- What are the hallmarks of ethical anti-cancer drug research?
- How are trial risks being minimized?
- What role does the community play in ensuring ethical anti-cancer drug research?
Note: When reviewing the Points to Consider, write your responses down. You’ll need them for later.
TOPICH E6Ethical considerations
- 6.2.5 a statement that the trial will be conducted in compliance with GCP, and the applicable regulatory requirements
- 6.1.2 description of ethical considerations relating to the trial
Local Regulations/ Declaration of Helsinki
The investigator will ensure that this study is conducted in full conformance with the principles of the "Declaration of Helsinki" (as amended in Tokyo, Venice, Hong Kong , Somerset West and Edinburgh) or with the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. For studies conducted in the USA, the investigator will ensure that the basic principles of "Good Clinical Practice" as outlined in CFR 312, subpart D, "Responsibilities of Sponsors and Investigators", CFR 21, pat 50, p 212-219, 1986, and CFR 21, pat 56, pp 219-227, 1986, are adhered to.
In other countries where "Good Clinical Practice Guidelines" exist Roche and the investigators will strictly ensure adherence to the stated provisions.
Informed Consent From Patients
It is the responsibility of the investigator to obtain written informed consent from each patient participating in this study, after adequate explanation of the aims, methods, anticipated benefits and potential hazards of the study. For patients not qualified or incapable of giving legal consent, consent must be obtained from the parent or legal guardian or custodian.
The investigator must also explain that the patients are completely free to refuse to enter the study or to withdraw from it at any time for any reason. The Case Report Forms for this study contain a section for documenting informed patient consent and the investigator must complete it appropriately.
Ethics Review Committees / Institutional Review Board
This protocol and any accompanying material provided to the patient (such as patient information sheets or descriptions of the study used to obtain informed consent), will be submitted by the investigator to an Institutional Review Board/Ethics Review Committee. Approval from the committee must be obtained before starting the study and should be documented in a letter to the investigator specifying the date on which the committee met and granted the approval.
Any modifications made to the protocol after receipt of the Institutional Review Board/Ethics Review Committee approval must also be submitted by the investigator to the Committee in accordance with local procedures and regulatory requirements.
STEP 1: You have completed this section of the protocol. Review the answers to the Points to Consider by clicking Here
- What are the hallmarks of ethical anti-cancer drug research?
Ethical anti-cancer drug research, like all ethical research, ensures informed consent, minimizes risks and maximizes benefits, secures review of the science and ethics of by an independent body, and involves the community in the research design.
- How are trial risks being minimized?
Through careful monitoring of physical and social harms, offering assistance to study participants to help with any study-related problem, and properly informing study participants of the trial risks that are known or may become known during the trial.
- What role does the community play in ensuring ethical anti-cancer drug research?
Ethical research must be acceptable to the community in which it is taking place. Community representatives play an important role in advising the researchers on the acceptability of the research to the community and representing community concerns in the planning and implementation of the research.
STEP 2: Take a brief quiz to assess your understanding.
STEP 3: Go to the Take Home Points.
Last update: Tuesday, May 31, 2011
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