• 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.

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.

USEFUL WEBSITES FOR SOCIAL/BEHAVIORAL RESEARCH AND THE IRB

The following websites offer excellent guidance and suggestion 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

RESEARCH IN FOREIGN COUNTRIES

Research conducted in a foreign country is subject to all of the IRB specifications in these guidelines. In certain circumstances, IRB requirements may be modified out of respect for the cultural and local customs of the country in which research is to be conducted. Investigators who seek modification of any IRB requirements must provide appropriate justification to the IRB. The regulations recognize that procedures normally followed in foreign countries may differ from those set forth in 45 CFR 46. In such instances, the Principal Investigator (PI) must show that the procedures prescribed by the foreign institution assure protections that are at least equivalent to those provided in 45 CFR 46 and which are ascribed to by the Northwestern University IRB.

For further information regarding research to be conducted in foreign countries, see letter (h) of the Federal Regulations.

Investigators may contact any of the translation services listed below for assistance in translating consent forms.

AD-Ex Worldwide
www.ad-ex.net
Quotes: translations@ad-ex.net
1-800-223-7753

Burg Translations, Inc.
http://www.burgtranslations.com/
312-263-3379

Corporate Translations
www.corporatetranslations.com/overview.htm
netinfo@corporatetranslations.com
(310) 376-1304 or (310) 376-1394

Northwest Translations Incorporated
www.nwtranslations.com
sales@nwtranslations.com
1-800-270-5620

Multilingual Planet
www.multilingualplanet.com/index.html
E-Mail Contact: info@multilingualplanet.com
1-617-566-7050

INFORMED CONSENT

Informed consent means that subjects should understand the nature of the research, and should be able to knowledgeably and voluntarily decide whether or not to participate in the proposed research. This assurance protects all the parties involved in the research - the subject, whose autonomy is respected, and the investigator, whose intent to conduct research ethically is recorded.

The first internationally recognized document addressing the issue of informed consent and experimentation on human subjects is the Nuremberg Code.

The first principle of the Nuremberg Code states:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
While informed consent is usually written, occasionally it may be obtained verbally in situations in which written consent is deemed culturally disrespectful or inappropriate. Verbal informed consent may also be useful in research involving informal data collection methods. In all cases, the IRB must review in advance the language that will be used in obtaining verbal informed consent. Researchers proposing to obtain informed consent verbally must include a script of the verbal consent language and content with their NPSF. Additionally, it is recommended that investigators keep a log documenting the verbal consent process throughout the duration of the study.

RECRUITMENT/INTRODUCTION LETTER

A recruitment /introduction letter may be used when a waiver of written consent has been granted. This letter typically accompanies a questionnaire but may be an introductory letter to direct someone to a website to respond to a questionnaire; to call if they wish to participate in an interview, or receive a questionnaire in the mail.

Elements of Letter should include the following:
Introduction and Identification of Researcher
Purpose of the research
Where the persons' name was obtained
What will subject be asked to do and how long will it take
Privacy and Confidentiality
Risks if there are any
Agreement to participate voluntarily
Contact Persons and Information

Template with Sample Language
Date
Dear (Give name of respondent):

I am a graduate student working under the direction of Professor (Give the full name of the Faculty Member who is serving as the Faculty Advisor on this project), in the (give Department's name) Department at Northwestern University) or a professor in the Department of (give Department's name) at Northwestern University)

I am conducting a research study to (state purpose of study-e.g., how young people obtain summer jobs in Evanston and what the experience of interviewing for a job is like or your opinion about whether the restaurants in Evanston contribute to the litter problem and what business owners should do about litter.

I obtained your name and address from (describe the source of the name-e.g., the local YMCA teen chapter, or the community directory of recycling club presidents)

I am asking you to participate by (describe what is being asked of the participant. Describe length of time it will take to do the task.)

It will take about 20 minutes to answer the questionnaire that is enclosed. When you are done with the questionnaire, please mail it back in the enclosed self-addressed, stamped envelope.

Your participation in this study is voluntary. If you choose not to participate or to withdraw from the study at any time, there will be no penalty.

The results of the research study may be published, but your name will not be used. [If anonymous questionnaires are completed, include statement that "The questionnaire is anonymous. The results of the study may be published but your name will not be known."].

If you have any questions concerning the research study, please call me [or Professor _____] at ( ) ___-_____.

Return of the questionnaire will be considered your consent to participate.

Sincerely,

Signature
Researcher's name
Address
Phone and E-mail
Signature
Faculty Advisor's Name
Address
Phone and E-mail

Additional Resources

1. Ethical Codes
2. General IRB and Human Subjects Information
3. Federal Agencies and Guidance
4. Northwestern Sites of Interest Related to Research
5. Bioethical Resources on the Web
6. Of Interest to Researchers and Human Subjects Staff and Board Members
7. Special Topics

1. DHHS Federal Regulations Governing Human Subjects
2. Health Insurance Portability and Accountability Act (HIPAA)
3. Guidance from Federal Agencies and Other Organizations
   1. Center for Disease Control
   2. Food and Drug Administration (FDA)
   3. International Conference on Harmonization
   4. Office for Research Integrity (ORI)
   5. Veterans Health Administration (VHA)

1. Ethics Organizations
2. Ethical Codes of Professional Organizations
3. Listserv E-Mail Groups

1. Mandated Reporting-State of Illinois
2. Minors/Emancipation-State of Illinois
3. Human Experimentation Resources on the Web
4. National Clearinghouse on Child Abuse and Neglect
5. Human Genome Project
6. AIDS Confidentiality Act-State of Illinois