Introduction
Preliminary Proposals
Full Proposals
Contact Information

Format for Preparation of Full Proposals Cover Page Title Page Table of Contents Summary Description of Proposed Preclinical Research Description of Proposed Clinical Studies Scientific Personnel and Their Qualifications Facilities and Equipment Collaborations Line-Item Budget with Justification Other Activities and Research Support Technology Transfer and Patents

Requirements for Research Involving:

Laboratory Animals

Risk of Exposure to Bloodborne Pathogens

Human Subjects Not Enrolled in Clinical Trials

INTRODUCTION

All potential applicants are strongly encouraged to consult the CONRAD Program staff before preparing an application for research support, and to submit a brief preliminary proposal before preparing a full proposal. Submission of the preliminary proposal is not mandatory, but is intended to assist the applicant.

All application materials should be written in English, typed single-spaced on 8.5 x 11 inch or A4 paper in 10-12 point type, and submitted in duplicate. U.S. citizenship is not required for applicants.

All applicants must be appointed at a non-profit institution, which can be located anywhere in the world, since funding awards for successful applicants are made to non-profit institutions for the benefit of the applicant, and not directly to the applicant. Awards are not made to for-profit entities.

Preliminary Proposals: The preliminary proposal should be brief (no more than five pages) and describe the research being considered for submission, including:

• a clear statement of the objectives and expected results,
• an outline of the approach and methods to be used,
• an estimated budget,
• an estimate of the time needed for the project, and
• a brief curriculum vitae or summary of the investigator's qualifications.

CONRAD technical staff reviews the preliminary proposals and provides comments to the investigator(s) in a timely manner. Those investigators whose preliminary proposals are considered appropriate for further consideration will be invited to submit full proposals, as described below, for complete peer review of programmatic and scientific merit.

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Full Proposals: Full proposals may be submitted to CICCR for either pilot subprojects or regular subprojects, and must follow the complete format for full proposals that is provided below.

Feasibility projects will generally be for one year or less in duration and have a limited budget. They are intended to demonstrate feasibility and produce preliminary results to attract industrial support for future research proposals, which will thus be eligible for CICCR matching support. Applications for matching funds or for open funding of contraceptive trials for microbicides should include information regarding the source, amount and nature of industrial support. Additional funding for microbicide development may be obtained through the Global Microbicide Project (GMP), another project of CONRAD.

Applications may be submitted at any time and must address each section of the format, but should be relatively brief. Applications will receive timely review by the CONRAD Program staff and, where necessary, knowledgeable consultants, who will be bound by a confidentiality agreement. Projects should be justified based on existing data.

All application materials, and any administrative questions regarding the preparation of the application materials, or technical questions regarding the scientific aspects of the proposed research, should be directed to:

Michael J.K. Harper	Phone:	(703) 276-4022
CICCR/CONRAD Program
1611 North Kent Street, Suite 806	Fax:	(703) 524-4770
Arlington, VA 22209-2111	E-mail:	mharper@conrad.org

FORMAT FOR PREPARATION OF FULL PROPOSALS

All full proposals should address each of the relevant sections indicated below.

1. Cover Page
   1. Brief descriptive title of the proposed subproject
      
   2. Names of the proposed investigator(s) and institution(s)
      
   3. Indication that the application is being made to the CONRAD Program
      
   4. Date of submission
      

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2. Title Page
   1. Title

   2. Name, academic degrees, title, mailing address (and, if different, street address for deliveries), telephone number, fax number, and signature of the:
      
      1. Principal investigator (P.I.)
         
      2. Official authorizing the P.I. to submit the application (e.g., department chairperson or dean)
         
      3. Official authorized to bind the institution contractually (i.e., who will sign the subproject agreement for the institution)
         
         
   3. Proposed duration of subproject with annual and total costs requested. The amount and nature of industrial support for the project must be specified, and the budget proposed should show how each funding component is to be used.
      
   4. Name of the institution to which reimbursement checks are to be made payable. (Reimbursement checks cannot be made payable to individuals.)
      
   5. Exact address to which checks should be mailed, including the name of any person to whose attention the checks should be directed
      
   6. Taxpayer ID number for the recipient institution
      

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3. Table of Contents - Indicate page locations for each of the principal sections of the proposal.
   
