| This guide is also available in print from OPHS and as a PDF file: Protecting Human Research Subjects. (Click on the link to download a copy, then print the file on 8.5x14 paper and fold it in four.) |
Protecting Human Research Subjects — Are you conducting research using human subjects?
Legal requirements to protect human subjects apply 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 apply, for example, to research that uses:
- Data collected through intervention or interaction with individuals. Intervention and interaction include not only physical procedures (like drawing blood) but also manipulation of a subject’s environment, interviews, surveys, and questionnaires.
- 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, nail clippings even if you did not collect these materials. (Such research may be considered exempt from some requirements or not human subjects research if materials are not personally identifiable.)
- Studies conducted to gain generalizable knowledge about categories or classes of people.
- Human beings to test devices, products or materials that have been developed through research.
- Human beings to evaluate environmental alterations — for example, on weatherization options or habitat modifications.
- Human beings to provide taste test opinions or other subjective responses.
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Are you conducting research using human subjects? If so, you must...
Comply with Federal regulations and UC Berkeley directives to protect human subjects. These requirements apply if your research is conducted using UC Berkeley facilities or property, supported with UC Berkeley funds, or performed by UC Berkeley employees, faculty, visiting scholars or adjunct faculty, postdocs, or students.
The Institutional Review Board (IRB) is responsible for making final decisions as to what constitutes UC Berkeley related human subject research and how subject protection must be implemented.
As stated in 45 CFR 46.102
Research — means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject — means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
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For a full-text version of these regulations and federal guidelines, see the Office of Human Research Protection home page at: http://www.hhs.gov/ohrp/. |
The two critical areas that you must be familiar with when conducting human subject research are Institutional Review Boards (IRBs) and Informed Consent.
What is the role of the Institutional Review Board (IRB)?
At the University of California, Berkeley, the Committee for Protection of Human Subjects (CPHS) serves as the IRB. The IRB must review and approve research if it involves human subjects. The process is designed to ensure that the rights and welfare of human subjects are protected throughout their participation in the research – for example, by minimizing risks, selecting subjects equitably, obtaining informed consent, and ensuring subject privacy and confidentiality.
IRB approval must precede initiation of any work involving human subjects. If research is ongoing, the IRB must review and approve the project at least once a year.
In addition, when changes occur in the procedures applied to human subjects, the IRB must review and approve these changes before they are implemented.
If human subjects are harmed, including physical injury, unexpected or adverse events, improper disclosure of private information, economic loss, or other harmful or potentially harmful occurrences, immediate IRB notification is required.
What if the research is conducted in collaboration with another institution?
As a general rule, you must obtain approval for your use of human subjects from both the UC Berkeley IRB (i.e., CPHS) and the IRB at the collaborating institution.
For more information on this subject contact the Office for the Protection of Human Subjects at ophs@berkeley.edu.
Types of IRB Review
Full Board (Convened) Review — Review of proposed research at a convened meeting at which a valid quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members present.
Expedited Review — Review of proposed research by the CPHS Chair or designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk* and for minor changes in approved research.
Exemption — Exemption from the requirement for IRB approval can be granted by the CPHS when it is determined that research involving human subjects falls into one of the categories listed under 45 CFS 46.101(b)(1)-(6). Any research projects involving human subjects thought to qualify as exempt must be submitted to CPHS for determination of exempt status.
*Minimal Risk — The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.
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What is Informed Consent?
The human subjects in your project must participate willingly, having been adequately informed about the research. If the human subjects in your project are part of a vulnerable population, such as prisoners or children, special protections are required. For more information on vulnerable populations, consult the OHRP web site at: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm.
Essentials of Informed Consent
Voluntary participation means that subjects have enough information to give true informed consent. Essential information includes:
- Purpose of the research.
- Benefits of the research to society and, possibly, to the individual human subject.
- All foreseeable risks or discomforts to the subject. Note that these include not only physical injury, but also possible psychological, social, or economic harm, discomfort, or inconvenience.
- Length of time subject is expected to participate.
- Person to contact for answers to questions, or in the event of a research-related injury or emergency.
- Statement that participation is voluntary and that refusal to participate will not result in any penalty or any loss of benefits which the person is otherwise entitled to receive.
- Subject’s right to withdraw from the study at any time.
In preparing a consent form, follow the guidance on the UC Berkeley CPHS web site at: http://cphs.berkeley.edu.
Consent documents must be clearly written and understandable to subjects. The language must be nontechnical and at a reading level adjusted for the age, socio-economic profile and cultural sensitivities of the subjects. Any scientific, technical, or medical terms must be plainly defined.
Informed consent, whether oral or written, may not include language that appears to waive subjects’ legal rights or appears to release the investigator or anyone else from liability for negligence. |
To learn more...
UC Berkeley CPHS/OPHS (IRB): http://cphs.berkeley.edu
UC Berkeley CPHS Committee: http://cphs.berkeley.edu/content/members.htm
UC Berkeley OPHS Staff and Contact Information:
http://cphs.berkeley.edu/content/contact.htm
UC Office of Research: http://www.ucop.edu/research
Office for Human Research Protections: http://www.hhs.gov/ohrp
CITI Human Subjects Research Training Program: http://www.citiprogram.org
U.S. Department of Education: http://www.ed.gov/about/offices/list/ocfo/humansub.html
U.S. Food and Drug Administration (FDA): http://www.fda.gov
Protecting Personal Health Information in Research (HIPAA Information): http://www.hhs.gov/ocr/hipaa/ |