The way in which potential donors are approached is dependent upon many factors. The following is a partial list of aspects that could influence how and where a donor is asked to participate, and who would conduct the outreach:

…By the patient’s doctor or nurse

Does the potential donor’s doctor or nurse play an official role in the protocol under which the donor is being asked to provide tissue and data? If so, that person may be directly involved in identifying patients who meet the medical criteria, approaching them in the office setting, engaging those patients in the informed consent process, and then actually collecting the tissue during office visits or surgery.

If not, the care provider has been informed that his or her patient might be approached to donate tissues and may have referred the patient to those who are running the protocol. The care provider can answer questions for the patient, but he or she might not be involved in the actual process of collecting tissues or data. In this case, the patient may be approached by a third party, for example during pre-operative visits during hospital admitting.

In cases like this, the potential donor may have been identified by a review of the upcoming surgical schedules or by scanning the medical records for patients who meet certain criteria. Typically, then, the patient would receive a phone call and an information brochure by mail to describe the program. This type of patient approach is most common when the potential donor is being cared for within an academic medical center, such as a university hospital.

…As part of a clinical trial

Is the patient being asked to participate in a clinical trial where donating tissue is a part of the protocol? A clinical trial is a controlled process to test new diagnostics, drugs or devices as part of gaining approval to market from the U.S. Food and Drug Administration (FDA). Modern clinical trials often include tissue collection because new molecular and genomic technologies permit a researcher to rapidly study how a donor’s tissue reacts at a molecular level, which can provide good clues as to how the patient will respond clinically.

In a clinical trial, the researchers conducting the trial may or may not be the donor’s doctor. If not, the researchers who are officially part of the clinical trial protocol will be the ones who approach the donor, ask for the donor’s consent, and actually do the tissue and data collection. These researchers would have been notified about the donor by the donor’s doctor or through a patient’s own efforts to be involved in a trial. In cases like this, the clinical trial researchers will work with the donor’s care providers (nurses, doctors and surgeons, and office staff) to assist in the tissue and data collection protocols.

…Through involvement in an advocacy group

Is the donor or donor’s family actively engaged with a patient, disease, or research advocacy group? With the increasing importance of tissue to successful biomedical research, many advocacy groups are providing their members with information, encouragement, and even kits and forms to collect tissue and data. In some cases, advocacy groups are operating their own biobanks and providing the material and data to qualified researchers who have gone through a merit review process.

In a situation like this, the patient donors themselves will approach their doctors or surgeons and provide them the necessary information to collect tissue and send it to the biobank.

…Post-surgery

Has the patient already had surgery, and excess tissue not needed for diagnosis been identified? When a patient undergoes surgery to remove tissue (e.g., a tumor), the first destination for that tissue is the pathology department, where the tissue is used to render diagnoses for patient care purposes. Commonly, however, there is more tissue than needed for the diagnosis, and this tissue will be discarded as medical waste unless it is retained for research purposes.

In this case, patients may be approached after surgery, to ask if the tissue that would be discarded may be added to the biobank. If the patients consent, they will also be asked if their medical data can be associated with the tissue.