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Table 1: Social-Behavioral Research Standards: Description

February 1, 2018

NORTH AMERICA
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): http://www.pre.ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf#page=21	Ethical Conduct for Research Involving Humans. Chapter 10. Qualitative Research (2014): http://www.pre.ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf#page=141	Protection of Human Subjects, Exempt Research (2009): http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html	Protection of Human Subjects, Expedited Research (1998): http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html	Frequently Asked Questions and Vignettes: https://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp
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: Nature of Qualitative Research 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: Research conducted in established educational settings involving normal educational practices ‒ 3. Research involving the use of tests, surveys, or interviews. Research involving the use of existing data, documents, or records.	The following expedited review categories apply to social-behavioral research: Collection of data from voice, video, digital, or image recordings made for research purposes. 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: The Common Rule and Sub-Parts What is the relationship between the Common Rule and the Federal Regulation for the Protection of Human Subjects? What are the Subparts of the regulations? Original agencies, departments and offices approving the Common Rule (1991) Where can I get authoritative and expert interpretation of the regulations? What parts of the regulations are applicable to my institution? 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? What are the overall goals of the federal policy (the Common Rule)? How can oversight be matched to risk in order to achieve the goals of the Common Rule? What does "minimal risk" mean in research? What does the Belmont Report have to do with IRB reviews? Social Science and the Common Rule What exemptions of the Common Rule are most appropriate to social science research? Child language studies in "Freedonia" (Vignette) Are third parties human subjects in research? Is secondary analysis of data human subjects research? What about merging public data files or enhancing a public data file? What if the project intends to link data from a new survey to existing individual-level data from public data sources? 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? What sorts of harm can arise from social and behavioral science research? Informed consent in social and behavioral science Exempt and Expedited Review and Informed Consent What exemptions of the Common Rule are most appropriate to social science research? Does this mean that all questionnaire, test, and interview-based studies are exempt? 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"? Problems and Advice on Dealing with Them What flexibility does the IRB have in applying the Common Rule? When a Signed Consent Form can Harm a Participant (Vignette) What if the researcher and the IRB disagree about the risk and appropriate action to be taken in the project? Advice to IRBs on Dealing with Researchers Advice to Researchers on Dealing with IRBs How should research involving "snowball samples" be handled from a human subjects perspective? How should IRBs deal with research in foreign countries? Can research proceed at a foreign institution if no foreign IRB has reviewed the research? Does research conducted as a classroom exercise count as human subjects research? How can research conducted as a classroom exercise be reviewed to protect human participants? Deception What issues arise concerning compensation Confidentiality-Privacy Does this mean that I cannot collect or record personal identifying information? Doesn't the Common Rule demand confidentiality in research records? What's the difference between privacy and confidentiality? What are the major techniques for protecting confidentiality? Where can I find information about confidentiality in data? Ethnography Is ethnography covered by the Common Rule? Is ethnographic research exempt? Is written documentation of informed consent required in ethnographic research? How should IRBs proceed in reviewing ethnographic research? What is "group consent" and how is it relevant to informed consent?

