Mission Statement: Hillside Family of Agencies provides individualized health, education, and human services in partnership with children, youth, adults, and their families through an integrated system of care.
Strategic Intent: Hillside Family of Agencies, in partnership with youth, families, and communities, will be the leader in translating research into effective practice solutions that create value (outcomes/cost.)
Hillside Family of Agencies IRB Overview: Hillside Family of Agencies has developed a centralized program to review and approve all research involving human subjects. Before a research project involving human subjects is initiated, it must be reviewed and approved by an Institutional Review Board (IRB). While the principal investigator has primary responsibility for the conduct of the study, it is Hillside’s responsibility to protect the rights and welfare of the participants involved in research.
Why have an IRB? While most IRBs are located within universities or medical institutions, some IRB reviews are conducted by private and public organizations. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations.
Why Our Own IRB?
- Foster partnerships with external investigators
- Provide a gateway and support for programs to initiate/conduct research and bring HFA’s work to a broader audience
- Risks to subjects are minimized
- Risks are reasonable in relation to benefits
- Selection of subjects is equitable
- Informed consent will be sought prospectively
- Informed consent is appropriately documented
- Research plan makes adequate provisions for safety monitoring
- There are adequate provisions to protect privacy and confidentiality
- Additional protections for vulnerable subjects
HFA IRB Responsibilities Include:
- Ensuring that potential risks to the subjects are clearly identified in the research protocol and in the informed consent form.
- The research risks are outweighed by the benefits to the research subjects, and the importance of the knowledge to be gained.
- The rights and welfare of all research subjects are adequately protected.
- The process provides an adequate explanation of the potential risks and safeguards as well as the benefits of participating in a research study.
All research involving human subjects must be reviewed by the HFA IRB if:
- The research is sponsored by Hillside, OR
- The research is conducted by or under the direction of any employee or agent of Hillside (including students) in connection with his or her responsibilities, OR
- The research is conducted by or under the direction of any employee or agent of Hillside using any property or facility of Hillside, OR
- An employee or agent of Hillside (including students) meets the criteria for “engaged in research” as defined in OHRP guidance of October 16, 2008 http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm OR
- The research involves the use of Hillside’s non-public information to identify or contact human subjects.
HFA Review of Research Protocols:
- Authority to: approve, require modifications to seek approval, or disapprove
- Require that information given to subjects is in compliance with CFR
- Shall require documentation of informed consent or waive documentation
- Notify investigators in writing of its decision
Requirements for Initial IRB Review: Individuals who propose to engage in any research activity involving the use of human subjects must submit a complete set of the following (including the primary and secondary reviewer form) 10 - 14 days prior to a full board meeting to the IRB Office:
- Required. A completed original IRB Application with collaborator(s), co-investigator(s), and Departmental Review Committee Chair’s electronic signature (if applicable);
- Required. A research proposal describing the rationale for the study, research questions to be answered, methods, procedures, data analysis plan, and other required information
- Required. An informed consent form or justification for Waiver of Informed Consent or Waiver of Documentation of Consent; the informed consent must contain the HFA IRB Chair's name and contact information for participants to contact with questions, concerns, or complaints: Christopher Dehon, Ph.D., Hillside Family of Agencies' IRB Chair, Phone: (585) 256-7812, Email: firstname.lastname@example.org
- Required. If the study involves the use of questionnaires, surveys or similar instruments, copies must be submitted;
- Required. Training Verification. This is to meet the Hillside Family of Agencies IRB requirements for training of researchers in the protection of human subjects in research (e.g. https://www.citiprogram.org/)
- Required if applicable. Site Letters, if applicable, for extramural research
- Required if applicable. Additional approval documentation
- Required if applicable Recruitment materials (flyers, posters, web-pages, email messages, etc.,)
- Required if applicable. Sponsor Protocol, if any.
Submission Schedule Requirements: There is one IRB meeting per month. Meetings are held on the fourth Wednesday of each month. The deadline for submission packets is approximately 7 days prior to the meeting date. If the study is eligible for an “Expedited or Exempt Review” process, it may be submitted at any time and will be reviewed in the order received and administratively reviewed.
Initial Evaluation of Submitted Projects: The IRB Administrator receives all research applications and will review all applications verifying the PI requested the appropriate review level: exempt, expedited, or full board, using the initial review checklist. Any questions about the appropriate review level, applicability of definition of human participants, jurisdiction of IRB, or otherwise relating to necessity of review are directed to the IRB Chair. IRB staff or the IRB Chair reviews the agenda for protocols involving vulnerable populations and determines that the IRB includes persons knowledgeable about or experienced in working with these participants or obtains consultation.
The full list of IRB policy and procedures can be found at the Department of Health and Human Services Office of Human Research Protection, which is located at: http://www.hhs.gov/ohrp/
Human Subjects Research Training: CITI Program: https://www.citiprogram.org/