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Orientation to Research with Human Subjects

Informed Consent: Statement of Risk Examples

Nature of Risk

Much of research takes place in or near the "service" sector of our culture. Patients in hospitals, the incarcerated in prisons, the "man on the street" walking along on the sidewalk minding his own business, are three examples. In addition, many researchers are also service providers, in fact, they may provide services primarily and research secondarily. They are, accordingly, fully aware of the risks of secondary infection and disease that come with stays in some hospitals, the risks of exacerbating juvenile delinquency behaviors in "juvie" facilities, the risks of being accosted by Girl Scouts selling cookies while just walking down the street.

Not only are service providers aware of these average risks, they are keenly aware that these risks do not have to be disclosed to those seeking hospitalization services, or to those being sent into "juvenile corrections" services for six months by a court, or to those who want nothing but the freedom to walk down the street unmolested. It is no wonder that these matters recede in the researcher's mind as risks, because they are so commonplace.

The problem is that research is of necessity such an artificial and controlled situation, and yet one does not easily recognize that the relationship between researcher and subject is different from that of medical professional and patient, or jail keeper and inmate, or passerby and pedestrian. Although professionals and patients, keepers and inmates, AND researchers and subjects do not meet as equals , the relationship between a service provider and a service receiver is different from that between researcher and subject.

The researcher is presumed to NOT know how the whole encounter will turn out, or at least, it is a matter of definition that research contains unknowns that are not present in the mere provision of services. Accordingly, the decision-making processes of the subject regarding risk are more immediately required than of patients and inmates and even of pedestrians. They need information about what they might be getting into, including being reminded of the array of commonplace risks, so they can decide whether to participate or not.

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