Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences May 22, 2001

This Epidemiology and Genetics Research Program (EGRP) Bulletin provides much information on policies and procedures important for grantees and grant applicants who may be supported through its Program. It also contains information about opportunities for research funding and availability of research resources. Our aim is to help you successfully navigate the grant application process and to support your research efforts.

This Bulletin reports on:

1. Help NCI Imagine and Build the Future of Cancer Research: Invitation for Ideas
2. NCI Requires Prior Approval to Submit Large, Unsolicited Grant Proposals, and Suspends Accepting R01 Applications Over $700,000 Per Year
3. EGRP Urges Taking Advantage of OHRP's Streamlined Process of Assurances for Protection of Human Subjects
4. NIH Requirements for Training in Human Subjects Protection Reviewed
5. What Reviewers Are Looking for in Human Subjects Information
6. Supplemental Funding Available for Dissemination of Promising Cancer Control Interventions Tested in Research Projects
7. RFA on Shared Resources for Scientists Issued
8. Program Announcements Sponsored by EGRP
9. Search EGRP's Research Portfolio on the Web
10. Improperly Formatted Applications May Be Returned by NIH Without Review
11. Revised NIH Grants Policy Statement Published
12. Web Site Provides Information on NCI Research Resources
13. EGRP Staff Contacts
14. Friends of EGRP Listserv

1. Help NCI Imagine and Build the Future of Cancer Research: Invitation for Ideas

Every three years, NCI seeks formal input from researchers, clinicians, and lay experts in the cancer field, asking them to suggest new, emerging research investment areas for the next 3-year cycle. This process is part of identifying "Extraordinary Opportunities for Investment" - areas where focused research efforts and increased resources can produce dramatic progress toward reducing the burden of cancer.

To propose a new investment opportunity, send your idea to extraordinary-opportunities@cancer.gov, fax it to 301-435-3876, or mail it to: Office of Science Planning and Assessment, National Cancer Institute, Bldg. 31, Rm. 11A03, Bethesda, Md. 20892. Please send you description no later than Oct. 15, 2001, and include: overall goal, recent advances that make the area a timely investment, elements that might be included in a plan, benefits of investing now versus waiting.

Six Extraordinary Opportunities have been identified to date, and the first three in particular, provide a road map for channeling DCCPS' activities: (1) genes and the environment; (2) research on tobacco and tobacco-related cancers; (3) cancer communications; (4) molecular targets of prevention and treatment; (5) cancer imaging; and (6) defining the signatures of cancer cells: detection, diagnosis, and therapy.

NCI articulates its annual plans and priorities, including the Extraordinary Opportunities, in The Nation's Investment in Cancer Research. This document has been called the "Bypass Budget" because NCI submits its budget request directly to the President for review and transmittal to Congress. The Nation's Investment in Cancer Research for Fiscal Year 2002 - Plans & Priorities" is now available at http://plan2002.cancer.gov. For more information and links to related sites, visit http://extraordinary-opportunities.cancer.gov.

2. NCI Requires Prior Approval to Submit Large, Unsolicited Grant Proposals, and Suspends Accepting R01 Applications Over $700,000 Per Year

NCI policy requires that unsolicited R01 grant applications over $500,000 in direct costs in any budget year have internal approval prior to submission of the applications. The policy also applies to unsolicited P01 grant applications over $6 million in direct costs in any budget year.

A memo on Fiscal Year (FY) 2001 grant funding policy from Dr. Richard Klausner, NCI Director, stated there has been a continuing shift to more expensive grants. These escalating costs have had an impact both in terms of the total monies need to funds these grants and the average cost per grant funded.

In response to these escalating costs, NCI will stop accepting unsolicited new (Type 1) R01s over $700,000 direct costs in any budget year. This is an interim measure that will be re-evaluated in the next few months. "Awaiting Receipt of Applications (ARAs)" for competing continuation/renewal (Type 2) applications that request an increase of 20% or less may be accepted at the discretion of Division Directors. Division Directors will carefully scrutinize Type 2 applications that request more than a 20% increase in costs. There will be no appeal or waiver process.

