New Full-Review Memos
- This is the template memo that investigators will receive if submissions do not meet the IRB standards for acceptance for review.
- This is the template memo that HSPP analysts use in preparing studies for review by the IRB.
- This document lists the IRB approval criteria and considerations for IRB review.
HIPAA Summary Information
Research using, creating or sharing protected health information must comply with the federal privacy rule under HIPAA.
The HIPAA Privacy Rule provides a number of privacy standards for use, access and disclosure of health information.
Washington state law and federal regulations for human subjects research have always required IRB review of research involving participants' confidential, private healthcare information.
Washington state's Uniform Health Care Information Act already has strict privacy provisions to protect individuals whose healthcare information is being used in research.
The privacy rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes.
A covered entity includes healthcare providers (organizations and individuals), health plans (insurers and payors) and healthcare clearinghouses (billing services). Seattle Children's (including its workforce) is a covered entity.
Researchers who use, create or share health care information must comply with the privacy rule.
Researcher responsibilities under the HIPAA Privacy Rule
- Obtain IRB approval for all research involving protected health information (PHI). Any PHI used for research (de-identified, identified or limited data set) requires IRB approval.
- Provide IRB with detailed information on how PHI will be used and shared
- Obtain signed authorization to use and share PHI from individual participants or their parents/guardian or
- Request a waiver of authorization from the IRB. If waiver is authorized, you will be asked to sign appropriate institutional agreements for use of PHI in specific research (Oath of Confidentiality, Data Use Agreement).
- Provide IRB documents as required when requesting patient data from sources within Children's:
- IRB Approval (cover sheets of IRB application with IRB chair signature)
- Oath of Confidentiality (where applicable)
- Complete forms required by Children's department supplying patient data. For example, “Research Chart Pull Request” form when asking for paper medical records.
- Track disclosures. When patients' PHI is reviewed for research purposes without their authorization, tracking is required if any member of the research team is not part of Children's workforce (Children's employee, Children's University Medical Group [CUMG] employee, resident or fellow working at Children's).
View all IRB HIPAA-related forms.
Responsibilities While Conducting Research at Children's
Just as Seattle Children's and the IRB must comply with federal regulations and honor agreements with the Department of Health and Human Services about how research is to be conducted at Children's, research investigators have certain responsibilities.
Each researcher is obligated to:
- Protect the rights and welfare of research participants
- Notify the IRB of the intent to conduct research involving human subjects by submitting an application for IRB review and approval, and not initiating a study until final IRB approval is received
- Defer the decision on whether a research proposal qualifies for exempt review status under the federal regulations to the IRB
- Provide copies of the IRB-approved consent and assent forms to each research participant to sign, unless the IRB has specifically waived this requirement for the study. All signed consent and assent forms must be retained for three years after the research is completed.
- Promptly report proposed changes for studies that have been approved by the IRB. Changes are not to be implemented until the IRB has reviewed and approved them. The only exception is when immediate action is necessary to avoid harm to participants.
- Report progress for studies underway to the IRB as often as required, and not less than once a year
- Promptly report unanticipated injuries or adverse effects involving research participants to the IRB
- Obtain verbal approval from the IRB chair or designee for emergency use of an investigational new drug or an investigational device with a single patient when there is not enough time to obtain formal IRB approval. Data collected for a single patient emergency use cannot be considered research data.
Clinical Research Forum: IRB Best Practices for Common Problems
This presentation was given on March 28, 2013, by HSPP staff in collaboration with clinical research associates about the types of incidents/deviations most frequently reported to the IRB, and suggestions for preventing problems and improving practices.
Information sheets provide background information and technical assistance to investigators and staff as they conduct research at Children's.
Refer to them when preparing an IRB application, modification or renewal report. They may also be useful when a situation arises that requires special attention, such as reporting of adverse effects or enrolling children and parents who do not speak English in research studies.
Please feel free to contact members of the IRB staff when you need further assistance. We will be happy to help.
All of the following information sheets are in PDF format.
The following websites provide information about research ethics and regulations. Links are also provided to other organizations with which researchers at Children's collaborate.
Office for Human Research Protections (OHRP)
U.S. Food and Drug Administration (FDA)
IRBs at other institutions