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Loyola University Chicago

Department of Sociology

Navigating the Institutional Review Board (IRB)

Resources, Samples and Practical Advice

BE INFORMED

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.

Resources

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!

CONSENT FORMS/PROCEDURES

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.)

MISCELLANEOUS.

 

[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?

  1. Is form written in second or third person with an educative tone?
  2. Is form organized into appropriate sections or paragraphs so that information can be easily followed?
  3. Is form readable in language that could be understood by the potential participants?
  4. Is all information in the form consistent with information in the research protocol?
  5. 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:

Loyola

Department of Sociology
Loyola University Chicago
1032 West Sheridan Road
Chicago, Illinois 60660
Tel: (773) 508-3445
Fax: (773) 508-7099

Notice of Non-discriminatory Policy