8. Working with an IRB
Description of the IRB
As defined by federal regulations, an Institutional Review Board is “a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.” According to the Office of Human Research Protections (a division of the U.S. Department of Health and Human Services, “The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB [Federal Policy §___.112]. The IRB also functions independently of but in coordination with other committees. For example, an institution may have a research committee that reviews protocols to determine whether the institution should support the proposed research. The IRB, however, makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected.”
Most IRB’s are housed in or affiliated with a college or university or a free-standing research center. For hospice agencies interested in conducting research, it may be possible to use a local college or university IRB for review and approval of research protocols. It is important to remember that IRB approval does not mean a particular research project is research in which your hospice agency “should” participate. IRB approval simply means that a particular research project has been reviewed by the IRB and has been found to offer adequate protection of human subjects. Hospice agencies still need to conduct their own reviews of research proposals to ensure that the proposed research is in the best interest of the agency, staff, patients, families, and the community.
Because most IRB’s are hospital-, college- or university-affiliated, it may be necessary for hospice agencies to partner with a faculty member willing to serve on research projects and co-author the IRB application. Some IRB’s may not be willing to process applications from individuals outside of the institution.
Advantages of Working with an IRB
When a hospice agency requires IRB approval of its research projects, it is demonstrating to the research community, staff, patients, and families that the organization takes the potential risks of research seriously and works to ensure staff, patients and families are adequately protected against such risk. Because many agencies do not have a research administrator or Director of Research on staff, the use of the IRB ensures that someone familiar with federal regulations regarding the protection of human subjects reviews each research project and judges the project to offer adequate protections for participants. The disadvantage of working with an IRB is the length of time it takes to process an IRB application. While most large universities have IRB’s that meet monthly, it may take anywhere from a month to 6 months to receive IRB approval, depending on the number of IRB applications the IRB is reviewing at the time. Hospice researchers should submit the IRB application as early as possible, preferably 3-4 months before the scheduled start-date of a particular research project.
Deciding if IRB Review is Needed
The federal regulations apply "to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency" that has adopted the human subjects regulations [Federal Policy §___.101(a)]. For hospice agencies not receiving federal funding to conduct research, IRB approval may not be required of their research. However, some hospice agencies have taken the step of requiring IRB approval for all research projects because of concerns regarding human subjects protection. If the goal is to publish the results of your research, most journals now require a statement of IRB review and approval. Some research may be exempt from the regulations requiring IRB review [Federal Policy §___.101(b)]. Examples of exempt research include:
- “educational testing and survey procedures where no identifying information will be recorded that can link subjects to the data, and disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects’ financial standing, employability, or reputation”
- “research that involves the use of existing data, documents, or specimens, where no identifying information will be recorded that can link subjects to the data.”
(You may still need an IRB to grant “exempt” status. If you have any questions regarding whether the proposed project is in need of IRB review, contact your IRB for guidance.)
Preparing an IRB Application
Identify the primary contact person for the IRB. Colleges or universities may have copies of the IRB application that can be downloaded from their websites. Follow the instructions given for the IRB application exactly. Include a copy of all researchers’ Curriculum Vitaes (c.v.) and copies of all data collection forms, consent forms, recruitment tools (fliers, mailings, etc). Remain in contact with the IRB (through the college or university’s Office of Research Compliance or Institutional Research) to ensure that you can respond to their need for additional documentation as quickly as possible. Once IRB approval is received, make sure to keep the IRB posted, in writing, of any changes you make to the research protocol or data collection tools. Once a research project has received IRB approval, make sure the consent forms used in the study bear the IRB stamp and study approval number. IRB’s also require annual review and reporting.
Hospices participating in federally-funded research being coordinated out of another site may need to complete a “federal-wide assurance” if they are not seeking their own IRB review. A federal-wide assurance indicates that the hospice will abide by the requirements of the IRB that did review and approve the research project. Information about federal-wide assurances can be found at http://www.hhs.gov/ohrp/assurances/assurances_index.html.