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Ethical Review/IRB

Most universities now require ethical review of research studies which involve human subjects (and even if your university does not require it, considering matters ethical can improve your study). Completing the forms required for ethical review however, can be confusing; review application/proposal forms designed to be appropriate for one research design may not be an exact match for another research design. Where the Grounded Theory research method is being used it is often difficult for the applicant to work out how to answer the questions – and difficult for reviewers to assess the review application/proposal. Dr. Odis Simmons of Fielding Graduate University, prepared some guidelines for reviewers at his university on how to assess a Grounded Theory Institutional Review Board (IRB) proposal and is kind enough to share them below. Naturally whilst interested in similar issues (including safeguarding the interests of research participants), different universities in different countries will have different questions to those asked by Fielding (and listed here). The material below is therefore unlikely to provide the exact answers that are required for your organisation's IRB/ethical review board; it may, however, provide you with ideas as to what might be an appropriate approach for you to take when reviewing or applying for ethical review.

Grounded Theory Guidelines for IRB reviewers at Fielding Graduate University

[IRB (Fielding Graduate University)form questions not included should be answered similarly to any other research approach]

1. Provide a brief description of the background and purpose of your research (this is your abstract). Avoid using technical terms and jargon. This should be no more than 350 words, and may only be a paragraph.
To avoid preconception, Grounded Theory studies expressly do not begin with predetermined goals or purposes beyond generating an explanatory theory directly from data. Research begins with only a general topic area. The specific topic is what the data indicates is relevant to participants, not the researcher. Once an explanatory theory emerges from the data it will provide theoretical foothold that individual scholar-practitioners and change agents can carry out within their own professional/personal interests, opportunities, and values. 

It is appropriate for Grounded Theory IRB applicants to discuss the whys and hows of their interest in the general topic area, but anything beyond that is to be avoided as a preconception.

2. Provide a brief description of the basic research question/issue.  Avoid using technical terms and jargon. This should be no more than one page, and may be only a paragraph.
To avoid preconception, Grounded Theory studies are required to begin without any pre-formulated research questions and/or hypotheses. Grounded Theory studies begin with only a general topic area. If, as is often but not always the case, the initial data is derived from an open-ended interview, the interview is initiated with a “grand tour” question. A grand tour question is a broad open-ended question related to the general topic area. A grand tour question is designed merely to prompt the participant to respond to the general topic, on their terms. Subsequent questions are derived from previous responses so that the participant always leads the interview. Grand tour questions are modified for each interview, according the purposes of the interview, as indicated by theoretical sampling. As defined by Glaser & Strauss (originators of the Grounded Theory method), “Theoretical sampling is the process of data collection for generating theory whereby the analyst jointly collects, codes, and analyzes his data and decides what data to collect next and where to find them, in order to develop his theory as it emerges” (Glaser & Strauss, The Discovery of Grounded Theory, 1967).

3. Provide a description of the design and procedure of your research. Avoid using technical terms and jargon. Be sure to describe all activities that participants will engage in and the total time required. Also, at each step in the procedure that you describe, list all of the means you will use to collect data during that step in the procedure (e.g. instruments, measures, tests, questionnaires, surveys, interview schedules, focus group questions, observations).
Grounded Theory is the research design.  Although Grounded Theory research can begin with any data source, typically initial data are gathered through open-ended interviews and/or open-ended naturalistic observation. These typically last about an hour. Ordinarily, at the end of an interview if it appears that the participant may have more of relevance to say, permission to request a follow up interview is sought, at the participant’s discretion and if the analysis of the first interview indicates it would be beneficial to the emerging theory. Subsequent data collection is determined by theoretical sampling. In Grounded Theory everything relevant to the general topic area is considered data that can be analyzed using the constant comparative method of analysis.  Grounded theory is emergent.  Once the research begins, every future step is determined by what is being discovered in the data.

