- What is the federal and state agency definition of research?
- What is human research review?
- Who reviews research for Washington State government agencies?
- Does my research require review by the WSIRB?
- What are the WSIRB procedures?
- Does my project meet the definition of human subject research?
- Could my research be exempt from review?
- Does my application require full-Board or expedited review?
- How do I begin the review process?
- How do I submit my application?
- What is the purpose of pre-review for Full-Board applications?
- How long does it take to complete the review process?
- Is human subjects protections training required of researchers?
- Will my application need to be reviewed by both WSIRB and my home institution?
- How do I make changes to my research once it has been approved?
- How long is study approval valid?
- How do I report a problem or adverse event?
Subject Recruitment and Consent
- What procedures may be used to recruit subjects?
- May state agencies disclose the identities of potential subjects without authorization?
- May state agencies disclose identifiable personal records and/or protected health information if subjects will not be recruited for research?
- Must signed consent for study participation always be obtained?
- Do minors always need the permission of their parents or guardians to participate in research?
- How does the HIPAA Privacy Rule affect my research?
1. What is the federal and state agency definition of research?
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and services programs may include research activities.
2. What is human research review?
Human research review is the process used by institutions that conduct human subject research to ensure that:
- the rights and welfare of human subjects are adequately protected;
- the risks to human subjects are minimized, are not unreasonable, and are outweighed by the potential benefits to them or by the knowledge gained; and
- the proposed study design and methods are adequate and appropriate in light of the stated research objectives.
Research that involves human subjects or their identifiable personal records should be reviewed and approved by an institutional review board (IRB) per requirements in federal and state laws and regulations and state agency policies. Institutional review boards perform the review on behalf of the institutions they represent.
3. Who reviews research for Washington State government agencies?
The Washington State Institutional Review Board (WSIRB) reviews research in the jurisdiction of the Washington State Department of Social and Health Services (DSHS), Department of Health (DOH), and Department of Labor and Industries (L&I). At their request, the WSIRB may review research in the jurisdiction of other state agencies. Under their Federalwide Assurances, the WSIRB also may review research for Public Health - Seattle and King County, Tacoma-Pierce County Health Department, Spokane County Health District, and Clark County Health Department.
4. Does my research require review by the WSIRB?
Human subject research requires review by the WSIRB if:
- the employees or agents of DSHS, DOH, or L&I intervene or interact with living individuals for purposes of research;
- the employees or agents of DSHS, DOH, or L&I use or disclose individually identifiable private information for purposes of research;
- DSHS, DOH, or L&I receive a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor or collaborator.
5. What are the WSIRB procedures?
The Washington State Institutional Review Board Procedures Manual provides detailed descriptions of Review Board purpose and authority; management and support; organization and membership; operations; and the human subject review process.
6. Does my project meet the definition of human subject research?
Some activities resemble research but actually are not research as defined in the federal regulations and state agency policy. Program evaluation, surveillance, disease investigation, and quality assurance and/or quality improvement are activities that may or may not constitute research that requires WSIRB review. You should consult the WSIRB Procedures Manual, Section 5.1, and then submit a Exempt Determination Request and all supporting documents. WSIRB staff will provide a determination of the nature of the proposed activity in writing. Contact the WSIRB staff for further guidance.
7. Could my research be exempt from review?
If your project is determined to meet the definition of research, it is possible that it may be exempt from needing WSIRB review. You should consult the Washington State Agency Policy on Protection of Human Research Subjects, Section XI, to make an initial determination, and then submit a Exempt Determination Request and all supporting documents. WSIRB staff will provide a determination of exempt status in writing. Contact the WSIRB staff for further guidance.
8. Does my application require full-Board or expedited review?
Some research qualifies for expedited review, which is conducted outside a WSIRB meeting by two or more WSIRB members. Research in this category must be minimal risk and fall into one of the categories listed in the Section X of the Policy on Protection of Human Research Subjects.