Principal investigators are responsible for communicating with NCI Program Directors and alerting them to the submission of large grants no less than one month prior to submission of the grant to the National Institutes of Health (NIH) Center for Scientific Review (CSR).

They are also responsible for examining research plans in relation to the budget to critically evaluate the costs of the study. NCI Program Directors are available to consult on the merits and potential concerns of proposed studies and corresponding budgets.

Failure to request and receive NCI approval for submission of large grants in a timely manner will result in the application being turned around without review, causing a review delay of one round. Refer to NIH Guide for Grants and Contracts, release date: March 20, 1998.

NCI Program Directors are required to submit an ARA form for signature by the respective Division Director. The approved ARA is then forwarded to CSR and serves as authorization to accept receipt of large grant applications. A new ARA form is required for any revised resubmittals, if the initial application is not funded.

Questions about this policy or large grants/ARAs may be directed to your Program Director.

For information on new developments, bookmark the DCCPS home page and follow its What's New items.

3. EGRP Urges Taking Advantage of OHRP's Streamlined Process of Assurances for Protection of Human Subjects

The Office of Human Research Protections (OHRP) has revamped the system for obtaining Assurances of protection for human subjects. One, simplified Federalwide Assurance (FWA) now can be obtained to cover all of an institution's federally supported human subjects research. Foreign institutions also may obtain FWAs.

The FWA eliminates the need for other types of Assurance documents, including the MPA and SPA. EGRP strongly encourages investigators to take advantage of the FWA.

Existing Multiple Project Assurances (MPA), Single Project Assurances (SPA), and Cooperative Project Assurances (CPA) remain in effect. Further, while reviewing comments and suggestions on the FWA, OHRP continues to accept applications for SPAs and MPAs until further notice.

Nevertheless, investigators are encouraged to apply for an FWA instead of a SPA. Among the FWAs' advantages is that, unlike the SPA, it can be used to cover subsequent projects. The FWA is also easier and quicker to obtain than the SPA.

Some key points:

• Each legally separate institution is required to have its own FWA. Collaborating institutions that do not have an existing MPA, SPA, or CPA, also need FWAs.
• All Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) are required to register with OHRP to facilitate future communications. Refer to OHRP's Questions and Answers for information about situations in which an institution can rely on another organization's IRB:
• Lists of the institutions that already have FWAs and registered IRBs and IECs are available on OHRP's Web site: See "IRB & Assurance Listings."
• There are training requirements prior to submitting an FWA. For U.S. institutions, the Institutional Signatory Official, Human Protections Administrator, and the IRB Chairperson(s) must complete the OHRP basic educational modules, or training certified to OHRP by the institution as equivalent to the OHRP modules. OHRP's training module can be accessed through its home page, by selecting "Educational Materials." IRB members and staff are required to complete relevant training before reviewing human subject research. Educational requirements for international institutions are also described on OHRP's Web site. For further information, refer to IRB Registration and FWA Questions and Answers.

Some key OHRP Web pages are:

• IRB Registration and FWA Questions and Answers
• procedures for filing FWAs and registering IRBs
• instructions for filing FWAs and forms
• instructions for registering an IRB or IEC

4. NIH Requirements for Training in Human Subjects Protection Reviewed

In addition to OHRP training requirements, NIH requires all investigators who are submitting grant applications, proposals for contracts, or who are receiving new or non-competing awards for research involving human subjects, to complete appropriate institutional training. Some ways to satisfy this requirement are described in "Required Education in the Protection of Human Research Subjects," NIH Guide for Grants and Contracts, release date: June 5, 2000.

NIH-funded investigators also may find it helpful to read the frequently asked questions and answers, developed by NIH's Division of Extramural Activities (DEA), about satisfying the requirement.

