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Qualitative Studies/Projects




Helpful Hints for Qualitative Studies/Projects

If you are doing a qualitative research project that uses people, you will have to fill out a Belmont IRB application for approval to do this work. Many sections of the application are completed in the same manner whether your research proposal is qualitative or a quantitative. Listed below are some of the sections of the application that may be different if you are proposing a qualitative study. You will also find some suggestions for completing those sections. An example of a qualitative full review application with an accompanying consent form are also available on the IRB Web site for your reference.

  1. Subjects section:

    Number of subjects
    The total number of subjects can be as few as one person or as many as 20 or more. If you plan to continue recruiting until “data saturation” is obtained and don’t know exact number of participants, try to predict the maximum number and then give a range for number of subjects.

    Controls
    There are many types of qualitative research that do not rely on controls because the study is trying to describe a phenomenon without comparing it to anything else. If this is your case, just leave the question blank or type ‘not applicable.’

    Procedures for subject recruitment
    As in a quantitative proposal, a recruitment script (such as a flyer, letter, or e-mail message) should be attached to the IRB application. This is the script that will be followed when initial contact is made with potential subjects. This should be similar to the consent form, ensuring that potential subjects know that you are asking them to participate in a research project, what you are asking them to do, and that their participation is voluntary.

    If “snowball” recruitment is used, you can provide your initial contact person(s) with an information sheet. The contact person can give the information sheet to people who they think might be interested in participating. These interested parties can then contact you if they are interested. You will need to include a copy of the information sheet in the IRB application.

  2. Description of the research plan section:

    Describe your study design
    State the type of qualitative design that will be used. Examples include (but aren’t limited to) case studies, phenomenological studies and ethnographies. Provide a rationale for using the design. In other words, how does this design help to answer your research question? (See full review application example.)

    Explain your instrumentation and methods
    If you will be using interviews as one of your data collection methods, please provide an interview guide that covers all the topics and areas that you plan to address so that the IRB can see how you have maintained protection of subjects.

    If you will be conducting participant observation, please provide the goal of the observation and your plan for collecting the needed information.

    If you will be conducting internet research, describe how you obtained the data and how you plan to use it. If you are conducting a Web survey, you will need to consider how the participants’ confidentiality, privacy and identity will be protected.

    Data analysis and statistics
    You will likely not have any statistical analysis if you are doing a qualitative study, so instead focus on how you will analyze your data. Describe an analytical strategy (e.g., thematic analyses, content analyses) that is congruent with the type of qualitative design that you will use and provide enough detail so others can understand what you plan to do. List steps (if any) that you plan to take to strengthen the trustworthiness of the study findings. Some examples include investigator triangulation, peer debriefing, creation of an audit trail.

  3. Assessment of risks and benefits section:

    Possible risks
    Because of the emerging nature of qualitative research methods, it is difficult to predict what responses will be elicited from participants when using broad, open-ended questions. Research with vulnerable populations or on sensitive topics may reveal information that is not related to the original purpose of the research. For this reason, the researcher should carefully consider risks, including possible psychological and emotional responses related to the issues (such as embarrassment or nervousness at being interviewed) that might surface.  

    Does this study involve deception?
    If deception is expected, for example in the form of covert observation, it is necessary to show how the participants’ interests are protected and the rationale for using this type of data collection.

  4. Confidentiality and data management section

    Subject confidentiality
    Data collection in a qualitative study may make anonymity impossible. Small sample sizes and thick descriptions can present problems with confidentiality. Consider carefully how you will protect the confidentiality of all participants and then describe your plan.
    If other independent researchers will be asked to read the raw data to establish confirmability or if findings will be returned to participants to validate the interpretations of the interview, participants need to be made aware by including this information in the consent form. Participants should know who will have access to their information.

    Data confidentiality
    When describing how you will keep participants’ information confidential, consider all information that you plan to collect, such as interviews, diary, field journals, memos, logs, video/audio tapes and describe how you will maintain confidentiality of these data.

  5. Informed consent section

    How often will consent be obtained?
     As in quantitative research proposals, informed consent must provide the purpose and scope of the study, types of questions that will be asked, how the results will be used, and how anonymity will be protected so that subjects can decide whether or not they want to participate. The emerging nature of qualitative research methods may require a change in one or more of these decisions. If there are significant changes from the original research plan, informed consent may need to be re-obtained so that the participant can be fully informed and decide to continue participation or not. Approval through the IRB of a revised informed consent form would be necessary before re-obtaining consent (see the New Findings section in the parental consent form as an example).



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