Human Subject || Research || Non-Research || Existing Data || Risk

HUMAN SUBJECT

A human subject is a living individual, as well as human embryos, fetuses, and any human tissue or fluids, about whom an investigator (professional or student) conducting scientific research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Thus, the scope of "subject" is interpreted broadly. Even if you are "just interviewing" people or conducting a survey, you are involving human subjects in your research.

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RESEARCH

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Not all data gathering or experimentation is necessarily research; it could be education or therapy. The difference is one of intent or primary goal. For example, if a physician finds a patient developing bad side effects from a drug, the physician may "experiment" using other drugs to see which works best with the fewest negative side effects. So long as the drugs being used are clinically approved (i.e., not themselves experimental), such activity would constitute therapy, not research. Yet, if this same physician decides to try these same drugs on a series of patients to see if the results are the same as they were with the original patient, then this activity is classified as research. Similarly, a teacher demonstrating how to make anthropometric measurements is engaged in teaching rather than research as long as the activities are confined to a particular class or classes. The moment these activities occur outside the pedagogic context, they become research.

Research done outside of the United States is subject to the same considerations and review as work within the USA. The federal government feels very strongly on this point, particularly since some underdeveloped nations are of the opinion that their citizens have been used as guinea pigs in experiments which would not be permitted in the USA. The investigator also must abide by the laws and values of the country in which the research is to take place.

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NON-RESEARCH

Occasionally, the OHRPP staff determine that an application involves activities that are not considered "research" under the definition because it is, for example, conducted for evaluation purposes for an entity (e.g., a government agency, commercial enterprise, workshop evaluation, or administrative review), but about which the investigator has no intention of publishing results or distributing outside the institutional setting, or the data are not used to evaluate or review a program in order to build a better program. It is therefore, not "designed to.....contribute to generalizable knowledge."

Another situation where this might occur is when the researcher has been hired by an outside agency as a consultant to conduct the research for the agency. The researcher would be required to write a report for the agency and turn all the data back to the agency. If the researcher is hired on his/her own time, holds no rights in the work, and neither the researcher nor the University retain any rights to the data, review and approval by the IUB IRB is not required.

The OHRPP staff are concerned, however, that investigators do not fully understand the implications of having their work classified as "non-research." Principally, results from such studies may not be published unless IRB approval had been obtained prior to collecting the data. To do so is in violation of IU policy (because if the data and data analysis are to be published, the study was, in fact, research and required prior review and approval). Further, some scholarly journals will not publish studies involving human subjects without an assurance that human subjects committee approval was obtained.

Investigators face the possibility that the chair of the committee will disapprove their application requesting approval for use of material which was once considered non-research that could have been reviewed prior to its commencement. In this type of situation, OHRPP staff or the chair of the committee will require the investigator to demonstrate that he or she could not reasonably have foreseen having an interest in publishing the results of the "research." While the "existing data" exemption may be available for qualifying research, the IRB is reticent to approve such applications where it feels that the investigator has attempted to circumvent human subjects policies by collecting data as non-research and then applying to use them as existing data. It is therefore in the investigator's best interest to consider carefully the likelihood that he or she will want to use the data for research purposes in the future, and to err on the side of inclusion and seek IRB approval prior to commencing the work.

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EXISTING DATA

To qualify for this category the data, documents, or specimens must already be in existence before the researcher applies for approval to access it. If some, or all, of the data are going to be collected by the researcher or another party after the researcher applies for approval to access it, it is NOT existing data and does not qualify for this category.

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RISK

The IRB must decide what degree of risk (if any) is involved. Risk can be social or psychological as well as physical. For example, breach of confidentiality might result in a child being labeled the "stupidest" in an entire school, or a family could be upset by their neighbors' learning that they suffer from a particular disease. Even if confidentiality is not involved, psychological damage may occur. For instance, suppose a psychologist wants to induce stress on his subjects to measure resultant changes. To do so, he gives them insoluble problems and psychometric tests which he then announces reveal various mental and emotional deficiencies. This procedure places the subject at risk psychologically and, if not (and even if) given an adequate explanation after the experiment, the participants could remain disturbed for some time.

The IRB realizes that risks are an inevitable and accepted part of life, but the IRB's task is to ascertain whether the proposed research increases risks beyond this normal level. If so, the IRB members must address two questions:

1. Could the research objective be attained through procedures bearing less risk? For example, could an aversive electric shock be given by batteries rather than by a transformer plugged into a 110 volt wall socket? Could anonymous numbers be used instead of names? Such risk-reducing options would be suggested to the investigator.

2. If the risk cannot be avoided, is the value of the research sufficient to justify the risk? This is the thorny "risk/benefit ratio" issue. While the regulations do not ordinarily require institutional review boards to concern themselves with the merit of the proposed research, when anything more than minimal risk is involved, the institutional review board must judge merit in order to evaluate the risk/benefit ratio. The benefit, if any, may be to the subject directly, to science, or to society in general.