|Under Federal regulations, certain
categories of activity are considered research, but can be declared exempt from
further review by the IRB. This determination is made by the IRB itself, not the
researcher. While the IRB might decide under these rules that a particular project is exempt from further review, it is still considered research
and a complete application must be submitted in order for the research to be granted the
The exemption categories found in 45CFR46.101(b) are:
|1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:|
|(i) research on regular and
special education instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
|This section could include research by pre-K-12th grade classroom teachers on their students if it involves normal educational practices.|
|2. Research involving the use of educational tests, (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: (i) information obtained is recorded in such a manner that the participants can be identified, directly or through identifiers linked to the participants; and (ii) the participants' responses, if they became known outside the research, could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. All research involving survey or interview procedures is exempt when the respondents are elected or appointed public officials or candidates for public office. Confidentiality must be maintained when required by federal statute.|
|One important amendment to this
section appears in Federal Education Law, and that is: If the subjects are children,
research involving interview or survey procedures and research involving observations of
public behavior in which the researcher(s) participate in the activities being observed
are not exempt. However, research involving the use of educational tests and
research involving observations of public behavior in which the researcher(s) do not
participate in the activities being observed are exempt. [34CFR97.401(b)]
In other words, when studying children, the exemption categories are much tighter. Interviews, surveys, and interactive observations are not exempt while educational tests and non-interactive observations are.
Research involving the
collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the information is
recorded by the investigator in such a manner that participants cannot be identified,
directly or through identifiers linked to the participants.
information research is exemptable unless it is possible to identify those being studied
through linkages in the data. This is also governed by applicable laws concerning
particular documents (i.e., birth certificates, for which state laws vary).
|4. Research and demonstration projects which are funded by a federal agency and determined to be exempt by the agency head and which are designed to study, evaluate, or otherwise examine:|
public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
|These types of studies, while research, are considered purely evaluative and are exempt from further review. Part of the reasoning behind this is that a person gives up some privacy rights upon becoming a client of a public program.|
|5. Research Taste and food quality evaluation and consumer acceptance studies,|
|(i) if wholesome foods without
additives are consumed or
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food an Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
|The FDA cares about your health and had some input into the law!|
by this policy takes place in foreign countries, procedures normally followed in the
foreign countries to protect human participants may differ from those set forth in this
policy. In these circumstances, if a department or agency head determines that the
procedures prescribed by the institution afford protections that are at least equivalent
to those provided in this policy, the department or agency head may approve the
substitution of the foreign procedures in lieu of the procedural requirements provided in
This area can be very difficult for IRBs to wrestle with. There have been recent public scandals about what is or is not appropriate research for American universities to be carrying out in other countries. Towson's IRB has asked researchers to explain the particular methods being used, their discipline's standards for this type of research, and for evidence of support for the research by the affected other country.