You know your study inside out. You have lived it and you know that the risks are reasonable and that everyone in your field agrees. Now you are presenting it to an external audience that is looking at it fresh. They are likely to evaluate those risks very differently.
You can alter the outcome with an excellent risk presentation. How might an outsider might evaluate the risks? Think outside the box. Explain and assess and mitigate. If the board determines that the risks are greater than “minimal risk” expedited review cannot be used.
RISK = a probability statement about the chance a harm occurring. RISKs can be described in terms of the nature of the possible harm, its severity or magnitude, its duration and its probability or frequency.
Look for the risks in your study and evaluate them in terms of what they are, what the causative factor might be, their probability, magnitude and duration.
1. Physical risks and discomforts
Physical problems are often dismissed as irrelevant to SBER. They are not common but they do occur. Think of studies in the realm of physical education, incarceration and drug abuse. Think of Philip Zimbardo’s study of prison guards.
2. Inflicted knowledge – unintended consequences
Information returned to a subject can cause the recipient to take further action. Certainly, information from standard diagnostic tests should be returned but there are many questions in other areas. Educational testing can be just as diagnostic and just as questionable as medical testing.
3. Emotional or social risk
Subjects who feel they have been treated as means to an end or whose concerns have not been adequated addessed are not only unhappy, they also call the IRB to complain, they sue more often and they tell others of their experiences.
4. Risky Behavior
Research on risky behavior such as premarital sex or partner notification of AIDS status been denied at many institutions. E&I accepts studies that are politically or socially sensitive but requires the application to have seriously considered the implications and prepared for the worst.
5. Financial risks
Subjects should not be out-of-pocket for the benefit of the investigator, or, if they are, they should be adequately warned. Subject costs may be direct as in being expected to pay forthe evaluation of a child, or may be hidden as in covering the time off work or the baby-sitter. Costs may also be unanticipated as when a third-party insurer rejects a claim. If this event was not foreseen, it would be a reportable unanticipated problem when it happens.
A new twist is crowd-sourced studies in which the subjects purchase a future something. These need to be carefully designed to separate sales, service and study.
6. Privacy risks
Trusting a researcher, participants yield lots of information much of which they might consider to be private. Loss of privacy is an expanding risk of participation. Despite the best safeguards and best training, briefcases have been lost, gossip has occurred in elevators and computers have been hacked. Confidentiality cannot be promised.
Database and computer based records poses problems since there is a wealth of data available to anyone with access. Protocols should address the means used to protect data.
A Certificate of Confidentiality protects an investigator from some forced release of information. It is available for some studies involving subjects who might be at legal risk should it become known that they even participated.