June 2002, Vol. 20 No. 6

Med School Faculty Honored Biomedical Technology Development Fund GlaxoSmithKline Award
Date for Distinguished Faculty Lectureship Culpeper Scholarships in Medical Science Michigan Diabetes Research and Training Center Pilot/Feasibility Study Grant Program
Ranks for Investment in R/D Burroughs Wellcome Fund Translations Research Grants Michigan Diabetes Research and Training Center Pilot Grants
Outside Employment Disclosures Marion Spencer Fay Award UM Postdoctoral Research Training Program
Use of Telephonic Consent in Research Involving Human Subjects Myositis Research Grants School of Public Health Master of Science Program
HHMI Pre-college Science Education Initiative Wiley Prize in Biomedical Sciences 2002 University Of Michigan Cancer Fall Research Symposium

HIGH HONORS FOR MEDICAL SCHOOL FACULTY
The Office of Research and Graduate Studies is pleased to announce two honors bestowed on UM Medical School Faculty. Rowena Matthews, Ph.D., Robert Greenberg Distinguished University Professor of Biological Chemistry, has been elected to membership in the National Academy of Sciences. Election to membership in the Academy is considered one of the highest honors that can be granted a US scientist or engineer. Bernard Agranoff, MD, R. W. Gerard Professor of Neurosciences in Psychiatry and Professor of Biological Chemistry, has been elected as a Fellow to the American Academy of Arts and Sciences. Election to the Academy recognizes those who have made outstanding contributions to all scholarly fields and professions. Congratulations to them both.

MARK YOUR CALENDARS
The Distinguished Faculty Lectureship will be presented by Dr. Christin Carter-Su on Thursday, June 13th at 4:00 PM in the Ford Amphitheater on the 2nd floor of the University Hospital. Dr. Carter-Su will give a lecture entitled, "Unraveling the Mysteries of Growth Hormone Signaling." A reception will follow the lecture.

THE STATE OF MICHIGAN RANKS SECOND FOR INVESTMENT IN R/D
According to "Science & Research Indicators 2002", the State of Michigan ranks second for investment in R/D. The complete report, published every two years by the National Science Board, is available online at
http://www.nsf.gov/sbe/srs/seind02/start.htm. This report to the President describes the state of scientific research and education and is a valuable resource for data on trends in academic as well as industrial R/D activity. A press release and other links about the report, from the NSF Office of Legislative and Public Affairs, is available online at: http://www.nsf.gov/od/lpa/news/02/pr0228.htm.

IT'S TIME TO MAKE YOUR ANNUAL OUTSIDE EMPLOYMENT DISCLOSURE TO THE MEDICAL SCHOOL
https://soleus.msis.med.umich.edu/oeac/logon.jsp
In 2001 the Medical School implemented an updated outside employment disclosure policy. All faculty members (instructional, clinical and research tracks) are required to prospectively request approval for outside activities that fall within the guidelines. Faculty who do not have outside activities must also complete one disclosure form indicating no activities.As promised last year, for 2002, faculty will complete outside employment disclosures via a web form. Access to the web form is at
https://soleus.msis.med.umich.edu/oeac/logon.jsp. This electronic format provides an easier mechanism for submitting disclosures and allows faculty to copy activities disclosed in 2001 into their 2002 record. Please contact your Department if you have not received guidance on completing this year's disclosure. Access to guidelines related to disclosable activities is linked to the website.

USE OF TELEPHONIC CONSENT IN RESEARCH INVOLVING HUMAN SUBJECTS
The Federal government has recently provided guidance to the University of Michigan and other Universities indicating that the use of telephonic consent procedures, whether or not they are witnessed and/or recorded, may not meet the regulatory requirements for written documentation of informed consent.

Written documentation of informed consent is a requirement of all human subjects research unless a specific waiver or alteration has been granted by the IRB. Telephonic consent procedures should therefore only be used in research projects where this form of consent has been specifically authorized by IRBMED. The conditions under which the IRBMED may approve use of telephonic conversations as part of the consent process for research involving human subjects are as follows:

1. As part of a specifically authorized, IRBMED-approved alteration of the informed consent process for projects meeting all of the following criteria:

a) The research has been found by IRBMED to present no more than minimal risk of harm to subjects.
b) Any use or disclosure of protected health information (PHI) involves no more than minimal risk to subjects' privacy (special HIPAA criteria apply).
c) The rights and welfare of the subjects will not be adversely affected by the use of telephonic rather than written consent.
d) The research cannot practicably be carried out without the use of telephonic consent.
e) Whenever appropriate, the subjects will receive additional information about their participation in the research after completion.

