4. Establishing and maintaining systems
Before a hospice agency begins the process of conducting or participating in research, agencies may want to consider putting specific internal systems in place for the purpose of tracking research requests, evaluating potential research projects, designing new research projects, applying for and managing grant funds, and disseminating results.
Role of Agency Review Committee
Each hospice agency should decide what functions they want the research committee to provide. A sample purpose statement might read: “The review committee at XYZ Hospice will review research projects to ensure that the proposed research is potentially beneficial and minimally harmful to patients, families, staff, and the organization.”
- Tasks of the committee may include:
- Establishing review criteria
- Reviewing research proposals
- Providing feedback to external and internal researchers
- Suggesting ways to adapt proposed research to hospice systems of care
Forming an Agency Review Committee
- An agency review committee might consist of:
- Hospice CEO/administrator
- Quality manager/director
- Board members
- Clinical staff members (representing the diversity of the IDT)
- Community representatives (perhaps bereaved caregiver)
- Program directors
For small agencies, the senior leadership team may be appropriate. When forming an agency Review Committee, let prospective members know the purpose of the committee and detailed information about what will be expected of them in terms of responsibilities and time commitment. Prospective members should be individuals who have had experience with the systems and standards of the hospice organization. A few members of the review committee should have a basic understanding of research methods as well. The organization will need to determine whether it would like the committee to meet on a regularly scheduled basis (for example, quarterly) or whether the committee should be convened on an as needed basis either by phone, e-mail, or in person as proposals are submitted throughout the year. For an organization new to research, it may make the most sense to convene the committee as needed until the volume of proposals increases.
Sample Review Forms
Research Review Packet
Internal Research Review Committee
(To be completed by person in charge of research at your agency before distributing to review committee)
Purpose of the Study (Please state research question):
- Start date
- End date
Protection of Human Subjects:
- Date IRB submitted:
- Date IRB approval received:
- Name of IRB:
Potential Policy Implications:
Potential Impact on Agency Staff and Volunteers:
Potential Impact on Patients and Families:
Potential Cost of Research:
Internal Review Committee Members (list names):
Instructions: Please reply via e-mail that you have reviewed the attached research proposal in the following review categories. (If your position is listed below a particular category (or categories), please make sure your review is focused primarily on this area). If you do not find the proposal satisfactory and feel it should either be revised or rejected, please state the reason(s) in your e-mail. Thank you.
Protection of Human Subjects
- (insert names of appropriate staff members)
Potential Impact on Patients, Families, Staff and Volunteers
Potential Impact on Public Policy
Potential Costs of Research
Sample Policies and Procedures
Hospice agencies involved in research should have a set of policies and procedures for research. Written policies and procedures help to remove any ambiguity about the review process and help to guide the agency in carrying out research.
The XYZ Hospice requires a formal review and approval process before research may be conducted.
- To provide for the rights of the research subjects via a formal review.
- To improve patient/family care through support of quality research.
- To provide an opportunity for professionals/students to conduct research.
- To ensure that research projects support the vision and mission of the agency.
- All requests to conduct research shall be formally submitted in writing to ___________. This application is required of everyone - employees, students, and independent researchers. See Procedure for Obtaining Research Approval.
- All research proposals shall be forwarded to the CEO/vice president/research director for preliminary review.
- Research proposals shall then be forwarded to the Research Committee for discussion and the formulation of specific recommendations regarding the research project. The Research Committee meets quarterly, and proposals will be reviewed by the Research Committee at these scheduled meetings only. Researchers will be informed of the next scheduled Research Committee meeting.
- When required, the proposal will be submitted to the University of ABC Institutional Review Board for approval.
- When a research proposal is approved, ______________ shall designate a staff member to serve as liaison between the agency and the researcher.
- Written reports of the research findings shall be submitted to the Research Committee within the time frames specified in the research proposal.
- All manuscripts must be reviewed by the CEO prior to submission for publication. Investigators are asked to please send a copy of their manuscript to the CEO at least one month before their submission deadline. Hospice reserves the right to determine whether or not the organization shall be acknowledged in publications containing information secured through the association of XYZ Hospice.
- XYZ Hospice reserves the right to claim joint ownership of all collected data related to research projects approved by the organization, unless other agreements are reached with the researcher prior to the commencement of their research.
Procedure for Obtaining Research Approval
- Schedule an appointment with the __________, to discuss your research proposal. Appointment may be made by calling ###-####.
All research proposals shall include the following: (Please limit to 10 pages maximum).
- Cover Sheet
- Purpose of the Study
- Hypotheses or Research Questions
- Benefits of the Study to Individuals or Humankind
- Description of Research Methods
- Time Line for Study (including review dates for Research Committee at specific intervals.)
- Reporting Methods/Time Frames
- Plans for Publishing Results (internally & externally)
- Copy of Informed Consent Forms
- Copy of Data Collection Tools
- Curriculum Vitae of All Investigators in Study
- Submit a copy of the entire proposal to _____________or at least forty-five (45) days prior to the Research Committee meeting in which you would like your proposal reviewed. The committee meets quarterly and as needed.
- If requested, plan to attend the Research Committee meeting when proposal is reviewed to answer questions about the study.
- Anticipate notification of approval or disapproval of research proposal within two (2) weeks of the Research Committee meeting.
- Upon completion of the study, a written report of findings must be submitted to _____________. This report is due within the time frame identified in the research proposal.
- Research findings shall be publicized internally and/or externally as specified in the research proposal.
- If the hospice is to be identified in any publication, the Executive Director requests the right to review the manuscript prior to submission for publication.
NOTE: XYZ Hospice reserves the right to claim joint ownership of all collected data related to research project approved.
Research Files, Confidentiality, and HIPAA
Hospice agencies need to maintain files of all documents pertaining to research projects. These files must be stored in a locked area (e.g. file cabinet) and should include documents such as grant proposals, research contracts, completed surveys and questionnaires, signed consent forms, and tapes and transcripts of interviews and focus groups. Hospice agencies should pay special attention to the Health Insurance Portability and Accountability Act (HIPAA) requirements pertaining to research, and should insure that their agency treats research information and documents in a manner that best protects the privacy of those involved. For more information about HIPAA, see the Department of Health and Human Services’ Office of Civil Rights web page at www.hhs.gov/ocr/hipaa.