Zubair Khalid

Virologist/Molecular Biologist | Veterinarian | Bioinformatician

Conventional & Molecular Virology • Vaccine Development • Computational Biology

Dr. Zubair Khalid is a veterinarian and virologist specializing in conventional and molecular virology, vaccine development, and computational biology. Dedicated to advancing animal health through innovative research and multi-omics approaches.

Dr. Zubair Khalid - Veterinarian, Virologist, and Vaccine Development Researcher specializing in Computational Biology, Multi-omics, Animal Health, and Infectious Disease Research

Category: Guides

Focus Groups in Qualitative Research: A Practical Guide

Focus groups are a qualitative research method in which a small group of participants gathers to discuss a specified topic, with the explicit use of group interaction as research data. This guide is written for students, researchers, life-science professionals, and informed general readers who plan to use focus groups for qualitative data collection. The practical outcome is a working knowledge of focus group design, moderator roles, question development, data analysis, and reporting, supported by a planning checklist and a moderator guide template.

What Defines a Focus Group as a Research Method

A focus group discussion is a research methodology in which a small group of participants gathers to discuss a specified topic or issue to generate data. The defining characteristic is interaction between the moderator and the group, as well as interaction between group members. The objective is to give the researcher an understanding of the participants' perspective on the topic under discussion. This distinguishes focus groups from the broader category of group interviews, because the group interaction itself is treated as research data instead of merely a convenient way to interview several people at once.

Focus groups have become an established part of qualitative research in health and medical fields. They are rapidly gaining popularity in health and medical research as a tool for understanding participant perspectives. The method is particularly valuable when the research question concerns shared experiences, social norms, or the range of opinions within a community. For example, focus group interviews have been used to describe patients' experiences of coping with daily life after stoma surgery, revealing how participants lived with uncertainty and worked to regain control of their lives. The interaction among participants in similar situations allowed them to exchange experiences in demanding areas such as body image, sexuality, and social activities.

The value of qualitative research generally is to explore people's experiences and gain a deeper understanding of the meaning of those experiences. Qualitative inquiries answer research questions about what, why, and how by implementing various research designs such as qualitative descriptive, qualitative case study, ethnological, phenomenology, or grounded theory designs. Focus groups fit within this landscape as a data collection technique that leverages group dynamics to surface perspectives that might not emerge in individual interviews.

When to Use Focus Groups and When Not To

Focus groups are appropriate when the research aim is to understand the range of views, experiences, or behaviors within a group of people who share a common characteristic or experience. They are particularly useful for exploring topics where group interaction can stimulate discussion and where participants may feel more comfortable sharing views in a group setting. The method is well suited for generating data about collective experiences, such as how community pharmacists implement a deprescribing guideline, how medical students perceive module study guides, or how public health professionals use data tools for situational awareness.

Focus groups are also effective for co-design work. In one study, researchers used an iterative co-design framework to investigate barriers to and facilitators of postpartum return to running. Focus groups were used in the discovery phase to identify what needed to be considered in a return to running intervention, including fitting it in, physical considerations, psychosocial considerations, and external considerations. The findings from the focus groups were then used to define the problem and develop solutions with an advisory group of postpartum runners.

Focus groups are less appropriate when the research question requires confidential disclosure of sensitive personal information, when the topic is so sensitive that participants would not speak openly in a group, or when the goal is to produce statistically generalizable findings. Individual interviews are better suited for deeply personal narratives. Surveys are better suited for measuring the distribution of opinions across a population. Focus groups do not produce numerical estimates of prevalence or incidence.

The method also requires careful consideration of group composition. Group stratification influences saturation, meaning that one focus group per stratum may be needed to identify issues, while two groups per stratum provide a more comprehensive understanding. Researchers should plan the number of groups based on the study purpose, the type of codes expected, group stratification, and the desired degree of saturation.

Core Principles of Focus Group Design

The design of a focus group study begins with a clear research question. The research question determines the type of participants to recruit, the number of groups to conduct, the content of the discussion guide, and the approach to analysis. A well designed focus group study has a defined purpose, a sampling strategy, a discussion guide, a moderator plan, and an analysis plan.

