Human Subjects Committee
Terms
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, you are involving human subjects in your research.
The IU-Northwest Campus Committee for the Protection of Human Subjects, known as the Human Subjects Committee (HSC), is charged with safeguarding the rights and welfare of human subjects, and no research or related activity involving humans can be undertaken without HSC approval. Every research project involving human subjects in any way must be reviewed by the HSC, including, but not limited to, projects dealing with data already collected by someone else, and pilot studies. Even projects which qualify as exempt from the federal regulations must be submitted for review to the HSC prior to commencement. Consequently, every investigator should consider all ramifications of his/her research before determining that human subjects are not involved and that HSC approval is therefore not required.
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 some of 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.
Non-Research
Occasionally the Committee determines 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, HSC review and approval is not required.
The Committee is 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 human subjects 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 requesting approval for what was once considered non-research that could have been reviewed prior to its commencement face the possibility that the Committee will disapprove their application. In this type of situation, the Committee will require the investigator to show 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 Committee 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 human subjects approval prior to commencing the work.
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.
Risk
The HSC 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 neighbor's 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, he/she could remain disturbed for some time.
The HSC realizes that risks are an inevitable and accepted part of life, but the Committee's task is to ascertain whether the proposed research increases risks beyond this normal level. If so, the HSC must address two questions:
- 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.
- If the risk cannot be avoided, is the value of the research sufficient to justify the risk? This is the thorny "risk/benefit ratio" which poses a perpetual problem. 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.