Further, NCI has developed a new on-line continuing education program "Human Participant Protections Education for Research Teams". It is not presently clear whether the new program satisfies OHRP's educational requirement, so at this time, investigators may wish to take advantage of the program as additional training.

5. What Reviewers Are Looking for in Human Subjects Information

Investigators may find instructive reading the new instructions that are being provided to reviewers who evaluate grant and cooperative agreement applications that involve human subjects. Knowing exactly what the reviewers are looking for can help ensure that your application is complete, and not delayed in the review process. The instructions are available on NIH's Office of Extramural Research Web site: See "Peer Review Document Policies."

The same Web site also offers decision trees for human subject protection and inclusion issues, that may help determine what is needed for your grant application.

6. Supplemental Funding Available for Dissemination of Promising Cancer Control Interventions Tested in Research Projects

DCCPS is offering support for dissemination of promising cancer control interventions to NCI-investigators who have R01, P01, P50, U01, or U19 cancer control intervention research grants or cooperative agreements, and who are in the final two years of their grants.

The supplements are to fund the dissemination of promising interventions where statistical significance and potential public health/clinical significance of interventions effects strongly suggest the merits of dissemination to the broader population from which the intervention sample was originally drawn. The supplements may also support cost-effectiveness evaluations of interventions, qualitative and quantitative research needed to adapt intervention products for use after formal research evaluation has ended, and dissemination of intervention products. About $2 million is being committed in FY 2002 for 12 to 15 supplements.

Letters of intent are due by July 16, 2001, and applications are due by August 16, 2001. Interested applicants are urged to contact their NCI Program Directors to review the appropriateness of this mechanism for their intervention research project.

The Letter Request for Applications (RFA) appeared in the NIH Guide for Grants and Contracts, release date: May 9, 2001. Also refer to the Instructions for Applying for these supplements and the Announcement Letter to Investigators on DCCPS' Web site.

7. RFA on Shared Resources for Scientists Issued

NCI has issued a RFA to establish cancer-related research resources to provide new sources of technical support and research materials to advance cancer research. Increasing the availability of core resources is expected to improve the ability of cancer investigators to conduct research, and thereby to facilitate scientific progress. To be eligible, applicant institutions cannot have an NCI-funded cancer center, and the application must identify six or more NCI-funded investigators who will utilize the services of the proposed resource. The research resource (R24) grant mechanism will be used. Letters of intent are due by June 5, 2001, and applications must be received by July 10, 2001.

Appropriate resources include but are not limited to tissue and data resources, unique database resources supporting research activities, agent development, assay support for research activities, animal models for diagnostic or therapeutic applications, and technology or instrumentation development.

NCI intends to commit about $3 million in FY 2002 to fund 10 to 15 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $200,000 per year, excluding facility and administrative costs on consortium arrangements. Awards are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Direct programmatic inquiries to Dr. Roger Aamodt, Division of Cancer Treatment and Diagnosis, NCI, tel.: 301-496-7147; e-mail: ra32u@nih.gov.

The RFA (CA-01-020) appeared in the NIH Guide for Grants and Contracts, release date: February 14, 2001.

8. Program Announcements Sponsored by EGRP

EGRP is sponsoring the following Program Announcements:

