Human Subjects Committee

The Human Subjects Committee’s (HSC) mission is to ensure that each human subject receives respect, beneficence, and justice during their involvement in research. Respect, entails making sure people are given the information they need to make a voluntary decision to participate. Beneficence is the maximization of benefits and minimization of harms. Justice requires that no individual or group should receive all the benefits of research nor face all of the risks.

Human Subjects Committee (HSC) – What is it?

The HSC is an “institutional review board”, created pursuant to the federal regulations on human subjects research (45 CFR Part 46). It is responsible for reviewing all research involving human subjects, ensuring the protection of human subjects in research conducted by researcher on the Northwest Campus (including non-IU researcher using subjects on the Northwest Campus), and overseeing the University’s compliance with the federal regulations and guidelines.

Why do you need HSC approval?

Under Federal regulations and University policy, all researchers who conduct research that involves human subjects or materials of human origin must submit an application to the HSC. Approval of the research protocol must be in place BEFORE the research (referred to as the principal investigator in federal law parlance) begins data collection. “Data collection” refers to any gathering of information from or about living human beings.

Research includes not only faculty research, but also, research conducted for master theses and doctoral dissertations, and may included undergraduate, staff, postdoctoral and research scientist research as well.

What constitutes Research Involving Human Subjects?

Research is defined as “a systematic investigation, including research development, testing, and evolution, designed to develop or contribute to generalizable knowledge”. Such studies may involve various invasive or non-invasive procedures such as removal of body tissues or fluids, administration of drugs, alteration of diet or environment, interviews, surveys, simple observation, administration of questionnaires, or review of records.

A good rule of thumb for determining whether or not a particular project qualifies, as research is to consider whether or not the results will be published in some form or forum outside of the institution. For example, is the project being undertaken with the notion that a paper or journal article may be published or that a paper may be presented at a conference? If so, the project most likely will be considered as research, and this is subject to review by the HSC.

Examples that you may be familiar with include:

• Interviews, telephone, or mail surveys
• Behavioral or educational testing
• Observation of individual or group behavior
• Study of existing data, documents, and archives on databases

Thus, a survey of students on their attitudes about drinking, observation of teachers in a classroom, interviews with chief executive officers of corporation on decision making processes, if conducted to “develop or contribute to generalizable knowledge,” would all constitute research involving human subjects.

The important point is that the umbrella of covered research is much broader than simply clinical research. If you have a question as to whether your research would be considered “research involving human subjects”, contact the Human Subjects Committee at (219) 981-5646.