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National report — Clinical research investigators need to be aware of their numerous responsibilities to sponsors, patients, the public and, sometimes, the government. Complying with rules might be more important than ever, given the recent media attention focused on problems surfacing with some medications years after they have been approved and on the market.
"There seems to be greater scrutiny regarding the conduct of clinical trials," says Betsy Tschosik, Ph.D., R.Ph., vice president of project management, Ninaza, an electronic data capture company, based in San Mateo, Calif. "Even for late phase studies, many sponsors are choosing to take a more conservative approach to address this heightened sense of concern and heightened focus on safety issues."
Investigator responsibilities One of the basic regulatory documents in clinical trials is the Form 1572, which lists the investigator's commitments. Investigators who sign the document are basically agreeing to:
Consenting subjects Investigators cannot involve human beings as subjects in research unless they have obtained informed consent documentation from the subjects or the subjects' legally authorized representatives.
"Basically, when people volunteer to participate in research studies, their status changes from being patients to subjects," Dr. Tschosik tells Dermatology Times.
Physicians should recognize the difference, especially since subjects might not be receiving the normal standard of care and the requirements for documentation of subjects' care might be markedly different than it is for patients, she explains.
Obtaining informed consent To obtain informed consent from subjects, investigators should be sure to give subjects adequate information and ensure they understand and comprehend that information; provide subjects with opportunities to consider other options; and respond in a timely manner to subjects' questions.
Investigators also are obligated to provide information to the subject during the course of clinical trials, especially if new information comes up that could change the minds of voluntary study participants.
"Obtaining the subject's signature on the informed consent form is very important," she says. "That is the way that we verify that the subject has given his or her consent to participate."
The IRB is a great resource about what is needed for informed consent.
Obtaining HIPAA authorization The investigator also is responsible for obtaining Health Insurance Portability and Accountability Act (HIPAA) authorization.
"Chances are good that any HIPAA forms that investigators use in their clinical practices would not cover research; so, usually investigators need a separate HIPAA form for study subjects," Dr. Tschosik says.