There is always a level of risk involved in any research activity. The Institutional Review Board (“IRB”) is an administrative committee of Teachers College (TC) whose purpose is to ensure that the rights and welfare of human subjects of research conducted at or sponsored by TC regardless of the source of funding are protected pursuant to federal regulations (45 CFR part 46 and 21 CFR part 56). Examples of human subjects’ research include surveys, observations of behavior, experiments involving human responses, individual interviews, focus group sessions, and collection of data from existing records.
The IRB is required to assess the level of risk involved in a research study when making a determination for review requirements. Some items factoring into the IRB’s risk assessment include possible risk to a subject’s psychological wellbeing, or the risk to a subject if their confidentiality is compromised. The more risk involved in a study, the higher the level of review and the more human subject protections required by the IRB.
You can read more about the different levels of risk, and the associated review categories for each, on the IRB visit:
All participants in research have the right to expect protection from physical, psychological, social, legal and economic harm at all times during study activities. Any participation in a research study is completely voluntary. An individual is free to decline to participate in a study for any reason. Even after they sign the consent form, they can still stop the study.
During times of significant risks, uncertainty, amidst a pandemic, or state of unrest within a region, researchers must take extra precautions to assess risk and ensure that they and others are safe. A researcher must stop a research study if they do not believe they can keep themselves or others safe. The research participant may also stop participating at any time or refuse to answer any individual questions.
If a researcher would like support with making such a decision, they can reach out to TC IRB (IRB@tc.edu).
Certain research may also present reputational, legal and / or economic risks to TC. As part of the ethical approval process for research involving human participants, researchers are required to identify potential risks associated with their research and the action they will take to mitigate risk. Depending on the risk level, researchers may be asked to submit their risk assessment to the IRB for review. The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how. It will help you to determine what risk control measures are needed and whether you are doing enough. For a guide on how to submit an IRB protocol, click here.
Here are some points for researchers to consider during the risk assessment process
The Occupational Safety and Health Administration (OSHA) has determined categories of risk for likely exposure to viruses during an outbreak for American workers. The determination of your risk level will depend on the specific activities that are carried out as part of your research work.
OSHA has divided job tasks into four risk exposure levels, as shown below.