• Geographic-based Research in Cancer Control and Epidemiology (R01) (PAS-00-120), and Small Grants for Geographic-based Research in Cancer Control and Epidemiology (R03) (PAS-00-121). Letters of intent are due by June 14, 2001, and applications are due by July 19, 2001. Contact: Mr. Burdette (Bud) Erickson, tel.: 301-435-4913; fax: 301-402-4279; e-mail: berikso@mail.nih.gov.
• Molecular Epidemiology of Prostate Carcinogenesis (PA-00-080).
  Contact Dr. Kumiko Iwamoto, tel: 301-435-4911; fax: 301-402-4279; e-mail: iwamotok@mail.nih.gov
• Mechanisms Underlying Individual Variations in Drug Responses (PA-99-016). Contact: Dr. Kumiko Iwamoto, tel.: 301-435-4911; fax: 301-402-4279; e-mail: iwamotok@mail.nih.gov.
• Occupational Safety and Health Research (PA-99-143). Contact: Dr. Kumiko Iwamoto, tel.: 301-435-4911; fax: 301-402-4279; e-mail: iwamotok@mail.nih.gov.
• Research Methods for Occupational Cancer (PA 99-148). Contact: Dr. Kumiko Iwamoto, tel.: 301-435-4911; fax: 301-402-4279; e-mail: iwamotok@mail.nih.gov.
• Small Grants Program for Cancer Epidemiology (PAR-01-021). Contact: Dr. A.R. (Joe) Patel, tel.: 301-435-4910; fax: 301-402-4279; e-mail: patelap@mail.nih.gov.
• Molecular Epidemiology of HIV-associated Cancers (PA-00-086). Contacts: Ms. Vaurice Starks, tel.: 301-402-9375; fax: 301-402-4279; e-mail: starksv@mail.nih.gov; and Dr. Sandra Melnick, tel: 301-435-4914; fax: 301-402-4279; e-mail: melnicks@mail.nih.gov.
• Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs. Contact: Mr. Jay Choudhry, tel.: 301-435-6613; fax: 301-402-4279; e-mail: choudhrj@mail.nih.gov.

9. Search EGRP's Research Portfolio on the Web

EGRP's research portfolio includes more than 400 extramural research projects that explore a wide variety of cancer risk factors, and methods or approaches to improve research capabilities. A compendium on FY 2001 projects is now available on EGRP's Web site. The compendium may be useful to understand the types of research being conducted in specific areas, identify gaps in research, and find investigators with shared interests.

This is the first time that EGRP has provided this resource for investigators. Let us know if it is useful and how it might be improved. In time, EGRP wants to be able to link directly from a grant title to its abstract if this would be helpful. Meantime, to view abstracts, refer to the Computer Retrieval of Information on Scientific Projects (CRISP) database on all NIH-funded research projects:

10. Improperly Formatted Applications May Be Returned by NIH Without Review

NIH recently issued a reminder about formatting requirements for research grant and cooperative agreement applications. Applications that are not in compliance with certain formatting and presentation requirements will be returned to investigators without review. NIH has received an increasing number of complaints from reviewers about applications not following all the specifications. Plus complying with the format specifications is important for accurate scanning of applications.

Applications that do not comply with the specifications for type size, page limits, or margins will be returned to the institution without review. These applications cannot be submitted in a corrected version until the next receipt cycle.

Formatting questions may be directed to: format@mail.nih.gov. See also frequently asked questions about application format.

The Notice (NOT-OD-01-012) appeared in the NIH Guide for Grants and Contracts, release date: January 8, 2001.

11. Revised NIH Grants Policy Statement Published

NIH issued a revised Grants Policy Statement (NIHGPS) that is effective for all grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The Statement supersedes, in its entirety, the NIH Grants Policy Statement as a standard term and condition of award. (The NIHGPS published in Oct. 1998 remains the standard term and condition for all grants and cooperative agreements with budget periods that began between October 1, 1998 and February 28, 2001.)

A Notice (OD-01-015) about the revised Statement, including mention of notable policy changes, appeared in the NIH Guide for Grants and Contracts, release date: February 27, 2001.

12. Web Site Provides Information on NCI Research Resources

The "NCI Research Resources" Web site, provides information on more than 100 products and services available for basic, clinical and epidemiologic researchers, without extensive negotiations or intellectual property issues. These resources include specimens, datasets, computer software, chemicals, and animals.

13. EGRP Staff Contacts

You are welcome to contact our Program Directors for advice and consultation about NIH and NCI funding and scientific review policies and procedures, the preparation of grant applications, and funding instruments that relate to EGRP's mission. Your contacts, by research topic, are:

Analytic Epidemiology Research Branch (AERB)
Sandra Melnick, Dr.P.H., Chief
Tel.: 301-435-4914; fax: 301-402-4279; email: melnicks@mail.nih.gov.

