UCSD Human Research Protections Program



|Introduction to the Qualitative Research Template |

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|Proposals that are primarily composed of qualitative methods (for example research in the field, phenomenological of ethnographic research |

|proposals) may not fit a traditional research design or Institutional Review Board (IRB) process. Still, from the standpoint of federal regulation|

|and professional ethical codes in the social sciences, the same principles and guidelines for protection of the rights and welfare of |

|subjects’/research participants applies. This document is designed to help you as the researcher identify and explain the study characteristics |

|needed for the regulatory review of Qualitative Research projects. It is the investigator’s responsibility to determine the type of research, the |

|methods, analysis, etc. |

| |

|Qualitative research presents special challenges to investigators as it can be difficult to accurately describe the nature of the research. The |

|IRB appreciates that qualitative research has the following special characteristics (Atwood, T., and McGough, H., 2007 PRIM&R SBER Conference): |

|It is experiential, |

|It is interactive, |

|It is not easily bounded by time and place, |

|It is often exploratory, |

|It morphs easily and often (new questions emerge during research), |

|The boundaries between normal activities and communication and data collection are blurred. |

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|Additional resources are included in the appendices. Appendix 1is a table of risk and harm and mitigation strategies for the study population and |

|during data collection/analysis. Appendix 2 provides notes to the IRB Reviewer. |

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|Maine Medical Center Institutional Review Board |

|Qualitative Research Protocol |

|1. Project Title |

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|2. Principal Investigator, Key study Personnel, Faculty Advisor, Supervisor |

|Describe qualification, training and roles of each study team member, including primary institution/affiliation. |

|3. Background/Significance (2-3 paragraphs maximum) |

|Provide the context for your study, including summarizing prior work done by others and yourself in your proposed area of study. Provide rationale for why the project |

|is important. Identify the gaps in knowledge that your study will address. Detail how the study will contribute to your field of inquiry. |

|4. Research Question |

|Succinctly describe the purpose of the proposed project and detail the specific objectives or questions to be answered. |

|5. Estimated duration of data collection |

|Describe the anticipated length of time you will be collecting data to answer the research question(s). Depending on the qualitative approach, researcher interactions |

|with the participants may differ in order to ensure adequate data collection. Please justify, in the context of your qualitative approach, the approximate length of |

|time of interaction with subjects (e.g. 2 hour interviews, day-long observation) and the number of anticipated interactions (e.g. 3 interviews over a 4 month period). |

|Please be sure to account for start and stop dates of data collection as appropriate and any anticipated need to modify procedures in response to evolving study |

|findings. |

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|If you plan to go back to speak with participants to validate and/or further understand your findings, then please account for the time needed do so. |

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|An amendment must be submitted to the IRB if actual durations exceed those estimated as detailed in this application. |

|6. Participant Population/Research Setting |

|In certain types of qualitative studies, including ethnographic studies or those involving observation or shadowing, participants may not be clearly defined (i.e. if a |

|question is focused on a setting or process instead of individuals or a discrete population.) However, in such cases potential participants should be described and any |

|vulnerable populations should be identified as such. |

| |

|If the qualitative method allows, describe the population or group of people who you propose to enroll in your study. Provide the rationale for choosing this group of |

|subjects and list the inclusion or exclusion criteria that you will apply in selecting study participants (e.g. age, gender, race, clinical status, social or cultural |

|context). |

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|If the research method allows, describe the sampling strategy in context of study design. If study design relies on saturation (i.e. when there is enough data to ensure|

|the research questions can be answered) to determine recruitment/end of data collection, include criteria to determine saturation. If study design requires |

|representative sampling (i.e. a small number of participants purposely chosen to represent the larger population), describe how these participants are to be chosen. |

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|If accessing protected health information for screening or recruitment purposes and this information includes any combination of the 18 HIPAA identifiers , you must |

|complete the “Submission Form: Request for Waiver/Alteration of Consent and/or HIPAA Authorization” before obtaining consent and HIPAA Authorization from subjects. |

| |

|If applicable, describe how participants will be recruited to participate in the study. Copies of all recruitment materials should be submitted with application |

|(examples include posters, sample email solicitations, or verbal scripts). Recruitment materials must include basic information about what participation involves (for |

|example, thirty-minute interview); what topics are being investigated; and identify that the study is research and participation is voluntary. |

