In their September 2007 Oncology Nursing Forum article, Deborah J. Bowen and her collegues described a process for recruiting patients with breast cancer (and their spouses and family members) from a clinical setting into behavioral and psychiatric research studies. The process addressed the barriers to recruitment for research created by Health Insurance Portability and Accountability Act (HIPAA) regulations. The article also described response rates and indicated interest among patients, spouses, and family members in participation in the studies. Bowen et al. concluded that thoughtful systems actually can improve rates of recruitment despite HIPAA regulations.
Barriers to Recruitment
Overall, only 2%-16% of patients with cancer participate in treatment trials nationwide. Key barriers to patient participation in clinical trials are often provider related.
* Time commitment
* Obtaining informed consent
* Intrusion of the study on the physician-patient relationship
* Conflict between researcher interest in access to patients and clinical staff workloads
HIPAA describes how clinical entities can use or disclose protected health information, including for research purposes. The rules affect the ways in which researchers interact with participants and hospitals, physicians, and other organizations that provide access to potential participants and their data. Entities can disclose protected health information to researchers only if the study has obtained direct consent from patients, signed HIPAA authorizations from patients, or 'waivers of authorization' from an institutional review board. Study recruitment materials and consent forms also must provide clear information to participants about who can access their medical information and how it will be used.
The rules have caused confusion and concern at many academic research facilities. Clinical facilities have been required to interpret the laws and adjust approved procedures for providing researchers access to patients.
The Method
The recruitment method that Bowen et al. (2007) developed is depicted in Figure 1. Specific steps in recruitment were identified and then assigned to appropriate clinical or research staff.
Figure 1: [FIGURE OMITTED]
Patient information crossed a 'semi-permeable' boundary between the clinical and research staff at only one point, when verified and consented contact information was passed from the clinical staff to the research staff. Only the initial approach (letters that offered an 'opt out' provision) to patients was performed by clinical staff. After a refined list of potential participants was created, all further steps were the responsibility of research staff.
The final data indicated that procedures to contact, recruit, and consent patients and family members to behavioral research activities complementary to their primary cancer treatment can be implemented successfully in the era of new stringent privacy regulations, even during the acute diagnosis and treatment period. Response rates were high among the three target groups: 77%, 95%, and 88% for patients, spouses, and female first-degree relatives, respectively. Interest was also high in all three target groups, with 77%, 87%, and 65% of responding patients, spouses, and female first-degree relatives, respectively. Research staff collaboration with clinical staff to plan and conduct the initial consent resulted in very few refusers at initial contact.
Strategies for making the relationship between research and clinical staff functional were identified. Strategies that reduced cost while improving yield included discussions between clinical staff and research staff, financial support of clinical staff by the research team, and adding the clinical director to the key personnel for research grants.
The experience of developing new procedures that met HIPAA regulations actually improved relationships between clinical and research staff because the roles of each were delineated clearly. Collaboration between overburdened clinical staff and research team members to modify and pilot procedures worked well and produced good recruitment yields.
Bowen, D.J., Fann, J.R., Andersen, M.R., Rhew, I.C., Gralow, J.R., Lewis, F.M., et al. (2007). Recruiting patients with breast cancer and their families to behavioral research in the post-HIPAA period. Oncology Nursing Forum, 34, 1049-1054.
HIPAAdvisory. (2003). HIPAA primer. Retrieved November 20, 2003, from http://www.hipaadvi sory.com/regs/HIPAAprimer.htm
Pamela Oestreicher, PhD, ONS Scientific Writer
RELATED ARTICLE: Key Definitions.
Behavioral intervention research: psychosocial interventions to improve coping; dietary change and exercise behavior as methods of preventing recurrence or improving physical functioning and quality of life
Health Insurance Portability and Accountability Act (HIPAA): a U.S. law that provides patients with access to their medical records and more control over how their personal health information is used and disclosed
Institutional review board (IRB): a group of scientists, doctors, clergy, and consumers at each facility that participates in a clinical trial. IRBs review and approve action plans for every clinical trial, checking to see that trials are well designed, do not involve undue risks, and include safeguards for patients--including meeting HIPAA regulations.
Recruitment yields: the percentages of eligible, contacted potential participants in research who actually agree to participate
Semipermeable barrier: a boundary across which information can move in only one direction or only at certain times
