Monday, January 28, 2008

Consent Links

Student Classroom Exercises:
Primary Goal: to learn about and practice anthropological field methods
Informants: adolescent males/females/groups

Below are numerous links on ethics and informed consent when participating/oberserving/writing about human informants

Science/Biomedical Approaches
• National Science Foundation: “Frequently Asked Questions”: Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research


What exemptions of the Common Rule are most appropriate to social science research?

The Common Rule states that there are 6 categories of research that are exempt (from full IRB review). The first 4 of the exemptions will be most appropriate for social science research:

  • Research in educational settings involving educational practices. (§ 101 (b) (1))
  • Research involving educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior, unless subjects are identified and disclosure of responses would involve more than reasonable risk. (§ 101 (b) (2))
  • Research involving educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior not exempt under preceding exemption if human subjects are elected public officials, and if federal statutes require confidentiality of identifiable information. ((§ 101 (b) (3))
  • Research involving the collection or study of existing data if publicly available or unidentifiable. ((§ 101 (b) (4))
  • Research and demonstration projects designed to study public benefit or service programs. ((§ 101 (b) (5))
  • Taste and food quality evaluation and consumer acceptance studies. ((§ 101 (b) (6))

Exempt research is free from continued oversight by the IRB although the institution (either a designated IRB representative, the entire committee, or some other institutional authority), not the researcher, must determine that the project is exempt in the first place. Usually this is accomplished through a brief review process.

Does this mean that all questionnaire, educational test, and interview-based studies are exempt?

Such studies are exempt UNLESS:

  • Specific individual human subjects can be identified directly or through identifiers linked to them (i.e., their names, telephone numbers or other unique identifiers are recorded in the data)

AND disclosure of their responses could place them at risk of:

  • criminal/civil liability, or
  • damage to their financial standing, employability, or reputation

Research on vulnerable populations may not be exempt. Consult with your local IRB or NSF program officer for guidance in specific cases.

When the subjects are public officials or candidates for public office, the research is exempt even when identifiers are included or disclosure might be harmful.

When the subjects are public officials or candidates for public office, the research is exempt even when identifiers are included or disclosure might be harmful. However, all research should be bound by professional ethics and respect for respondents to guard their privacy whether or not the research is exempt (unless the participants understand that their information may be made public and permission is granted).

Classroom Exemptions (NSF Site):
Does research conducted as a classroom exercise count as human subjects research?
The Common Rule defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (§ 102.d)
This includes activities, which are intended to lead to published results, or for example, findings presented at a professional meeting. Classroom exercises, involving interactions with human participants, which are part of an educational program, and are not designed to advance generalizable knowledge, are not covered by this regulation. Similarly, evaluations for quality improvement or assessment of instruction are not considered research so long as they are not designed to create generalizable knowledge.

How can research conducted as a classroom exercise be reviewed to protect human participants?
Since the Common Rule exempts classroom exercises (see above), the IRB has no mandated role to play in reviewing such exercises. However, the IRB typically is the only institutional store of expertise about human subjects protections, and may in principle be involved in such research in an oversight function. The following suggestions are offered as guidance for institutions seeking to protect participants from harm in such situations without overburdening IRBs with needless review responsibilities.
The relevant department should set up a Human Research Committee to review classroom exercises for harm to participants.
The department should state, in writing, what sort of research is reviewed in the department (i.e., classroom exercises, non federally-funded research, etc. ) in contrast to research which must go to the IRB.
The department should state, in writing, the criteria used to evaluate proposals (i.e., voluntary participation, informed consent, lack of risk of harm, lack of deception, procedures for ensuring confidentiality of data), and the mechanism used to perform the evaluation (i.e., a standing committee, an ad hoc committee appropriate to specific proposals, etc. )
The department should specify, in writing, the records it will keep. This may consist of the proposal itself, each reviewer's comments, correspondence with the researcher including requests for revisions and responses to requests. These records should be open for inspection at any time by the IRB or the designated institutional official. There should be at least one review per year.
It is a good idea for one member of the departmental committee to be a formal member of the IRB, to insure appropriate levels of communication between the department and the IRB, and training for the departmental committee.

Research v. Classroom Exercises

Activities that require IRB review are strictly limited to research; CFR 46.112 (d) defines research:
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
• This site, supported by the federal government, carefully lays out the issues of research with human subjects for medical researchers
• The Federal “Common Rule”: informed consent
• Special cases within the “Common Rule” (including children and minors)

On-line Training Course: Research with Human Subjects:
U.S. Dep't of Health and Human Services
Health Resources and Service Administration

American Anthropological Association Response to Federal Guidelines: Research with Human Subjects, and Institutional Review Boards (IRB)
• American Anthropological Association Code of Ethics
• American Anthropological Association Statement on Ethnography and Institutional Review Boards
• Human Research Ethics: history/documents
• Human Subjects Protection: Statement by Stuart Plattner

NSF Guidelines on Ethnographic Research

Is ethnography covered by the Common Rule?
Ethnography refers to a type of social science research where the researcher studies human behavior in a natural setting, rather than in a laboratory, for purposes of understanding the culture of that particular population. Research may involve observations and/or interviews with people in that setting. Since human participants are involved, the research is covered by the regulations.

