Institutional Review Board (IRB) FAQ

Is My Project Considered Research?

Does your project meet the federal definition of research described below? If not, it may not need to be reviewed by the IRB.

Definition 1. This definition is for all projects that are not regulated by the FDA.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigation: An activity that involves a prospective plan that incorporates data collection (quantitative or qualitative) and data analysis to answer a question or address a hypothesis.
Designed: The activity has a predetermined purpose and intent.
Generalizable: The results may be applied more broadly beyond the individuals studied or beyond a specific time and/or location, such as to other settings, circumstances, or categories. Publishing or presenting does not necessarily make a project generalizable.


What is research?

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:

It is basically a study that is done to answer a question.

Scientists do research because they do not know for sure what works best or to better understand why or how things happen.

Some other words that describe research are clinical trial, protocol, survey, or experiment.

Research is not the same as treatment.


Why is the FAQ plug-in not working?

The FAQ tab needs both a 'q' and an 'a'. For example, [faq q='question' a='answer']. If it has both of those check to make sure your quotation marks are correct and you are either mixing double quotes and single quotes or you are using the codes for quotations
The code for double-quotes is " and the code for single quotes is '
another possible issue is that you might have a linebreak between your q and a fields.


My research uses non-identifiable data, do I need IRB approval?

If your research involves only the use of non-identifiable biological specimens and/or data, you may not need IRB approval.


How long does the IRB review process take?

Multiple factors affect the time required for IRB review. They include:

  • type of application
  • level of review (e.g., exempt, minimal risk, full committee)
  • complexity of the study
  • involvement of other compliance offices or institutions
  • quality and completeness of the application when first submitted

We encourage researchers to plan for sufficient time for review based on the research and their particular situation.

Allocate adequate preparation time before submission, in most cases a minimum of two weeks to one month.

  • For full IRB review, plan for at least 12 to 16 weeks for the review and approval process.
  • For Minimal Risk review, plan for at least 6 to 8 weeks.
  • For Exempt review, plan for at least 2 to 3 weeks.


Can I start working with human subjects before finishing the IRB review process?

no


What if there are changes to my study after I receive IRB approval?

You are required to obtain IRB approval before implementing any changes to an approved study.

The only exception to this requirement is when an immediate change is made to eliminate a risk or hazard to a subject. In such a case the change must be submitted to the IRB as soon as possible for review.

Minor changes to a study not involving greater than minimal risk usually undergo an expedited review by a subcommittee of the IRB. Major changes to a study require full IRB review.

Do I have to obtain IRB review from both my US and foreign institution?

In most situtations yes, but talk to your mentor team.


When may I advertise to recruit participants for my study?

The IRB must review and approve any materials you plan to use to recruit research participants before you begin contacting individuals.

This includes advertisements that appear in the newspaper or on radio, television or the Internet. Flyers, letters of approach and telephone scripts must also be approved.

Recruiting materials should provide basic information about the study, including the time involved; the primary purpose of the research, e.g., testing an experimental drug; and an overview of procedures and testing.

The materials should also describe potential benefits to participants and compensation when applicable.


Are there templates available or should I create my own forms?

Here are some templates from the University of Washington.

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