Working with Us

For each subject, we collect where they are overall on the Fitzpatrick scale. We also record their Monk scale for the following sites: fingernail, dorsal, palmar, inner/upper arm, forehead. Additionally, we collect objective skin pigment data from the same sites with a Konica Minolta Spectrophotometer CM-700d.

The sponsor is responsible for providing their pulse oximiters and placing them on the research subjects. They also must collect their device’s data and provide that to the lab after study completion (if requesting a report for FDA). If a sponsor would like other secondary data (eg. arm circumference, a different skin pigment scale), they should collect this data themselves with permission from the subjects. Sponsor staff must be present during the study.

We use two different reference oximeters, the Nellcor PM1000N and the Masimo Radical 7.

The FDA requires that a validation study should have subjects with a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool depending on the study size. The Hypoxia Lab has traditionally used the Fitzpatrick scale to categorize skin pigment (see below). We aim to schedule 25% of the subjects in the Fitzpatrick V or VI range. For example, if we do a study with 12 subjects, 3 will be Fitzpatrick V or VI.

Six subjects can be studied in a single day, with 20-25 arterial blood samples from each subject. Ten to 12 subjects can be studied over two days, also with 20-25 arterial blood samples each.

For a validation study, you will need a minimum of 10 subjects in order to have enough data to submit an FDA report. However, the standard protocol in our lab is to recruit 12 subjects, for data stability and quality.

Clinical research is the way doctors and scientists learn about new ways to prevent and treat illness in people. Clinical research is the fastest way to find answers to the many questions about health and disease. It is sometimes called “human research” or a “clinical trial.”
At UCSF most research that needs human volunteers happens in hospitals and clinics. Other types of research studies take place in a doctor’s office, a treatment center, a nursing home, or a community clinic. Some studies involve asking questions in an office, by telephone, or even on the street or in a home.

There are different ways volunteers participate in clinical research. For example:

• Volunteers participate by filling out questionnaires about their health, or they may answer questions about their health in an interview with researchers.
• Volunteers may be asked to donate specimens such as a tube of blood or a tissue sample for a clinical research study.
• Volunteers may participate in clinical research to find out if new treatments, or new ways of using known treatments, are safe and effective to use in people.

The faculty, staff and doctors at UCSF are dedicated to research and are deeply committed to finding new ways to prevent and treat illness and improve the health of patients who come to the University Medical Center for healthcare.

A typical study session lasts around 1 hour.

30-40 minutes of this time includes blood sample data collection and breathing on the circuit, while the remainder of the time is allocated to pre- and post-study tasks (i.e., signing the consent and skin color data collection beforehand, waiting ~10 minutes after study to apply pressure to wrist and ensure subject experiences no adverse effects).

There will be no out-of-pocket expenses for participants. The Hypoxia Lab has received funding from several grants in order to cover research-associated costs.

According to the UCSF Institutional Review Board (IRB) website, an IRB is “a committee — operating under federal regulations, state laws and institutional policy — that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.”

All human subject research must be reviewed and approved by the IRB in order to be carried out. All of the Hypoxia Lab studies have received IRB approval prior to being conducted.

According to the World Health Organization’s (WHO) website, clinical trials are “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.” This may include the testing of medical interventions such as “drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.”

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