Is ethnographic research exempt?
Depending on the specifics of the research project, ethnographic research may be exempt, qualify for expedited review, or require full IRB review. Although research involving public behavior is exempt under the Common Rule, projects focusing on sensitive information, where the disclosure of responses could harm the respondent, require full review.

How should research involving "snowball samples" be handled from a human subjects perspective?
In a "snowball sample" each respondent is asked to suggest other persons for inclusion in the research. These persons are then contacted to see if they wish to serve as research participants. This is a valid procedure often used by investigators who seek to recruit from populations for which adequate sample frames are not available. For example, a researcher seeking to study patterns of informal leadership in a community may ask individuals to name others who are influential in a community. Similarly, studies of the diffusion of ideas and acceptance of new technologies can be traced through scientific and medical communities.
Snowball samples in and of themselves do not necessarily pose a risk for human subjects. IRBs should follow the normal procedure of examining the project for risks of harm commensurate with normal life. Each respondent is given the opportunity to participate or to decline participation.
For studies studying sensitive topics, study protocols should adhere to the recommendations for confidentiality. For example, studies of networks of drug users or tracking sex partners of HIV+ cases require extreme caution with information gathered from one subject about another. All information should be treated confidentially. (See Certificate of Confidentiality)

Is written documentation of informed consent required in ethnographic research?
Ethnographic research interviews are not necessarily formal interviews with a questionnaire. They often are simple conversations on the respondent's home ground (as opposed to the researcher's laboratory). Competent adult individuals have the option of participating and responding to questions or the respondent has the choice of not allowing the researcher access to his or her person, ignoring requests for information, giving misleading replies, or responding to requests in other ways that preserve the respondent's dignity and independence. Informed consent is usually implied by the respondent's willingness to talk to the researcher.
In most ethnographic projects a request for a written, formal consent would seem suspicious, inappropriate, rude and perhaps even threatening. In other words, written consent can potentially harm the research interaction and generate rather than ameliorate concern in respondents. In many parts of the world, for many people with a history of exploitation and unfair dealings with authorities and government, a request to sign a form is fraught with danger. Respondents may not be fully literate, may not have familiarity or experience with social science research, and may have learned to expect the worst from strangers through experience or popular belief.
The roles of women and minors are not necessarily the same in other societies as in the US. In many cultures women and children are forbidden from making any agreement without their husband's or father's permission, which may not be appropriate in all situations. Written informed consent in such cases would be impossible to obtain, or if obtained would generate concern in respondents.
Researchers should be sensitive to such cultural differences within the US as well as in cultures outside the US. A vital aspect of protecting and respecting human subjects is to "do your homework" of learning about the cultural norms of those you wish to study. Expertise regarding the locale is essential and may be provided by the investigator or a consultant. In these circumstances the Common Rule authorizes a waiver of written documentation. § 117 (c) (1) discusses situations where the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality.
§ 117 (c) (2) deals with waiving written documentation of informed consent in situations where "the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context." This covers a large portion of ethnographic research on non-sensitive topics.

How should IRBs proceed in reviewing ethnographic research?
As with any project, the IRB administrator should assess the research to determine if there is any risk of harm to participants (beyond that which might be experienced in daily life), to determine whether the research is exempt or qualifies for expedited or full review.

What is "group consent" and how is it relevant to informed consent?
The concept of informed consent derives moral force as a mark of respect for persons. The request for informed consent envisions each human being as autonomous and capable of making informed judgments about appropriate personal activities.
Many traditional societies rely on an elder or group of leaders to express decisions with respect to the group. An individual community member who acted independently, without the knowledge and consent of the group, might be seen as suspicious, perhaps acting counter to the best interests of everyone. The appropriate way for a foreigner to get permission to do research in a setting like this would be to present the project in an open meeting, allowing questions to be raised and answered publicly. After formal group approval, any individual member of society would be free to cooperate or not with the research project.
In all societies, when research is planned in sharply defined communities, consultation with community representatives may be necessary in order to avoid negative gossip and refusals to participate. Such community consultation and public relations is part of a good research design and not a substitute for individual informed consent.

Richard Stockton Application To Undertake Research With Human Subjects (from Stockton's IRB)

Exemptions to Federal Regulations (to be reviewed by the Stockton IRB)
Appendix A
Paragraph 46.101
(b) Unless otherwise required by Department or Agency heads, research activities in which he only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal education practices,such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods, unless (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b)any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,interview procedures or observation of public behavior, unless: (please see a and b above)
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,interview procedures or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office, or (ii) Federal statute(s) require(s)without exception that the confidentiality of the personally identifiable information will be maintained throughout the
research and thereafter.
(4) Research involving the collection or study of existing data. documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of the Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.Department of Agriculture.
Source: 63FR 60364-60367, November 9, 1998. Department of Health and Human Services.

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