? Does the consultation represent adequate peer review? Does the consultation fulfill his ethical responsibilities?
- What if a senior investigator has repeated experience with the decisions of the IRB? Can he make decisions for himself and his graduate students about the risks of an experiment? What would be the benefits and risks of such a system of review?
Joshua also speaks with a senior graduate student who teaches the department’s research methods course. She tells him that she requires her undergraduate students to develop and conduct small experiments, and that these experiments implemented for didactic purposes do not need IRB approval. She reasons that Joshua’s pilot study will be conducted for a similar didactic purpose (graduate student training) and therefore falls into the same rubric for exempt research.
- Is the senior graduate student’s argument complete? Does it overlook any important issues?
- Where is the line that divides “student research” from research conducted to contribute to “generalizable knowledge”?