Study Purpose and Research Question

The study purpose should be specific enough to guide every subsequent decision. A narrowly defined objective with a relatively homogenous study population will reach saturation within a smaller number of focus group discussions. Studies with broader objectives, such as multi-country research or studies seeking meta-themes, will need larger samples for saturation. Researchers should articulate the study purpose in writing before recruiting participants.

Participant Recruitment and Sampling

Purposive and snowball sampling methods are commonly used to recruit participants for focus groups. Purposive sampling involves selecting participants who have the characteristics relevant to the research question. Snowball sampling involves asking initial participants to refer other potential participants. Recruitment materials should describe the purpose of the study, the time commitment, and any incentives offered.

The number of participants per group typically ranges from four to eight for research purposes. Smaller groups allow more speaking time per participant and are easier to manage for complex topics. Larger groups may generate more ideas but can limit the depth of individual contributions. The moderator should aim for a group size that allows everyone to participate meaningfully.

Group Composition and Stratification

Group composition affects the quality of interaction. Participants who share a common experience or characteristic are more likely to engage in discussion. However, groups that are too homogenous may produce limited range of perspectives. Groups that are too diverse may inhibit participation if power imbalances exist among participants.

Group stratification is a design decision that affects saturation. One focus group per stratum may be sufficient to identify issues, but two groups per stratum provide a more comprehensive understanding of issues. Additional groups beyond two per stratum provide little additional benefit. Researchers should identify the strata relevant to their research question before recruiting participants.

At a Glance: Focus Group Design Decisions

Design Decision Options Considerations
Group size 4 to 8 participants Smaller groups allow deeper discussion, larger groups generate more ideas but limit individual speaking time
Number of groups 4 to 8 groups for homogenous populations Saturation is often reached within 4 to 8 focus group discussions for studies with homogenous populations and narrow objectives
Group stratification One or two groups per stratum One group per stratum identifies issues, two groups per stratum provide more comprehensive understanding
Modality In person, virtual, or hybrid Virtual groups improve geographical accessibility but require attention to digital literacy and data security
Analysis approach Verbatim transcription or direct audio analysis Direct audio analysis is cost effective and trustworthy when conducted by experienced researchers

Moderator Roles and Responsibilities

The moderator is central to the success of a focus group. The moderator's role is to facilitate discussion, keep the group focused on the topic, encourage participation from all members, and manage group dynamics. The moderator must balance the need to cover the discussion guide with the need to allow participants to express their views in their own words.

Moderator Skills and Preparation

Effective moderators are skilled in active listening, probing, and managing group dynamics. They must be able to ask open-ended questions, follow up on participant responses, and redirect the discussion when it drifts off topic. Moderators should be familiar with the discussion guide but flexible enough to pursue unexpected but relevant lines of discussion.

The moderator should be neutral regarding the content of the discussion. The moderator's role is to elicit participants' perspectives, not to share their own views or evaluate participant responses. Neutrality helps participants feel comfortable expressing their genuine opinions.

Moderator Guide Template

A moderator guide is a structured document that outlines the topics to be covered, the questions to be asked, and the approximate time allocation for each section. The guide serves as a roadmap for the moderator and helps ensure consistency across multiple groups.

A basic moderator guide template includes the following sections:

  1. Introduction and ground rules (5 minutes)
  2. Opening question to build rapport (5 minutes)
  3. Introductory questions on the broad topic (10 minutes)
  4. Key questions on the central research topic (30 to 40 minutes)
  5. Closing question inviting final thoughts (5 minutes)
  6. Summary and thanks (5 minutes)

The introduction should explain the purpose of the study, how the data will be used, and the ground rules for discussion. Ground rules typically include speaking one at a time, respecting different opinions, and maintaining confidentiality. The opening question should be simple and nonthreatening to help participants feel comfortable speaking in the group.

Key questions are the core of the discussion guide. They should be open-ended, clear, and focused on the research question. Probing questions can be used to encourage participants to elaborate on their responses. The moderator should avoid leading questions that suggest a particular answer.

Co-Moderator and Note Taker Roles

A co-moderator or note taker can support the moderator by managing logistics, observing group dynamics, and recording nonverbal communication. The note taker can also operate recording equipment and monitor the time. Having a dedicated note taker allows the moderator to focus fully on facilitating the discussion.

Question Design for Focus Groups

Question design determines the quality of data generated in a focus group. Questions should be open-ended, clear, and relevant to the research question. The discussion guide should move from broad introductory questions to more specific key questions.