   
4. Summary (no more than two single-spaced pages) - Provide a summary of the proposed research, including:
   1. A concise statement of the general objectives
      
   2. How the objectives contribute to the mission of CICCR to improve or develop new contraceptive products for developing countries
      
   3. The general approach proposed
      
   4. A list of the specific aims
      
   5. Estimated time to completion
      

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5. Description of the Proposed Research (no more than ten single-spaced pages, exclusive of appendices)
   
   
   1. For Preclinical Studies:
      
      
      1. Introduction and Background - Describe:
         1. The overall design of the proposed subproject
            
         2. The relationship of the proposed subproject to present knowledge in the field
            
         3. Relevant work by the applicant(s) and others in the field, including results of any preliminary studies and complete citations for all published information
            

         Relevant publications or other materials may be included as appendices but should not be substituted for a complete discussion in the Introduction and Background section.

      2. Detailed Description of the Proposed Studies - Describe:
         1. The experimental design, with an explicit rationale for each step
            
         2. The methods to be used, with an evaluation of their feasibility and limitations, and complete references
            
         3. All data to be collected, with statistical justification of proposed sample sizes
            
         4. The method of analysis
            
         5. All potential obstacles, scientific or other, with proposed solutions
            
         6. A schedule for completing each phase of the proposed studies, with time lines for each activity in the project
            

         As above, relevant publications, etc., may be appended but should not be substituted for a complete description of the proposed studies.
         
         

      3. Anticipated Results - Describe all of the expected results from the proposed subproject, including data, chemical or pharmaceutical agents, devices, publications, actions undertaken relative to regulatory agencies, and others.

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   2. For Clinical Studies (Phase I and II Clinical Trials):

      1. Ordinarily, the principal investigator for subprojects involving human subjects in a clinical study will assume the roles of both a sponsor and an investigator. In multicenter studies organized by the CONRAD Program, however, only the responsibilities of an investigator will be applicable.

         1. Sponsors are responsible for:
            1. Selecting qualified investigators (in this case, sub-investigators)
            2. Providing investigators with the information needed to conduct investigations properly
            3. Ensuring proper monitoring of the investigation(s)
            4. Ensuring that the investigations are conducted in accordance with the general investigational plan and protocols contained in an Investigational New Drug Exemption (IND) or Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA)
            5. Maintaining an effective IND or IDE with respect to the investigations
            6. Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug or device
            7. Having the drug or device under investigation shipped only to qualified investigators participating in the study

         2. Investigators are responsible for:
            1. Ensuring that an investigation is conducted according to the signed investigator statement, the general investigational plan, and all applicable regulations
            2. Protecting the rights, safety, and welfare of subjects under the investigator's care
            3. Controlling the distribution of drugs and devices under investigation

            More detailed information regarding the responsibilities of sponsors and investigators may be found in Title 21 of the Code of Federal Regulations (21 CFR), parts 312 (drugs) and 812 (devices), which is available from the Superintendent of Documents at the U.S. Government Printing Office in Washington, DC, or from the CONRAD Program.

      2. IND/IDE Information - Relevant IND/IDE information should be included in all applications for clinical studies to be conducted in the U.S., or to be conducted outside the U.S. but investigating a drug or device manufactured in the U.S. Information to be provided should include the IND/IDE title and number, date filed, and the date of expiration for the 30-day waiting period. In some cases, the IND/IDE may be obtained by the CONRAD Program or another agency.

      3. Protocol - The protocol should include:
         1. Title page, with the protocol title, protocol number (if any), and date
            
         2. Table of contents
            
         3. Statement of objectives for clinical study or trial
            
         4. Background and introduction, including rationale for conducting the proposed study and relationship to present knowledge, with previous work in the area by the applicant and other investigators
            
         5. Description of test article: Summarize information provided in Section V.B.4, below, Description of the Drug or Device.
            