Please note that some research meeting all these criteria may be eligible for waiver of the entire consent process, and hence may not require telephonic consent.

2. As part of a specifically authorized, IRBMED-approved waiver of the requirement for documentation of informed consent when the research meets one of the following criteria:

a) The only record linking the subject and the research is the consent document, and the principal risk is the potential harm resulting from a breach of confidentiality.
b) The research has been found by the IRBMED to present no more than minimal risk of harm to subjects, and does not include any procedure for which written consent would be required if it were to be performed for clinical management.

Please note that administration of investigational or approved medications, or diagnostic or therapeutic doses of radiation, would not qualify for this waiver of documentation even if written consent would not ordinarily be required for clinical purposes.

3. As part of the following specifically approved process involving the use of a 'short form' for documentation of informed consent:

a) The IRBMED approves a written summary document that contains the information necessary for granting informed consent.
b) The summary document is presented to the subject or subject's legally authorized representative in writing, by fax, email, or via the Internet.
c) After providing the written summary information, the investigators must make a telephone presentation to the subject or the subject's legal representative in the presence of a third person who will act as a witness to the presentation. (The IRBMED recommends using the Health System's witnessed telephonic consent operator for this purpose.)
d) After answering any questions the subject or their representative may have, an IRBMED-approved separate written form documenting the execution of the consent process must be signed by the subject or the subject's legally authorized representative, returned by fax to the investigator, and then signed by both the investigator obtaining the consent and the witness. The witness must also sign a copy of the approved written summary of the information presented to the subject.
e) A copy of the written summary of the information, and of the short form documenting the consent, must be provided to the subject or the subject's legally authorized representative.

Additional guidance about telephonic consent will soon be available on the IRBMED web site at www.med.umich.edu/irbmed. If you feel that your research might qualify for the use of telephonic consent, but this has not been specifically authorized by IRBMED, submit an amended application. This should describe the technique(s) you will employ, any required associated documents (such as the written short form summaries), and an explanation of why you think the use of telephonic consent is necessary and justified. If you are not sure whether telephonic consent is appropriate for your research, or have questions about any aspect of the informed consent process for research, contact the IRBMED office at irbmed@umich.edu. Thank you for your ongoing commitment to the protection of research participants.

Robert Cody, MD, and Vernon K. Sondak, MD, IRBMED Co-Chairs
Patricia Ward, IRBMED Director

FUNDING OPPORTUNITIES

Howard Hughes Medical Institute Pre-college Science Education Initiative
Internal deadline: July 12, 2002
Howard Hughes Medical Institute has announced an initiative to promote enhanced pre-college science education. The UM may submit one nomination. Grants range from a total of $200,000 to $600,000 for up to four years. Successful proposals need to include significant participation from faculty in the Medical School, School of Dentistry, or School of Public Health, but need not be limited to these units. Projects must include a plan for evaluating the progress of the project and for providing feedback that will help to maximize the projects success.

Projects should include one or more of the following activities:

  • Student programs that serve children and youth from preschool through high school
  • Professional development for pre-K – 12 teachers
  • Outreach programs that serve families or community groups
  • Programs for graduate students and postdoctoral fellows to work with pre-K – 12 teachers, students, or family members.

To be considered for the institutional nominee, submit the following by July 12, 2002: a list of project participants, a two-page CV for each participant, and a two-page statement summarizing both the objectives of the project and the qualifications of the participants to carry out the project. Submit applications to Prof. James Penner-Hahn, Associate Vice President for Research, 4080 Fleming, 1340. Contact: Prof. Penner-Hahn at jeph@umich.edu or 764-1185. The breadth of the HHMI announcement suggests that successful projects will require participation by two or more units. Potential participants who would like assistance in locating partners are encouraged to contact OVPR for assistance.

