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116.5 Organization Policy on Use of Research Data in Cases of Questionable Consent Documentation
Research projects that are conducted over a period of many years may experience problems with study documentation. Changes in study personnel, including change in the PI, may result in confusion about where original consent forms are filed or stored. The JHM IRBs periodically receive requests from PIs to use data in cases where consent documentation is in question. The Organization will allow the JHM IRBs to consider use of data in these cases only as follows:
- When data continues to be collected through interaction with participants, or the PI has existing data he/she wishes to use and knows the patient/subject population is still available for contact, the PI must reconsent the participants before continuing to use the existing data or collects additional data. Data from any individuals who do not reconsent when approached must be discarded. Contact with the subjects to ask for reconsent must be through use of an IRB approved document.
- When data exists and interaction with participants is not possible (either due to relocation of the participants, lost to follow-up, or the participant is deceased), data may be used only if the research record (or the medical record) contains a note that a research consent was obtained and in the case of biospecimens, the IRB approved consent form did not contain an opt out provision for subjects to indicate they did not wish their samples to be used for research purposes. The note in the record must specify who obtained the research consent and the date on which it was obtained. If a note exists in the record, but the consent form approved by the IRB contains an opt out provision, the data must be discarded, as one could not determine that a subject had or had not restricted future use of their data. If the research record or medical record does not contain a note attesting to consent having been obtained, data must be discarded.
- Samples and data from pediatric populations represent a unique case. In cases where written parental permission was obtained, if the signed consent form is not available to indicate parental permission was granted in writing to obtain a samples or data for research purposes, then they may not be used in the research. In cases for which parental permission was obtained under a waiver of documentation of consent/parental permission granted by the IRB (e.g. an oral consent), then any samples/data from the child may be used only if the participant’s study file contains original documentation that consent was obtained from either or both parents via that process.