Types of Questions

Opening questions are simple questions that help participants feel comfortable and begin speaking. They should be easy to answer and relevant to the topic. For example, in a study about module study guides, an opening question might ask students to describe their overall experience with study guides in their current module.

Introductory questions introduce the topic and encourage participants to think about their experiences. They should be broad enough to allow multiple perspectives. For example, a question might ask participants to describe what they find helpful or unhelpful about study guides.

Key questions are the central questions of the focus group. They address the research question directly and generate the data that will be analyzed. Key questions should be designed to elicit detailed descriptions, explanations, and examples. For example, a key question might ask participants to describe how they use study guides to prepare for assessments.

Closing questions give participants the opportunity to add anything they have not yet said. A closing question might ask participants if there is anything important about the topic that has not been discussed.

Probing and Follow-Up Questions

Probing questions are used to encourage participants to elaborate on their responses. Examples of probes include "Can you tell me more about that?" and "Can you give me an example?" Probes should be neutral and should not suggest a particular answer.

Follow-up questions are used to explore a topic in greater depth or to clarify a participant's response. The moderator should listen carefully and ask follow-up questions that build on what participants have said. The moderator should also invite other participants to respond to what has been said, using the group interaction to generate richer data.

Common Question Design Errors

Leading questions suggest a particular answer and should be avoided. For example, asking "Don't you think the study guides are too long?" suggests that the expected answer is yes. A better question would be "What are your thoughts about the length of the study guides?"

Double-barreled questions ask about two topics at once and are difficult for participants to answer clearly. For example, asking "How useful are the study guides and how easy are they to use?" combines two separate questions. These should be split into separate questions.

Closed questions that can be answered with yes or no do not generate rich discussion. They should be rephrased as open-ended questions. For example, instead of asking "Did you find the study guides helpful?" ask "How helpful did you find the study guides?"

Conducting Focus Group Sessions

The conduct of focus group sessions involves several practical steps: planning, recruitment, ambience, group sessions, and evaluation. Each step requires attention to detail to ensure the quality of the data collected.

Planning and Logistics

Planning begins with defining the research question and identifying the participant population. The researcher should develop a recruitment plan, a discussion guide, and a logistics plan. Logistics include scheduling, venue or platform selection, recording equipment, and participant materials.

The venue should be comfortable, accessible, and free from distractions. For in-person groups, the seating should be arranged so that all participants can see each other and the moderator. A circular or semicircular arrangement facilitates discussion. For virtual groups, the platform should be accessible to all participants and should allow recording.

Recording equipment should be tested before the session. A backup recording device is recommended in case the primary device fails. The moderator should also have a printed copy of the discussion guide and a notepad for recording observations.

Recruitment and Consent

Recruitment should follow the approved sampling strategy. Participants should receive clear information about the purpose of the study, the time commitment, and any incentives. Informed consent should be obtained before the session begins. Consent forms should explain how the data will be used, how confidentiality will be protected, and the voluntary nature of participation.

For virtual focus groups, informed consent and data security require particular attention. Participants should be informed about how their data will be stored and who will have access to the recordings. The platform should comply with applicable data protection requirements.

Ambience and Group Climate

The ambience of the focus group session affects the quality of participation. Participants should feel welcome and comfortable. The moderator should begin by welcoming participants, explaining the purpose of the study, and establishing ground rules. Refreshments for in-person groups can help create a relaxed atmosphere.

The moderator should monitor group dynamics throughout the session. Some participants may dominate the discussion while others remain quiet. The moderator should encourage quieter participants to share their views and may need to manage dominant participants diplomatically. The moderator should also be alert to signs of discomfort or distress and should be prepared to address these appropriately.

Managing the Session

The moderator should follow the discussion guide while remaining flexible enough to pursue relevant lines of discussion. The moderator should keep the group focused on the topic and manage the time allocation for each section. The moderator should also monitor the recording equipment and make notes about nonverbal communication and group dynamics.

At the end of the session, the moderator should summarize the main points of the discussion and invite participants to add anything they have not said. Participants should be thanked for their time and reminded of how the data will be used.

Virtual and Digital Focus Groups

Digital technologies have transformed the conduct of focus group discussions. Online platforms and AI-driven analysis techniques offer new opportunities and present distinct challenges. Virtual focus groups have notably enhanced geographical accessibility, facilitating the inclusion of marginalized populations previously limited by logistical or geographical barriers.