Biomedical Technology Development Fund
Deadline: July 15, 2002 and November 15, 2002

The Biomedical Technology Development Fund (BTDF), created by the Dean of the Medical School, is intended to provide funding for research and development projects or programs that have already demonstrated technology transfer promise through basic research, but are not ready for commercial translation. This fund is specifically designed to support activities that would increase or maximize the potential for these projects to be transferred out of the University. Grants up to $50,000 will be considered. Average grants are expected to be between $20,000 and $25,000. Applications may be funded for up to two years pending successful review of an annual progress report. All awardees are required to submit a final report upon completion of their project. For further information and an application form visit the Tech Transfer website at
http://www.med.techtransfer.umich.edu/btdf.html or call 734-763-6363.

Culpeper Scholarships in Medical Science
Internal Deadline: July 12, 2002
The Rockefeller Brothers Fund is pleased to announce the continuation of its Charles E. Culpeper Scholarship Program to support the career development of academic physicians. Up to four awards of $100,000 per year for up to three years will be granted. Applicants must have at least one year of postdoctoral clinical training and have not achieved a rank higher than assistant professor. All scientific research relevant to human health is eligible for consideration. Each institution may nominate one candidate. Additional information may be obtained from the Fund at http://www.rbf.org. For consideration as the institutional nominee, submit the following by July 12, 2002: a 2-3 page research summary, a list of all participants involved (with level of effort), CVs of all involved, and a nominating letter from the department chair. Submit all internal applications to the Office of Research and Graduate Studies, 4107 Med Sci I, Box 0624. Contact: Denise Swayze, 763-4086 or dswayze@umich.edu.

Burroughs Wellcome Fund Translations Research Grants
Internal Deadline: August 5, 2002
The Fund is accepting applications for its Clinical Scientist Awards in Translational Research. These awards are designed to support established independent physician-scientists who are dedicated to translational research (the two-way transfer between work in the laboratory and the treatment of patients). Awards are $150,000 per year over a period of five years. Candidates must have a MD or M.D.-Ph.D. and be at the late assistant professor or associate professor level (tenure track). The UM may nominate up to two candidates. For consideration as institutional nominees, submit the following by August 5, 2002: a 1-2 page research summary, a CV, and a nominating letter from the department chair. Submit all internal applications to the Office of Research and Graduate Studies, 4107 Med Sci I, Box 0624. Contact: Denise Swayze, 763-4086 or dswayze@umich.edu. Complete details on this award can be found on the Fund's website at http://www.bwfund.org/translational_research.htm.

Marion Spencer Fay Award
Deadline: June 14, 2002
The National Board for Women in Medicine, Medical College of Pennsylvania Hahnemann University is accepting nominations for the 41st Annual Marion Spencer Fay Award. This award is given to a distinguished woman physician/scientist. The Award Committee is seeking nominations of women physicians and scientists who have made significant contributions to health care either as a practitioner, a medical educator or administrator, or a research scientist in medicine or a related field. The award includes a $20.000 grant to support the recipient’s work. For complete details and nomination forms see: http://www.nationalboardforwomeninmedicine.com.

New Fellowships and Grants Supporting Myositis Research
Deadline: July 31, 2002
The Myositis Association of America is pleased to announce new fellowships and grants supporting basic and clinical myositis research. Research Fellowships are designed to support an environment conducive to beginning a career in myositis research and will generally be awarded for two years at $40,000 per year. Research Grants will fund programs supporting new or innovative research projects to $50,000 per year; and more established projects to a maximum of $100,000 per year: each generally for a period of two years. For complete information go to MAA's website at http://www.myositis.org.

Wiley Prize in Biomedical Sciences
Deadline: July 31, 2002
The Wiley Prize is intended to recognize contributions that have opened new fields of research or advanced novel concepts or their applications in a particular biomedical discipline. The award may recognize a specific contribution or a series of contributions that demonstrate the nominee's significant leadership in the development of research concepts or their clinical application. The award includes a $25,000 grant and an invitation to deliver a lecture at Rockefeller University.
See the Wiley Foundation website for complete nomination guidelines at
http://www.wiley.com/legacy/wileyfoundation/.

GlaxoSmithKline Drug Discovery and Development Award
Deadline: July 31, 2002
GlaxoSmithKline invites applications for Drug Discovery and Development Award for HIV/AIDS Research. The one-time awards will range from $25,000 to $150,000 and are intended to further the development of inventive treatments for HIV/AIDS, including therapies aimed at treating infection as well as prophylactic vaccines or microbicides designed to prevent transmission of the virus. For detailed information about the GSK Awards or to request an application form, telephone the program's office at (888) 527-6935.

