Table 1: Social-Behavioral Research Standards: Description

February 1, 2018

No. 1 2 3 4 5
Country Canada Canada United States United States United States
Title, Year, and Link Ethical Conduct for Research Involving Humans. Chapter 2. Scope and Approach (2014): Ethical Conduct for Research Involving Humans. Chapter 10. Qualitative Research (2014): Protection of Human Subjects, Exempt Research (2009): Protection of Human Subjects, Expedited Research (1998): Frequently Asked Questions and Vignettes:
Description / Summary This chapter presents three exemptions from the requirement for research ethics board (REB) review for:
  • 2.2: Publicly available information
  • 2.3: Observations in public places
  • 2.4: Secondary use of anonymous information or anonymous biological materials
For each exemption, the chapter explains key terms and highlights types of social-behavioral research that require IRB/REB review.
This chapter has two sections. The second section has five Articles pertaining to qualitative research:
  1. Nature of Qualitative Research
  2. Research Ethics Review of Qualitative Research
    • 10.1: Timing of the research ethics board review
    • 10.2: Modalities of expression of consent
    • 10.3: Observational studies: Exceptions to the general requirement for consent
    • 10.4: Privacy and confidentiality in the dissemination of research results
    • 10.5: Qualitative research using involving emergent designs
This regulation delineates exempt categories that often apply to social-behavioral research:
  1. Research conducted in established
  2. educational settings involving normal educational practices
  3. ‒ 3. Research involving the use of tests, surveys, or interviews.
  4. Research involving the use of existing data, documents, or records.
The following expedited review categories apply to social-behavioral research:
  1. Collection of data from voice, video, digital, or image recordings made for research purposes.
  2. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
This web page discusses the following topics:
  1. The Common Rule and Sub-Parts
    1. What is the relationship between the Common Rule and the Federal Regulation for the Protection of Human Subjects?
    2. What are the Subparts of the regulations?
    3. Original agencies, departments and offices approving the Common Rule (1991)
    4. Where can I get authoritative and expert interpretation of the regulations?
    5. What parts of the regulations are applicable to my institution?
    6. My institution's assurance is with DHHS through OHRP, which has adopted subparts B, C, and D. Does this mean that all research conducted through this institution must comply with the particulars of these subparts?
    7. What are the overall goals of the federal policy (the Common Rule)?
    8. How can oversight be matched to risk in order to achieve the goals of the Common Rule?
    9. What does "minimal risk" mean in research?
    10. What does the Belmont Report have to do with IRB reviews?
  2. Social Science and the Common Rule
    1. What exemptions of the Common Rule are most appropriate to social science research?
    2. Child language studies in "Freedonia" (Vignette)
    3. Are third parties human subjects in research?
    4. Is secondary analysis of data human subjects research?
    5. What about merging public data files or enhancing a public data file?
    6. What if the project intends to link data from a new survey to existing individual-level data from public data sources?
    7. What if the project decides to link data from a new survey to existing individual-level data from public data sources after the survey has been completed?
    8. What sorts of harm can arise from social and behavioral science research?
    9. Informed consent in social and behavioral science
  3. Exempt and Expedited Review and Informed Consent
    1. What exemptions of the Common Rule are most appropriate to social science research?
    2. Does this mean that all questionnaire, test, and interview-based studies are exempt?
    3. My university does not have an "exempt" category for research, only "expedited" and "full review" categories. What does this mean in terms of social science projects that the federal government has declared "exempt"?
