Research & Patient Privacy

In some studies, researchers interact directly with patients. For example, they might take a blood sample, or offer you an experimental drug or treatment. In other studies, researchers use the health information that is part of patients’ medical records, or leftover biospecimens, and never interact with patients themselves. This kind of information can include age, weight, and health conditions. It can also include information from blood tests or imaging scans.

Researchers then pool a large amount of health information together to look for patterns, similarities, or differences across patients who have the same medical conditions, which can give clues on better ways to predict, diagnose and treat illness. U-M Health, like most university medical centers, participates in this kind of health research to improve patient care or make the hospital experience better.

There are federal laws, state laws, and U-M Health rules that protect patient privacy. All staff, faculty, and learners agree to a U-M Health code of conduct related to protected health information. In addition, we have robust technology systems that control who can access health data, and monitor, at all times, who does access protected health information or biospecimens. 

Additionally, there are strict controls on which researchers can access and use health information and biospecimens for their work, and how they must handle them. 

Before a researcher can access patient health information, they must submit their proposed plan to a group of research experts on our Institutional Review Board (IRB), which assesses risks to patient safety, privacy, and confidentiality. The IRB is made up of members from several different fields – including research scientists, health ethics specialists, privacy law experts, and individuals from the community. The IRB will make sure the risk of data use is minimized.  The IRB also ensures the research meets several other protective requirements. Once approved, researchers are given access to the minimum amount of data needed to successfully complete their research. 

View our Protecting Your Privacy page to view and download a copy of the University of Michigan Notice of Privacy Practices. If you have questions about anything contained in this notice, please feel free to contact the Privacy Director using the contact provided in the last section of our NPP.

Research with patient health information and leftover biospecimens (for example, blood leftover from a diagnostic test or tissue not necessary for patient care that was removed during surgery) can help us better understand diseases and health conditions. We can learn what causes health conditions, how to treat them, how to prevent them, and how to improve ways to get the right help to patients at the right time.

This kind of research is the basis of many of the treatments that patients benefit from today. Hospitals across the country, including U-M Health, do this kind of research with patient health information and biospecimens. It can help us learn how to make health care more efficient and effective, so that more people can get the care they need, when they need it. Health information and biospecimens can support research that might improve health care for you, your community, or other patients like you.

There are strict controls on which researchers can access and use patient health information and biospecimens for their work, and how they must handle them. Researchers who might be given access to patient health data and biospecimens include:

Internal researchers, including U-M Health faculty and staff, often do research with de-identified information and specimens. If they would like to do research with identified information or specimens, they must report their proposed research to our Institutional Review Board (IRB), which assesses risks to patient safety, privacy, and confidentiality. The IRB is made up of members from several different fields – including research scientists, health ethics specialists, privacy law experts, and individuals from the community. The IRB will make sure the risk of data use is minimized. The IRB also ensures the research meets several other protective requirements. Once approved, researchers are given access to the minimum amount of data needed to successfully complete their research. 

External researchers: U-M Health works with external partners that meet our high standards for research and patient privacy. Often those external partners will be given de-identified information and specimens. U-M Health will only allow external partners access to identified protected health information and specimens with your permission, or under very limited and controlled circumstances, without your permission, in adherence with the law and U-M Health policy. We put patient privacy and ethical use of data at the forefront of all decisions about what external partners we work with and what health information and specimens they have access to. Aside from covering the expenses associated with managing these data, U-M Health does not make any money from these activities and does not “sell” data or biospecimens to external partners.

No. External partners who are approved to use the minimum amount of health data necessary for their research may be asked to help cover the expenses associated with managing and safeguarding your health data used for their research. Aside from covering the expenses associated with managing these data, U-M Health does not make any money from these activities and does not “sell” data to external partners. 

Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of patient data/biospecimens data or associated discoveries. You will not have rights to these discoveries or any proceeds from them.

The rules surrounding the use of health information and biospecimens can be different depending on whether they are “identified” or “de-identified.” 

Information and specimens which are identified include information that is unique only to a single patient, like their name, date of birth, address, or social security number. View a full list of the type of information that is considered “identifiable.”

Information and specimens which are de-identified do not have this kind of information linked to them. There are also additional safeguards in place that minimize the risk of being able to link de-identified information and specimens back to you.

No. U- Health is a teaching and research institution. Researchers may use patient health information and specimens for minimal risk research and commercial product development as appropriate under federal and state law and U-M Health research policy. 

Researchers pool a large amount of health information together to look for patterns, similarities, or differences across patients who have the same medical conditions, which can give clues on better ways to predict, diagnose and treat illness. This requires none of those individuals be excluded from the analysis so that all populations are represented in the research and there is equity in medical care delivery. 

Before a researcher can access patient health information, they must submit their proposed plan to a group of research experts on our Institutional Review Board (IRB) which assesses risks to patient safety, privacy, and confidentiality. The IRB is made up of members from several different fields – including research scientists, health ethics specialists, privacy law experts and individual community members. The IRB will make sure the risk of data use is minimized. The IRB also ensures the research meets several other protective requirements. Once approved, researchers are given access to the minimum amount of data needed to successfully complete their research. 

Visit our Protecting Your Privacy page to view and download a copy of the University of Michigan Notice of Privacy Practices. If you have questions about anything contained in this notice, please feel free to contact the Privacy Director using the contact provided in the last section of our NPP.

Thank you for your interest in helping with health research at University of Michigan Health. We need your help today for better medicine tomorrow. There are opportunities to participate in specific clinical studies as a healthy volunteer or as someone with an existing medical condition. Visit UMHealthResearch.org to learn about opportunities to get involved or search for studies you may be eligible to participate in.

You can also make a difference by helping support important research at U-M. A gift today can empower breakthrough research in a number of individual disease areas.