• Biometry - Mr. Burdette Erickson, M.Sc., tel.: 301-435-4913; fax: 301-402-4279; e-mail: berikso@mail.nih.gov.
• Diet, Nutrition, and Cancer - A.R. (Joe) Patel, Ph.D., tel.: 301-435-4910; fax: 301-402-4279; e-mail: patelap@mail.nih.gov.
• Geographic Information Systems as Tools in Cancer Epidemiology - Mr. Burdette Erickson, M.Sc., tel.: 301-435-4913; fax: 301-402-4279; e-mail: berikso@mail.nih.gov.
• Infectious Disease and AIDS-malignancy Epidemiology Programs - Ms. Vaurice Starks, tel.: 301-402-9375; fax: 301-402-4279; e-mail: starksv@mail.nih.gov; and Sandra Melnick, Dr.P.H., tel.: 301-435-4914; fax: 301-402-4279; email: melnicks@mail.nih.gov.
• Environmental/Molecular Epidemiology Programs - Kumiko Iwamoto, M.D., Dr.P.H., tel.: 301-435-4911; fax: 301-402-4279; e-mail: iwamotok@mail.nih.gov.
• Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs - Mr. Jay Choudhry, M.S., tel.: 301-435-6613; fax: 301-402-4279; e-mail: choudhrj@mail.nih.gov.
• Tobacco Research - A.R. (Joe) Patel, Ph.D., tel.: 301-435-4910; fax: 301-402-4279; e-mail: patelap@mail.nih.gov.

Clinical and Genetic Epidemiology Research Branch (CGERB)
James Hanson, M.D., Acting Chief
Tel.: 301-435-6612; fax: 301-435-5477; e-mail: hansonj@mail.nih.gov.

• Cancer Genetics Network - James Hanson, M.D., tel.: 301-435-6612; fax: 301-435-5477; e-mail: hansonj@mail.nih.gov; Susan Nayfield, M.D., M.Sc., tel.: 301-594-7344; fax: 301-435-5477; e-mail: nayfiels@mail.nih.gov; and Carol Kasten-Sportes, M.D., tel.: 301-402-8212; fax: 301-435-5466; e-mail: kastenca@mail.nih.gov.
• Clinical Epidemiology Program - Susan Nayfield, M.D., M.Sc., tel.: 301-594-7344; fax: 301-435-5477; e-mail: nayfiels@mail.nih.gov.
• Genetic Epidemiology Program and Cancer Family Registries for Breast and Colon Cancer - Daniela Seminara, Ph.D., M.P.H., tel.: 301-496-9600; fax: 301-435-5477; e-mail: seminard@mail.nih.gov.
• Clinical, Social, and Behavioral Epidemiology Research in Genetics - Susan Nayfield, M.D., M.Sc., tel.: 301-594-7344; fax: 301-435-5477; e-mail: nayfiels@mail.nih.gov. (You may be referred to Michael Stefanek, Ph.D., Basic Biobehavioral Research Branch, DCCPS; tel.: 301-496-8776; fax: 301-435-7547; e-mail: stefanekm@mail.nih.gov.)

14. Friends of EGRP Listserv

EGRP's Listserv, "FRIENDS-OF-NCI-EGRP-L," is used to send the EGRP Bulletin and announcements to grantees and other researchers who may be interested in occasionally hearing from us. You are welcome to spread the word about "FRIENDS." To subscribe (or unsubscribe), access the NIH LISTSERV Web site. Click the "Browse" button, and then click on "Access unlisted lists." Type "FRIENDS-OF-NCI-EGRP-L" and follow the prompts. If you have difficulty, contact Ms. Linda Anderson, e-mail: andersol2@mail.nih.gov, provide your name, and she'll subscribe you.