  4. Problems and Advice on Dealing with Them
    1. What flexibility does the IRB have in applying the Common Rule?
    2. When a Signed Consent Form can Harm a Participant (Vignette)
    3. What if the researcher and the IRB disagree about the risk and appropriate action to be taken in the project?
    4. Advice to IRBs on Dealing with Researchers
    5. Advice to Researchers on Dealing with IRBs
    6. How should research involving "snowball samples" be handled from a human subjects perspective?
    7. How should IRBs deal with research in foreign countries?
    8. Can research proceed at a foreign institution if no foreign IRB has reviewed the research?
    9. Does research conducted as a classroom exercise count as human subjects research?
    10. How can research conducted as a classroom exercise be reviewed to protect human participants?
    11. Deception
    12. What issues arise concerning compensation
  5. Confidentiality-Privacy
    1. Does this mean that I cannot collect or record personal identifying information?
    2. Doesn't the Common Rule demand confidentiality in research records?
    3. What's the difference between privacy and confidentiality?
    4. What are the major techniques for protecting confidentiality?
    5. Where can I find information about confidentiality in data?
  6. Ethnography
    1. Is ethnography covered by the Common Rule?
    2. Is ethnographic research exempt?
    3. Is written documentation of informed consent required in ethnographic research?
    4. How should IRBs proceed in reviewing ethnographic research?
    5. What is "group consent" and how is it relevant to informed consent?
No. 1 2 3 4 5 6 7
Country Finland France Norway Norway Sweden United Kingdom United Kingdom
Title, Year, and Link Ethical Principles of Research in the Humanities and Social and Behavioural Sciences and Proposals for Ethical Review (2009): Opinion on the Ethics of Research in the Sciences of Human Behavior No. 38 (1993): Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2016): Ethical Guidelines for Internet Research (2014): Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2011): ESRC Framework for Research Ethics (2015): Good Practice in Research: Internet-Mediated Research (2016):
Description / Summary The document presents a series of five proposals regarding the structure, scope, and evaluation procedures of ethical review:
  1. Creation of an ethical review system for the humanities and social-behavioral sciences
  2. Establishment of ethical review committees
  3. Delineation of types of studies that require ethical review
  4. Ethical opinion
  5. Needed legislative changes, education in research ethics, and evaluation of the newly proposed system
The guideline then delineates a series of ethical principles and procedures:
  • 1. Autonomy of research subjects
  • 1.1: Voluntary participation
  • 1.2: Autonomy and research involving minors
  • 1.3: Autonomy and age limits
  • 1.4: Information for subjects
  • 1.5: Exceptions from informed consent
  • 2. Avoiding harm
  • 2.1: Avoiding mental harm
  • 2.2: Avoiding financial and social harm
  • 2.3: Studies containing risks of harm
  • 3. Privacy and data protection
  • 3.1: Protecting research data and confidentiality
  • 3.2: Storing or destroying research data
  • 3.3: Protecting privacy in research publications
  • 4. Ethical review
  • 4.1: Guidelines for reviewing studies
  • 4.2: Special review guidelines for different research designs
The guideline spells out four main principles:
  1. Freedom of persons
  2. Safety
  3. Justice, human dignity
  4. Ethical review by independent bodies
The document then addresses questions raised by protocols submitted to the Committee:
  1. Consent
  2. Safety
  3. Problems of equity
  4. Review of protocols
This document consists of sections on the following topics:
  1. Research, society, and ethics
    1. Norms and values of research
    2. Freedom of research
    3. Responsibility of research
    4. Responsibility of institutions
  2. Respect for individuals
    1. Human dignity
    2. Privacy
    3. Duty to inform
    4. Consent and obligation to notify
    5. Confidentiality
    6. Limited re-use
    7. Storage of personal data
    8. Responsibility for avoiding harm
    9. Respect for third parties
    10. Protection of children
    11. Respect for privacy and family life
    12. Respect for the value and motives of others
    13. Respect
    14. Defining roles and responsibilities
  3. Respect for groups and institutions
    1. Respect for private interests
    2. Respect for public administration
    3. Respect for vulnerable groups
    4. Preservation of cultural monuments and remains
    5. Research on other cultures
    6. Limits on cultural recognition
  4. Research community
    1. Co-authorship
    2. Good citation practice
    3. Plagiarism
    4. Scientific integrity
    5. Data sharing
    6. Impartiality
    7. Relations with colleagues
    8. Student-supervisor relationship
    9. Responsibilities of supervisors and project managers
  5. Commissioned research
    1. Different types of research
    2. Commissioned research
    3. Responsibility of researchers in large projects
    4. Independence and conflict of interests
    5. Transparency in research funding
    6. Presentation and use of results
    7. Right and duty to publish
  6. Dissemination of research
    1. Dissemination as an academic responsibility
    2. Requirements for individuals and institutions
    3. Interdisciplinary discourse and public deliberation
    4. Participation in public debate
    5. Accountability in dissemination
    6. Reporting results to participants
This document features discussions on these topics:
  1. Definitions
  2. Private or public data
  3. Free and informed consent
  4. Children's right to protection
  5. Personal data, confidentiality, and anonymity
  6. Regard for third parties
  7. Use of quotes from the internet
  8. Reporting of results
The section on Observational Studies Conducted Through Participating, Observing, and Recording (pages 42-45) makes these key points:
  1. Approval must sought from an ethics review board if the research uses personally sensitive data
  2. If the research falls within the scope of the Act Concerns the Ethical Review of Research Involving Humans, the project must be reviewed by a regional ethics review board