            
         6. Design:
            
            1. Phase of study
               
            2. Type of study, e.g., open, comparative, or controlled (parallel, crossover)
               
            3. Number of centers, with addresses and names of investigators
               
            4. Number of subjects receiving the drug or device under investigation.
               
            5. Use and number of control subjects or subjects receiving alternative treatment
               
            6. Prevention of bias, e.g., blinding or randomization procedures
               
               
         7. Selection of subjects:
            
            1. Population from which subjects will be drawn
               
            2. Inclusion/exclusion criteria
               
            3. Post-admission withdrawal criteria, including lost-to-follow-up criteria
               
            4. Rules regarding concomitant medications
               
               
         8. Study procedures for each visit, including:
            
            1. Informed Consent procedures
               
            2. Dose, frequency, timing, and route of treatment
               
            3. Labwork
               
            4. Compliance monitoring
               
               
         9. Criteria for discontinuation (premature termination) of study
            
            
         10. Study materials:
             
             1. Packaging of drug or device under investigation, including control or placebo articles
                
             2. Plans for shipping drugs or devices to the investigation sites
                
             3. Disposition of returned study drugs or devices
                
                
         11. Management of intercurrent events:
             
             1. Protocol deviations
                
             2. Adverse event recording and reporting
                
             3. Pregnancy
                
             4. Subjects who discontinue (and replacement policy)
                
             5. Modifications of protocol
                
                
         12. Statistical considerations:
             
             1. Justification of sample size
                
             2. Rules for termination of study
                
             3. Data analysis plan, including outcome variables and anticipated results
                
                
         13. Schedule for conducting the proposed study
             
         14. Protocol supplements (append special procedures, patient instructions, etc.)
             
         15. References

      4. Description of the Drug or Device - For drugs or devices already marketed, provide an appendix with the proprietary name, chemical composition, amount of drug present per dose, and name and address of manufacturer.

         For new drugs or devices, give complete composition of the drug or device, the source, manufacturing data and amount present per dose, as well as a statement on the availability of such materials. Summarize all relevant preclinical investigations in animals. Describe concisely the main pharmacological actions of the compound and appropriate toxicological data. If available, give results of studies already conducted in humans. The above information should be provided for all active compounds, as well as for all vehicles or carriers.

      5. Data Collection Forms - Append copies of all Case Record Forms to be used in collecting data for each subject and visit.

      6. Protection of Human Subjects (Informed Consent) - All investigators (U.S. and non-U.S.) are expected to comply with U.S. FDA regulations regarding the protection of human subjects and informed consent (21 CFR 50).

         Append a copy of the Informed Consent Form. If any subjects will receive an Informed Consent Form in a language other than English, a certified English translation of the Informed Consent Form should be included.

      7. Institutional Review - All investigators (U.S. and non-U.S.) are expected to comply with U.S. FDA regulations requiring Institutional Review Board (IRB) approval of studies involving human subjects (21 CFR 56).

         Since the welfare of human subjects is a matter of concern to the CONRAD Program and the Eastern Virginia Medical School, advisory groups, consultants, and staff may review all research involving human subjects and prohibit research which presents unacceptable hazards. This provision, however, shall not derogate in any manner from the responsibility of the investigator's institution.

         For U.S. institutions with an IRB having a Department of Health and Human Services (DHHS) assurance number: Append documentation showing the DHHS assurance number, the IRB identification number, and a letter from the Chair of the IRB indicating approval of the study. Protocols will be reviewed by the CONRAD staff and will be forwarded to the IRB of the Eastern Virginia Medical School only if concerns or questions remain.

         For U.S. institutions with an IRB not having a DHHS assurance number: Append a letter from the Chair of the IRB indicating approval of the study. In addition, include documentation of the IRB membership, composition, and operating procedures. Protocols will be reviewed by the CONRAD Program staff and will be forwarded to the IRB of the Eastern Virginia Medical School only if concerns or questions remain.

         For non-U.S. institutions: Append a letter from the Chair of the IRB indicating approval of the study. In addition, include documentation of the IRB membership, composition, and operating procedures. All protocols will be reviewed by the CONRAD Program staff and forwarded to the IRB of the Eastern Virginia Medical School for review and approval.

      8. Additional regulatory requirements for clinical studies outside the U.S. - Studies that are conducted outside the U.S. with unmarketed drugs or devices must be performed in accordance with the regulations applicable in the country where the study is conducted. A summary should be appended describing these regulations and identifying the relevant regulatory agencies. Evidence of compliance with all applicable regulations must be provided to the CONRAD Program, including documentation that the protocol has been reviewed and approved by the appropriate regulatory agency and copies of all correspondence between the investigator and the relevant regulatory agencies.

