New NSF Proposal Guidelines

The new version of the NSF Grant Proposal Guide (GPG) incorporates the July notice from NSF concerning the broader impacts review criterion. (See http://www.nsf.gov/pubs/2002/iin127/imptnot.pdf.) Other revisions include new guidance on the inclusion of URLS in the project description, revised instructions for completion of the biographical sketch, additional information on Conflicts of Interest, and Fastlane enhancements for proposal file updates and withdrawals.

Please be sure that all proposals submitted to NSF on or after October 1, 2002 follow the new Grant Proposal Guidelines. Proposals that do not comply with the stated requirements will be returned without review.

Effective for proposals due October 1, 2002 or later, NIH will no longer send out the list of upcoming renewals and the pre-printed face pages. Grantee institutions will have to access an NIH Web site to obtain the renewal information. R&SP will review the Web site on a monthly basis and will continue to send project directors a memo notifying them of the upcoming deadlines. The memo will also include a Web site for downloading the non-competing renewal forms.

Additional changes in the NIH non-competing renewal process are anticipated. Watch the Communicator for updates. For additional information, contact Research and Sponsored Programs at (317) 274-8285 or rspinfo@iupui.edu.

Site Visit Clarification The August issue of the R&SP Communicator included an article concerning site visits conducted by an agency in relation to the potential funding of a grant or contract application (http://www.iupui.edu/%7Erspcommu/nl-august-02.htm#pointer). Several questions arose concerning site selection visits conducted by pharmaceutical companies prior to initiating a clinical trial. While it is not necessary to notify Research and Sponsored Programs (R&SP) when a pharmaceutical company comes on campus for this type of visit, R&SP should be contacted if the company wishes to discuss financial or contractual terms and conditions. For additional information, contact Research and Sponsored Programs at (317) 274-8285 or rspinfo@iupui.edu.

IRBs Clarify Human Subjects Recruitment Procedures
Since 1997, the IRB has maintained a policy for recruitment of human subjects in research that calls for the initial contact to be made by someone involved in the patients care (e.g., physician, nurse) if that contact will be by either a letter or telephone call. It does not specifically address recruiting face-to-face. The current IRB guidelines (http://www.iupui.edu/%7Eresgrad/irbpacket/irbpacket.htm#section8) relate to the recruitment of subjects for participation in research as a result of screening existing healthcare data. The guidelines state that subjects can only be approached (e.g., via a letter or telephone call) by someone involved with their care. There are additional guidelines to recruiting via a letter or memo (go to the above link for additional information); however, this article only addresses who may contact the potential subject.

Examples of who that "someone involved with their care" is include the patient's physician, nurse or a delegate working on behalf of the physician. The IRB's concern is not that investigators must get "permission" from the physician to approach potential subjects, but that the subject's privacy is considered and they are not being approached by someone they do not know.

Current information on the most recent version of the summary safeguard statement form must be submitted if:

• The study is still enrolling subjects ("ongoing"); or
• The study will be initiated (will enroll subjects)

Current SSS information is required, but a recent version of the SSS form may not be required for those studies that remain open with the IRB (subjects are still active or data is still being analyzed, etc.), but are permanently closed to subject enrollment.

For example, if the SSS form questions/elements change (after the previously submitted SSS for the specific study) and those changes do not apply to the continuation of the study, then the new version of the form does not need to be submitted. However, if the current version of the form is not used, then the investigator must attest that the information within the SSS, which is submitted with the continuing review, is up-to-date and accurate.

No SSS form needs to be submitted with the continuing review form if the study:

• Will not be initiated
• Is completed (close the study)
• Is terminated (close the study)

To aid investigators when submitting their continuing review, the continuing review form will be changed to indicate when the most recent version of the SSS form needs to be used.

For additional information, contact the Research Compliance Administration office at 274-8289.

At the meeting in January, 2002, the NHRPAC committee agreed upon clarification regarding third parties in research. Of note is that simply because reference to a third party is contemplated or a third party's information is recorded does not necessarily suggest that he/she is a human research subject. However, if it is determined that, based on the information being collected, the third party is considered a human research subject, the same confidentiality and protection guidelines would apply.