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|If the qualitative approach allows, provide the anticipated number of participants that you will enroll in your study, both for the group as a whole and within each |

|subgroup, if applicable. The IRB recognizes this as an estimate, which is affected by many factors that may be outside the researcher’s control. An amendment must be |

|submitted to the IRB when /if actual numbers enrolled exceed those estimates. |

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|Researchers should also recognize power imbalances may impact the validity of data collected, as when participants could reasonably be expected to hide information |

|relevant to that imbalance. For example, participants may exaggerate work performed or minimize mistakes made if interviewed by their manager. If a power imbalance is |

|assumed to exist, then steps to mitigate the negative effects of the imbalance should be described. See Appendix 1, Harm and Risk table for additional information. |

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|Protection for any vulnerable population should be described in the study methods and consent documents. |

|7. Qualitative Research Design and Method – Description of Procedures (1 page maximum) |

|Describe in detail how you will collect and analyze the data required to complete your study. |

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|Describe the methods and techniques that you will use to obtain the information required by the specific objectives of your study. Justify your qualitative approach and|

|the methods you will use to obtain data (e.g. participant observation, interviews, focus groups, use of public, private, governmental or other records, administration |

|of tests etc.). Detail how, when and by whom the data will be collected. |

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|Acknowledge study staff relationship to participants and how this many impact data collection and analysis. |

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|Provide copies of any data collection tools (i.e. interview scripts or questionnaires/surveys, etc.). Note that an amendment must be submitted to the IRB if changes are|

|made to these tools. |

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|For interview methods that employ interview guides, which are not read verbatim and change across interviews, provide a list of topics, with examples of questions and |

|probes. This list must be clearly labeled as a “Tentative Interview Guide.” Describe the conditions in which the guide may be subject to change. Note that an amendment|

|must be submitted to the IRB if changes to the guide involve additional topics or if changes to the data collection protocols are made. |

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|Describe how data will be recorded (e.g. written notes, audio and/or video recordings, completed surveys), transformed (transcripts of interviews), stored and managed. |

|Address any threats to privacy or confidentiality identified [See Appendix 1: Risk and Harm Table]. |

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|Describe the method(s) you will use to analyze and interpret the data collected in your study (e.g. strategies to code, including how coding discrepancies will be |

|addressed, and to identify themes). |

|8. Risk of Harm |

|Describe how participation in this project may affect the participant, including risks of participation in terms of the nature and severity of potential harms, and the |

|likelihood that these harms will occur. In qualitative research, common sources of potential harm are invasion of privacy, stigmatization, or breach of confidentiality.|

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|Certain topics carry greater risks of harm than others. Harm may happen to individuals, groups or the communities to which they belong, and may include psychological, |

|reputational and financial harm. The Risk and Harm table (Appendix 1) is a resource that can be used when discussing potential harms. |

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|If a potential harm is identified, describe the steps taken to reduce the probability of occurrence. Address the need to satisfy mandatory reporting conditions if |

|applicable. |

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|During the conduction of the study, if a harm were to occur to a participant (anticipated or not) that may be study-related, describe the process to communicate this to|

|the IRB. |

|9. Benefits |

|Describe the anticipated benefit of the research for the individual, the community, your profession, or for society in general. If there is no direct benefit to the |

|individual, describe the potential benefits of the knowledge gained from the research project. |

|10. Confidentiality |

|Describe how participant information will be protected and how study data will be safeguarded. |

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|If you are collecting private information: (1) identify what the information is (name, address, etc.); (2) explain how the private information will be protected while |

|collecting the data and during data cleaning and analysis, including how confidentiality and anonymity will be maintained; (3) explain any negative consequences that |

|could occur if the information became available and what you will do to help ensure these risks are minimized. |

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|If you plan to record any direct participant identifiers (name, contact information): (1) explain why you are using this technique, (2) describe how you will protect |

|against disclosure of this information. If you retain identifiers linked to the data: (1) explain how long the identifiers will be kept; (2) how confidentiality will be|

|maintained; (3) explain who will have access to the data (sponsor, advisors, government agency), including their level of access. |

