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 determined as "exempt" and therefore a waiver request was not necessary.
A waiver of informed consent is NOT normally granted by the CSUSB IRB. There are regulatory requirements that and investigator must meet for the IRB to consider a request to waiver the informed consent. It is the investigators responsibility to provide the IRB with evidence to support a request for waiver of the consent. OHRP (Office of Human Research Protections) requirements for informed consent and for waiver of informed consent are located on the OHRP website below. See section 46.116 of the regulations at OHRP Federal Regulations on Informed Consent and Waiver of Informed Consent
Research Integrity Resources
- World Organization on Research Integrity Singapore Statement
- World Organization on Research Integrity Montreal Statement
Guidelines for Research with Native Americans & Tribal Codes of Conduct
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. 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. z
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
Ethical Guidelines and Research Items of Interest
- AERA Publications - Standards for Reporting on Empirical Social Scienc Research - Provides an excellent advanced overview (which you can simplify for an IRB protocol) in organizing a human participants study protocol and includes topics such as Problem Formulation, Design and Logic, Sources of Evidence, Measurement and Calculation, Analysis and Interpretation, Quantitative and Qualitative Methods, Generalization, and Title Abstracts and Headings. (American Educational Research Association, 2009).
- 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.
- Online Ethics Center - 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.
- On Being A Scientist 3rd Edition - Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine
The scientific research enterprise is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.
On Being a Scientist was designed to supplement the informal lessons in ethics provided by research supervisors and mentors. The book describes the ethical foundations of scientific practices and some of the personal and professional issues that researchers encounter in their work. It applies to all forms of research--whether in academic, industrial, or governmental settings-and to all scientific disciplines.
This third edition of On Being a Scientist reflects developments since the publication of the original edition in 1989 and a second edition in 1995. A continuing feature of this edition is the inclusion of a number of hypothetical scenarios offering guidance in thinking about and discussing these scenarios.
On Being a Scientist is aimed primarily at graduate students and beginning researchers, but its lessons apply to all scientists at all stages of their scientific careers. Retrieved from (On Being A Scientist 3rd Edition, 2009).
- 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.
- Retraction Watch - Retraction Watch follows and reports the latest scientific paper retractions and a good resources for teaching students, staff, faculty and administrators about ethics, responsible conduct of research and research integrity.
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 Conference on Harmonization - The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. See this list of international organizations.
- 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.