      9. Liability Insurance - All institutions or organizations conducting clinical studies should have professional liability insurance and a statement to this effect from the responsible official must be appended. For subprojects developing new drugs or devices, a statement on the existence of liability insurance for such products should also be included.

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6. Scientific Personnel and Their Qualifications

   Provide curricula vitae with pertinent publication lists as appendices for all scientific personnel.

7. Facilities and Equipment

   Describe the existing facilities and equipment that will be used for the proposed studies.

   Investigators are expected to have access to all equipment that is necessary for the proposed studies. If not, the investigator's institution is expected to purchase equipment as a cost-sharing measure. If new equipment must be requested in this application to the CONRAD Program, a full description and a strong justification will be required (see

Section IX, below, Line-Item Budget with Justification). Any equipment costing over $2,500 (U.S.) will require that three competitive bids be submitted to the CONRAD Program for approval and selection.
8. Collaborations

   For all studies involving more than one principal investigator, academic department, or institution, or involving other collaborative arrangements, describe the nature of the collaboration proposed, the relative responsibilities, and the mechanisms for assuring efficient interaction.

   When unique materials, services, consultations, or other collaboratively obtained resources are essential to conducting the proposed studies, appropriately detailed and signed Letters of Collaboration from the individuals or other parties involved should be included as appendices.

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9. Line-Item Budget with Justification

   A detailed budget, as in the sample below, must be included with each proposal, with a complete justification for each line-item. If a multi-year subproject is proposed, the budget submitted should include a separate annual budget for each year. Any proposed subcontracts must have a separate budget with the same format.

   SAMPLE BUDGET:
   Category	Year 1	Year 2	Total (Years 1-2)
   Key Personnel (listed individually with % time) Support Personnel (as above) Fringe Benefits (with rates) Consultants Equipment Laboratory Supplies Animals Human-Subject-Related Costs Travel Office Supplies and Services Publication Costs Other Direct Costs Subtotal (Industrial Support) TOTAL REQUESTED FROM CICCR/CONRAD

   The budget section should include a complete justification for each line-item in the budget. Attention should be paid to the following:

   1. Personnel - Key personnel are those individuals whose contribution are unique and essential to the conduct of the proposed study, and cannot be changed without approval from the CONRAD Program. Support personnel generally have technical or administrative responsibilities that can be met by other appropriately trained individuals, and can be changed by the investigator.

   2. Consultants - A list of consultants, their curricula vitae, the number of days needed, and the proposed daily fee should be specified. The CONRAD Program will provide the necessary forms that must be completed by each proposed consultant.

   3. Equipment - List the cost and justify the need for each item. (Note Section VII, Facilities and Equipment, above.)

   4. Laboratory Supplies - Include all chemicals, glassware, disposable laboratory items, etc., with their intended use.

   5. Animals - Specify all purchase, maintenance, and other animal-related costs.

   6. Human-Subject-Related Costs - Specify costs involved with human subject participation including advertising, subject reimbursement, clinical supplies, and lab tests, as well as other costs which are human-subject-related but not included in other categories.

   7. Travel - Limited travel support will be considered for the investigator's attendance at meetings directly related to the proposed studies. Support for foreign travel may be included, but may require an additional request for approval approximately three months before the anticipated departure.

   8. Office Supplies and Services - Appropriate costs for supplies, as well as mail, telecommunications, and photocopying, etc., may be included.

   9. Publication Costs - Anticipated publication costs, including purchase of reprints, may be included.

   10. Other Direct Costs - Any other anticipated direct costs not included above.

       Addition of items A through J results in a subtotal.
       
       

   11. Industrial Support - The amount of any industrial support should be shown here. This should be contemporaneous or prospective, but not historical. A brief description of the nature of this support should be given. Assign a dollar figure to support provided in kind.
       
       
   12. Facilities and Administrative (F&A) Costs - Consistent with the expectation of the foundations funding CICCR that the investigator's institution will cost-share expenses of the project, no F&A costs will be permitted.
       
       
   13. Total Requested - This should be the subtotal less the industrial support shown in item K.
   
   

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10. Other Activities and Research Support

    List any current support or pending applications for the proposed or related research for each individual involved with the proposed studies. Include the research topic, current or pending source of funds, amount of support awarded or requested, and the percent of time devoted to other research projects. The allocation of funds for any potentially overlapping research must be clearly delineated.