EUROPE
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): http://www.tenk.fi/sites/tenk.fi/files/ethicalprinciples.pdf	Opinion on the Ethics of Research in the Sciences of Human Behavior No. 38 (1993): https://www.ccne-ethique.fr/en/publications/opinion-ethics-research-sciences-human-behaviour	Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2016): https://www.etikkom.no/globalassets/documents/english-publications/60127_fek_guidelines_nesh_digital_corr.pdf	Ethical Guidelines for Internet Research (2014): https://www.etikkom.no/en/ethical-guidelines-for-research/ethical-guidelines-for-internet-research/	Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2011): https://publikationer.vr.se/en/product/good-research-practice/	ESRC Framework for Research Ethics (2015): http://www.esrc.ac.uk/files/funding/guidance-for-applicants/esrc-framework-for-research-ethics-2015/	Good Practice in Research: Internet-Mediated Research (2016): http://ukrio.org/wp-content/uploads/UKRIO-Guidance-Note-Internet-Mediated-Research-v1.0.pdf
Description / Summary	The document presents a series of five proposals regarding the structure, scope, and evaluation procedures of ethical review: Creation of an ethical review system for the humanities and social-behavioral sciences Establishment of ethical review committees Delineation of types of studies that require ethical review Ethical opinion 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: Freedom of persons Safety Justice, human dignity Ethical review by independent bodies The document then addresses questions raised by protocols submitted to the Committee: Consent Safety Problems of equity Review of protocols	This document consists of sections on the following topics: Research, society, and ethics Norms and values of research Freedom of research Responsibility of research Responsibility of institutions Respect for individuals Human dignity Privacy Duty to inform Consent and obligation to notify Confidentiality Limited re-use Storage of personal data Responsibility for avoiding harm Respect for third parties Protection of children Respect for privacy and family life Respect for the value and motives of others Respect Defining roles and responsibilities Respect for groups and institutions Respect for private interests Respect for public administration Respect for vulnerable groups Preservation of cultural monuments and remains Research on other cultures Limits on cultural recognition Research community Co-authorship Good citation practice Plagiarism Scientific integrity Data sharing Impartiality Relations with colleagues Student-supervisor relationship Responsibilities of supervisors and project managers Commissioned research Different types of research Commissioned research Responsibility of researchers in large projects Independence and conflict of interests Transparency in research funding Presentation and use of results Right and duty to publish Dissemination of research Dissemination as an academic responsibility Requirements for individuals and institutions Interdisciplinary discourse and public deliberation Participation in public debate Accountability in dissemination Reporting results to participants	This document features discussions on these topics: Definitions Private or public data Free and informed consent Children's right to protection Personal data, confidentiality, and anonymity Regard for third parties Use of quotes from the internet Reporting of results	The section on Observational Studies Conducted Through Participating, Observing, and Recording (pages 42-45) makes these key points: Approval must sought from an ethics review board if the research uses personally sensitive data 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 Ideally, research participants should provide written consent to research participation Covert participant observation should be the exception to the rule For studies involving participant observation, the identity of the subjects must not be revealed If a subject is under 15 years of age, permission from both guardians and the child must be sought Video-Recording Video-recording should only be used when other data collection methods are not feasible. Consent should explain: Whether faces or voices will be disguised Whether copies of the video will be made Whether the video will also be used for non-research purposes Whether other analyses will be performed Whether the informants will be able to watch the video Whether any associations between the video and other personal data will be coded Whether the video will be destroyed if the subject withdraws Video storage and destruction at the conclusion of the study In some research fields, consent should be given following a two-step process: Approval of the initial videotaping After having the opportunity to view the video, approval to analyze the video 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: 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 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: Ethical principles applied within ethical review in the UK Autonomy Beneficience Non-maleficence Confidentiality Integrity Specific items to consider Offline, online, or neither Communities, individuals, and data Communities Deception Valid consent Age Research involving security-sensitive material Social media Web-generated data Data mining Lurking or observation Collecting textual led data Interacting with groups, communities, or individuals Surveillance Researching key influencers 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 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

ASIA/PACIFIC
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): https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research#toc__359	National Statement on Ethical Conduct in Human Research, Exempt Research (2015): https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research#toc__1253	Social and Behavioural Sciences Research for Health (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf	On the Protection of Traditional Knowledge (2014): http://cbd.minjust.gov.kg/act/view/ru-ru/202149/20?cl=ru-ru	Ethical Guidelines for Health-Related Social Research (2017): hhttp://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg	Scope of exempt human studies to be reviewed by the Ethics Review Board (2012): http://www.mohw.gov.tw/EN/Ministry/	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: 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 Justice Explication of inclusion and exclusion criteria 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 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: General Issues Consent process Community research Management of risks and harms Access to services or benefits Provision of feedback to participants in field research	This regulation delineates four exemption categories that often apply to social-behavioral research: Non-interactive, non-intrusive studies conducted in public Use of data that is legally known and its use is consistent with its original purpose Evaluations of the effectiveness of public policies Studies of educational assessment, testing, teaching skills or teaching effectiveness Minimal risk studies that the IRB designates as exempt	This regulation defines two exempted review categories that often apply to social-behavioral research: Collection of data from voice, video, digital, or image recordings made for research purposes. Those data are not identifiable, or may not affect his/her job, insurance, financial, and social relationships. To study individual or group characteristics or behavior, but not the potential cause of personal or ethnic discrimination.

MIDDLE EAST
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): http://prod.kau.edu.sa/Med/ali/files/Publications/Guide/National_Committe_of_BioEthics-Regulations_of_the_Law_of_Ethics_of_Research_on_Living_Creatures.pdf	Implementing Regulations of the Law of Ethics of Research on Living Creatures. Categories of Social-Behavioral Research That do not Require Continuing Review (2016): http://prod.kau.edu.sa/Med/ali/files/Publications/Guide/National_Committe_of_BioEthics-Regulations_of_the_Law_of_Ethics_of_Research_on_Living_Creatures.pdf
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: Research involving study of information and data previously collected, provided one of the two following terms is fulfilled: If the information is generally and publicly available; If the information is recorded in a manner that does not reveal the identity of the source person. Research including educational tests, surveys, interviews or public behavior monitoring, except in the two following cases: If the information is recorded in a manner that reveals the identity of the source person. 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. Research conducted for educational purposes.

