Human and Animal Subjects Information

Q & A on Informed Consent , Human Subjects Quiz, Research Sites, OHRP Decision Chart, Human Subject Online Tutorials

Q&A on Informed Consent

Question: What is meant by “waiver of informed consent” and why it is misleading?

Answer: for future requests for exempt status please note the following error in your request. The protocol states that the researcher is "requesting waiver of informed consent." In fact, what you are requesting is a waiver of the requirement for documentation of informed consent.

Waiver of the requirement for documentation of informed consent is automatically accorded to a protocol that has been approved as "exempt." Therefore your waiver request was not necessary.

The university never waives the requirement that there be a process of informed consent and that all human subjects' participation be voluntary. The process of informing consent can occur in many different ways other than signed receipt of a formal document of information. Waiver of informed consent is under 45 CFR 46 of the OHRP guidelines.

Reference Site to OHRP see 46.117

Reference Site to CDC

Protections of Human Subjects Quiz

Human Subject Regulations Decision Charts

OHRP Decision Chart

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:

whether an activity is research that must be reviewed by an IRB

whether the review may be performed by expedited procedures, and

whether informed consent or its documentation may be waived.

Considerations

The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.

The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

CSUSB Statistical Information for Research

Office of Institutional Research

Ethical Guidelines and Research Items of Interest

AcademyHealths Ethical Guidelines - AcademyHealth is the professional home for health services researchers, policy analysts, and practitioners, and a leading, non-partisan resource for the best in health research and policy. AcademyHealth promotes interaction across the health research and policy arenas by bringing together a broad spectrum of players to share their perspectives, learn from each other, and strengthen their working relationships.
Center for the Study of Ethics in the Professions-Code of Ethics Online (Illinois Institute of Technology) - In June 1996, our Center received a grant from the National Science Foundation to put our collection of over 850 codes of ethics on the World-Wide Web. We are including our codes of ethics of professional societies, corporations, government, and academic institutions. Earlier versions of codes of ethics of some organizations represented are available so researchers can study the development of codes. A literature review, an introduction to the codes, and a User Guide are included. The production of this site was accomplished in collaboration with IIT's Instructional Multimedia Center.
Google Search for Scholars Google Scholar enables you to search specifically for scholarly literature, including peer-reviewed papers, theses, books, preprints, abstracts and technical reports from all broad areas of research. Use Google Scholar to find articles from a wide variety of academic publishers, professional societies, preprint repositories and universities, as well as scholarly articles available across the web. Just as with Google Web Search, Google Scholar orders your search results by how relevant they are to your query, so the most useful references should appear at the top of the page. This relevance ranking takes into account the full text of each article as well as the article's author, the publication in which the article appeared and how often it has been cited in scholarly literature. Google Scholar also automatically analyzes and extracts citations and presents them as separate results, even if the documents they refer to are not online. This means your search results may include citations of older works and seminal articles that appear only in books or other offline publications.
Presidents Council on Bioethics - Advising the President (U.S.) on ethical issues related to advances in biomedical science and technology.
OnlineEthics - This site is the Online Ethics Center for Engineering and Science at Case Western Reserve University. Excellent case materials, readings, and essays provided here.
Office of Research Integrity (ORI) The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science (OPHS) within the Office of the Secretary of Health and Human Services (OS)
Pfau CSUSB Library - Online Database Resources and Search Engines - Available to CSUSB campus users and those with library cards. Off-campus users can purchase a CSUSB library card to use online resources.
Other Agencies and Organizations of Interest
IRB Forum Discussion and News Forum - Promotes the discussion of ethical, regulatory and policy concerns with human subjects research. The IRB Forum strives to create an atmosphere for open and respectful conversation about issues of mutual interest to the members. Although the privacy of e-mail cannot be guaranteed, the members of The IRB Forum should respect the confidentiality and opinions of others on the list. Please review the features, policy and procedures of The IRB Forum before requesting membership. Individuals who fail to abide by the terms of membership are subject to removal from The IRB Forum.
U.S. Food and Drug Administration - FDA advises public on safety concerns related to food and water in addition to, informing the public on recently approved drugs, bioterrorism, medicine, and various other topics related the public safety concerns, federal policies and procedures.
International Federation of Pharmaceutical Manufacturers Associations - The International Federation of Pharmaceutical Manufacturers Associations is a non-profit, non-governmental Organization (NGO) representing, through our member associations, the worldwide research-based pharmaceutical industry and manufacturers of prescribed medicines.
National Institutes of Health - The National Institutes of Health is the steward of medical and behavioral research for the Nation. The NIH comprises the Office of the Director and 27 institutes and centers. The Office of the Director is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all NIH components. NIH headquarters are located in Bethesda, Maryland, and the surrounding area.
PRIM&R (Public Responsibility In Medicine and Research) - Dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. PRIM&R’s conferences, educational programs, and training resources serve the full array of individuals and organizations involved in biomedical and behavioral social/science research.
The Hastings Center: Leading Bioethics into the Future - The Hastings Center is an independent, nonpartisan, and nonprofit bioethics research institute founded in 1969 to explore fundamental and emerging questions in health care, biotechnology, and the environment. The Center's research projects are diverse; recent topics range from genetic paternity testing to newborn screening to palliative care. The work is carried out by interdisciplinary teams that convene at the Center's home, overlooking the Hudson River, to frame and examine issues that inform professional practice, public conversation, and social policy. Brings the best scholarship and commentary in bioethics to members and other readers worldwide.

TUTORIALS ONLINE - Note that these training sites do not meet the CSUSB requirements for training but are for your use to help faculty advisors, research investigator, and staff to understand the importance, requirements, and need in protection of human subjects in research.