Institutional Review Board

Do I need to submit a proposal to the IRB?

Generally, surveys and other summative research does not need to go before the IRB, but if you are unsure, contact Institutional Research for assistance – there are still many regulations that govern the administration of surveys and other research that involves OC students and staff, and our office will help you navigate the laws and ethical standards that may apply to your project.

Researchers do not have the authority to determine if their own research qualifies for exempt status. Research may not begin until the researcher has received notification from the OC IRB that the research is approved (with or without modifications) or qualifies for exemption.

Typically, exempt research includes:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(a) research on regular and special education instructional strategies, or

(b) 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:

(a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and

(b) any disclosure of the human subject’s 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.

Note: This exemption does not apply to research involving survey or interview procedures or observation of public behavior when individuals under the age of 18 are subjects of the activity except for research involving observations of public behavior when the investigator does not participate in the activities being observed.

3. Research not exempt under #2 above, if:

(a) the human subjects are elected or appointed public officials or candidates for public office or:

(b) 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:

(a) public benefit or service programs,

(b) procedures for obtaining benefits or services under those programs,

(c) possible changes in or alternatives to those programs or procedures, or

(d) possible changes in methods or levels of payment for benefits or services under those programs.

Adapted from 45 CFR 46.101(b)(1)-(6), Department of Health and Human Services. For the full list of potentially exempt research, see U.S. Department of Health & Human Services, Office for Human Research Protections webpage.

How do I submit my research proposal to the IRB?

If your proposal requires IRB review, there are two routes:

• Expedited Review: in some cases, your research may be eligible for an expedited review, where your proposal is evaluated by the Chair of the IRB on an ad-hoc basis. This process is typically faster and does not require you to submit your proposal to a full committee meeting of the IRB. The Executive Direct of the OIE is authorized to make an initial determination as to whether your research proposal may qualify for expedited review, however the final determination rests with the Chair of the OC IRB. Examples of research activities that may eligible for expedited review are outlined in section 46.101 of the Code of Federal Regulations, Title 45, Part 46. Ensure that you submit all required supporting documents to ensure your proposal can be promptly reviewed.
  Expedited Review Form
• Full Review: If your proposal requires a full IRB review, you will need to complete and submit the OC IRB Research Project Form. Ensure that you submit all required supporting documents to ensure your proposal can be promptly reviewed.
  OC IRB Research Project Form

All proposals should be submitted to OCIRB@olympic.edu

What does the IRB do?

The first thing the IRB Chair will do is determine whether:

The activity is or is not research and/or involving human subjects, or that the research qualifies for exemption from IRB review.

If the IRB Chair determines that the proposal constitutes research which is subject to IRB Committee review, the Committee will discuss the proposal and take one or more of the following actions:

• Approve
• Conditionally Approve
• Require Modifications
• Defer
• Disapprove
• Terminate or suspend some or all parts of a study

What happens next?

The decision of the IRB is final; there is no process of appeal. If your project is approved (with or without modifications), the IRB will define a reporting cycle for your research. You will need to provide updates and any requested supporting documentation in accordance with the reporting schedule and using OC IRB reporting forms (which will be provided to you), or your IRB approval may be revoked and your project terminated.

The OC IRB typically meets quarterly (and not during the summer). Therefore, it is important that you allow enough time before you plan to begin your research, for the IRB to review your proposal, provide you with their decision, and for you to resubmit with any modifications that may be requested. For major research projects (such as graduate thesis research), we recommend allowing at least three months from your proposal submission to the start of your research. There is no process for accelerating the review.