Research that is more than minimal risk, or research that does not fall into one of the expedited categories, is reviewed in a convened meeting of the full Review Board. Proposals that require full Board review are pre-reviewed before they are placed on the agenda of a Board meeting.
Consult with WSIRB staff to determine if your proposal will qualify for expedited review.
9. How do I begin the review process?
Download the current version of the WSIRB Research Application and Appendices. Save the application and the relevant appendices as Word files on your computer, and complete the requested information. The Policy on Protection of Human Research Subjects and the Calendar of Review Board Meetings are helpful resources in preparing your application. Notify the Review Section by e-mail or telephone before you submit an application for review. We advise researchers to call and discuss their research with WSIRB staff prior to submitting a proposal for review.
10. How do I submit my application?
For expedited review, submit an electronic copy of the proposal when it is ready for review. Your proposal will generally be reviewed within two weeks of its arrival in our office and you will be informed of the results of the review shortly thereafter. You will be asked to submit a written response to any issues identified in the expedited review and to submit a revised proposal for further review. The original and two paper copies of the proposal with all required signatures should be submitted at that time.
For full Board Review, submit an electronic copy of the proposal for pre-review by the application deadline for a meeting. You will be informed no later than a week after the deadline whether the proposal has been accepted for full Board review or whether it requires revision or additional information before full Board Review. When the proposal is ready for full Board review you will be asked to submit eighteen paper copies for distribution to the WSIRB. If the proposal involves an application for federal funding, you should also submit two copies of the completed grant, contract, or cooperative agreement application.
11. What is the purpose of pre-review for Full-Board applications?
Pre-Review is intended to identify proposals that require revision or submission of additional information to avoid being deferred during the full Board review. If a proposal is found deficient in the pre-review, the investigator will be informed of the revisions that need to be made, or the additional information that needs to be submitted, before the proposal will be placed on the meeting agenda. The investigator is allowed one week to submit a revised electronic proposal and paper copies for distribution to the Board prior to the meeting. Pre-review increases the likelihood that applications will be approved or conditionally-approved at the Board meeting.
12. How long does it take to complete the review process?
You should allow at least six weeks from the time you submit your proposal to complete the expedited review process.
If a proposal for full Board Review is conditionally approved at the Board meeting, the researcher will be asked to confirm acceptance of the approval conditions and make necessary revisions prior to final study approval. If the Review Board has more extensive questions or concerns about the proposed research, the proposal likely will be deferred pending submission of a revised proposal or additional information. If a proposal is deferred, it must be reconsidered at a subsequent Board meeting. Allow at least eight to ten weeks from the time you submit the proposal to complete the full Board Review process, and longer if the response to initial review issues must go back through a subsequent Board meeting.
13. Is human subjects protection training required of researchers?
All principal investigators, co-investigators, and staff with access to study subjects or confidential data must document completion of appropriate training in the protection of human research subjects prior to the approval of their application. Re-certification of human subjects protection training is required every three years. Further information can be found on our Training webpage.
14. Will my application need to be reviewed by both WSIRB and my home institution?
The WSIRB has established multiple project IRB Authorization Agreements with the University of Washington, Eastern Washington University, Washington State University, and the Fred Hutchinson Cancer Research Center. These Agreements allow one institution to rely on the IRB review of another institution. If you are affiliated with any of these institutions, review the relevant IRB Authorization Agreement and check with the IRB of your home institution to determine whether they will rely on the WSIRB for the review of your research.
15. How do I make changes to my research once it has been approved?
All changes in approved study objectives, procedures, or study groups must be submitted as a study amendment and approved by the WSIRB before the changes are implemented. Most study amendments can be reviewed through the expedited process; more substantial changes may require full Board Review. You should submit a Study Amendment Request describing the modifications, along with copies of any new data collection instruments, consent documents, etc. Major changes in the research objectives, procedures and/or study groups may require submission of a new application. Consult with WSIRB staff if in doubt about what to submit with a request for an amendment to your approved research.
