OFFICE OF MANAGEMENT AND BUDGET (OMB) STANDARDS FOR COLLECTING AND REPORTING DATA ON RACE AND ETHNICITY:

OMB Directive No. 15 (www.whitehouse.gov/OMB/fedreg/ombdir15.html) defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting (including NIH and AHRQ). The categories in this classification are social-political constructs and should not be interpreted as being scientific or anthropological in nature. The standards were revised in 1997 and now include five racial categories: American Indian or Alaska Native, Asian;, Black or African American, Native Hawaiian or Other Pacific Islander, and White. There are two categories for ethnicity: “Hispanic or Latino,” and “Not Hispanic or Latino.” Reports of data on race and ethnicity shall use these categories. NIH and AHRQ are required to use these definitions to allow comparisons to other Federal databases, especially the census and national health databases. The following definitions apply for the ethnic and racial categories (OMB Directive 15).

Ethnic Categories:

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin” can be used in addition to “Hispanic or Latino.”

Not Hispanic or Latino

Racial Categories:

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)

Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

Standards for Collecting Data.  If the research will include data collection items on race and ethnicity, the categories identified above should be used. The collection of greater detail is encouraged. However, items that are more detailed should be designed in a way that they can be aggregated into these required categories. Self-reporting or self-identification using two separate questions is the preferred method for collecting data on race and ethnicity. When race and ethnicity are collected separately, ethnicity shall be collected first. Respondents shall be offered the option of selecting one or more racial designations. When data on race and ethnicity are collected separately, provision shall be made to report the number of respondents in each racial category who are Hispanic or Latino. When aggregate data are presented, the investigator shall provide the number of respondents who selected only one category, for each of the five racial categories. If data on multiple responses are collapsed, at a minimum the total number of respondents reporting “more than one race” shall be made available. Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.

Additional Information to be Provided for NIH-Defined Phase III Clinical Trials:

If an NIH-dDefined Phase III clinical trial (see Section III.B. on page 36 for definition) is proposed, address whether the applicant expects to find clinically important sex/gender and/or race/ethnicity differences in the intervention effect. The discussion may include supporting evidence and/or data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. The research plan must also include one of the following plans:

·         Plans to conduct valid analyses to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

·         Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender and racial/ethnic groups is not required as subject selection criteria, but inclusion is encouraged.), OR

·         Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

completing the tables for reporting race and ethnicity data for subjects in clinical research:

New Applications.  Complete the Targeted/Planned Enrollment Table format page (RTF or PDF). Provide the study title and plans for the total number of subjects proposed for the study. Also provide the distribution by ethnic categories and by sex/gender according to the format in the Targeted/Planned Enrollment Table. If there is more than one study, provide a separate table for each study. List any proposed racial/ethnic subpopulations below the table. If the proposed research uses existing data, then applicants must use the formats for competing continuation applications.

Competing Continuation Applications. For competing continuation applications involving the collection of new/additional clinical data, use the Targeted/Planned Enrollment Table format page (RTF or PDF) to estimate the distribution of subjects proposed for the study. Provide the study title and plans for the total (cumulative) number of subjects proposed for the study (total planned enrollment). Provide the distribution of subjects by ethnic and racial categories and by sex/gender according to the format in the Targeted/Planned Enrollment Table format page. If there is more than one study, provide a separate table for each study.

For competing continuation or competing supplement applications that do not involve the collection of new/additional clinical data, the data on ethnicity/race and sex/gender should be provided on the Inclusion Enrollment Report Table format page (RTF or PDF).

Note on use of the Inclusion Enrollment Report Table:  Successful competing continuation applications involving collection of new/additional clinical data will be required to use the Inclusion Enrollment Report Table format page (RTF or PDF) in subsequent annual progress reports. The Inclusion Enrollment Report Table format page contains two parts: Part A is for all subjects and Part B is for Hispanics or Latinos.

For Part A, provide the distribution of subjects by ethnic and racial categories and by sex/gender according to the format in the Inclusion Enrollment Report Table.

