Bulletin #2 Reviewing Human Subjects Research Proposals (9/2004)

There are several ways that an IRB can review a new research proposal. These range from doing "nothing" to requiring a detailed description of your research presented before the full IRB. Here is how we decide which review process is appropriate and what you need to do in each case.

Briefly, the decision on how to review a new proposal depends on the risk that subjects incur in the research, and the specific federal regulations that govern it. The rules for what kind of review may be used are extensive and sometimes confusing, but the ideas behind them are clear. They are summarized below.

1. When is your research exempt from IRB review?

   There are several categories of studies that may need no IRB review at all. Examples are:

   1. Activities that are not "your research" according to Federal guidelines because you are not taking part in the design, the analysis, or the publication.
   2. Research that does not involve humans (e.g. animal studies).
   3. Research that poses no risk to humans because
      1. The participants are dead OR
      2. The participants who contributed the data absolutely cannot be identified by anyone in the world. (Note that an identifier instead of a name won’t do if there is a code anywhere that could link the two.) Note: These data must already exist. No new collections can be exempted from review.

   For a more compete description of what can be considered "Exempt" see §46.101 (b) (http://ohsr.od.nih.gov/guidelines/45cfr46.html#l46101)

2. What do you do if you think your research satisfies one of these criteria?

   First, check with the IRB Chair or Administrator to confirm that you may be exempt. If so, you need to complete a "Request for Review of Research Activity Involving Human Subjects" (http://ohsr.od.nih.gov/info/info.html) . (You can get a hard copy from Jane Lambert). The IRB Administrator or Chair can help you to complete this but cannot approve the exemption; only the NIH Office of Human Subjects Research can do this. Principal Investigators should not determine for themselves whether or not their research is exempt. When you have completed the form, return it to Ms. Lambert. She will fax the information to NIH and will tell you within a few days if your exemption has been approved. In case it was not, you may be eligible for expedited review, as explained below.

3. When can the review of your new research be "expedited" by a subcommittee of the IRB without waiting for a full board meeting?

   If your research presents minimal risk to the participants, it may be eligible for expedited review. There are many rules that detemine eligibility, but the following cases may generally be expedited:

   1. Studies where small amounts of blood are drawn from healthy adults except in cases where genetic assays may be done, and the investigator wishes to keep identifiers for participants
   2. Collection of physical data using non-invasive means such as blood pressure measurements or electrocardiography
   3. Collection of information using survey research instruments such as questionnaires, focus groups, etc.
   4. Research that was formerly approved by the full IRB but now is in the data analysis phase, with all research interventions finished

4. What do you do if you think your research may be eligible for expedited review?

   First, talk to the IRB Chair or Administrator, who must take steps to confirm that expedited review is possible. If it is, you must fill out a "Standard Format" application (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/irb_stan_format_04.pdf)   (25K) and obtain the necessary clearances (http://www.niehs.nih.gov/about/orgstructure/boards/irb/apps.cfm#clearances). You may download the document or contact the IRB office, and the IRB Administrator (http://www.niehs.nih.gov/about/orgstructure/boards/irb/help.cfm) can help you. The same clearances that are required for Initial Review Applications going before the IRB (e.g., Scientific and Clinical Review) also are required for protocols receiving expedited review. The application can be submitted at any time. It will be reviewed by the Chair or by someone on the IRB delegated to do the review. Within a few weeks you should receive a letter outlining any necessary revisions. You have 30 days in which to make a response. Once satisfactory revisions have been received, you will be notified of the approval by the NIEHS IRB, and your protocol will be sent to NIH for final approval. Notice of final approval is usually received within 2 weeks of NIH's receipt of the protocol package.

5. What if your research cannot be exempt or expedited?

   Research that cannot be exempt or expedited must be reviewed by the full Institutional Review Board, using primary (and usually secondary) reviewers. You should check with the Administrator to make sure full review is necessary. If so, fill out a "Standard Format" application as you would for expedited review (see above) and get the necessary clearances. The application MUST BE RECEIVED IN THE IRB OFFICE NO LESS THAN FOUR WEEKS BEFORE THE IRB MEETS. (This is usually the second Thursday of odd months, but the exact dates can be found on our Web site, or call the IRB office at (919) 541-5047. Extra meetings are often scheduled as needed). You may be contacted by the primary reviewer if clarification is needed, and you will usually be asked to present a 5-minute overview before the IRB in session to highlight any risks to research participants. After the meeting you will receive a letter outlining any necessary revisions, as you would if the application were expedited. You must respond in 30 days, and approval will follow within a few days of the receipt of a satisfactory document.

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