16. How long is study approval valid?
Research is generally approved for the maximum period of one year. High risk research may be approved for shorter periods. You will be notified by email approximately two months before the end of your approval period. If your research will continue beyond your approval period, you will be asked to submit a progress report for continuation review and approval. Progress reports should be submitted on our Continuation Approval Request.
17. How do I report a problem or adverse event?
Researchers must promptly report an Unanticipated Problem and/or Adverse Events to the WSIRB. An adverse event is an "undesirable or unintended result of therapy or other intervention with a human subject." An unanticipated problem involves problems with the study or reactions to recruitment, consent, and/or study procedures OR any event that may adversely effect the rights and welfare of study subjects. Researchers are advised to call the WSIRB staff at 360.902.8075 to discuss adverse events or problems prior to making the report.
Subject Recruitment and Consent
18. What procedures may be used to recruit subjects?
If subjects will be identified through DSHS, DOH, or L&I records and/or information, first contact with potential subjects must be made by agency representatives. This initial contact is to request permission for the state agency to disclose the identity of the individual to the researcher for study recruitment. Ideally, this initial contact will be from the individual's case manager or health care provider, and could be made either in person or by telephone. In some cases, first contact can be made by an official agency letter to the prospective subject. WSIRB staff can advise researchers on appropriate procedures for identifying and contacting potential subjects.
19. May state agencies disclose the identities of potential subjects without their written authorization?
If subjects will be identified through agency records and will be contacted for purposes of the research, you should assume that their written authorization will be required for the agency to disclose their identities and contact information to the researchers. If the researcher documents that the general criteria in state law and federal regulations for waiver of authorization are satisfied, the Review Board may consider approving a prior notification procedure in lieu of obtaining a written authorization to disclose subjects' identities for study recruitment. The prior notification procedure must include provisions for prospective subjects to decline permission for the agency to disclose their identities to the researchers. Information needed for the IRB to approve a waiver of authorization is requested in the WSIRB Research Application, Appendix I, Section 4.
20. May state agencies disclose identifiable personal records and/or protected health information if subjects will not be recruited for research?
You should assume that the written authorization of subjects will be required, unless you document that the general criteria in state law and federal regulations for waiver of authorization are satisfied, and the WSIRB approves the waiver. If waiver of authorization is approved, identifiable personal records held by DSHS and DOH may be disclosed under the state research records law (RCW 42.48). The ability to disclose identifiable personal records without authorization also is governed by specific statutes and regulations that protect the confidentiality of information regarding children receiving child welfare services and persons receiving mental health services, alcohol/drug abuse treatment, and/or treatment for sexually transmitted diseases. Information needed for the IRB to approve a waiver of authorization is requested in the WSIRB Research Application, Appendix I, Section 4.
21. Must signed consent for study participation always be obtained?
The WSIRB will consider approving waiver of the requirement for signed consent if the researcher documents that the criteria in 45 CFR Part 46.117(c) have been met, as requested in the WSIRB Research Application, Appendix I, Section 1. Waiver of signed consent usually is approved for minimal risk research involving telephone or mailed surveys. However, potential subjects always must be given sufficient information for them to make an informed decision about study participation.
22. Do minors always need the permission of their parents or guardians to participate in research?
You should assume that the permission of one or both parents or of the legal guardian will be required, unless you document that the criteria in 45 CFR Part 46.408(c) have been met, as requested in the WSIRB Research Application, Appendix I, Section 3, and the WSIRB approves a waiver of parental permission.
23. How does the HIPAA Privacy Rule affect my research?
The Privacy Rule, which took effect on April 14, 2003, adds new privacy protections for subjects involved in research. The Rule specifies criteria that must be met for an IRB to approve waiver of the subject's written authorization for use or disclosure of his or her protected health information (45 CFR 164.512(i)). The Rule also specifies several new requirements for information that must be in a valid authorization form for use or disclosure of protected health information (45 CFR 164.508). Additional information on these requirements is found in HIPAA Privacy Rule Requirements for Research, and in the WSIRB Research Application, Appendix I.