  3. Ideally, research participants should provide written consent to research participation
  4. Covert participant observation should be the exception to the rule
  5. For studies involving participant observation, the identity of the subjects must not be revealed
  6. If a subject is under 15 years of age, permission from both guardians and the child must be sought
  1. Video-recording should only be used when other data collection methods are not feasible.
  2. Consent should explain:
    1. Whether faces or voices will be disguised
    2. Whether copies of the video will be made
    3. Whether the video will also be used for non-research purposes
    4. Whether other analyses will be performed
    5. Whether the informants will be able to watch the video
    6. Whether any associations between the video and other personal data will be coded
    7. Whether the video will be destroyed if the subject withdraws
    8. Video storage and destruction at the conclusion of the study
  3. In some research fields, consent should be given following a two-step process:
    1. Approval of the initial videotaping
    2. After having the opportunity to view the video, approval to analyze the video
  4. The researcher must assure secure storage and restricted access to the video
This Framework details minimum requirements for research proposals and addresses several frequently asked questions:
  1. ESRC's minimum requirements
    • 1.1 Ethics issues should be identified in the proposal
    • 1.2 All ESRC-funded research should be subject to ethics review
    • 1.3 Criteria for ethical consideration of research proposals
    • 1.4 RECs should be constituted and operate in accordance with the framework standards
    • 1.5 Research Organizations should establish procedures for monitoring research
    • 1.6 Complaints, appeals, and conflict of interest procedures should be in place
    • 1.7 Arrangements should be made for training researchers, research students, supervisors, and members of RECs
    • 1.8 Student research and ethics review
    • 1.9 Arrangements should be made for collaborative research
    • 1.10 Duplication of submission should be avoided
    • 1.11 Legal and data protection requirements should be met
  2. Frequently asked questions
    • 2.1 Assessing risk
    • 2.2 Consent
    • 2.3 Medical research
    • 2.4 Internet-mediated research
    • 2.5 Research governance
This document defines internet-mediated research and discusses:
  1. Ethical principles applied within ethical review in the UK
    • Autonomy
    • Beneficience
    • Non-maleficence
    • Confidentiality
    • Integrity
  2. Specific items to consider
    • Offline, online, or neither
    • Communities, individuals, and data
    • Communities
    • Deception
    • Valid consent
    • Age
    • Research involving security-sensitive material
  3. Social media
    • Web-generated data
    • Data mining
    • Lurking or observation
    • Collecting textual led data
    • Interacting with groups, communities, or individuals
    • Surveillance
    • Researching key influencers
  4. Private or public spaces and data
    • Discrepancy in expressed concerns for privacy vs. internet users' behavior
    • Consent
    • Balancing interests of the research, participants, data, and the online platform
    • Right to be forgotten
  5. Data management
    • Data protection considerations
    • Data security and sharing
    • Copyright law and other relevant legislation
    • Presenting findings
    • Anonymity
    • Legal and/or moral duty to disclose or break confidentiality
No. 1 2 3 4 5 6 7
Country Australia Australia India Kyrgyz Republic Philippines Taiwan Taiwan
Title, Year, and Link National Statement on Ethical Conduct in Human Research, Qualitative Methods (2015): National Statement on Ethical Conduct in Human Research, Exempt Research (2015): Social and Behavioural Sciences Research for Health (2017): On the Protection of Traditional Knowledge (2014): Ethical Guidelines for Health-Related Social Research (2017): h Scope of exempt human studies to be reviewed by the Ethics Review Board (2012): Scope of human studies to be reviewed by expedited process by the Ethics Review Board (2012). No URL.
Description / Summary This chapter presents examples of qualitative research methods:
  • Interviews
  • Oral history
  • Focus group
  • Observation
  • Archival research
  • Online research
  • Action research
The chapter then delineates four principles of ethical research:
  1. Research merit and integrity
    • Relationships between researchers and participants
    • Researcher's professional skills that may become relevant to the relationship
    • Description of settings and contexts
    • Purposive sampling
    • Rigor not judged on sample size
    • Recruitment strategy and selection criteria
    • Rigor assessed by quality and credibility of data collection and analysis
  2. Justice
    • Explication of inclusion and exclusion criteria
  3. Beneficence
    • Protection of participant identity
    • Disclosure of potential of being identified
    • Protocols to deal with participant distress
    • Researcher training to deal with participant distress
    • Relationships between researchers and participants
  4. Respect
    • Verification of accuracy and completeness of transcript by research participant
    • Written vs. oral consent
    • Implied consent
The guideline also includes an exempt category for research that involves only negligible risk and uses only existing collections of non-identfiable information:
  • 5.1.22: Research involves the use of existing collections of non-identified information.