11. Technology Transfer and Patents

    All potential recipient institutions must document their technology transfer capability, including:

    1. A statement of already existing patent rights relevant to the proposed studies
       
    2. The patent policy of the potential recipient institution
       
    3. Any written procedure for processing invention disclosures
       

    All subproject agreements contain a patent clause in which the recipient institution is granted patent rights for invention disclosure; however, the U.S. Government reserves certain rights. The CONRAD Program also reserves the right to share in intellectual property rights when substantive input has been contributed by CONRAD Program staff.

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12. Requirements for Research Involving Laboratory Animals

    The CONRAD Program requires that the use of all vertebrate animals in research be governed by the Principles for Use of Animals and, in the case of warm-blooded vertebrates, the Guide for the Care and Use of Laboratory Animals. These documents are available from the Office for Protection from Research Risks, National Institutes of Health, Bethesda, MD 20892, USA. The Principles for Use of Animals provides for humane treatment and care of animals in research. Animals are not to suffer unnecessary discomfort, pain, or injury and are to receive proper care and maintenance.

    All U.S. applicant institutions proposing the use of animals in research must indicate that the applicant institution has filed with the Department of Health and Human Services a written assurance which commits it to following the standards established by the Animal Welfare Acts and above documents. All U.S. applicant institutions must also have or establish a review committee to assist in meeting the commitment to humane treatment and care. Investigators working outside the U.S. are expected to apply similarly high standards for the humane treatment and care of animals used in research.

13. Requirements for Research Involving Risk of Exposure to Bloodborne Pathogens

    All research involving potential exposure to Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or other bloodborne pathogens must comply with the OSHA/VOSH 1910.1030 Bloodborne Pathogen Standard [Federal Register Vol. 56, No. 235, Dec. 6, 1991; OSHA Department of Publications, U.S. Department of Labor, Room N3101, 200 Constitution Ave., NW, Washington, DC 20210, USA; Phone (202) 523-9667]. This standard is intended to minimize or eliminate exposure to bloodborne pathogens by a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, Hepatitis B vaccination, signs, labels, and other provisions.

    All U.S. and non-U.S. institutions conducting research involving risk of exposure to bloodborne pathogens must provide written assurance to the CONRAD Program that full compliance is being maintained with this standard. Appropriate measures should also be taken to insure against infection by agents of nonhuman origin (including Simian Immunodeficiency Virus, among others), and corresponding assurance that these measures are being taken should also be provided to the CONRAD Program.

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14. Requirements for Research Involving Human Subjects not Enrolled in Clinical Trials

    The CONRAD Program requires IRB approval for all research that involves collection of human blood, semen, or cervical mucus; biopsy of human tissues; sampling of human surgical tissues; or similar procedures (see

Section V.B.7).

Informed consent of the human subjects involved is also required (see Section V.B.6, and append the Informed Consent Form), unless the tissues to be used were collected for another purpose (e.g., for another study or for diagnostic use) and are used anonymously. In the latter case, the manner in which the proposed study methods ensure the subjects' right to confidentiality must be explained in the application.

Note: Other conditions that must be agreed to when awarded funding from CONRAD/USAID include:

Lobbying Activities

No CONRAD funds shall be used by the recipient institution or any subcontractors to influence or attempt to influence an officer or employee of any U.S. federal agency or a member of the U.S. Congress.

Prohibition Against Profit

No funds shall be paid as profit to any recipient institution that is a commercial organization. Profit is any amount in excess of allowable costs.

Clean Air and Water Pollution Control (US recipients only)

The recipient institution must comply with all applicable standards, orders, or regulations issued pursuant to the Clean Air Act (42 U.S.C. 7401 et seq.) and the Federal Water Pollution Control Act as amended (33 U.S.C. 1251 et seq.).

Additional Required Consultation(s)

The recipients agree that they will consult with CONRAD: a) prior to assignment of intellectual property rights concerning materials being developed under this or previous CICCR/CONRAD contracts to parties other than the original inventors, and b) prior to the initiation of any clinical trials that are to be conducted with materials being developed under this or previous CICCR/CONRAD contracts, even where the intention is for funding to be provided by sources other than CICCR/CONRAD.

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** Revised January 2003