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    Contracts and Grants
    Human Subjects Certificate Letter

    Print friendly version: Human Subjects Certificate Letter (Microsoft Word). Should you have any questions, please feel free to contact Florence Odusanya at 415-600-7404 or email:

    The content of the letter is shown below.

    • Grant Specialist Name

    • Agency

    • Address

    • Grant Name

    • Grant Number

    • Principal Investigator

    Dear Mr./Ms.:

    Pursuant to NIH Grants Policy Statement regarding the requirements affecting the welfare and rights of individuals, we are presenting below the training status of all key personnel for the above named grant. A description of each training course is provided below the list.

    Key Personnel:
    Course Title:
    • UCSF Course

    • NCI Course

    • NIH Course


    Sarah T. Love
    Grants and Contracts Director

    PI name Principal Investigator:

    Course Descriptions:

    UCSF Human Subjects Protections: Basic Course
    1. Key historical events and current issues that impact guidelines and legislation on human participant protection in research.

    2. Ethical principles and guidelines that should assist in resolving the ethical issues inherent in the conduct of research with human participants.

    3. The use of key ethical principles and federal regulations to protect human participants at various stages in the research process.

    4. A description of guidelines for the protection of special populations in research.

    5. A definition of informed consent and components necessary for a valid consent.

    6. A description of the role of the IRB in the research process.

    7. The roles, responsibilities, and interactions of federal agencies, institutions, and researchers in conducting research with human participants.

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    National Institutes of Health Office of Extramural Funding

    The mission of the National Institutes of Health (NIH) is to improve human health through biomedical and behavioral research. Conducting research involving human participants* is a necessary and important part of that mission.

    The NIH is committed to the ethical conduct of research and to providing appropriate education for researchers whose work involves human participants. Since October 2000, the NIH has required education in the protection of human research participants for all investigators and key personnel submitting NIH applications for grants or proposals for contracts, or receiving new or noncompeting awards.

    National Cancer Institute
    As part of its commitment to the protection of human participants, the NIH has developed this tutorial: "Human Participant Protections: Education for Research Teams." This course offers one option to fulfill the obligation for education in the area of human participant protection.

    • Identify and describe at least five historical events that have influenced current ethical guidelines and Federal regulations

    • Identify the three fundamental ethical principles that guide the ethical conduct of research involving human participants

    • Describe the role of international guidelines in the protection of human participants

    • Recognize when a study requires human participant protections

    • Describe the responsibilities of at least four organizations or individuals in protecting human participants

    • Identify issues to consider when selecting participants for a study and the policies and regulations that apply to special groups

    • Define privacy and confidentiality as it applies to protecting human participants and describe how these can be maintained throughout the research process

    • Define informed consent and describe the elements that should be included in an informed consent document

    • Describe conditions that may affect a person's capacity to consent and the responsibilities of the researcher in seeking consent from research participants

    • Identify at least one new and emerging issue in informed consent that should be considered

    • Define institutional review board (IRB), describe its membership requirements, and identify at least four responsibilities of an IRB

    • List the criteria each study must meet in order to be approved by an IRB

    • List and describe four ways that ongoing protections of human participants are ensured throughout the conduct of a study

    • List and describe special challenges to investigators that may arise when conducting international research

    • Describe the regulations and policies applicable to international research supported by U.S. federal monies.

    Office of Extramural Funding Course
    Upon completion of this course, you should be able to:
    • Describe the history and importance of human subjects protections

    • Identify research activities that involve human subjects

    • Discover the risks a research project might pose to participants

    • Understand how to minimize the risks posed by a research project

    • Describe additional protections needed for vulnerable populations

    • Understand additional issues that should be considered for international research

    • Describe appropriate procedures for recruiting research participants and obtaining informed Consent

    • Identify the different committees that monitor human subjects protections

    • Understand the importance of study design in the protection of research participants

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