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| Date/Time | Activity | Topic/Content | Faculty | Locations |
| Thurs 8/6/2009 9:00 AM-10:15 AM | Lecture | IRB review and assessment of risks and benefits IRBs are required to review the risks and benefits of submitted protocols, to assure that risks are acceptable in light of the expected benefits and that the risks have been minimized. Researchers need to consider differ kinds of benefits and risks, including direct and collateral benefits and psychosocial risks such as confidentiality. In the protocol, investigators need to explain how they will maximize benefits and minimize risks and protect vulnerable research participants.Required Reading:
Note/Slide Files: IRB1 8-6 7-21b class.ppt (188 KB) Assignment Files: RCR 09 syllabus 7-21d.doc (81 KB) | B Lo | HSW-302 |
| Thurs 8/13/2009 9:00 AM-10:15 AM | Lecture | Informed consent One of the basic protections for participants in clinical research is informed and voluntary consent. Researchers need to understand what the federal regulations require concerning informed consent and how the consent process might be improved. It is also important to understand that in certain low-risk research, consent or written consent forms are not needed.Required Reading:
Note/Slide Files: Lo, Consent 8-13.ppt (417 KB) | B Lo | HSW-302 |
| Thurs 8/20/2009 9:00 AM-10:15 AM | Lecture | What is research misconduct and why does it matter? Recent scandals in research have included the death of healthy volunteers and the fabrication and falsification of data. These episodes have generated intense public scrutiny, led to new regulations, and focused professional attention on what consitutes research misconduct and how to respond to allegations of misconduct.Required Reading:
Note/Slide Files: Lo,Misconduct8-20-09 class.ppt (192 KB) | B Lo | HSW-302 |
| Thurs 8/27/2009 9:00 AM-10:15 AM | Lecture | Authorship All investigators are pleased to obtain the prestige of authorship. Authorship also involves responsibilities. All authors named on a manuscript need to meet the criteria for authorshop. Fellows and junior faculty commonly encounter disputes and ethical problems regarding authorship. This session will suggest how to respond to such situations.Required Reading:
Note/Slide Files: Lo, author8-27 class.ppt (427 KB) | B Lo | HSW-302 |
| Thurs 9/3/2009 9:00 AM-10:15 AM | Lecture | What you want to know about the UCSF Institutional Review Board (IRB) What are the most common problems with protocols submitted to the UCSF IRB (called the Committee on Human Research, CHR): Investigators need to understand how the CHR addresses requests for expedited review and exemption from review, as well as how eligible participants may be contacted. What is the CHR looking for in responses to the questions on the forms? What suggestions does the CHR staff have for investigators submitting protocols for review? Learning the answers to these questions may help reduce the time needed to obtain CHR approval for your study.Required Reading:
Note/Slide Files: Wagner,Responsible Conduct of Research 9-3-09.ppt (150 KB) | L Voss R Wagner | HSW-302 HSW-302 |
| Thurs 9/10/2009 9:00 AM-10:15 AM | Lecture | Conflicts of Interest Industry sponsorship of research provides resources and materials that may allow important research that otherwise would not be carried out. However, in recent incidents, biased design of clinical trials and withholding of negative results has been associated with drug company sponsorship. This session analyzes requirements to disclose financial conflicts of interests and how certain relationships may need to be managed or prohibited.Required Reading:
Note/Slide Files: Lo, COI RCR 9-10 class.ppt (302 KB) | B Lo | HSW-301 |
| Thurs 9/17/2009 9:00 AM-10:15 AM | Lecture | International Research Research in resource-poor countries is essential to develop affordable prevention and treatment for conditions that afflict these nations. Furthermore, drug manufacturers are increasingly conducting clinical trials overseas. However, research in resource-poor countries raise ethical concerns about informed consent and exploitation. This session will discuss how clinical trials in developing countries offer lessons for all investigators regarding the use of placebos, informed consent, and access to the study intervention after the trial is completed.Required Reading:
Note/Slide Files: Lo, ResourcePoor9-17-09 class.ppt (216 KB) | B Lo | HSW-303 |
| Thurs 9/24/2009 | Other | Required Project Due (no late projects accepted after 5:00pm) Assignment Files: RCR exam 2009.doc (40 KB) RCR Final Project 09 LP revised(b).doc (41 KB) | n/a | n/a |