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|If you retain data: (1) explain what data will be retained and for how long; (2) when data will be destroyed describe how. If retaining the data places participants at |

|risk for criminal or civil liability or may be damaging to their financial standing, employability or reputation, please explain the potential harm and what measures |

|you are taking to mitigate this risk. A federal Certificate of Confidentiality is one way to help mitigate risk. |

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|If your study requires the use of translators/ interpreter your study may require additional safeguards to protect confidentiality. |

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|11. Compensation for Participation |

|Disclose any compensation that participants might receive (including food, gas and parking). Compensation is customarily provided for time and travel costs associated |

|with participating in the project. Compensation is not a benefit and may not be structured as an inducement to participate in the study. |

|12. Consent Procedures/Process |

|If a participant is identified for the study, describe how participant consent will be obtained. Provide a general script or a list of points you will cover when |

|obtaining informed consent. Explain how the researcher interacts with participants (for example in-person, by-phone of via video-conference) prior to consent. |

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|In some cases, involving minimal risk to the participant, options for consent may include altering the elements of informed consent or a waiver of documentation. This |

|is a study specific determination. If either an alteration or waiver is sought, provide justification by completing “Submission Form: Supplement E Waiver Alteration |

|Consent”. If a PI is seeking a waiver of documentation of consent, ONE of the following must be true: |

|The only record linking the subject and the research is the informed consent document and the principal risk is potential harm resulting from a breach of |

|confidentiality. |

|The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research |

|context. |

|If thedocumentation requirement is waived, the IRB may require the investigator to provide subjects, or their legally authorized representatives, with a written |

|statement regarding the research. |

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|If there is a need to obtain full consent, follow the consent template provided by the IRB. |

|13. Bibliography (1 page maximum) |

|This is not an exhaustive list, but should support the need to perform this study and some information about the study topic. |

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Appendix 1: Harm and Risk Table

| | |EXAMPLES |CAVEATS |MITIGATION STRATEGIES |

|STUDY |RISK |

|POPULAT| |

|ION | |

| |Vulnerable |Vulnerable populations traditionally include: |Difficult to anticipate all |Informed consent when applicable |

| |populations |pregnant women, fetuses or neonates; children; |potential threats to enrolling | |

| | |prisoners and other institutionalized populations; | |Consider withdrawal of consent |

| | |mentally incapacitated adults (developmentally |Unexpected data/themes may lead to|procedures |

| | |disabled adults, mentally incapacitated elderly, |unanticipated uses or archiving of| |

| | |others with dementia, mental illness or other |data and require alteration of |Consent as a continual process |

| | |conditions that impair decision making |consent |with participant input with any |

| | | | |changes in design |

| | |Disparity of power between the researcher and the | | |

| | |population being studied may increase vulnerability..| |Cultural sensitivity |

| | |(This is especially the case if the researchers have | | |

| | |either a supervisory or therapeutic role (e.g. | |Recognition of possible power |

| | |educators, healthcare providers, chaplains, etc.)) | |disparities |

| | | | | |

| | |Perceived vulnerability may depend on the topic of | |Study personnel should fully |

| | |the research and impact on their safety or well-being| |disclose role in relation to the |

| | |(e.g. terminal illness, abuse) | |population being studied. |

| |HARM |

| |Physical |Discomfort or symptom exacerbation (i.e. exploring |Unintentional physical discomfort |Provide mechanism for treatment of|

| | |personal experiences with anxiety attacks; or impact |or pain may be triggered by |symptoms or for follow-up care |

| | |of dyspnea in end-stage COPD) |observation or discussion of | |

| | | |sensitive topics | |

| |Psychological |Coercion |Harm may be dependent on personal |Disclose roles and |

| | | |history and experience and |responsibilities of research staff|

| | |Loss of self-control over identity |therefore difficult to predict | |

| | | | | |

| | |Breach of confidentiality |Participants may self-edit in |Define boundaries of research |

| | | |response to perceived researcher |staff relationship with |

| | |Invasion of privacy |reaction and this may effect |participants |

| | | |validity of data collected | |

| | |Unintended therapeutic encounter | |Describe methods to ensure |

| | | |Participants may assume a |confidentiality of data |

| | |Fear of stigma or stigma |therapeutic role with study staff | |

| | | |depending on role of that |Provide mechanisms for follow-up |

| | |Anxiety/distress |individual (healthcare provider, |care for any psychological needs |

