Navigating the Institutional Review Board (IRB)
Resources, Samples and Practical Advice
Conducting your research in a sound ethical manner is a professional responsibility. However, it might be helpful to keep in mind that navigating university Institutional Review Boards is also a mandatory bureaucratic process (the university may refuse to accept your work for the degree if you have not received the appropriate approvals).
Complete the required on-line course before drafting your IRB application materials.
Do everything possible to submit complete and polished materials to avoid unnecessary delays.
- ASA "Code of Ethics"
- Office of Human Subjects Research (OHSR), Health and Human Services (Scroll down page to section titled Human Research Protections)
- The Belmont Report
- Smart QandA. "What are the ethical guidelines for a human research subject?"
- Loyola's IRB Handbook
- Singer, Eleanor and Felice J. Levine. 2003. "Protection of Human Subjects of Research: Recent Developments and Future Prospects for the Social Sciences." Public Opinion Quarterly 67:148-164.
- American Association of University Professors. "IRBs and Social Science Research."
- Brainard, Jeffrey. 2001. "The Wrong Rules for Social Science? Scholars say U.S. Human-Subjects Protections, Designed for Medical Studies, Hinder Vital Work." The Chronicle of Higher Education (March 9): A21-A23. (Text Available On-line in Full Text Journals)
- Shea, Christopher. 2000. "Don't Talk to the Humans: The Crackdown on Social Science Research." Lingua Franca (September, v 10, no. 6)
- Thorne, Barrie. 1980. "You Still Takin' Notes?: Fieldwork and Problems of Informed Consent." Social Problems 27:284-297.
USE THE EXPEDITED REVIEW PROCESS
Many fieldwork projects may qualify for exemption. However, many multiple methods research projects (e.g., fieldwork and audio-taped in depth interviewing) will need to be submitted for expedited review.
"Fieldwork, or ethnographic research, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time. Since fieldwork is a research process that gains shape and substance as the study progresses, it is difficult, if not impossible, to specify detailed contents and objectives in a protocol.
After gaining access to the fieldwork setting, the ongoing demands of scientifically and morally sound research involve gaining the approval and trust of the persons being studied. These processes, as well as the research itself, involve complex, continuing interactions between researcher and hosts that cannot be reduced to an informed consent form. Thus, while the idea of consent is not inapplicable in fieldwork, IRBs and researchers need to adapt prevailing notions of acceptable protocols and consent procedures to the realities of fieldwork. IRBs should keep in mind the possibility of granting a waiver of informed consent." OHRP's Institutions Review Board Guidebook, Ch. 5).
USE THE EXPEDITED REVIEW PROCESS
Many, probably most, of your research projects will be eligible for expedited review. IRB applications submitted through the expedited review process are more likely to be approved smoothly and quickly (i.e., they are reviewed by a subcommittee of three board members rather than the full board). Projects are eligible for expedited review when: they pose no more than "minimal risk," do not involve "vulnerable populations" or potentially coercive researcher-participant relationships, and use approved low-risk procedures (e.g., interviews, observations). (See Loyola's IRB Handbook for specific guidelines).
For example, an interview-based study with adults about everyday legal activities (e.g., work experience, parenting, and community-involvement) would be eligible for expedited review.
CRAFT YOUR MATERIALS CAREFULLY
Your IRB application should be complete, but not excessive. Remember, sometimes less is more! Be sure to address all of the main substantive questions on the IRB. (See the Departmental IRB Ring-Binder located in the Lopata Graduate Lounge for sample IRB Applications).
Be honest in your application, but do not raise unnecessary red flags. For example, if you are interviewing parents about child rearing practices, you can say that you will be sensitive to potentially stressful topics that arise. However, don't imagine the worst (and most unlikely things) that could happen and put it in your application. For example, don't say "If the mother confesses to having drowned five of her previous children in the bathtub, I will advise her to turn herself into the police." If it is a minimal risk study, present it honestly as one.
