Nutrition 209 uses data collected from individual human subjects. No data are collected as part of class activities, but many of the examples and exercises use data collected by others. Some data sets are drawn from textbooks. Others come from published research articles. Others are based on approved Human Nutrition Research Center studies. Whenever I use a data set from an HNRC study, I alter it. The alterations change the data without changing the underlying message. If, for example, diet A outperformed diet B in the original study, this would be true of the altered data but the difference in performance might be changed slightly. The purpose of the alterations is to insure that no one could take the data and publish them. There are no subject identifiers. Age, if present, is never finer than to the nearest year. The date of collection is never given, so knowing that a particular piece of data came from a 54 year old female, for example, would be of almost no use in identifying the individual because all the user would know for sure is that she is now older than 54, assuming the value hadn't been altered to begin with.

The use of data from individual human subjects, even the type just described, automatically raises human subjects concerns. Some might wish to dismiss the need for institutional review by saying it is necessary only for research. Analyzing data as part of an introductory statistical methods course is not research. Therefore, no review is necessary. This approach has its problems. It is easy to imagine someone collecting or using data "not for research purposes" only to find them unexpectedly so compelling that s/he now wishes to publish them as research. While there are allowances for this in the Code of Federal Regulations, such situations tend to leave a very bad taste in everyone's mouths and are best avoided.

It is the policy of the Friedman School of Nutrition Science and Policy at Tufts University to seek institutional review for every activity involving the use of data collected from individual human subjects. Many of these activities will be found to be exempt from Federal Policy for the Protection of Human Subjects. However, it is up to the University's Institutional Review Board (IRB), not the individual instructor, to make this determination.

There are six situations under which an exemption can be granted (from Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
   1. research on regular and special education instructional strategies, or
   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
   1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
   2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
   1. the human subjects are elected or appointed public officials or candidates for public office; or
   2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. 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 subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
   1. Public benefit or service programs;
   2. procedures for obtaining benefits or services under those programs;
   3. possible changes in or alternatives to those programs or procedures; or
   4. possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies,
   1. if wholesome foods without additives are consumed or
   2. if a food isconsumed 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 and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.