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. 

• What are the known and theoretical physical harms from this activity or the various procedures?
• Are the risks being minimized through selection of appropriate and trained personnel both at the level of the principal investigators and the staff?
• Are there procedures that require special training?  (e.g., interviews with abusers)
• Are there any procedures that might cause physical discomforts or fears such as from claustrophobia or isolation?

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.  

• What is the potential for misinformation?
• Is the information accompanied by counseling or information?
• If the results are unclear, what might be the emotional and financial consequences?
• Might there be a delay in sending information?
• What is the role of the primary physician, teacher, evaluator?
• What are the considerations for and against reporting individual results?

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.

• Failure to pay promised compensation or reimbursement on time causes anger and is the most common complaint made to the IRB.
• Being identified as being in a group may cause social stigma.  Gene identification and pedigree studies have particular stigmatization risks.
• Children can be shunned by other children just as can adults.

Early termination of a person from a protocol can cause substantial distress unless there is orderly transition to other care.

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.

• Have the appropriate people agreed to have the study done on their premises or with their clients?
• Has a management protocol been developed to manage a crisis when it does occur?

One writer (Stuart Rossner) has described a political protocol in which persons who are likely to have to respond to a crisis are informed in advance.

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.

• What costs are involved for the subjects or their third-party payer? For additional visits?  For transportation?  How much time off work (or need for baby-sitting) might be involved?
• Will an insurer be involved?
• What is the maximum amount a subject might be asked to assume?

Is there any way to minimize costs such as by providing child care?

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.

• MIght the fact that someone participated in the study be stigmatizing?
• Will any records contain individual identifiers? Is it possible to code the information so identities are not transmitted beyond the investigator?  How is the code protected?
• What source documents (e.g., grades, court records) will be needed.  How will they be accessed?
• Where will the individual subject records and consent forms be stored? Will such records be identifiable or coded? How long will they be retained?

What will happen to the records at the end of the retention period. How will they be destroyed?

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.

• Are there passwords for the computer? How often are they changed? Who has access to restricted areas of the database?
• What identifiers will be used on case report forms, and on the database? If there is no extremely good reason for use of the social security number or medical chart number, those numbers should not be considered.
• If outside reports are gained (bills, insurance statements, etc.) how are identifiers hidden?

Receiving a false positive result may initiate more testing with related costs.

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.