Platforms and Modalities

Virtual focus groups can be conducted using platforms such as Zoom, Microsoft Teams, WhatsApp, Facebook, and Reddit. Synchronous online focus groups allow real-time interaction similar to in-person groups. Asynchronous online discussions allow participants to contribute over a longer period, which can be useful for participants with scheduling constraints.

Hybrid approaches combine traditional face-to-face interactions with asynchronous online discussions. Gamification techniques, including interactive exercises, role-playing, digital storytelling, and mobile app-based focus groups, have shown promise in promoting participant engagement and enriching qualitative insights.

Benefits and Challenges of Virtual Groups

The main benefit of virtual focus groups is geographical accessibility. Participants can join from different locations, which can increase the diversity of the sample and reduce travel costs. Virtual groups may also be more convenient for participants with mobility limitations or caregiving responsibilities.

Key challenges include informed consent, data security, power imbalances among participants, and inclusivity for those with limited digital literacy. Researchers must ensure that participants understand how their data will be handled in a virtual environment. The platform should have appropriate security features, and the researcher should have a plan for managing technical difficulties.

Adapting Moderator Techniques for Virtual Settings

Moderating a virtual focus group requires adaptations to the moderator's techniques. The moderator must manage turn-taking more actively because participants cannot use visual cues to signal that they want to speak. The moderator should also be alert to participants who may be less comfortable with the technology and may need additional support.

The moderator should test the platform before the session and provide participants with clear instructions for joining. A technical support contact should be available during the session. The moderator should also have a plan for managing participants who are disconnected or experience technical difficulties.

Data Analysis in Focus Group Research

Data analysis in focus group research involves several coding procedures performed by the researcher or using a coding software program. The analysis approach should be determined before data collection begins and should be consistent with the research question and study design.

Transcription and Data Preparation

The traditional approach to focus group data analysis begins with verbatim transcription of the recorded discussion. Transcription is time consuming and requires significant investment of time and resources. An alternative approach is to directly analyze the audio recordings without transcription.

Research comparing these two approaches found that the themes generated using each technique were consistent, with no different themes or subthemes identified. The direct analysis method appears to have advantages. It is cost effective, trustworthy, and possibly a superior alternative when used with focus group data. However, the audio only method requires experienced researchers who understand the context, and combining the two approaches takes time.

Coding and Thematic Analysis

Thematic analysis is a common approach to analyzing focus group data. The process involves reading the data, identifying codes, grouping codes into themes, and interpreting the themes in relation to the research question. Coding can be done deductively, using a preexisting framework, or inductively, allowing themes to emerge from the data.

In one study of community pharmacists implementing a deprescribing guideline, transcripts were deductively coded and analyzed thematically using the Tailored Implementation for Chronic Diseases checklist. This approach allowed the researchers to identify determinants relevant to implementation across seven domains, including the guideline itself, personal level factors, patient level factors, and professional interaction.

Saturation and Sample Size

Saturation is commonly used to determine sample sizes in qualitative research. Saturation is reached when additional data collection does not generate new themes or insights. Studies using empirical data reached saturation within a narrow range of focus group discussions, typically 4 to 8 groups, particularly for studies with relatively homogenous study populations and narrowly defined objectives.

Two types of saturation have been identified in focus group research. Code saturation is reached when four focus groups are sufficient to identify a range of new issues. Meaning saturation requires more groups to fully understand these issues. Group stratification influences meaning saturation, with one focus group per stratum needed to identify issues and two groups per stratum providing a more comprehensive understanding.

Six parameters influence saturation in focus group data: study purpose, type of codes, group stratification, number of groups per stratum, and type and degree of saturation. Researchers should consider these parameters when estimating sample sizes before data collection.

Artificial Intelligence in Data Analysis

Emerging AI-driven tools such as Natural Language Processing for automated transcription and thematic analysis, alongside sentiment analysis, have streamlined qualitative data analysis. These tools can capture complex emotional nuances effectively. However, research comparing manual and automated approaches found significant limitations in AI analysis, including quote distortions, generation of non-existent information, and one-sided analysis.