Part B should include information on the race of all Hispanics (or Latinos) enrolled as reported in Part A. If there is more than one study, provide a separate table for each study. Provide information on any proposed ethnic/racial subpopulations as an attachment to the table. In completing the Inclusion Enrollment Report Table, do not assume or guess a subject’s ethnic or racial affiliation. Collect the data using instruments that, at a minimum, allow all respondents to select their ethnic and racial affiliation separately. Under racial affiliation, subjects must be provided the option of selecting more than one race. When reporting these data to NIH, subjects who selected only one of the five racial categories should be designated in that category. Subjects who selected more than one racial category should be reported in the “More than one race” category. For previously funded studies that used an earlier NIH reporting format, the earlier reporting format is NOT directly transferable to the new format. For additional information, review the instructions and frequently asked questions about using the new format at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.

Foreign Populations

If you are conducting clinical research outside of the U.S., you should design culturally sensitive and appropriate data collection instruments that allow participants to self-identify their ethnic and racial affiliation. These items, however, should be designed in a way that allows you to aggregate the information into the Office of Management and Budget (OMB) minimally required ethnic and racial categories and complete the Targeted/Planned Enrollment Table and/or the Inclusion Enrollment Report. When completing the Targeted/Planned Enrollment Table or the “Inclusion Enrollment Report, you should add an asterisk and footnote the report to indicate that data is from foreign participants. If your study includes both domestic and foreign participants, we suggest submitting two separate reports – one for domestic data and one for foreign data, with an asterisk and footnote explaining the foreign data.

Inclusion of Children

If Item 9 on the Face Page of the application is marked “Yes,” create a subsection heading entitled “Inclusion of Children.” Place it immediately following the “Women and Minority Inclusion in Clinical Research” subsection of the application.

NIH policy requires that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by NIH, unless there are clear and compelling reasons not to include them. (For additional information, see http://grants.nih.gov/grants/funding/children/children.htm and the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects [http://grants.nih.gov/grants/guide/notice-files/not98-024.html].) Therefore, applications for research involving human subjects must includeprovide a description of plans for including children. If children will be excluded from the research, the application must present an acceptable justification for the exclusion.

In the subsection entitled “Inclusion of Children,” the applicant should provide either a description of the plans to include children or, if children will be excluded from the research, the application must present an acceptable justification (see below) for the exclusion.

If children are included, the description of the plan should include a rationale for selecting or excluding a specific age range of children.

When children are included, the plan also must include a description of the expertise of the investigative team for dealing with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study.

Scientific Review Groups (SRGs) will assess each application as being “acceptable” or “unacceptable” with regard to the age-appropriate inclusion or exclusion of children in the research project.

Justifications for Exclusion of Children

It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:

1.       The research topic to be studied is not relevant to children.

2.                   There are laws or regulations barring the inclusion of children in the research.

3.       The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study would be redundant. Documentation of other studies justifying the exclusions should be provided. NIH or AHRQ program staff can be contacted for guidance on this issue if the information is not readily available.

4.       A separate, age-specific study in children is warranted and preferable. Examples include:

a.       The relative rarity of the condition in children, as compared to adults (in that extraordinary effort would be needed to include children, although in rare diseases or disorders where the applicant has made a particular effort to assemble an adult population, the same effort would be expected to assemble a similar child population with the rare condition);

b.       The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; or

c.       Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages or different age-related metabolic processes). While this situation may represent a justification for excluding children in some instances, consideration should be given to taking these differences into account in the study design and expanding the hypotheses tested, or the interventions, to allow children to be included rather than excluding them.

5.       Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis.

6.       Study designs aimed at collecting additional data on pre-enrolled adult study subjects (e.g., longitudinal follow-up studies that did not include data on children).

7.       Other special cases justified by the investigator and found acceptable to the review group and the IC Director or Administrator, AHRQ.

Definition of a Child

For the purpose of implementing these requirements, a child is defined as an individual under the age of 21 years.

The definition of child described above will pertain to these guidelines (notwithstanding the FDA definition of a child as an individual from infancy to 16 years of age, and varying definitions employed by some States). Generally, State laws define what constitutes a “child,” and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address when a child can consent to participate in research.

