May 2004, Issue 2

Human Research Protocols - Full Review, Expedited Review, or Exempt

The IRB for the Social and Behavioral Sciences on the Medford campus serves researchers whose work involves living human subjects, tissue or material from living humans, or data concerning identifiable human subjects. The IRB is in the process of expanding and improving its website, with the goal of providing helpful information for those doing research involving human subjects or identifiable human subjects' data. If you or one of your students are planning to do human subjects research, the first thing you should do is refer to the Medford IRB website to see if you may be eligible for an exemption or if you will need to submit a protocol for either expedited or full-committee review. Questions should be addressed to the Medford IRB administrator. You must complete and sign the Human Subject Review Form and have all members of your research team complete the on-line IRB educational tutorial. A certificate of tutorial completion must be submitted along with the Human Subject Review Form. In addition, you must submit any survey questions you plan to ask your subjects.

After reviewing these documents, the IRB office will determine which route your research protocol can take — full review, expedited review, or exemption.

Full Review
If your protocol requires full review, it is placed on the agenda for the next regular monthly meeting of the IRB. The meeting schedule is posted on the Medford IRB website.

Expedited Review
Your protocol may be eligible for expedited review if it involves minimal risk* or if it designates

• materials that have been collected or will be collected for non-research purposes
• data that are to be collected from existing voice or image recordings
• data that are to be collected on individual or group behavior characteristics
• minor changes to a previously approved protocol during the approved research period
• continuing review under certain circumstances

*Note: as defined in the Code of Federal Regulations (CFR), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The standard for an expedited review and the materials that you submit are the same as for a full review. The only difference is that the expedited review is done by a single member of the IRB outside of the regular monthly meetings.

Exemption from Review
After reviewing all required forms, the IRB administrator may exempt your protocol from IRB review in cases where

1. Research is to be conducted in established or commonly accepted educational settings, involving normal educational practices. An example would be a comparison of the effectiveness of two generally accepted instructional strategies.

2. Research will involve the use of educational tests, survey procedures, interview procedures, or observation of public behavior UNLESS the information is recorded in a manner in which the subject can be identified AND disclosure would place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation. This does not apply where the subjects are children except where it involves passive observation of public behavior.

3. Research will involve the use of educational tests, survey procedures, interview procedures or observation of public behavior where the subjects are elected or appointed officials or candidates for public office. (Note: "public official" is not broadly defined.)

4. Research will involve the collection or study of EXISTING data, documents, records, or specimens if the sources are publicly available or the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers or codes. (Note: even brief use of identifiers or codes disqualifies a protocol from exemption.)

5. Research and demonstration programs are designed to study, evaluate, or examine Federal public benefit or service programs. (The research must be sponsored by the program/government and be approved at a high level within the organization. (This is a narrow exemption that is rarely considered).

6. Taste and food quality evaluation and consumer acceptance studies involve wholesome foods without additives or with additives or chemicals below established "safe" levels.

For more information on human subjects research protocol reviews for the Medford campus, go to http://www.tufts.edu/central/research/IRB/main.htm