Why do human subjects applications have the kind of numbers they do? Is there any significance to the parts of the number?
These numbers, like library call numbers, convey significant information to anyone familiar with the system, and allow materials to be routed, filed, and retrieved efficiently. However, because the information they contain is not immediately obvious, it may be useful to provide a brief explanation of their meaning.
A standard human subjects application number has four parts: a group of two digits, followed by a group of four digits, followed by a letter (or two) and another group of two digits.
The least informative part of the number is the second group of digits. This is simply an acquisition number, or counter. These numbers are assigned in order, as applications come in the door, beginning with 0001. Like a speedometer, the counter goes until it reaches 9999, then returns to 0001. There has not yet been a year in which more than 9999 applications have been received; until there is, each application will have a uniquely identifying number.
The first pair of numbers consists of the last two digits of the year the application was first submitted. An application submitted in 1995 will begin with "95-"; one submitted in 2000 will begin with "00-", and one submitted in 2005 begins with "05-". It is possible, but unlikely, that the same numbering system will still be in use when this counter returns to a year that has already been used.
The last pair of digits refers to the year of approval of the application. For an application in its first year of approval, this will be "-01"; for an application in its fifth year of approval, this will be "-05".
In general, the first pair of digits and the last pair of digits should add to the current year. In other words, an application submitted and approved in 2000 should be numbered "00-xxxx-L 06" in 2006; one submitted and approved in 1999 should be numbered "99-xxxx-L 07" in 2006. Since the current human subjects division database contains separate entries for each year of approval, it is important to make sure that materials have the correct date of approval on them, and this rule is a handy way of checking to see that the number is accurate.
The L in the previous paragraph stands for the third section of the standard application component, which consists of a one letter, or perhaps two letters separated by a slash.
When it consists of a single letter, it refers to the Human Subjects Review Committee that reviewed and approved the application. An application reviewed and approved by Committee A in 2000 would be numbered "00-xxxx-A 06" in 2006; an application reviewed and approved by Committee C would be numbered "00-xxxx-C 06". (The full list of these committees is available on the HSD web site.)
When this section consists of two letters separated by a slash, it can mean one of three different things. If the letters are any letter but E, it means that the application was reviewed by two committees, one behavioral and one biomedical, because it covered an activity that involved significant behavioral and biomedical risks. The primary reviewing Committee is given first; the contributing Committee is given second. An application with a number like "05-xxxx-A/G 01" is in its first year of approval in 2006, was submitted in 2005, was primarily reviewed by Committee A because the study's risks were largely biomedical, but was also reviewed by Committee G because there was a substantive behavioral risk as well. Similarly, a study with a number like "04-xxxx-C/B 02" is in its second year of approval in 2006, was submitted in 2005, and was primarily reviewed by Committee C because the risks were largely behavioral or social, but with significant contributions from Committee B because there were also substantive biomedical risks.
An application containing the letter "E" has received some sort of minimal risk review outside the full Committee process. But this could be one of two types.
If the initial letter is E, the application was reviewed by a minimal risk subcommittee operating under authority delegated by the Committee listed after the slash. An application containing "E/A" would have been reviewed by a biomedical minimal risk subcommittee acting under the authority of Committee A; an application containing "E/G" would have been reviewed by a behavioral minimal risk subcommittee acting under authority delegated by Committee G.
On the other hand, if E is the second letter, the application received full review by the Committee listed first, and minimal risk review from a subcommittee with expertise in the other aspect of risk. So, if the application number contains "C/E" it received full behavioral risk review by Committee C, and minimal risk biomedical review by a biomedical minimal risk subcommittee. Similarly, an application containing "D/E" has received full biomedical risk review by Committee D, and behavioral minimal risk review by a behavioral minimal risk subcommittee.