Drop the jargon. Write for an educated lay audience. The IRB is composed of professionals and community members from many different disciplines. Don't assume members will be familiar with disciplinary specific terms, theories, or debates.
Be consistent. If you are attaching a research proposal (e.g., a dissertation proposal) to the application, be sure that the application and proposal documents are consistent. For example, if you say an interview will take one hour in the proposal and consent letter, make sure it says one hour in the application!
- INTERVIEW SCHEDULES. If your study involves interviewing, spend sufficient time developing a well thought out interview schedule (see the Departmental IRB Ring-Binder for sample interview schedules). What domains or topic areas will you cover? In most cases, the Board simply wants to see that the interview topics to be addressed are minimal risk. You should also include a statement such as "These are sample questions that will guide the initial interviews. New questions of a similar nature may be added as the interview process evolves." (See also Weiss, Learning from Strangers ).
- PARTICIPANT-OBSERVATION: Outline the general types of interactions or settings you will observe and record in your fieldnotes. Be honest, but show the Board that what you are proposing is minimal risk. For example, if you are observing the regular meetings of a volunteer organization, you may want to note that you will be observing and taking notes on "naturally occurring interactions and conversations between volunteer leaders, volunteers, and clients of the organization." You should also assess privacy and confidentiality issues for your setting. Will the data be collected anonymously (e.g., public behavior at the zoo), confidentially (e.g., volunteer behaviors and conversations at the soup kitchen, but using pseudonyms), or identifiably (e.g., Board of Education members). How will you gain consent in these situations? Will you use a verbal consent script? An informational letter? (See Departmental IRB Ring-Binder for samples).
- Interview Projects: PLEASE COPY THE BOILER-PLATE LANGUAGE FROM THE SAMPLE CONSENT FORM BELOW. Of course you will need to tailor sections of the consent forms to your particular study, but there is no need to write the consent form from scratch. The consent form is both an educative and a legal document. We know that nationally most IRB applications are returned to the researcher solely for changes to the consent form/procedures. Strive to "get it right" the first time. There will be exceptions, but many of your interview-based projects will fit this model. (See Consent Form Checklist).
- Participant-Observation Projects: In many fieldwork settings, getting participant consent is not a one-time event. You should strive to provide meaningful opportunities for participants to consent or opt out of your research observations. Be thoughtful about how you will achieve this goal. For example, if there is an official director or leader (e.g., at a non-profit volunteer organization), you may wish to seek a letter of support for your observational research work. My advice: write the letter for the "gatekeeper" and ask for a signature. It makes their work lives easier, and in the long run, yours too (see the samples in the Departmental IRB Ringer Binder). You should seek opportunities to announce/explain your researcher status/role to those you intend to observe. You might post and/or publish a notice explaining your research and your researcher role (see samples). You should think through how you will alert new-comers to your research role and seek their consent. While we should not have to wear " Warning: Researcher--Do Not Approach " t-shirts, we should seek consent from participants in meaningful ways. When participants opt out of research, respect their wishes by excluding them from your notes.
- Recruitment Letters and Fliers: If your recruitment procedures involve written materials to be distributed or posted, create these documents with care and flair. They should be clear of typographical errors and misspellings. They should be ready to post.
LEAVE ADEQUATE TIME FOR YOUR ADVISOR TO REVIEW YOUR MATERIALS
Submit your IRB application and supporting materials to your advisor/mentor at least a week or two in advance of the university IRB deadline. DO NOT expect to walk in, get a signature, and submit to the IRB on the same day. Expect to revise your application. (You might further facilitate the process by asking a peer/colleague to read and comment on your IRB materials--even if it is simply a proofread--before submitting to your faculty advisor/mentor.)
- Know the difference between confidentiality and anonymity and which you are promising (In most cases, you will be talking about "confidentiality").
- The single most common risk in most of sociological research is breach of participant confidentiality. Have clear guidelines for protecting your participants' confidentiality. How will you handle tapes, interview transcripts, and consent forms? (In many cases, sociologists have been promising to destroy/erase tapes at the end of the project.) How will you protect confidentiality in publications and presentations? Will you use pseudonyms? Will you store consent forms separately from interview transcripts? Will transcripts be "cleansed" of identifiers?
