Human Subjects Policy and Program

Dr. Kieran Sullivan Esther Pham 10/16/09

Conducting Research Involving Human Subjects

Anyone conducting research involving human subjects at Santa Clara University has two obligations

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Participate in Training Submit application for approval from the Human Subjects Committee

Why? The SCU Human Subjects Policy

Santa Clara University is committed to a policy of safeguarding the rights and welfare of all human subjects in research.

 Based on the principles set forth by the national Commission for the Protection of Human Subjects in its report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report).  These principles highlight the necessity for review of a research project independent of the investigator to ensure optimum protection of human subjects.  The commitment extends beyond the requirements of federal regulations and is not affected by the sources of research funding.

HHS Regulations & Applicability

The Belmont Report

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Ethical Principles and Guidelines for the Protection of Human Subjects of Research

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The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979

Principles of the Belmont Report

Respect for Persons: Human subjects must be treated as autonomous and able to make responsible choices. This principle leads to the requirement of informed voluntary consent.

Beneficence: Subjects must be protected from harm and their well-being must be secured. Justice: The risks and benefits of research must be distributed fairly without creating differences in treatment among ethnic, racial, religious, sexual, or age-defined classes. exploit special categories of persons less able to refuse participation .

Determining Applicability

 Does the activity involve is research ?

 Does the research involves human subjects ?  What level of review does this research require?

Definition of Research

A systematic investigation designed to develop or contribute to generalizable knowledge  includes research development, testing, evaluation, e.g., pilot studies   Activities generally considered to be research

Student Work

are considered generalizable and meet the regulatory definition of research. conducted to meet the requirements of a degree

Intent to publish

(although not automatically an indication of intent to do research) might signify that generalizable results are anticipated, and is taken into consideration when making a determination of research.

Definition of Human Subject

A living individual about whom an investigator conducting research obtains

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data through intervention or interaction with the individual, or

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identifiable private information*

 identity of the subject readily ascertained by the investigator or associated with the individual

Institutional Review Board (IRB) Review

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IRB review ( Human Subjects Committee at SCU)

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A committee charged with the review of human subject research to ensure that the rights and welfare of research subjects are adequately protected.

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Bradley Joondeph is the Area representative for law

Types Of Institutional Review

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Exempt from Full Review - 48 hrs.

Expedited Review - one week Full/Regular Review - as needed Note: An application requires full review if the research puts human subjects at more than minimal risk.

Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Informed Consent

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Key principles of the informed consent process:

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Full disclosure of the nature of the research and the subject's participation,

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Adequate comprehension on the part of the potential subjects

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The subject's voluntary choice to participate

Secure Informed Consent

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Make real efforts to see that subjects understand the project

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Provide a “way out” for subjects if they desire one

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Provide a way for subjects’ questions to be answered.

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Systematically evaluate risks and benefits of the research.

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Select subjects in a fair manner that does not exploit some especially vulnerable category of people.

Useful Information

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SCU Human Subjects web page: http://cms.scu.edu/provost/research/Human-Subjects.cfm

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Human Subjects on-line training through CITI: http://www.citiprogram.org/

Human Subjects Contacts

Human Subjects Committee Chair Kieran Sullivan Phone: 408.554.4480

E-mail:

[email protected]

Law Area Representative Bradley W. Joondeph Phone: 408.554.4726

E-mail:

[email protected]

Research Compliance & Integrity Esther Pham Director Phone: 554-5591 E-mail:

[email protected]

Elaine Anderson Administrative Assistant Phone: 408. 554-4408 E-mail:

[email protected]