| | | |chaplain, etc.) and disclose more | |

| | |Burden of participation |than they would unless being |Reimburse participants for |

| | | |treated |inconvenience as appropriate |

| |Social & Economic |Financial/Employment |Including reports of abuse or |Disclose roles and |

| | | |neglect (i.e. elderly patients |responsibilities of research |

| | |Criminal or civic liability |disclosing abuse at hands of |staff, including mandated |

| | | |caregiver, etc.) |reporting of abuse or harm |

| | | | | |

| | | | |Define boundaries of research |

| | | | |staff relationship with |

| | | | |participants |

| | | | | |

| | |EXAMPLES |CAVEATS |MITIGATION STRATEGIES |

|STUDY |RISK |

|DESIGN/| |

|DATA | |

|COLLECT| |

|ION & | |

|ANALYSI| |

|S | |

| |Bias |Single researcher study designs (where the |Rigor may be judged differently |Rigorous study design |

| | |researcher conducts data collection and analysis|depending on the method chosen | |

| | |without input from others) should be avoided – |for the study (i.e. validity & |Clear rationale for design |

| | |limited perspective |reliability vs. creditability, |decisions and populations chosen |

| | | |transferability, dependability | |

| | | |and confirmability) |Ensure mechanism for validation |

| | | | |of findings (i.e. multiple |

| | | | |researchers performing analysis) |

| | | | | |

| | | | |Assessment of study staff as |

| | | | |research instruments that may |

| | | | |affect data |

| | | | | |

| | | | |Acknowledgment of any potential |

| | | | |personal bias and their |

| | | | |relationship to the |

| | | | |subject/population being studied |

| | | | |by research personnel |

| | “Hawthorne effect”1 |Studies which are designed to observe or elicit |Balance between protection of |Acknowledgement of this potential|

| |or Observation bias |input about a behavior may change the likelihood|subjects and observation may be |and address it as possible in |

| | |of that behavior occurring (i.e. studying |difficult; study design and |study design/analysis techniques |

| | |smoking habits in pregnant women). |research personnel may need to | |

| | | |adapt to acquire meaningful data| |

| | | | | |

| | | |Participants may change views, | |

| | | |beliefs or behaviors based on | |

| | | |interaction with study staff and| |

| | | |this may impact validity of data| |

| | | |collected | |

| |Confidentiality | |It may be necessary to use |De-identification of data |

| | | |members of the target population| |

| | | |to enhance rapport and data |Secure storage of data |

| | | |collection. However, this may | |

| | | |increase the chance of |Research designs that minimize |

| | | |unintentional disclosure and |unintentional disclosure of |

| | | |harm and should be included in |personal data to communities |

| | | |the consent | |

| | | | |Use caution in employing |

| | | |Speech-patterns, context or |interpreters or members of a |

| | | |described events may allow for |community for primary data |

| | | |identification even when all |collection |

| | | |discrete identifiers removed | |

Appendix 2: Notes for IRB Reviewer

Section 6. Participant Population/Research Setting

Some qualitative studies use the concept of data saturation or thematic saturation to determine the number of participants to enroll, which depends on analysis of data as it is collected. Saturation is reached when researchers determine that additional participants are unlikely to introduce new themes. It may be useful to ask researchers what criteria they will use to determine saturation. In some cases, data saturation is impossible or impractical to attain. Research aims should reflect possibility that additional themes are likely to exist.

Section 7. Qualitative Research Design and Method- Description of Procedures

Qualitative data analysis is difficult to describe, particularly in advance, but it typically involves several steps. First, indexing the data, using pre-specified and/or emergent codes, which segments, labels and organizes the data. This coding process is reiterative and may be conducted by individuals or teams. Second, identification and exploration of themes—usually implicit ideas or patterns that inform the research questions. In reality, there is generally overlap between these steps, and the process is ongoing and shifts, based on the data.

Qualitative content analysis involved transforming qualitative data into categorical data, which can be statistically analyzed. When such analysis is planned, plans for determining categories of responses are necessary. Furthermore, typical considerations of quantitative research are relevant if formal content analysis is being utilized.

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