This chapter addresses:
  • 9.0 Overview
  • 9.1 Some key features
  • 9.2 Addressing the ethical challenges:
  • 9.2.1 Design and conduct of the study
  • 9.2.2 Ethical review
  • 9.2.3 Risk assessment
  • 9.2.4 Risk mitigation
  • 9.2.5 Community engagement
  • 9.2.6 Informed consent
  • 9.2.7 Privacy and confidentiality
  • 9.2.8 Duty to disclose sensitive information
  • 9.2.9 Studies using deception
  • 9.2.10 Safety of participants
  • 9.2.11 Safety of research teams in the field
  • 9.2.12 Qualitative research
This law defines traditional knowledge as “knowledge, methods, and techniques, used in various fields of human activity that have been passed from one generation to another in a certain order and meaning.” The law consists of 18 articles organized into five chapters:
  • Chapter 1: General provisions
    • Article 1: Legal regime of protection of traditional knowledge
    • Article 2: Basic concepts
  • Chapter 2: State regulation of traditional knowledge
    • Article 3: Goals and objectives of state regulation
    • Article 4: Authorized state body
  • Chapter 3: Subjects of legal relations in the field of traditional knowledge
    • Article 5: Subjects of legal relations
    • Article 6: Representation of the holders of traditional knowledge
  • Chapter 4: Provision of protection in the field of traditional knowledge
    • Article 7: Legal protection in the field of traditional knowledge
    • Article 8: Patenting objects created on the basis of traditional knowledge
  • Chapter 5: Registration of traditional knowledge
    • Article 9: Application for registration
    • Article 10: Consideration of the application
    • Article 11: Registration of traditional knowledge and certification
    • Article 12: Term of validity
    • Article 13: Amendments
    • Article 14: Contract for use of traditional knowledge
    • Article 15: Fees
    • Article 16: Funds
    • Article 17: Use of traditional knowledge
    • Article 18: Consideration of disputes
This Guideline presents guidelines on the following topics:
  1. General Issues
  2. Consent process
  3. Community research
  4. Management of risks and harms
  5. Access to services or benefits
  6. Provision of feedback to participants in field research
This regulation delineates four exemption categories that often apply to social-behavioral research:
  1. Non-interactive, non-intrusive studies conducted in public
  2. Use of data that is legally known and its use is consistent with its original purpose
  3. Evaluations of the effectiveness of public policies
  4. Studies of educational assessment, testing, teaching skills or teaching effectiveness
  5. Minimal risk studies that the IRB designates as exempt
This regulation defines two exempted review categories that often apply to social-behavioral research:
  1. Collection of data from voice, video, digital, or image recordings made for research purposes.
  2. Those data are not identifiable, or may not affect his/her job, insurance, financial, and social relationships.
  3. To study individual or group characteristics or behavior, but not the potential cause of personal or ethnic discrimination.
No. 1 2
Country Saudi Arabia Saudi Arabia
Title, Year, and Link Implementing Regulations of the Law of Ethics of Research on Living Creatures. Expedited Research (2016): Implementing Regulations of the Law of Ethics of Research on Living Creatures. Categories of Social-Behavioral Research That do not Require Continuing Review (2016):
Description / Summary Article 10.18g: Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or behavior of an individual or group without violation of privacy of the human subject. Article 10.32:
  1. Research involving study of information and data previously collected, provided one of the two following terms is fulfilled:
    1. If the information is generally and publicly available;
    2. If the information is recorded in a manner that does not reveal the identity of the source person.
  2. Research including educational tests, surveys, interviews or public behavior monitoring, except in the two following cases:
    1. If the information is recorded in a manner that reveals the identity of the source person.
    2. If participation in the research should bring a person outside the scope of research to be subject to criminal or civil liability or jeopardize his financial position or career.