- Don't make promises you will later regret (For example, DO promise to clean data of identifying information. DO NOT promise to destroy your transcripts or data).
- Do include contact information, but be careful that you don't open yourself up to unwanted calls/attention on your home phone line. Do include your university address and e-mail if it is useful.
[SAMPLE CONSENT FORM - PLEASE TAILOR FOR YOUR RESEARCH.]
CONSENT FORM (print this form)
POJECT TITLE: TEMPORARY CARE: TRAVELING AND AGENCY NURSES
You are being asked to participate in a [DISSERTATION/MASTERS THESIS/CLASS] research project being conducted by [RESEARCHER NAME] at Loyola University Chicago, Department of Sociology and Anthropology.
The purpose of this research is to learn more about temporary (traveling and agency) nursing. The researcher will be interviewing approximately 50 people familiar with temporary nursing employment, including temporary nurses, full-time staff nurses, hospital administrators and temporary agency personnel. The interview will take place at the researcher's office or at another mutually agreed upon location. It will take one to two hours, depending on your situation.
If you agree to participate, you will be asked questions on your educational background, work history, and work experiences. Your interview will be audio-taped and the tapes will be stored in a locked file cabinet in the researcher's office. To ensure your confidentiality all interview consent forms will be kept in a separate locked storage cabinet, to which only the researcher has access. Your name and identity will not be used in the work; pseudonyms will be used in all writings, publications or presentations to further protect your confidentiality. After the research project is completed, all the audiotapes will be erased.
The interview is completely voluntary and you may refuse to answer any questions at any time or withdraw from participation completely without penalty. Furthermore, you may interrupt to ask questions concerning the research or research procedures at any time.
The study is designed to learn about the experiences and views of people in general and not to benefit you personally. If you agree to participate, you will be adding to the body of knowledge about the experiences and needs of professional workers in temporary employment arrangements.
If you have any questions about this research study, you may contact the researcher, [STUDENT NAME] of Loyola University at [EMAIL ADDRESS OR WORK PHONE NUMBER] or the researcher's faculty advisor, Dr. [FACULTY ADVISOR NAME] of Loyola University at [(773) 508-XXXX.] If you have questions about your rights as a research participant, you may contact Loyola University 's Research Compliance Manager at (773) 508-2689.
Your signature below indicates your consent to participation in this research project.
Signature of Investigator Date:
Signature of Interviewee Date:
CONSENT FORM CHECKLIST
Is form written in second or third person with an educative tone?
- Is form written in second or third person with an educative tone?
- Is form organized into appropriate sections or paragraphs so that information can be easily followed?
- Is form readable in language that could be understood by the potential participants?
- Is all information in the form consistent with information in the research protocol?
- Are all of the following included?
- Introduction of researcher
- Explanation of purpose of study
- Description of all research activities required of participants
- Explanation of how long the project will last and what kind of time commitment is required of participants
- Description of any potential risks and/or benefits of the study (If no direct benefit, provide a statement to this effect)
- Statement that participation is completely voluntary; that the refusal to participate in any part of the research will involve no penalty.
- Statement that potential participants may withdraw at any time without penalty.
- Contact person and telephone number should participants have questions about the research.
- Telephone number of Loyola's Compliance Manager (773) 508-2689 should participants have questions about their rights as research participants.
- A final consent statement ( e.g., "Your signature below indicates your consent to participation in this research project.")
- A place for participants to sign and date the consent form.
- Proper pagination (if form is more than one page long).
If appropriate, include:
- Statement that the project is being done for thesis or dissertation research.
- Faculty sponsor name and contact information.
- Statement about limits to confidentiality (e.g.,. if researcher is a mandated reporter).
- Information about audio or video taping and final disposition of tapes.
- Information about compensation (if any) for participation.
- Information about how to return form (if not signed in researcher's presence).