RESEARCH INVOLVING HUMAN IN VITRO FERTILIZATION

NIH GUIDE, Volume 22, Number 26, July 23, 1993



PA NUMBER:  PA-93-101



P.T. 34



Keywords:

  Human Reproduction/Fertility 

  Embryology 



National Institute of Child Health and Human Development



PURPOSE



The National Institute of Child Health and Human Development (NICHD)

invites investigator-initiated research grant applications to conduct

basic and clinical research involving human in vitro fertilization

(IVF), for the purpose of enhancing the treatment of certain forms of

human infertility.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This Program

Announcement, Research Involving Human In Vitro Fertilization, is

related to the priority area of family planning.  Potential applicants

may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.

017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.  Women,

members of minority groups, and persons with disabilities are

encouraged to apply.  Applicants for First Independent Research Support

and Transition (FIRST) Awards (R29) must meet specific eligibility

requirements.  In addition, foreign institutions are not eligible for

the FIRST Award.



MECHANISM OF SUPPORT



Mechanisms available for the support of this program are the research

project grant (R01) and the FIRST Award (R29).



RESEARCH OBJECTIVES



Many infertile couples have been treated with a variety of assisted

reproductive techniques, ranging from such simple methods as timed

natural intercourse or artificial insemination, through ovulation

induction, to in vitro technologies such as IVF.  Many of these

techniques are being used empirically, without appropriate rigorous

scientific evaluation.



The President has signed into law the NIH Revitalization Amendments of

1993 that contain certain Miscellaneous Repeals (Sec. 121), one of

which is directly relevant to this program announcement.  This repeal

is for the provision in the current Code of Federal Regulations

pertaining to the protection of human subjects, 45 CFR 46.204(d), that

requires a Federal-level Ethical Advisory Board review for applications

involving human IVF.  With the lifting of this requirement, the NIH can

now conduct and support research involving human IVF, in accord with

the recommendations of the grantee institution's Institutional Review

Board, without the need for a special Federal-level Ethical Advisory

Board in each case.  It is anticipated that applications involving

certain types of research that relate to human IVF will still be

subject to special review on a case-by-case basis.



This program announcement is designed to encourage investigators to

apply for research support for basic and clinical studies that will

enhance the outcome of IVF in the normal course of treatment for human

infertility.  Such research might include, but not be limited to:



o  improved patient selection procedures for treatment with IVF



o  improved ovulation induction in IVF protocols



o  improved methods for gamete collection



o  improved conditions for fertilization



o  improved conditions for embryo transfer



o  IVF outcome in different racial and ethnic groups



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women in

study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder or condition under study;

special emphasis must be placed on the need for inclusion of minorities

and women in studies of diseases, disorders and conditions which

disproportionately affect them.  This policy is intended to apply to

males and females of all ages.  If women or minorities are excluded or

inadequately represented in clinical research, particularly in proposed

population-based studies, a clear compelling rationale must be

provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information must be included in the form PHS 398 (rev.

9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5,

Human Subjects.  Applicants are urged to assess carefully the

feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans (including American Indians or Alaskan

Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale

for studies on single minority population groups must be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded. However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the review will be deferred until the information is provided.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.  The receipt dates for

applications for AIDS-related research are found in the PHS 398 (rev.

9/91) instructions.



Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grants

Information, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone

301/710-0267.  The title and number of the announcement must be typed

in Section 2a on the face page of the application.  Applications for

the FIRST Award (R29) must include at least three sealed letters of

reference attached to the face page of the original application.  FIRST

Award (R29) applications submitted without the required numbered of

reference letters will be considered incomplete and will be returned

without review.



The completed original application and five legible copies must be sent

or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit by study sections of the Division of

Research Grants, NIH, in accordance with the standard NIH peer review

procedures.



The second level of review will be provided by an appropriate national

advisory council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Donna L. Vogel, M.D., Ph.D.

Center for Population Research

National Institute of Child Health and Human Development

Building 61E, Room 8B01

Bethesda, MD  20892

Telephone:  (301) 496-6515

FAX:  (301) 496-0962



Direct inquiries regarding fiscal matters to:



Melinda Nelson

Office of Grants and Contracts

National Institute of Child Health and Human Development

Building 61E, Room 8A07

Bethesda, MD  20892

Telephone:  (301) 496-5481



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.864, Population Research.  Awards are made under authorization

of the Public Health Service Act, Title IV, Part A (Public Law 78-410,

as amended by Public Law 99-158, 42 USC 241 and 285) and administered

under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR

Part 74.  This program is not subject to the intergovernmental review

requirements of Executive Order 12374 or Health Systems Agency review.



.

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