Definitions

What is research?  Research is defined as a systematic investigation designed to develop or contribute to generalized knowledge, or investigation designed to test a hypothesis.

What exactly qualifies as human subjects research?  Any systematic investigation (including curricular evaluation) that is designed to develop or contribute to generalized knowledge, and which uses living humans or identifiable private information about living humans, qualifies as human subjects research.

What does “risk” mean?  Risk refers to the probability of harm or discomfort (these can be physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and the magnitude of possible harm may vary from minimal to significant.

What does “minimal risk” mean?  A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those encountered in daily life.

What is informed consent?  Informed consent is a person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information (purpose of study, methods used, risks and benefits involved from participation etc…), to participate in research.

What does the IRB consider to be a "sensitive topic"?   It is up to the Office of Research Integrity and the IRB to determine what qualifies as a "sensitive topic". However, some common examples are sexual activity, domestic or sexual violence, drug use/abuse, child abuse and other illegal activities.

What is a "Vulnerable Population"?  The Department of Health and Human Services (45 CFR 46.111(b)) and Food and Drug Administration (21 CFR 56.111(b)) regulations require that additional safeguards be in place to protect the rights and welfare of research subjects "when all or some of the subjects are likely to be vulnerable to coercion or undue influence". The regulations do not provide a definitive list of vulnerable populations; they leave it largely to the discretion of the IRB. Some populations/groups that may be considered "vulnerable" include: pregnant women, children, prisoners, mentally challenged individuals, economically or educationally disadvantaged individuals and groups, etc. Research that specifically targets a vulnerable population will receive a higher level of scrutiny than other protocols. This additional scrutiny is to insure that individuals are not being coerced into participation, that the consent process is culturally appropriate, etc. It is also important to remember that vulnerability must be considered in terms of the specific research proposed - not all groups are vulnerable in all situations.