3a. Provide a listing that has the name followed by a short description of the tests, instruments, or measures and attach copies of instruments and questionnaires for review. For some well-known instruments, it may not be necessary to send a copy – please check with the IRB for final determination.  
The only time data that was derived from a research instrument would be used in a Grounded Theory study would be from an already existing external source. Such instances would be rare because research instruments require preconception, which is inconsistent with Grounded Theory.

5. Does the proposed research require that you deceive participants in any way?  If your response is “yes,” describe the type of deception you will use, indicate why it is necessary for this study, and provide a copy of the debriefing script.
There is nothing in Grounded Theory that requires or allows deception.  This question should always be answered, “no.”

9. Indicate the total number of participants you plan to include or enroll in your study.  
The total number of participants in a Grounded Theory study cannot be known in advance.  It is determined by “theoretical saturation,” which occurs when data and analysis no longer yield new variations, concepts, or categories.  This can be vastly different with each individual piece of research.

11. Name and/or describe the site(s), location(s), or organization(s) from which you will recruit participants. Please attach any permission request letters you intend to send to the site(s). 
Following the initial data collection and analysis, participants will be selected according to theoretical sampling, so other than the initial location there is no way to know locations and organizations in advance.  Of course, if there is a specific location or organization from which the first interview or other data will be collected, the proposal should include this.

12. Describe the process you will use to recruit participants and inform them about their role in the study.  Please attach copies of advertisements, flyers, website postings, recruitment letters, oral or written scripts, or other materials used for this purpose. If you use a nomination process, indicate how you will advise participants about who nominated them. If relevant, describe how you will ensure voluntary participation free from coercion.
Other than the first or sometimes first several participants, how participants will be recruited cannot be know in advance.  This depends upon where theoretical sampling leads data collection. Participants are invited to participate in a non-coercive way and requested to read and sign an informed consent form.  If relevant to an individual research project, the other components of this question should be addressed.  

13. Describe the inclusion and exclusion criteria and how these will be sensitively communicated to potential participants. What will you say to potential participants who do not meet your inclusion criteria? Please attach copies of any letters or scripts you will use to exclude potential participants.
Participants may include anyone who might have something to offer that is relevant to the general topic area. Initial participants are usually selected based upon opportunity. Future participants are selected entirely through theoretical sampling. Thus, selection criteria are contingent upon the emerging theory and cannot be predetermined.  
Consistent with theoretical sampling, participants are selected according to their potential relevance to the emerging theory. Thus, exclusion is not relevant. Data collection ceases when the analysis reaches “Theoretical saturation” (The point at which data and analysis no longer yields new variations, concepts, or categories).

14, 15, 15a, and 15b. re risks.
The epistemologal integrity of a Grounded Theory study is dependent upon participants at all times being in complete control of what they say and do. The researcher can do nothing to interfere with this without ungrounding their study/theory. Procedures are built into the method to assure that this doesn’t occur. Thus, although it is extremely unlikely discomfort would occur, whatever discomfort a participant may feel would be entirely by their choice. Furthermore, they retain complete control over what course of action to take to avoid or relieve any discomfort.

15c. Referrals for participants experiencing distress
Participants are always in complete charge of the conditions of their participation. If in the highly improbable event a participant were to ask the researcher for a recommendation for referral they would be referred to an appropriate professional.

18. Describe the steps you will take to address the confidentiality and/or anonymity of the participants and data.  Indicate how you will safeguard data that includes identifying or potentially identifying information (e.g. coding).  Indicate when identifiers will be separated or removed from the data. Also, indicate where and how you will store the data and how long you plan to retain it.  If you are going to dispose of the data, describe how you will dispose of it (e.g. erasure of tapes, shredding of data).
Grounded Theory focuses on patterns of behavior not individual people. As such, the only purpose for identifying individual data sources would be for contact purposes in case of a follow-up interview. Once this need has passed, there is no need to associate names with interviews. Interviews can be identified with a number. In a Grounded Theory write-up short quotes from the data (e.g., an interview or field notes) may be used to illustrate a concept. Individuals or any type of identifying information are never connected to quotes. As with all types of research, all field notes and interview transcripts must be kept under lock and key, accessible only to the researcher.

© Odis Simmons, 2009