COMPLEXITIES IN CONDUCTING RESEARCH WITH LIMITED POPULATIONS
Rationale/Background:Children with rare diseases or living in less populated areas need to be studied. One of the challenges of including these individuals in research is the increased potential for loss of confidentiality and anonymity. Specialty clinics may see only 10 or 20 children per year with a specific diagnosis. Similar issues may occur in specialty clinics in less populated communities where only a small number of children with a specific chronic illness are seen.
Methods:Recruitment in these populations is a major concern. The clinic staff will know participants for studies are being recruited and they will know who meets the criteria for the study. Both of these scenarios can present ethical concerns if clinic staff encourage or discourage potential subject’s participation in the study. Research designs may also influence study recruitment.
Data collection must be sensitive to personal health information (PHI), but potential identifiers must be considered more broadly. Zip codes may make a participant from a rural community identifiable. No links to the chart or other records should be retained, this includes scanning consent into electronic medical records. (Although this may differ if the research includes drugs or other materials which can affect the pathophysiology of the disease process). Such information as school name or distance from health care might also make a participant identifiable. Privacy must be insured during data collection, this may also include insuring siblings are not listening to data collection. Consent forms should be kept in a separate, locked file with no links to the data files. One strategy is to include these children in studies which are non-categorical, that is multiple diagnoses are used to meet the entry criteria.
Results: Careful implementation of the methods discussed above can insure that participants with rare diseases or from clinics with a small number of patients meeting study criteria will consider participation. Attention must be given to the entire research process so the subject’s confidentiality and anonymity remains intact.
Implications: Great care must be taken when doing research with children when the rarity of their disease makes them more easily identified. Consideration of data which would not be identifiable in larger populations must be given. These include information on zip code and school attended.