Collapse to view only § 63.2 - Definitions.

§ 63.1 - To what programs do these regulations apply?

(a) The regulations in this part apply to research traineeships awarded by the Director, NIH, each director of a national research institute of NIH, the Director of the National Library of Medicine, and the Director of the National Center for Complementary and Alternative Medicine, or their designees, pursuant to sections 402(b)(13), 405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively.

(b) The regulations of this part do not apply to research training under the National Research Service Award Program governed by 42 CFR part 66 or to the Mental Health Traineeship Program governed by 42 CFR part 64a.

(c) Except as otherwise permitted under section 413(b)(3) of the Act, the regulations of this part do not apply to residency training of physicians or other health professionals.

[65 FR 66512, Nov. 6, 2000]

§ 63.2 - Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.).

Award means an award of funds under sections 402(b)(13), 405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of the Act which authorize research training or traineeships.

Awardee means an individual awarded a traineeship under sections 402(b)(13), 405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of the Act which authorize research training or traineeships.

Director means the Director, NIH, the director of a national research institute of NIH, the Director of the National Library of Medicine, and the Director of the National Center for Complementary and Alternative Medicine, or any official of NIH to whom the authority involved has been delegated.

HHS means the Department of Health and Human Services.

NIH means the National Institutes of Health.

PHS means the Public Health Service.

Research misconduct shall have the same meaning as prescribed in § 93.103 of this chapter.

Traineeship means an award under the regulations of this part to a qualified individual for that person's subsistence and other expenses during the period that person is participating in the research training approved under the award.

[60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000; 85 FR 72909, Nov. 16, 2020]

§ 63.3 - What is the purpose of traineeships?

The purpose of an NIH research traineeship is to provide support for financial subsistence to an individual during a period in which the awardee is acquiring training in:

(a) Basic and/or clinical biomedical or behavioral research relating to human health, including extending healthy life and reducing the burdens of illness, or

(b) Medical library science or related fields pertaining to sciences related to health or the communication of health sciences information.

Traineeships are intended to make available in the United States an increased number of persons having special competence in these research fields through developmental training and practical research experience in the facilities of NIH, with supplemental training at other qualified institutions (see § 63.8(a)).

§ 63.4 - What are the minimum qualifications for awards?

Minimum qualifications for any traineeship shall be established by the Director and shall be uniformly applicable to all applicants in each traineeship program. These minimum qualifications may include requirements as to citizenship, medical standards, academic degrees, professional or other training or experience, and other factors as may be necessary to the fulfillment of the purpose of the traineeship. The Director may, as a matter of general policy or, in individual cases, waive compliance with any minimum qualification so established to the extent that the applicant or applicants have substantially equivalent qualifications or have such special training, experience or opportunity for service as to make an award particularly appropriate, and to the extent the Director finds it is consistent with the fulfillment of the purpose of the traineeship.

§ 63.5 - How will NIH make awards?

Subject to the regulations of this part, the Director may award traineeships to those qualified applicants who are best able in that official's judgment to carry out the purpose of the traineeships. These awards may be made for a period of one (1) year or other period, including extensions or renewals, as may be specified.

§ 63.6 - How to apply.

(a) Application for a traineeship shall be made in writing as prescribed by the Director.

(b) In addition to other pertinent information, the Director may require each applicant to submit the following information:

(1) Certification of the applicant's citizenship status;

(2) The applicant's educational background and other qualifications and experience, including previous academic and professional degrees, if any; and

(3) The subject area of the proposed training.

(c) By applying, eligible individuals agree to abide by HHS, PHS, and NIH regulations, and the terms and conditions of the traineeship award which may require compliance with policies and procedures that apply to the proper conduct of research, such as research involving human and animal subjects, patient care, hospital and laboratory procedures, handling of confidential information, and outside employment.

§ 63.7 - What are the benefits of awards?

(a) Subject to the availability of funds, each individual awarded a traineeship may receive a stipend fixed in an amount determined by the Director.

(b) Additional allowances and benefits may be authorized by and at the discretion of the Director, taking into account the cost of living and other factors such as the requirements of the training program and availability of discretionary funds. Discretionary allowances and benefits may include: health benefits coverage; dependents' allowance; travel to pre-award interviews, to first duty station, and return to the place of origin upon conclusion of the traineeship; tuition and institution fees; and other specific costs as may be necessary to fulfill the purpose of the training program.

§ 63.8 - What are the terms and conditions of awards?

All traineeships shall be subject to the following terms and conditions:

(a) Training must be carried out at a facility of the NIH, but may be supplemented by additional training acquired at another institution which is found by the Director to be directly related to the purpose of the traineeship and necessary to its successful completion.

(b) Payments shall be made to the awardee or to the institution for payment to the awardee in accordance with payment schedules as prescribed by the Director for each traineeship program.

(c) The awardee shall reimburse NIH for any overpayment of stipends or other allowances because of early termination of the traineeship or any other reason, unless waived for good cause shown by the awardee.

(d) The Director may establish procedures and requirements applicable to traineeship awards, consistent with the regulations in this part, regarding: (1) The proper conduct of research investigations, including research involving human and animal subjects; (2) patient care; (3) hospital and laboratory procedures; (4) handling of confidential information; (5) outside employment; and (6) additional conditions the Director finds necessary to fulfill the purpose of the traineeship.

(e) The awardee shall sign an agreement to comply with the terms and conditions of the traineeship.

§ 63.9 - How may NIH terminate awards?

The Director may terminate a traineeship at any time:

(a) Upon written request of the awardee; or

(b) If it is determined that the awardee has committed research misconduct, is ineligible, or has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which the award was made; or

(c) If the awardee is convicted of a felony, or an offense involving any illegal drug or substance, or any offense involving a lack of financial integrity or business honesty; or

(d) Because of programmatic changes or lack of funds.

[65 FR 66513, Nov. 6, 2000, as amended at 85 FR 72909, Nov. 16, 2020]

§ 63.10 - Other HHS regulations and policies that apply.

Several other policies and regulations apply to awards under this part. These include, but are not necessarily limited to:

45 CFR part 46 - Protection of human subjects. 45 CFR part 76 - Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants). 45 CFR part 80 - Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services - effectuation of title VI of the Civil Rights Act of 1964. 45 CFR part 81 - Practice and procedure for hearings under part 80 of this title. 45 CFR part 84 - Nondiscrimination on the basis of handicap in programs and activities receiving Federal financial assistance. 45 CFR part 86 - Nondiscrimination on the basis of sex in education programs and activities receiving or benefiting from Federal financial assistance. 45 CFR part 91 - Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance. 59 FR 14508 (March 28, 1994) - NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. (Note: Interested persons should contact the Office of Research on Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-0161; telephone 301-402-1770 (not a toll-free number) to obtain copies of this policy.) 59 FR 34496 (July 5, 1994) - NIH Guidelines for Research Involving Recombinant DNA Molecules. (Note: Interested persons should contact the Office of Biotechnology Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010; telephone 301-496-9838 (not a toll-free number) to obtain copies of the policy.) “Public Health Service Policy on Humane Care and Use of Laboratory Animals” (Revised September 1986), Office of Laboratory Animal Welfare, NIH. (Note: Interested persons should contact the Office of Laboratory Animal Welfare, NIH, Rockledge Building I, 6705 Rockledge Drive, Suite 1050, MSC 7982, Bethesda, MD 20892-7982; telephone 301-496-7163 (not a toll-free number) to obtain copies of the policy.) [60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000]