LATIN AMERICA
No.	1
Country	Brazil
Title, Year, and Link	Resolution No. 510 of April 7, 2016: http://conselho.saude.gov.br/resolucoes/2016/Reso510.pdf
Description / Summary	This Resolution consists of 30 substantive articles: Types of research not to be registered or evaluated by the CONEP system Terms and definitions Ethical principles Establishing relation of trust between researcher and participant Communication of consent by means of oral expression Consent process done at the appropriate moment, condition, and location Allow expression of fears or doubts Information transmitted in a timely, accessible, and transparent manner Rights of the participant Clarify the nature of the research, objectives, methods, rights, risks, and potential benefits Importance of consent for persons in a relationship of authority or dependency Justification for inclusion of children, adolescents, and persons with diminished decision-making capacity Seeking of consent in traditional, indigenous, or religious communities Waiver of informed consent Documentation in the Record of Consent Registration of the Record of Consent Content of the Record of Consent Assessment of risk based on methodological procedures Precautionary measures to protect from risks Protective measures for children, adolescents, or persons whose autonomy is reduced Gradation of risks as minimum, low, moderate, or high Documentation for IRB/REC approval Registration in the Brazil platform Preliminary research steps not subject to IRB/REC review IRB/REC evaluation focus on ethical issues Scientific evaluation conducted by academic bodies IRB/REC evaluation focus on methodological procedures that entail risks IRB/REC reviewers qualified in humanities and social sciences Research by students Researcher responsibilities

AFRICA
No.	1	2	3	4
Country	Botswana	Malawi	Nigeria	South Africa
Title, Year, and Link	Anthropological Research Act 45 (1967): http://webcache.googleusercontent.com/search?q=cache:A7aea2ZEMhkJ:static1.1.sqspcdn.com/static/f/723732/25889598/1422112465653/ch59-02%2BANTHROPOLOGICAL%2BRESEARCH.pdf%3Ftoken%3DTSMJNydkWHdUJ7iPvvm7Qkzk4uU%253D+&cd=1&hl=en&ct=clnk&gl=us	Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi (2011): http://www.ncst.mw/wp-content/uploads/2014/03/NATIONAL-FRAMEWORK-OF-GUIDELINES-IN-SSH.pdf	Nigerian Code of Health Research Ethics (2007): http://www.nhrec.net/nhrec/NCHRE_10.pdf	Principles, Processes, and Structures, Section 3.3.7(i) (2015): http://www.commerce.uct.ac.za/Downloads/Ethics%20in%20Health%20Research%20Final%20A%20used.pdf
Description / Summary	This law requires the Ministry of Health to give prior permission for the conduct of anthropological research. The law contains five sections: Short title Interpretation Regulation of anthropological research Entry upon land Entry into defined areas of persons who are not citizens of Botswana	The Framework consists of the following sections: Introduction Preamble Value of research in the social sciences and humanities 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 Autonomous implementation of the framework Research communication 6.1. Authorship 6.2. Research dissemination Appropriate research environments Affiliation and research clearance Format for research proposals 9.1. General format 9.2. Specific format Monitoring system Application of the framework	This guideline outlines the following exempt categories that often apply to social-behavioral research: Research conducted in established educational settings involving normal educational practices Research involving the use of tests, surveys, or interviews. 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.

INTERNATIONAL
No.	1
Country	UNESCO
Title, Year, and Link	Code of Conduct and Ethical Guidelines for Social Science Research: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/SHS/pdf/Soc_Sci_Code.pdf
Description / Summary	This document presents 19 ethical guidelines for social science research, providing a 1-2 sentence description of each guideline: Responsibility of principal investigators Integrity of research enterprise Research topic addresses important intellectual issue Consideration of potential effects of research Awareness of potential harmful effects Competent conduct of research, without bias Compliance with local customs, standards, laws, and regulations Respect for host culture Communication of principal investigator's ethical principles Avoidance of undue intrusion into lives of research subjects Informed consent No coercion Participants informed of potential harmful effects Confidentiality of information and anonymity of participants Disclosure of research results to participants Wide reporting of research Communication of research methods to allow proper assessment Proper acknowledgement of other scholars' work Preservation of research materials

Content created by Office for Human Research Protections (OHRP)
Content last reviewed February 21, 2018

This is archived HHS content.