Large language models cannot replace humans in deep qualitative data analysis but are effective as primary processing tools. An algorithm for working with large language models for qualitative data analysis has been developed, but researchers should verify AI-generated findings against the original data. The use of AI in data analysis should be disclosed in the methods section of any publication.

Quality and Reporting Standards

Quality in focus group research depends on systematic methods, transparent reporting, and attention to trustworthiness. Several resources are available to support researchers in designing and reporting qualitative studies.

Reporting Guidelines

The EQUATOR Network is an international initiative that provides reporting guidelines for health research. The network hosts a comprehensive collection of reporting guidelines, including those relevant to qualitative research. Researchers should consult the EQUATOR Network to identify the appropriate reporting guideline for their study design.

The Consolidated Criteria for Reporting Qualitative Research, commonly known as COREQ, is a checklist for reporting qualitative studies. One study of patients with a stoma followed the COREQ checklist for reporting qualitative research. The checklist covers three domains: research team and reflexivity, study design, and analysis and findings.

Research Data Management

The National Institute of Standards and Technology provides a Research Data Framework that describes the components of research data management. The framework addresses the full data lifecycle, from planning and collection through analysis, sharing, and preservation. Researchers should consider data management requirements when planning a focus group study, including how recordings and transcripts will be stored, who will have access, and how confidentiality will be protected.

The NC3Rs Experimental Design Assistant is a free online tool that guides researchers through the design of experiments. While designed primarily for animal research, the tool supports rigorous study design and can help researchers think through the rationale for their design decisions. The National Center for Biotechnology Information provides literature resources for finding relevant research, and PubMed is a database of biomedical literature that can be used to identify prior focus group studies in the researcher's field.

Trustworthiness and Reflexivity

Trustworthiness in qualitative research refers to the credibility, transferability, dependability, and confirmability of the findings. Researchers should document their methods in sufficient detail that readers can assess the quality of the study. Reflexivity involves the researcher's awareness of their own influence on the research process and findings.

The moderator and research team should consider how their own perspectives, experiences, and assumptions may influence the design, conduct, and analysis of the study. This consideration should be documented in the methods section of any publication.

Common Failure Patterns in Focus Group Research

Focus group research can fail in predictable ways. Recognizing these failure patterns can help researchers avoid them.

Inadequate Planning

The most common failure is inadequate planning. Researchers who do not clearly define their research question, sampling strategy, and analysis plan before data collection often produce data that do not answer the research question. The discussion guide should be developed and piloted before the first focus group session.

Poor Moderation

Poor moderation can undermine the quality of data. Moderators who dominate the discussion, ask leading questions, or fail to manage group dynamics may produce data that do not reflect participants' genuine perspectives. Moderators should be trained and should practice with a pilot group before conducting actual data collection sessions.

Insufficient Groups for Saturation

Conducting too few focus groups can result in data that do not reach saturation. Researchers should plan the number of groups based on the study purpose, the homogeneity of the population, and the degree of saturation required. For studies with homogenous populations and narrow objectives, 4 to 8 focus group discussions are often sufficient. Studies with broader objectives or stratified populations will require more groups.

Transcription Errors and Data Loss

Transcription errors and data loss can compromise the quality of analysis. Recording equipment should be tested before each session, and a backup recording should be made. Transcription should be checked against the recording for accuracy. If using direct audio analysis, the researcher should be experienced and familiar with the context.

Overreliance on AI Analysis

Overreliance on AI analysis tools without verification against the original data can produce findings that include quote distortions or non-existent information. AI tools should be used as primary processing tools, but the researcher should verify AI-generated findings against the original data.

Limitations of Focus Group Research

Focus group research has inherent limitations that researchers should acknowledge. The method does not produce statistically generalizable findings. The data are context specific and reflect the perspectives of the particular participants in the particular groups conducted.

Group dynamics can influence what participants say. Some participants may conform to the views expressed by others, while dominant participants may shape the discussion. Participants may be reluctant to express views that they perceive as socially undesirable in a group setting.

The quality of data depends heavily on the skill of the moderator. Inexperienced moderators may produce data that are superficial or that do not address the research question. The method requires significant time and resources for recruitment, conduct, transcription, and analysis.

Cross-cultural research using focus groups requires attention to cultural differences in communication styles, group dynamics, and the acceptability of discussing certain topics in a group setting. Researchers should consider whether focus groups are appropriate for the cultural context of their study population.

