DH450 : The Class : The Proposal : Ethics : Ethical/Legal

Ethical and Legal Considerations

In the past, medical research resulted in injury to subjects. An example of this is Thalidamide, a drug that resulted in birth defects.

Since that time, laws and recommendations such as The Declaration of Helsinki protect the rights of Human subjects involved in research.

The Principle Investigator
The responsibilities of the Principle Investigator are listed in Federal Law 812

• Ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations
• Protecting the rights, safety, and welfare of subjects under the investigator's care
• Controlling devices or drugs under investigation.
• Ensuring that informed consent is obtained

• Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval.
• Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan
• Supervising device use.
• Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
  

• Records, reports and inspections are required.
  If product is submitted for FDA approval, records must be kept 2 years after FDA approval
  or 5 years after submission to FDA.
  If not submitted to FDA records should be kept for 2 years after the investigation is terminated.
• Records
• Inspections
• Reports
• Disqualification of the Investigator
  An investigator can be disqualified for failure to conduct research in a legal and ethical manner

Informed Consent

• The protection of subjects requires that the subject understand what they are consenting to.
  The following are essential parts of informed consent:
• Explain the procedures
• Use lay terms that the subject can understand
• Describe any risks involved
• Describe any benefits
• Discuss other choices the subject has for treatment
• Offer to answer any questions

• A written document is required and must be signed by the investigator, the subject and a witness.
• Children need the form signed by their parent or legal guardian.
• Subjects must have the choice to withdraw consent and discontinue participation AT ANY TIME before or during the study, without prejudice.
• Without penalty or loss of benefits
• Subjects must not be coerced into participating in a study.
• Ex: Your grade depends on it
• You will not be treated if you don't....

Confidentiality

• Individual's identity should be withheld
• Numerical coding
• Results can be compiled, disseminated and published without identifying individual participants

Review Board

• Federal regulations require that all research be reviewed and approved by a board of experts prior to the study.
• If a study is determined not to have significant risk to subjects, the review board approval is sufficient
• If a study is determined by the review board to have "significant risk", the FDA must also approve the study prior to it start.
• Prior to the study, the board evaluates the risks, importance of knowledge to be gained, the protection of subjects, informed consent, equitable subject selection, qualification and experience of investigators
• The board also reviews the activity at timely intervals
• Most Universities have their own review boards
• NAU Review Board
• There are also private review boards for research that is not affiliated with a University

Go on to Duties of the Principle Investigator
or
Go back to Ethics/IRB/Legal

E-mail Tricia Moore at Tricia.Moore@nau.edu or call (520) 523-4012

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