In NHRPAC's recommendation, investigators and IRBs are advised to consider whether any of the information being collected is private and/or identifiable. The following factors should be considered when making the determination of whether a third party should be considered a human research subject:

• Quantity, nature, and sensitivity of information being collected and the possibility that such information might cause harm;
• The manner in which the investigator will record the information; and
• How the third party being considered a human research subject impacts the rights of the original human subject.

For additional information on this topic, please go to: http://ohrp.osophs.dhhs.gov/nhrpac/documents/third.pdf.

For additional information on the National Human Research Protections Advisory Committee (NHRPAC), please go to: http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm.

Select the Word icon to view the response envelope.

Forward all blank forms to the IUPUI Biosafety Manager at the following address:

James W. Klenner, MSc, MPH, MPA
Biological Safety Manager
Indiana University-Purdue University Indianapolis
Department of Environmental Health & Safety
620 Union Drive, Room 043
Indianapolis, IN 46202
Fax (317) 278-2158

For additional information, contact Jim Klenner at (317) 274-2830 or jklenner@iupui.edu.

R&SP New and Returning Faculty Orientation Provides a Fast Start for Researchers and Scholars
The two hour R&SP New and Returning Faculty Orientation: Focus on Research, Scholarship, and Creative Activity included sessions on the State of Research Funding at IUPUI, Overview of Campus Research Support Services Office, Key Steps for Developing and Submitting Sponsored Funding Proposals, Introduction to Award Administration, Research Compliance Issues, and Resources for the IUPUI Research Community. Participants left the R&SP New and Returning Faculty Orientation with a general knowledge of the services offered by R&SP and specific resources for future research related information and inquiries. The complete R&SP New and Returning Faculty Orientation PowerPoint presentation is now on the Research and Graduate Education Web site. Go to http://www.iupui.edu/~resgrad/.

During the program, the R&SP presenters were challenged with two questions from the participants that required further investigation. As promised by the presenters during the orientation, the answers to these questions is posted below.

1. Question:
   A question was raised with regard to whether or not an IUPUI/Clarian Institutional Review Boards (IRBs) review should be sought if an investigator is publishing an article from a dissertation that was completed at another institution. Similarly, a question was raised as to whether an investigator should seek IRB review for publishing an article based on a research project that was completed at another institution.

   Answer:
   The most salient issue to consider when addressing this question is whether or not data analysis is complete. For example, for either question, if an article is written based on a data set that has been previously analyzed or no new data analysis will be conducted, IRB review is not necessary. However, if any new data analysis is planned in an effort to write such articles (even if the research itself is "completed" or all of the data is collected), IRB review should be sought. Investigators should note, too, that if an article is written and no new data analysis is performed to do so, but the article's publisher requests new analyses be performed so that the article may be published, IRB review should be sought.

   Depending upon the characteristics of the data set, differing levels of IRB review may be necessary. In order to ascertain the appropriate level of IRB review to request, investigators should consult the IRB application packet for guidance. Go to http://www.iupui.edu/~resgrad/spon/download.htm. In addition, investigators are encouraged to contact the Research Compliance Administration staff for assistance in determining whether or not a research project requires IRB review or for preparing such an IRB submission. For additional questions, call or e-mail Research Compliance at (317) 274-8289 or resrisk@iupui.edu.
   

2. Question:
   A question was asked pertaining to a graph presented in The State of Research Funding at IUPUI session to clarify the time span of the figures presented on the PowerPoint slide Funding per Principal Investigator.

   Answer:
   The time span that is referred to on the PowerPoint slide Funding per Principal Investigator is for the fiscal year 2002. For additional questions, call or e-mail Research and Sponsored Programs at (317) 274-8285 or rspinfo@iupui.edu.

