Social and Behavioral Sciences Information

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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. If you are new to Northwestern, please see our Welcome Letter

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

NEWS FOR SOCIAL AND BEHAVIORAL SCIENCE RESEARCHERS

Guidance on exemption category 2, data security for international researchers, and upcoming conversion of paper projects to the eIRB system.

1) Guidance on types of research approvable under exemption Category 2

Exemption category 2 provides for exemption of several types of research unless the data collected is both identifiable—that is, if someone could connect it to research participants—and if it could be potentially harmful to participants if compromised. The criteria of risk and identifiability are important, but it is equally important to note that the regulation in question on permits exemption for a limited number of data collection methods. Note that for research to be exempt under this regulation, it must first be determined that the research methods used include only methods listed in the regulation, specifically, “educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.”

Note that “educational tests” must be understood narrowly. Procedures which are not educational may not be exempt under this clause of the regulation. This means that cognitive measures or diagnostic instruments, for example, may not be exempt under this regulation unless they are somehow “educational.” Submit research that uses these kinds of procedures and is of no greater than minimal risk for expedited review.

2) Guidance on data security and US Border Searchers

Several groups have drawn attention to the practice of seizure of laptops and data downloading practiced at US border crossings.

A letter to the Department of Homeland Security from the president of the American Anthropological Association is here:

http://www.aaanet.org/issues/AAA-Letter-on-Homeland-Security-Searches.cfm

The following are links to additional media coverage:

“Expanded Powers to Search Travelers at Border Detailed” Washington Post, 9/23/08

“Search and Replace” [editorial], Post, 8/13/08

“US Border Agency Says It Can Seize Laptops” PC World, 8/3/08

“Travelers' Laptops May Be Detained At Border: No Suspicion Required Under DHS Policies” Washington Post, 8/1/08

Research projects that involve data collection outside the United States should address the question of transport of data back into the country and should incorporate procedures to avoid data compromise should computers or data storage media or devices be confiscated at the border.

3) Conversion of Paper Projects to eIRB

We have converted all full review social and behavioral science projects to the eIRB system and will be immediately moving on to convert expedited projects. Projects will be converted in order of IRB project number. PIs will receive an email about their projects prior to the beginning of the conversion, at which point no modifications can be made to the project until the IRB conversion process is completed. Projects that are due for continuing review within six weeks will have conversion delayed until the continuing review is completed.

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
Institutional Review Board
Rubloff Hall, 7th floor
750 N. Lake Shore Drive
Chicago, IL 60611

Phone: (312) 503-9338
FAX: (312) 503-0555
irb@northwestern.edu

Additional information regarding:
Research in Foreign Countries
Informed Consent
Recruitment/Introduction Letter

A. Bioethical Resources on the Web top ^

www.nih.gov/sigs/bioethics/IRB.html

B. Of Interest to Researchers and Human Subjects Protections Staff and Board Members top ^

Ethics Organizations
PRIM&R Public Responsibility in Medicine and Research
AAMC American Association of Medical Colleges--AAMC Research Compliance Resources
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
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 ^

D. Northwestern and Affiliate Sites Related to Research top ^

Office for Research (Vice President's Office) (OR)
Office of Clinical Research and Training (OCRT)
General Clinical Research Center (GCRC) located at Northwestern Memorial Hospital
Office for Research Safety (ORS)
Office of Sponsored Research (OSR)
Accounting Services for Research and Sponsored Programs (ASRSP)
Northwestern Memorial Hospital Research Office
Rehabilitation Institute of Chicago Research Office
VA Chicago Healthcare System Research Office
Carol Lane, ACOS
Carol.Lane2@med.va.gov
312-569-6166
PI Guide (pdf), PI Guide (MS Word)
Childen's Memorial Hospital Research Office

Affiliates Information

The following organizations are affiliated with the IRB:

Northwestern Memorial Hospital (NMH)
Northwestern Memorial Physician’s Group (NMPG)
Northwestern Memorial Home Health Care (NMHHC)
Northwestern Medical Faculty Foundation (NMFF)
Rehabilitation Institute of Chicago (RIC)
VA Chicago Health Care System

Northwestern and Affiliate Sites Related to Research

Northwestern's Federalwide Assurance number is: FWA00001549.

Anyone wishing to verify compliance can do that at the Office for Human Research Protections (OHRP) website by clicking here.

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. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45CFR 46.102(d)).

A Human Subject is a living individual about whom an investigator (professional or student) conducting research obtains: data through intervention or interaction with the individual or identifiable private information (45 CFR 46.102 (f)).

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. Social/Behavioral Research must also apply the Ethical Principles which guide the protection of human subjects of research, especially when subjects are exposed to more than minimal risk.

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. No person should be placed at risk as a subject of research unless the risks are reasonable in relation to the anticipated benefits of the research. The risks and burdens to subjects should not be unjustly distributed. The recruitment and selection of subjects should be reasonably related to the research and should not impose inequitable risks and burdens on any segment of society. Special consideration and protection should be given in research to persons who may lack full capacity to secure their own rights and interests, due to age, mental capacity, involuntary custody, cultural barriers or other special circumstances.

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. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by ¤46.116. Informed consent will be appropriately documented, in accordance with, and to the extent required by ¤46.117. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

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 Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

See the Social/Behavioral Timeline for further information.