  3. Research conducted for educational purposes.
No. 1
Country Brazil
Title, Year, and Link Resolution No. 510 of April 7, 2016:
Description / Summary This Resolution consists of 30 substantive articles:
  1. Types of research not to be registered or evaluated by the CONEP system
  2. Terms and definitions
  3. Ethical principles
  4. Establishing relation of trust between researcher and participant
  5. Communication of consent by means of oral expression
  6. Consent process done at the appropriate moment, condition, and location
  7. Allow expression of fears or doubts
  8. Information transmitted in a timely, accessible, and transparent manner
  9. Rights of the participant
  10. Clarify the nature of the research, objectives, methods, rights, risks, and potential benefits
  11. Importance of consent for persons in a relationship of authority or dependency
  12. Justification for inclusion of children, adolescents, and persons with diminished decision-making capacity
  13. Seeking of consent in traditional, indigenous, or religious communities
  14. Waiver of informed consent
  15. Documentation in the Record of Consent
  16. Registration of the Record of Consent
  17. Content of the Record of Consent
  18. Assessment of risk based on methodological procedures
  19. Precautionary measures to protect from risks
  20. Protective measures for children, adolescents, or persons whose autonomy is reduced
  21. Gradation of risks as minimum, low, moderate, or high
  22. Documentation for IRB/REC approval
  23. Registration in the Brazil platform
  24. Preliminary research steps not subject to IRB/REC review
  25. IRB/REC evaluation focus on ethical issues
  26. Scientific evaluation conducted by academic bodies
  27. IRB/REC evaluation focus on methodological procedures that entail risks
  28. IRB/REC reviewers qualified in humanities and social sciences
  29. Research by students
  30. Researcher responsibilities
No. 1 2 3 4
Country Botswana Malawi Nigeria South Africa
Title, Year, and Link Anthropological Research Act 45 (1967): Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi (2011): Nigerian Code of Health Research Ethics (2007): Principles, Processes, and Structures, Section 3.3.7(i) (2015):
Description / Summary This law requires the Ministry of Health to give prior permission for the conduct of anthropological research. The law contains five sections:
  1. Short title
  2. Interpretation
  3. Regulation of anthropological research
  4. Entry upon land
  5. Entry into defined areas of persons who are not citizens of Botswana
The Framework consists of the following sections:
  1. Introduction
  2. Preamble
  3. Value of research in the social sciences and humanities
  4. Ethical principles and obligations
    • 4.1. Informed consent
    • 4.2. Privacy and confidentiality
    • 4.3. [absent]
    • 4.4. Accountability and transparency
    • 4.5. Obligations to others
    • 4.6. Responsibility to the public
    • 4.7. Responsibility to colleagues and fellow researchers
    • 4.8. Responsibility to students and trainees
    • 4.9. Non-discrimination
    • 4.10. Avoidance of conflict of interest
    • 4.11. Objectivity
    • 4.12. Integrity
    • 4.13. Coercion and undue influence
  5. Autonomous implementation of the framework
  6. Research communication
    • 6.1. Authorship
    • 6.2. Research dissemination
  7. Appropriate research environments
  8. Affiliation and research clearance
  9. Format for research proposals
    • 9.1. General format
    • 9.2. Specific format
  10. Monitoring system
  11. Application of the framework
This guideline outlines the following exempt categories that often apply to social-behavioral research:
  1. Research conducted in established educational settings involving normal educational practices
  2. Research involving the use of tests, surveys, or interviews.
  3. Research involving the use of existing data, documents, or records.
This guideline states that minimal risk research involving the secondary use of data can be reviewed using Expedited review procedures.
No. 1
Country UNESCO
Title, Year, and Link Code of Conduct and Ethical Guidelines for Social Science Research:
Description / Summary This document presents 19 ethical guidelines for social science research, providing a 1-2 sentence description of each guideline:
  1. Responsibility of principal investigators
  2. Integrity of research enterprise
  3. Research topic addresses important intellectual issue
  4. Consideration of potential effects of research
  5. Awareness of potential harmful effects
  6. Competent conduct of research, without bias
  7. Compliance with local customs, standards, laws, and regulations
  8. Respect for host culture
  9. Communication of principal investigator's ethical principles
  10. Avoidance of undue intrusion into lives of research subjects
  11. Informed consent
  12. No coercion
  13. Participants informed of potential harmful effects
  14. Confidentiality of information and anonymity of participants
  15. Disclosure of research results to participants
  16. Wide reporting of research
  17. Communication of research methods to allow proper assessment
  18. Proper acknowledgement of other scholars' work
  19. Preservation of research materials
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