Professional Escalation Criteria

Researchers should seek additional guidance or escalate concerns in several situations.

If the research involves human participants, the study should be reviewed and approved by an appropriate ethics committee or institutional review board before data collection begins. Researchers who are uncertain about ethical requirements should consult their institution's research office.

If participants disclose distress, harm, or risk of harm during a focus group session, the moderator should follow the approved protocol for managing such disclosures. This may include providing information about support services, reporting to appropriate authorities, or escalating to a supervisor.

If the research involves clinical populations or health interventions, researchers should consult relevant clinical guidelines and involve appropriate clinical expertise in the design and conduct of the study. The NCBI Literature Resources and PubMed can be used to identify relevant clinical literature.

If the research involves regulated products, practices, or data, researchers should consult the relevant regulatory requirements. The Research Data Framework from the National Institute of Standards and Technology provides guidance on research data management that may be relevant to regulatory compliance.

Focus Group Planning Checklist

The following checklist can be used to plan a focus group study.

  1. Define the research question and study purpose.
  2. Determine whether focus groups are the appropriate method.
  3. Identify the participant population and sampling strategy.
  4. Determine the number of groups and group stratification.
  5. Develop the discussion guide and pilot it.
  6. Recruit participants and obtain informed consent.
  7. Arrange logistics, including venue or platform and recording equipment.
  8. Train the moderator and note taker.
  9. Conduct the focus group sessions.
  10. Analyze the data using a predetermined approach.
  11. Report the study using the appropriate reporting guideline.
  12. Store and preserve the data according to the data management plan.

Frequently Asked Questions

How many focus groups should I conduct?

For studies with relatively homogenous study populations and narrowly defined objectives, saturation is often reached within 4 to 8 focus group discussions. Studies with broader objectives, such as multi-country research or studies seeking meta-themes, will need larger samples for saturation. Group stratification also influences the number of groups needed, with one group per stratum needed to identify issues and two groups per stratum providing a more comprehensive understanding.

How many participants should be in each focus group?

Focus groups for research purposes typically include 4 to 8 participants. Smaller groups allow more speaking time per participant and are easier to manage for complex topics. Larger groups may generate more ideas but can limit the depth of individual contributions. The moderator should aim for a group size that allows everyone to participate meaningfully.

What is the difference between a focus group and a group interview?

Focus groups are distinguished from the broader category of group interviews by the explicit use of group interaction as research data. In a focus group, the interaction between participants is part of the data. In a group interview, the researcher typically asks questions to each participant in turn, and the interaction between participants is not the focus of analysis.

How do I develop questions for a focus group discussion guide?

The discussion guide should move from broad introductory questions to more specific key questions. Opening questions help participants feel comfortable and begin speaking. Introductory questions introduce the topic and encourage participants to think about their experiences. Key questions address the research question directly and generate the data that will be analyzed. Closing questions give participants the opportunity to add anything they have not said.

Can focus groups be conducted online?

Yes, virtual focus groups can be conducted using platforms such as Zoom, Microsoft Teams, WhatsApp, Facebook, and Reddit. Virtual groups have enhanced geographical accessibility and can facilitate the inclusion of marginalized populations. However, researchers must address informed consent, data security, power imbalances among participants, and inclusivity for those with limited digital literacy.

How do I know when I have reached saturation?

Saturation is reached when additional data collection does not generate new themes or insights. Code saturation is reached when four focus groups are sufficient to identify a range of new issues. Meaning saturation requires more groups to fully understand these issues. Six parameters influence saturation: study purpose, type of codes, group stratification, number of groups per stratum, and type and degree of saturation.

What are the main limitations of focus group research?

Focus group research does not produce statistically generalizable findings. Group dynamics can influence what participants say, and some participants may conform to the views expressed by others. The quality of data depends heavily on the skill of the moderator. The method requires significant time and resources for recruitment, conduct, transcription, and analysis.

Should I use artificial intelligence to analyze focus group data?

AI-driven tools can streamline qualitative data analysis, including automated transcription and thematic analysis. However, research has found significant limitations in AI analysis, including quote distortions, generation of non-existent information, and one-sided analysis. AI tools can be effective as primary processing tools, but the researcher should verify AI-generated findings against the original data.

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References and Further Reading

This article is educational and does not replace institutional policy, professional advice, or applicable safety and regulatory requirements.