For more information about the Office of Science Grant Program, go to the Office of Science Grants and Contracts Web Site.

A Human Subject is a living individual about whom an investigator (whether professional or student) is conducting research.

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Protection of human subjects applies to a much broader range of research than many investigators realize. In addition to covering traditional biomedical studies, legal obligations to protect human subjects also includes:

• Human beings to test devices, products or materials that have been developed through research.

• Data collected through intervention or interaction with individuals. Intervention includes not only physical procedures (like drawing blood), but also manipulation of a subject's environment.

• Private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.

• Bodily materials such as cells, blood or urine, tissues, organs, hair, and nail clippings even if you did not collect these materials. (Such research may be considered exempt if materials are not personally identifiable.)

• Studies conducted to gain generalizable knowledge about categories or classes of subjects such as DOE workers.

• Human beings to evaluate environmental alterations -- for example, weatherization options or habitat modifications.

NEW OR RENEWAL APPLICATIONS:

If activities involving human subjects are not planned at any time during the proposed project, check the box marked "NO" under Item #1 on the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001). No further action is required.

If activities involving human subjects are planned at any time during the proposed project, check the box marked "YES" under Item #1 on the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001).

If Item #1 of the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001) has been marked "YES", please provide the following information in new and renewal applications:

1. Describe the characteristics of the subject population, such as their anticipated number, age ranges, sex, ethnic background, and health status. Identify the criteria for inclusion or exclusion. Explain the rationale for the use of special classes of subjects, such as fetuses, pregnant women, children, institutionalized mentally disabled, prisoners, or others who are likely to be vulnerable.

2. Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records or data.

3. Describe plans for the recruitment of subjects and the consent procedures to be followed, including the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects and the method of document consent. State if an institutional review board has authorized a modification or waiver of the elements of consent or the requirements for documentation of consent. Copies of consent forms must be submitted with your application for support.

4. Describe any potential risks--physical, psychological, social, legal or other--and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects.

5. Describe the procedures for protecting against or minimizing any potential risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for insuring necessary medical or professional intervention in the event of adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the data collected to insure the safety of the subjects.

6. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result.

7. Include as part of this section, if applicable, the date and assurance number of the most recent human subject assurance approval that was given to your applicant organization by the Office of Protection from Research Risks, National Institute of Health.

Progress Reports:
Annual Progress Reports must include the date of the annual review and approval by the organization's Human Institutional Review Board and must contain sufficient information about the progress and planned research activity as it relates to human subjects.
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* You must comply with Federal regulations and U.S. Department of Energy (DOE) orders to protect human subjects. These requirements apply if your research is conducted using DOE facilities or property, supported with DOE funds, or performed by DOE employees or contractors.

The Office of Science is responsible for making final decisions as to what constitutes DOE-related human subject research and how human research subject protection must be implemented.

Proprietary or classified projects, are not exempt from DOE Human Subjects regulations.

NEW OR RENEWAL APPLICATIONS:

If activities involving vertebrate animals are not planned at any time during the proposed project, check the box marked "NO" under Item #2 on the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001). No further action is required.

If activities involving vertebrate animals are planned at any time during the proposed project, check the box marked "YES" under Item #2 on the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001).

If Item #2 of the RESEARCH & RELATED Other Project Information form (OMB Number: 4040-0001) has been marked "YES", please provide the following information in new and renewal applications for support:

1. Identification of the species and approximate number of animals to be used;

2. Rationale for involving animals, and for the appropriateness of the species to be used;

3. A brief description of the proposed use of the animals;

4. A brief description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals;

5. A description of any euthanasia method to be used;

6. Certification number and date for AAALAC approval of facilities should be included; if not AAALAC approved or on probation, the reasons should be stated; and

7. Those organizations that have an approved animal assurance on file with the Office for Protection from Research Risks (OPRR), the National Institutes of Health, must provide the assurance number and the date of the OPRR assurance approval.

Progress Reports:
Annual Progress Reports must contain sufficient information about the progress and the planned research activity as it relates to the use and care of vertebrate animals.

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