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What's New General Information eIRB Templates <NU Investigators VA Investigators Policy Manual / Member Handbook Committee Lists / IRB Meetings Research Subject Information Education and Training HIPAA IRB ListServe SSBS Information |
SOCIAL AND BEHAVIORAL SCIENCES INFORMATION If you are new to Northwestern..... We are revamping this page to provide information of special interest to social and behavioral science researchers. Please contact Erik Kjeldgaard if you have any suggestions or requests for information that we should include. The deadline for submission of full review projects will now be three weeks prior to our meeting dates. A calendar of 2008 and 2009 IRB meeting dates including those for Panel E appears here: link All social and behavioral science projects must go to our social and behavioral sciences panel, Panel E, for review. Panel E members have the appropriate expertise to review social behavior studies that include medical procedures.
USEFUL WEBSITES FOR SOCIAL/BEHAVIORAL RESEARCH AND THE IRB The following websites offer excellent guidance and suggestions regarding social/behavioral research methods using human subjects, risks and benefits of social/behavioral research, definitions, ethical codes and the IRB. The National Institutes of Health offers helpful information in the Protection of Participants in Behavioral and Social Science Research to further assist in determining whether your social/behavioral research qualifies for IRB review and approval. The National Science Foundation (NSF) provides information related to the common rule in the form of a Frequently Asked Question and answer website. The American Anthropological Association provides excellent definitions, guidelines and information regarding ethnographic research. The American Anthropological Association also has an excellent code of ethics related to IRB issues. The American Sociological Association highlights the ethical considerations in conducting research involving human subjects and the issue of informed consent. The Oral History Association offers guidance and information regarding IRB review and oral history. The American Psychological Association ethics code lists five ethical principles for conducting psychological research. The American Political Science Association offers a guide to professional ethics in political science. The American Research Education Association provides a document on activities related to human research protections. The Declaration of Helsinki provides recommendations guiding medical doctors in biomedical research involving human subjects. The Consortium Of Social Science Associations (COSSA) Washington Update # 20 provides information on the Human Research Participants Protections . If you are uncertain or have questions regarding whether social/behavioral research requires IRB review and approval, please review the federal regulations regarding the protection of human subjects, or contact our office. Office for the Protection of Research Subjects Phone: (312) 503-9338
For additional information regarding
For additional information regarding:
RECRUITMENT/INTRODUCTION LETTER 1. Ethics Organizations PRIM&R Public Responsibility in Medicine and Research AAMC American Association of Medical Colleges--AAMC Research Compliance Resources 2. Ethical Codes of Professional Organizations American Anthropological Association American Educational Research Association American Folklore Society American Political Science Association American Psychological Association American Sociological Association 3. Listserv E-Mail Groups The IRB Forum: The IRB Forum promotes the discussion of ethical, regulatory and policy concerns with human subjects research. The IRB Forum is open to past and current members of Institutional Review Boards (IRB) or Research Ethics Committees (REC), IRB/REC administrators, individuals involved in IRB/REC oversight and others with professional involvement in IRB/REC and/or research activities. Others will be admitted if their involvement in human subjects research will contribute to the discussion of issues pertinent to The IRB Forum. Go the website to sign up for the Forum. OHRP Listserve: The Office for Human Research Protections (OHRP) has created a LISTSERV in order to provide interested individuals with information regarding human subject research protection, and upcoming educational workshops and other programs. Go to the website for information on how to subscribe. C. Special Topics top ^
2. Minors/Emancipation - State of Illinois 3. Human Experimentation Resources on the Web 4. National Clearinghouse on Child Abuse and Neglect Information 5. Human Genome Project 6. AIDS Confidentiality Act-State of Illinois
Affiliates Information
Northwestern and Affiliate Sites Related to Research Northwestern's Federalwide Assurance number is: FWA00001549. Social Science The Office for the Protection of Research Subjects' IRB consists of trained professionals dedicated to protecting the rights and welfare of human research subjects. The IRB engages in assisting investigators and the NU research community at large to achieve compliance with all federal, state and institutional regulations including the minimization of risk to the human research subject. This also includes social/behavioral research involving human subjects. Social and behavioral science research encompasses a variety of disciplines including, but not limited to, anthropology, sociology, psychology, political science, education, social work, art education and history, theatre, and, music. Much of this research uses qualitative research methods such as formal and informal interviews, participant observation, questionnaires, surveys, focus group discussions, oral history, ethnographic research, program evaluation and collection or study of existing data, documents and records. These research methods are used to measure beliefs, behaviors, attitudes, and responses, or evaluation of the effectiveness of particular programs or instructional methodologies. However, the research must still be carried out with due consideration of the Ethical Principles regarding research involving human subjects. According to federal regulations all social/behavioral research involving human subjects as defined below must be reviewed and approved by an Institutional Review Board (IRB) prior to initiation of the research project to assure that the rights and welfare of human subjects are protected. Additionally, all investigators including faculty and students must complete the required Human Subjects Protection Training for Social/Behavioral Research prior to initiation of research involving human subjects. A Human Subject is a living individual about whom an investigator (professional or student) conducting research obtains: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. Minimal risk is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals, or in the routine medical, dental or psychological examination of healthy individuals. All projects involving special populations as subjects, such as children (less than 18 years of age), prisoners, individuals with physical or mental disabilities, economically or educationally disadvantaged persons, institutionalized individuals, pregnant women, or fetuses require additional protections. Appropriate precautions must be taken to ensure the confidentiality of the research subjects. ETHICAL PRINCIPLES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH
Every person has the right to determine what shall be done to him or her, what activities he or she shall engage in and what risks he or she will take. Consequently, research on human subjects cannot be carried out without the subjects' competent, voluntary and informed consent. ¤46.111 CRITERIA FOR IRB APPROVAL OF RESEARCH.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. Categories Exempt from Panel Review:
Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:1 See the Social/Behavioral Timeline for further information. |
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Mailing address: Office for the Protection of Research Subjects : Rubloff Hall, 7th Floor, 750 N. Lake Shore Drive, Chicago, IL 60611-3078 Chicago: (312) 503-9338 .:. Evanston: (847) 467-1723 .:. Comments: irb@northwestern.edu Last modified 10/22/08 .:. World Wide Web Disclaimer and University Policy Statements | © 2007 Northwestern University |
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