Research Use of Information and Samples from Patient Care

Research Use of Information and Samples from Patient Care


Hello! The HHS Office for Human Research Protections,
or OHRP, created this video to help you learn more about a common type of research that
uses existing information and biological samples that are left over from earlier medical visits. When you go to the doctor’s office or hospital,
doctors and nurses regularly collect information about your health and document it in your
medical record. As part of your medical care, they sometimes
run tests on your biological samples, such as blood, urine, or tissue from a biopsy. The leftover samples are generally discarded
when they are no longer needed for your medical care, but medical centers also can share them
with researchers for scientific research. Information from your medical record and leftover
samples from your medical tests are valuable resources for science. Researchers can develop new treatments, learn
how to prevent diseases, or gain important knowledge about the human body from this kindof scientific “recycling” that can benefit many people. For example, researchers might want to find out which of two common blood pressure medicines works better. They could conduct a big clinical trial to
compare the drugs. In a clinical trial, people volunteer to take
one of the medicines and agree to follow procedures for the research. Or maybe researchers could get an answer by
studying information that already exists in the medical records of patients who are already
taking these medicines. By reviewing patients’ medical records,
researchers can find out how well each medicine controls the patients’ blood pressure and
learn about their side effects. This way, researchers don’t have to ask
patients to ‘do’ anything special for the research. By studying the data in medical records and
leftover samples that were already collected for patients’ clinical care, researchers
do not need to have people go through additional procedures to collect their data and samples
for research. In this way, researchers avoid exposing people to risks and discomforts of those research procedures. Moreover, using existing information and samples
could save both time and money, and be a good way of using available resources to enable
research on important questions to move forward. Often, when researchers use leftover samples
or review health information from medical records, they don’t know the names or identities
of the people the materials came from. So, in this case, the information and samples
are considered to be “unidentifiable.” Other common terms used to describe unidentifiable
materials include “de-identified” and “anonymized.” Using unidentifiable information and samples
helps to protect people’s privacy because researchers don’t know who the individual
people are. In many cases, researchers don’t need to
know the identity of the people whose materials and data are being used in research. However, sometimes it is important for researchers
to know the identities of these people. For example, researchers may need patients’
names to match their tumor samples with their medical records to find out if their cancer
responds to a certain treatment. In most cases, for research that is funded
by the Federal government, if researchers need to know who the samples or information
came from, they must follow Federal regulations that protect those individuals. The researchers must keep people’s information
confidential. Usually, they are required to ask people’s
permission before using their identifiable samples or information for research, except
for some low risk research when certain regulatory conditions are met and protections are in
place. Research using leftover biological samples
and people’s health information has led to new knowledge and treatments for a wide
range of diseases. For example, it has led to the discovery of
cancer-causing genes, such as the HER-2 gene found in some breast cancers, and treatments
specific to these cancers. The ability to study health information and
leftover biological samples is a key factor for the progress made in medical treatments
over the last thirty years. Scientists regularly conduct these studies
without knowing the identities of their sources. The practice is valuable and happens all the
time. As researchers come up with new ways to study
biological samples, and new technologies enable analysis of bigger and more complex data sets,
the ability to use leftover biological samples and information from medical records to make
advances in medicine and healthcare will expand, and the practice will become even more common. We hope that this video helped you learn more
about research. We encourage you to check out the OHRP website
at www.hhs.gov/about-research-participation to find other
related resources.

Leave a Reply

Your email address will not be published. Required fields are marked *