- Does the IRB need to look at this project?
- If the project is affiliated with the DSHS, yes. It is the responsibility of the IRB to determine whether or not the proposal fits the definition of research.
- Can I e-mail or fax my application to the DSHS IRB #1 office?
- No. The DSHS IRB #1 requires original signatures of both the principal investigator and program contact on the Application form, so the submission should include one signed original and the appropriate number of copies. The copies should be double-sided.
- What is the estimated time line from submission to determination?
- The average turnaround time for a application undergoing IRB review, from receipt through final approval, is 4-5 weeks. Three weeks of this time involves a pre-review process, meeting arrangements, and time for board members to prepare before the convened IRB meeting. The length of time after the meeting will depend on the investigator's ability to address stipulations made by the IRB, with time allotted for re-review and approval.
- What is the difference between full, expedited, and exempt review?
- Full IRB Review - means the research is reviewed by the IRB at a convened meeting. Full IRB review is required for all research protocols involving more than minimal risk, such as research involving invasive procedures, investigational drugs and devices, multiple blood sample collection, or research that involves vulnerable populations including subjects under 18 years of age, pregnant subjects, or special classes of at-risk populations.
Expedited Review – Expedited review means the activity may be reviewed by one or more designated IRB members, but convened board review is not required. To qualify for expedited review the research must present no more than minimal risk to human subjects and involve only non-invasive procedures. In addition, the research must meet one of the specific categories of activities identified in the regulations as eligible for expedited review. Expedited Categories
Exempt Review – Exempt review means that the activity may be reviewed by one or more designated IRB members to determine if the research project qualifies for exempt status. Research activities that qualify for exemption are exempt from compliance with the federal regulations. To qualify for exempt status the research must have little, if any, associated risk and fall into one or more of the six exempt categories permitted by the federal regulations. Further Clarification
An application for IRB review is required for all research protocols regardless of the review category. Attach the appropriate expedited/exempt review request form, as appropriate.
- Who is required to complete the human participants training?
- The principal investigator listed on the application must take the training. Documentation of that training must be submitted with the application. It is highly recommended that all co-investigators and co-researchers also take this training. Documentation of that training does not need to be submitted with the application.
- What can I do to minimize delays to my project's approval?
- Use the most recent IRB forms
- Be sure to get all appropriate signatures
- Review your cover leter, surveys, advertisements, and informed consent document for typos, readability, soundness, and grammar.
- Use the informed consent document checklist to ensure all elements of informed consent are present within your document.
- Use the submission checklist to ensure all required documents are included in your submission
- Can I make changes to the protocol without informing the IRB?
- No. All changes/modifications/amendments need IRB approval before the change can be implemented. To notify the IRB:
- Complete an Application marking the Application Type "Amendment."
- Complete an Amendment Request form
- Attach additional sheets of paper to detail the amendment(s) and the reasons for the change(s).
- There has been an adverse event within my study. What should I do?
- Researchers are required to report adverse event or serious adverse events immediately to the IRB in the form of a letter or memorandum, unless you already have a formed designed specifically for reporting adverse events.
- How long must I hold onto my records after my study closes?
- The Code of Federal Regulations, 45 CFR 46.115(b) requires all "records relating to research, which is conducted, shall be retained for at least 3 years after completion of the research." "Completion of research" includes completing all data analysis.
- How do I inform the IRB that my project has closed?
- Complete and submit a Final Report upon Termination of Project form.
- I have completed data collection and am performing data analysis only. Do I need to renew my approval past the expiration date?
- Yes. Your study is considered ongoing, even if you are "only" analyzing data (especially if you have data with identifiers).
- My approval has expired. What should I do now?
- Federal regulations do not allow research to continue past the approval expiration date. You must stop the research, "unless the IRB concludes that it is in the best interest of individual subjects to continue participation in research interventions or interactions." Enrollment of new subjects cannot occur after the exiration of IRB approval. This also applies to the release of data for use in the study. A new application must be submitted and reviewed to reinstate approval.
Helpful Hints and General Tidbits
It is important to complete all parts of the DSHS IRB #1 application form, make sure:
- A DSHS Program Contact is listed on the application or
- A cover letter requesting the DSHS IRB #1 to consider serving as the IRB
- All relevant boxes have been checked
- Both the principal investigator and program contact have signed the Application
The project description summary/synopsis must clearly state the work to be conducted, make sure:
- A clear general description including the projects main objectives is provided
- Specific scientific protocols should not be detailed in this section
The research plan should contain sufficient details to provide the reviewer with a clear, step by step picture of what a human subject will experience as they participate in the project, make sure to include:
- Sampling methods – how will potential subjects be considered for inclusion/exclusion?; what is the sample size required for the chosen research design?
- Vulnerable subject population – are there children under 18 years of age in the project?; have special populations been clearly included/excluded for the correct reasons?
- Recruitment plan – how will potential subjects be contacted?; who will make the contact?
- Intervention/assessment – what protocols can potential subjects expect to complete if they participate?; how many days, hours, etc.?; where should they report to?
- Informed consent – has the language/comprehension level of the consent been crafted for the target population?; have technical terms/jargon been simplified and explained?
- DSHS IRB #1 1-800 # – who should a participant call if they have questions about their rights as a research subject?
The Principal Investigator must retain all project notes and materials for a minimum of three years beyond the completion, cancellation, or termination of the project.
All documents must be presented exactly the way that a study participant would see them. Submit one signed original and 14 copies (double-sided).
- Application (completed, typed, with a response to all items)
- Study-Specific Informed Consent documents
- Study-Specific Children’s Assent documents
- Survey Instruments
- Focus Group Questions
- Letters to be sent to study participants
- Informational Materials that will be used in the study or seen by study participants
- Scripts for interactions with study participants
- Documentation that the human subject education requirement has been met.