Organ Transplant Infection Prevention and Detection Project 1.0; Cohort Study of Transplant Recipients at "Ultra-High" Risk for Invasive Fungal Infections

This is a longitudinal cohort study. Participation in the research database is limited to placement of the subjects' identifiable medical information related to their organ transplantation and immunosuppression use. Participants can consent to allow only medical information collected and/or provide blood and tissue samples.

Patients seen by the Infectious Disease/Transplant team will be asked to provide their written informed consent to allow their past, current and future identifiable medical record information related to their condition placed in the research database. The medical record information that will be placed in the database will be related directly to the patients'-participants' disease process. However, since concurrent medical conditions and treatments (i.e., not related directly to transplantation) may impact substantially the patients'-participants' condition, it is likely that all of the patients'-participants' past, current and future identifiable medical record information will be placed in the research database. Consent will be obtained in the pre-transplant period. The advantage of this system is that consent is obtained directly from the patient (rather than from a proxy, as would be necessary in situations where consent is obtained post-transplant). Secondly, since the timing transplantation can not be predicted with certainty and may occur at hours during which research coordinators are not working, consent prior to transplantation ensures that the entire post-transplant period is covered by consent. This would ensure that early post-transplant infections are not missed, thereby eliminating a form of systematic bias. The disadvantage of this system is that some patients undergo informed consent who do not subsequently undergo transplantation. Additionally, occasional patients who present with acute organ system failure (for example, patients with fulminant hepatic failure) will not undergo pre-transplant consent. We will attempt to minimize this risk by pre-study and subsequent meetings with transplant surgeons to ensure the study team is informed about such patients on a timely basis.

Participant medical information will be stored electronically within the research data base.

The names, social security numbers, and medical record numbers of the participants will be deleted from their stored medical information and replaced with a linkage code. Access to participant medical information contained within the research database will be restricted to the research investigator and research staff..

Information linking the linkage codes to the participants' names, social security numbers and medical record numbers will be stored in a secure location separate from the medical information. Access to the information linking the linkage codes with participant names, social security numbers and medical record numbers will be granted only to the Principal Investigator and research coordinator of this research database.