Research Review
- 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?
- Where can I learn more detailed information about the WSIRB?
Process Questions
- 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?
- How long does it take to complete the Application review process?
- Is human subjects protections training required of researchers?
- Will my application need to be reviewed by both WSIRB and my home institution?
Recruitment and Consent
- What procedures may be used to recruit subjects?
- May state agencies disclose the identities of potential subjects without subjects' 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 be obtained?
- Is permission of minor children's parents or guardians required?
- How does the HIPAA Privacy Rule affect my research?
Confidentiality Agreements - Using Identifiable Data
- Does my study require a Confidentiality Agreement?
- What is the purpose of a Confidentiality Agreement?
- What is the legal basis for using or disclosing personally identifiable records or Protected Health Information (PHI) for research purposes?
- Who must sign a Confidentiality Agreement?
- How do HIPAA regulations affect my Confidentiality Agreement?
After Approval
25.How do I make changes to my research once it has been approved?
Help
28. Who can help me if I need assistance?
Research Review
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.
Unless deemed exempt, 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. IRBs 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 Children, Youth, and Families (DCYF), Department of Health (DOH), Department of Social and Health Services (DSHS), Health Care Authority (HCA), Department of Corrections (DOC), Department of Labor and Industries (L&I), and the Office of Financial Management (OFM). At their request, and under an IRB Authorization Agreement, the WSIRB may review research in the jurisdiction of other state agencies or other institutions.
4. Does my research require review by the WSIRB?
Human subject research requires review by the WSIRB if:
- the employees or agents of DCYF, DOH, DSHS, HCA, L&I, DOC, or OFM intervene or interact with living individuals for purposes of research;
- the employees or agents of DCYF, DOH, DSHS, HCA, L&I, DOC, or OFM use or disclose individually identifiable private information for purposes of research;
- DCYF, DOH, DSHS, HCA, L&I, DOC, or OFM 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. Where can I learn more detailed information about the WSIRB?
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.
Process Questions
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 Washington State Agency Policy on Protection of Human Research Subjects, Section XI, and Washington State Institutional Review Board Procedures Manual, Section 5.1 to make an initial determination, contact the HRRS staff to discuss your project or obtain further guidance, and then if instructed submit a Exempt Determination Request and all supporting documents.
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 further WSIRB review. You should consult the Washington State Agency Policy on Protection of Human Research Subjects and Washington State Institutional Review Board Procedures Manual to make an initial determination, contact the HRRS staff to discuss your project or obtain further guidance, and then if instructed submit an Exempt Determination Request and all supporting documents. WSIRB staff will provide a determination of exempt status in writing. Contact the HRRS 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 a sub-committee of WSIRB members. Research in this category must be minimal risk and fall into one of the categories listed in the Section X of the Washington State Agency 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.
9. How do I begin the review process?
Log in to IRBManager and follow the directions in the user manual to start a new submission. The Washington State Agency Policy on Protection of Human Research Subjects and the Calendar of Review Board Meetings are helpful resources in preparing your application.
11. How long does it take to complete the Application review process?
If the study team has provided a complete and accurate Application, including an authorized Appendix G (if applicable), and when needed Agency Pre-Review delays may be minimized. You should allow at least 90 days from the time the fee for review is received for your proposal to complete the expedited review process, longer if a Confidentiality Agreement is required. Please refer to our Fees page for questions regarding review service fees.
If a proposal for full Board Review is conditionally approved at the Board meeting, the researcher will 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.
12. 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. Further information can be found on our Training webpage.
13. 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, Fred Hutchinson Cancer Research Center, other state agencies and other institutions. 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/or check with the IRB of your home institution to determine whether they will rely on the WSIRB for the review of your research.
Recruitment and Consent
14. What procedures may be used to recruit subjects?
If subjects will be identified through DSHS, DOH, L&I, HCA, DOC, OFM, or DCYF records and/or information, first contact with potential subjects should 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.
15. May state agencies disclose the identities of potential subjects without subjects' 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 indicated in the application protocol in IRBManager.
16. 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, DOH, L&I, HCA, DCYF, OFM, or DOC may be disclosed under the state law (RCW 42.48). The disclosure of 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 indicated in the application protocol in IRBManager.
17. Must signed consent for study participation 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 Application. Waiver of signed consent generally 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.
18. Is permission of minor children's parents or guardians required?
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 waiver section of the application protocol in IRBManager, and the WSIRB approves a waiver of parental permission.
19. How does the HIPAA Privacy Rule affect my research?
The Privacy Rule adds 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 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 the waiver section of the research application in IRBManager.
Confidentiality Agreements - Using Identifiable Data
20. Does my study require a Confidentiality Agreement?
A Confidentiality Agreement is required for studies that involve personally identifiable State Agency (DCYF, DOC, DOH, DSHS, or HCA) records or PHI (Protected Health Information) used or disclosed for research without the written authorization of the person to whom the records pertain. A Confidentiality Agreement may be required in other circumstances. Typically a Confidentiality Agreement is used whenever it is not possible or not feasible to obtain the subjects’ written authorization.
21. What is the purpose of a Confidentiality Agreement?
- To provide safeguards for the use or disclosure of personally identifiable records or PHI for research,
- To provide legal authority for the use or disclosure of personally identifiable records or PHI for research.
22. What is the legal basis for using or disclosing personally identifiable records or PHI for research purposes?
- The default position is to obtain written permission from the persons to whom the records pertain.
- In 1977, the National Privacy Protection Study Commission concluded that medical records can legitimately be used for research without the individual’s explicit authorization provided that certain criteria are met. These criteria were later incorporated into today’s laws and regulations governing this process (State laws: RCW 42.48, RCW 70.02; Federal Regulations: 45 CFR 46.116(d), 45 CFR 164.512(i)(2)).
23. Who must sign a Confidentiality Agreement?
Each State Agency that has custody of the records identifies the Agency individuals who have the authority to authorize the use of records for research purposes and signs the Confidentiality Agreement. Generally this individual is an Assistant Secretary. The Principal Investigator and all research staff who will have contact with personally identifiable data or PHI at any stage of the research must also sign the Agreement.
24. How do HIPAA regulations affect my Confidentiality Agreement?
The regulations require stricter data security protections and require more rapid reporting time, in the event of a breach of confidentiality. To assure that all parties involved are aware of these requirements a Data Security Requirements Exhibit is part of all Confidentiality Agreements involving personally identifiable information or PHI that were signed after the regulations went into effect.
After Approval
25. How do I make changes to my research once it has been approved?
ALL changes in the approved project must be submitted as a study amendment and approved by the WSIRB before the changes are implemented. Study Amendment Requests may be completed and submitted in the IRBManager system. See the user manual for directions. 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 review by the WSIRB at a convened meeting.
26. How long is study approval valid?
Research projects may be approved for up to one year. Higher risk research may be approved for shorter periods. You will generally be notified by email approximately two months before the end of your approval period to submit a Continuation Approval Request
27. How do I report a problem or adverse event?
Researchers must promptly report Unanticipated Problems 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 affect the rights and welfare of study subjects. Researchers are advised to call the HRRS staff at 360.902.8075 to discuss adverse events or problems prior to making the report.
Help
28. Who can help me if I need assistance?
Contact the WSIRB staff by phone at 360.902.8075 or by email at wsirb@dshs.wa.gov.