The next R&SP New and Returning Faculty Orientation will be presented on Tuesday, January 7, 2003 from 8:45 to 11:15 AM in the IUPUI University Library Auditorium. More information will be included in future issues of the R&SP Communicator. The R&SP staff is available Monday - Friday from 8:00 AM to 5:00 PM to assist staff, faculty, and students with all sponsored program related questions and concerns. To contact R&SP:

• Call (317) 274-8285 for General Information, Proposal/Project Development, Proposal Processing, or Award and Contract Assistance or send e-mail to rspinfo@iupui.edu

• Call (317) 274-8289 for Research Compliance, IRB, IBC or send e-mail to resrisk@iupui.edu

• Send FAX (317) 274-8744

R&SP Communicator readers:
IUPUI faculty, staff, and students interested in or involved with the conduct of research

Submit news articles to:
Shannon Walden
Coordinator of Educational Programs for Responsible Conduct in Research
UN 618
620 Union Drive, Room 618
Indianapolis, IN 46202-5167
Phone - (317) 274-8285
Fax - (317) 274-8744
E-mail: sfwalden@iupui.edu

Research Coordinator Education Program Offered September 25-27, 2002

Announcing the IU Research Coordinator Education Program
September 25th, 26th, & 27 th, 2002

WHAT:
On behalf of the Clinical Trials Program, the Outpatient Clinical Research Facility, Indiana University School of Nursing and in collaboration with the General Clinical Research Center, and Research Compliance Administration a program for the education of research coordinators has been developed. The program is designed to introduce the new research coordinator to the world of clinical research and to provide specific guidance about how to conduct and coordinate clinical drug studies at Indiana University. The three-day session will be held September 25th, 26th, 27th, 2002.

WHY:
To provide a formalized training experience for study coordinators involved in industry-sponsored clinical research. To provide a local, cost-effective training mechanism for study coordinators as an alternative to the other more distant, more expensive training programs. A variety of investigational studies are conducted on this campus and utilize some of the same knowledge base. The research coordinators involved in most of them may benefit from this program, but the major thrust of the three days is spent on industry sponsored drug and device trials.

FOR WHOM:
The program is targeted for the new study coordinator (conducting trials for less than 1 to 2 years) employed by the Indiana University School of Medicine or Dentistry, Clarian Health Partners, Inc., the VA or Wishard Hospital.

BY WHOM:
The program's presenters include several highly qualified Indiana University study coordinators and other IU employees with diverse clinical research experience.

TOPICS COVERED:
The first two days will include presentations on the following topics:

• An overview of drug development
• GCPs and drug law
• Study feasibility assessment, budgeting and routing the proposal
• Study startup and the study approval process
• Pre-study preparation, study conduct (including the informed consent process and adverse event reporting)
• Audits and study closeout
• Clinical research resources available at Indiana University

Particular emphasis will be placed on conducting specific procedures and the resources available at Indiana University.

The final day will be an interactive exercise designed to put together the presentations of the preceding days. During the course of the day, a study simulation will take place covering all aspects of study conduct and allowing for interactions with presenters and participants.

COST:
Cost of the program is $320 if registered by September 6, 2002. After September 6, the cost is $370. Payment from grant accounts or other IU accounts is acceptable.

WHERE:
The program will be held in the basement level of Riley's new Outpatient Building, "The ROC" in the "Ruth Lilly Learning Center" Conference Rooms A & B.

CONTACT HOURS:
Will be provided by the IU School of Nursing, an accredited provider of continuing education in nursing by the American Nurses Credentialing Center's Commission on Accreditation.

REGISTRATION INFORMATION:
An online registration is available. Go to http://nursing.iupui.edu. Click on Lifelong Learning, then to the left choose this program. Participation is limited to 40 registrants. Because a waiting list already exists, it is important to sign up early. If you have asked to be placed on this waiting list please submit a Registration Form. The Registration Form.

QUESTIONS: For questions about the program contact Marta Sears at 274-3974. For questions about the CE program and registration or payment, contact Diane Garner at IUSON Lifelong Learning/Continuing Education at 274-7779 or email censg@iupui.edu.

The Agenda, which will be finalized soon, pending speaker confirmations.

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RSPCOMMU@iupui.edu.