Informed consent is a basic ethical tenet of scientific research on human populations. Human beings can not be involved as a subject in research without the informed consent of the subject or the subject's legally authorized representative, except as otherwise specified in this document. Researchers must recognize the possibility of undue influence or subtle pressures on subjects that may derive from researchers' expertise or authority, and they take this into account in designing informed consent procedures.
Scope of Informed Consent
(a) Researchers obtain consent from subjects or their legally authorized representatives:
- When data are collected from subjects through any form of communication, interaction, or intervention; or
- When behavior of subjects participants occurs in a private context where an individual can reasonably expect that no observation or reporting is taking place.
(b) Despite the paramount importance of consent, researchers may seek waivers of this standard when:
- The research involves no more than minimal risk for research participants, and
- The research could not practicably be carried out were informed consent to be required. Waivers of consent require approval from institutional review boards or, in the absence of such boards, from another authoritative body with expertise on the ethics of research. Under such circumstances, the confidentiality of any personally identifiable information must be maintained unless otherwise set forth.
(c) Researchers may conduct research in public places or use publicly available information about individuals (e.g., naturalistic observations in public places, analysis of public records, or archival research) without obtaining consent. If, under such circumstances, the researcher has any doubt whatsoever about the need for informed consent, they consult with their departmental body or with the Institutional Review Board before proceeding with the proposed research..
(d) In undertaking research with vulnerable populations (e.g., youth, recent immigrant populations, the mentally ill), researchers need to take special care to ensure that the voluntary nature of the research is understood and that consent is not coerced.
(e) Researchers should be familiar with and conform to applicable state and federal regulations and, where applicable, institutional review board requirements for obtaining informed consent for research.
Informed Consent Process
(a) When informed consent is required, researchers enter into an agreement with research subjects or their legal representatives that clarifies the nature of the research and the responsibilities of the investigator prior to conducting the research.
(b) When informed consent is required, researchers use a language that is understandable to, and respectful of, research subjects or their legal representatives.
(c) When informed consent is required, researchers provide research subjects or their legal representatives with the opportunity to ask questions about any aspect of the research, at any time during or after their participation in the research.
(d) When informed consent is required, researchers inform research subjects or their legal representatives of the nature of the research; they indicate to subjects that their participation or continued participation is voluntary; they inform subjects of significant factors that may be expected to influence their willingness to participate (e.g., possible risks and benefits of their participation); and they explain other aspects of the research and respond to questions from prospective subjects. Also, if relevant, the researchers explain that refusal to participate or withdrawal from participation in the research involves no penalty, and they explain any foreseeable consequences of declining or withdrawing. Researchers explicitly discuss confidentiality and, if applicable, the extent to which confidentiality may be limited as set forth.
(e) When informed consent is required, researchers keep records regarding said consent. They recognize that consent is a process that involves oral and/or written consent.
(f) Researchers honor all commitments they have made to research subjects as part of the informed consent process except where unanticipated circumstances demand otherwise as set forth.
Informed Consent with Minors
(a) In undertaking research with minors, the researcher obtains the consent of children to participate, to the extent that they are capable of providing such consent, except under circumstances where consent may not be required as set forth.
(b) In undertaking research with children, the Board obtains the consent of a parent or a legally authorized guardian. Researchers may seek waivers of parental or guardian consent when:
- the research involves no more than minimal risk for the research subjects,
- and the research could not practicably be carried out were consent to be required, or
- the consent of a parent or guardian is not a reasonable requirement to protect the minor (e.g., neglected or abused children).
(c) Researchers recognize that waivers of consent from a child and a parent or guardian require approval from The Institutional Review Boards or, in the absence of such a Board, from another authoritative body with expertise on the ethics of research. Under such circumstances, the confidentiality of any personally identifiable information must be maintained unless otherwise set forth.
Use of Deception in Research
(a) Researchers do not use deceptive techniques unless they have determined that their use will not be harmful to research subjects; is justified by the study's prospective scientific, educational, or applied value; and that equally effective alternative procedures that do not use deception are not feasible.
(b) Researchers never deceive research subjects about significant aspects of the research that would affect their willingness to participate, such as physical risks, discomfort, or unpleasant emotional experiences.
(c) When deception is an integral feature of the design and conduct of research, the researchers attempt to correct any misconception that research participants may have no later than at the conclusion of the research.
(d) On rare occasions, researchers may need to conceal their identity in order to undertake research that could not practicably be carried out were they to be known as researchers. Under such circumstances, the research is undertaken if it involves no more than minimal risk for the research subjects and if has been obtained to proceed in this manner from the Institutional Review Board or from their departmental body. Under such circumstances, confidentiality must be maintained unless otherwise set forth.
Use of Recording Technology
Researchers obtain informed consent from research subjects, or others prior to videotaping, filming, photographing, or recording them in any form, unless these activities involve simply naturalistic observations in public places and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm.
Planning and Implementation
(a) In planning and implementing research, the researcher minimizes the possibility that results will be misleading.
(b) Researchers take steps to implement protections for the rights and welfare of research subjects and other persons affected by the research.
(c) When conducting a study, researchers do not encourage activities or themselves behave in ways that are health- or life-threatening to research participants or others.
(d) Researchers consult those with expertise concerning any special population under investigation or likely to be affected.
(e) Researchers consider their ethical acceptability as set forth in this document. If the best ethical practice is unclear, the Institutional Review Board is consulted their departmental body.
(f) Researchers are responsible for the ethical conduct of research conducted by them or by others under their supervision or authority.
Unanticipated Research Opportunities
If during the course of teaching, practice, service, or non-professional activities, the researcher determines that they wish to undertake research that was not previously anticipated, they make known their intentions and take steps to ensure that the research can be undertaken consonant with ethical principles, especially those relating to confidentiality and informed consent. Under such circumstances, the researchers will seek the approval of the Institutional Review Board or their departmental body.
Offering Inducements for Research Participants
Researchers should not offer excessive or inappropriate financial or other inducements to obtain the participation of research subjects, particularly when it might coerce participation. Researchers may provide incentives to the extent that resources are available and appropriate.
Reporting on Research
(a) Researchers disseminate their research findings except where unanticipated circumstances (e.g., the health of the researcher) or proprietary agreements with employers, contractors, or clients preclude such dissemination.
(b) Consistent with the spirit of full disclosure of methods and analyses, once findings are publicly disseminated, researchers permit their open assessment and verification by other responsible researchers with appropriate safeguards, where applicable, to protect the anonymity of research participants.
(c) Researchers share data in a manner that is consonant with research subjects interests and protection of confidentiality of the information they have been given. They maintain the confidentiality of data, whether legally required or not; remove personal identifiers before data are shared; and if necessary use other disclosure avoidance techniques.
Note: This document was adapted from the Ethical Standards of the American Sociological Association and American Psychological Association by the Institutional Review board of Southern Oregon University, June, 2000.