45 CFR 46 (Subpart D, Sections .401-409) addresses HHS protections for children who participate in research and relies on State definitions of “child” for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some States consider a person that is 18 years of age to be an adult and, therefore, one who can provide consent without parental permission.

Data and Safety Monitoring Plan

If Item 9 on the Face Page is marked “Yes” and the proposed research involves a clinical trial (whether or not it involves an NIH-defined Phase III clinical trial as provided in Item 9c), create a subsection heading entitled “Data and Safety Monitoring Plan.”” Place it immediately following the “Inclusion of Children” subsection.

NIH policy requires that investigators (including Kirschstein-NRSA Individual Fellowship applicants) submit a general description of the Data and Safety Monitoring Plan for clinical trials (biomedical and behavioral intervention studies) as part of applications for research and research training (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). (See “Human Subjects” in Section III.B, Other Information, Subsection B. Policies, Assurances, and Certifications, for definitions of clinical research, clinical trial, and NIH-defined Phase III clinical trial).

A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring, and how Adverse Events (AEs) will be reported to the Institutional Review Board (IRB) the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA) in accordance with Investigational New Drug (IND) or Investigational Device Exception (IDE) regulations. Although no specific page limitation applies to this subsection of the application, be succinct.

In developing the Data and Safety Monitoring Plan, you should refer to the NIH Policy for Data and Safety Monitoring (http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

The frequency of monitoring will depend upon the potential risks, complexity, and nature of the trial. Therefore, a number of options for monitoring trials are available. These include, but are not limited to, monitoring by a:

·         Principal Investigator (required)

·         Independent individual/Safety Officer

·         Designated medical monitor

·         Internal committee or board with explicit guidelines

·         Data and Safety Monitoring Board (DSMB - required for multi-site clinical trials)

·         Institutional Review Board (IRB - required)

NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the subjects and, generally, for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.

A detailed Data and Safety Monitoring Plan must be submitted to the sponsoring institution’s IRB and subsequently to the funding NIH IC for approval prior to the accrual of human subjects (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).

(6)                 Vertebrate Animals.

If Item 10a on the Face Page of the application is marked “Yes,” create a section heading entitled “Vertebrate Animals.” Place it immediately following the “Literature Cited” section of the application (or after “Human Subjects Research,” if applicable.)

Under the “Vertebrate Animals” heading address the following five points. In addition, when research involving vertebrate animals will take place at a collaborating site(s) or other performance site(s), provide this information before discussing the five points. Although no specific page limitation applies to this section of the application, be succinct.

1.       Provide a detailed description of the proposed use of the animals in the work outlined in the “Research Design and Methods” section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.

2.       Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.

3.       Provide information on the veterinary care of the animals involved.

4.       Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.

5.       Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

Item 30c, Respective Contributions.

Describe the collaborative process between the sponsor and the applicant in the development, review, and editing of the research training proposal described in Item 30b. Do not include the respective roles in accomplishing the proposed research.

Item 30d, Selection of Sponsor and Institution

(1)     Explain why the sponsor and institution were selected to accomplish the research training goals.

(2)     Doctorate or Current Institution. Since training is expected to broaden a fellow's perspective, postdoctoral applicants requesting training at either their doctorate institution or at the institution where they have been training for more than a year must explain why further training at that institution would be valuable. Senior applicants requesting training at their employing institution should provide a similar explanation. Ordinarily, the new training value of an environment diminishes as your association there lengthens. If you are staying at the same institution, explain briefly.

(3)     Foreign Institution. Show that the foreign institution and sponsor offer special opportunities for training that are not currently available in the United States. Key factors in the selection should be described. If applicable, the need for and level of proficiency in reading, speaking, and comprehending the foreign language should be addressed.

Item 30e, Responsible Conduct of Research

Applications must include the applicant’s plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described.

While NIH does not establish specific curricula or formal requirements, applicants are encouraged to creatively tailor a plan to meet their own needs in relation to the proposed research training. It may include participating in formal activities like established courses as either an instructor or a student (for-credit or non-credit), or informal activities such as discussion groups. Suggested areas could include conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, policies regarding the use of animals and/or human subjects, and institutional vs. individual responsibilities for scientific integrity.

 

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