Michigan Diabetes Research and Training Center Pilot/Feasibility Study Grant Program
Deadline: June 17, 2002
The purpose of the MDRTC P/FS Grant Program is to enable investigators to generate a sufficient body of preliminary information for a successful application for major research funding from national granting agencies. P/FS Grant proposals may be in areas of basic or clinical biomedical research, behavioral or epidemiological research, or in areas of translational research for the prevention and control of diabetes. For information on how to apply, call 763-5730 or visit the MDRTC website at http://www.med.umich.edu/MDRTC/.

Michigan Diabetes Research and Training Center Pilot Grants
Deadline: July 1, 2002
MDRTC Pilot Grants for Pancreatic Islet Encapsulation Research are available for one year of support. Awards are $250,000. Individuals who hold full-time instructional or research faculty positions at UM are eligible to apply as principal investigators. Collaborative projects between diabetes investigators and individuals working in areas such as engineering, chemistry, or physics are also encouraged. Postdoctoral fellows or residents are not eligible. For complete details and research topics that would qualify for these funds, contact Jack L. Kostyo, Ph.D., Director of Grants Program, MDRTC at jkostyo@umich.edu or 763-5730.

TRAINING PROGRAMS & SYMPOSIUM

UM Postdoctoral Research Training Program
The Postdoctoral Research Training Program will be held this year from July-September 2002. The program is designed to introduce individuals with a strong interest in pursuing a career in academic medicine to new and emerging concepts in cell and molecular biology. The course is divided into two basic categories: 1) cell biology and biochemistry and 2) molecular biology and genetics. The two sections will be introduced by a core of 10 faculty members chosen from the Departments of Biochemistry, Human Genetics, Physiology, Pathology, Pharmacology, Biology, Internal Medicine, and HHMI. The program is constructed to provide a basic framework of knowledge in a variety of disciplines. It is designed to introduce the students to the methods of scientific thought, inquiry and analysis via the presentation of specific research topics. The Program does not emphasize techniques, but rather problem solving exercises. To apply, applicants should send their CV and a brief paragraph stating why they are interested in this Program to their Division Chief or Chairperson. Questions should be directed to Stephen J. Weiss, MD, 5220 MSRB III/0640, 764-0030.

UM SPH Master of Science Program in Clinical Research Design and Statistical Analysis
This On Job/On Campus program provides a way for physicians, dentists, pharmacists, pharmacologists, and others who are involved in clinical research to develop expertise in research design and statistical analysis while continuing their professional employment. Participants meet at the School of Public Health for a 30-hour, four-day weekend once every four to five weeks. The program lasts 18 weekends spread over 19 to 20 months. The start date is October 2003. For complete information and application materials, contact Amanda Cumming at 615-9817 or
cumminga@umich.edu.

2002 University Of Michigan Cancer Fall Research Symposium
The University of Michigan Cancer Research Committee is making plans for the Cancer Research Symposium to be held October 31, 2002 from 8 AM to 6 PM at Dow Auditorium at the University of Michigan Medical Center.

The Cancer Research Committee plans to invite 4-5 outside speakers whose research has impacted greatly on our understanding of the biology, clinical management, or prevention of cancer. In addition to talks by outside speakers, abstracts from postdoctoral and predoctoral fellows will be solicited for a poster session and a platform presentation session. Some informal "Meet-the-Expert" type sessions will also be held during the day, though attendance for such sessions will be strictly limited and advance registration will be needed. Although the orientation of the symposium will be directed toward the cancer problem, the material discussed at the symposium will likely be of great interest to individuals working in areas of molecular and cell biology, biochemistry and immunology, as well as in other clinical fields. Attendance is, therefore, encouraged from all University of Michigan faculty, postdoctoral fellows, and students who have interest in the topics being discussed at the symposium.

A follow-up announcement will be mailed later in the year that details the final agenda including speakers and titles of their presentations, as well as a request for abstract submission. Until then, please mark your calendars for October 31, 2002. Contact Ginny Schneider at 936-9603 or
ginnysch@umich.edu, with any questions.