Frequently Asked Questions and Vignettes
Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research
Click on the applicable heading to go to a specific subject:
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?
- 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 & 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?
- 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?
- 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?
- What issues arise concerning compensation
- 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?
- 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?
What is the relationship between the Common Rule and the Federal Regulation for the Protection of Human Subjects?
The "Common Rule" is the term used by eighteen federal who have adopted the same regulations governing human subjects of research. (See List of Federal agencies). Each agency's regulations are printed in the Code of Federal Regulations (CFR) with different preface numbers but the same section (§) numbers. The text of the regulation in each case is identical.
Thus NSF's regulation is listed as 45 CFR Part 690 §101…124, while DHHS' regulation, consisting of the identical text, is 45 CFR Part 46 §101…124.
Some agencies have adopted additional regulations ("subparts", see below) dealing with special populations. The Common Rule is also referred to as "Subpart A" of the DHHS regulations of human research 45 CFR 46, to distinguish it from the other subparts listed below.
Institutions assure that they will comply with the regulations regarding human subjects research. This assurance is normally filed with the appropriate federal agency that sponsors their research. Most universities have assurances from DHHS. Under the Common Rule, each agency (e.g., NSF) agrees to accept an assurance issued by DHHS as a commitment that the institution will follow the regulations.
What are the Subparts of the regulations?
Subpart A, known as the Common Rule, relates to human subjects research in general. The other subparts (B, C and D of the DHHS version) relate to special research populations and have been adopted by some agencies. (See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)
Subpart B relates to research on fetuses, neonates, and pregnant women;
Subpart C relates to research with prisoners, and in general stipulates that the IRB include a prisoner or prisoner representative (among other requirements);
Subpart D relates to research with children, and in general mandates that adequate provisions be made for soliciting the assent of children and permission of their parents or guardians.
NSF has chosen not to adopt subparts B, C, and D. Only subpart A regulations are necessarily relevant for NSF funded projects. The Common Rule indicates that vulnerable populations include subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons.
Institutions which follow subparts B, C, and D for DHHS-sponsored research may not need to do so for NSF-sponsored projects.
Many institutions have signed Federal Wide Assurances with DHHS in which they may have agreed to apply the subparts to all research. If this poses a problem in conducting the NSF-sponsored research, institutions are advised to consult with their NSF program officer. In many cases problems are caused not by the regulations themselves, but by overly restrictive interpretations by IRBs. For example, Subpart C's mandate of an IRB member who is "a prisoner, or prisoner's representative with appropriate background and experience ..." can be met by a suitable member of the sociology or criminal justice faculty, the regulations do not require a formal affiliation with a prisoner association. Subpart D's mandate of informed consent is subject to "the extent that consent is required by §46.116 of Subpart A..." and does not automatically and invariably require written consent forms. As § 46.116.d. (same as § 690.116.d) specifies, informed consent can be modified or waived for a project which:
- could not practicably be carried out without the waiver or alteration,
- is of no more than minimal risk,
- the waiver or alteration will not adversely affect the rights and welfare of the subjects,
- where appropriate, the subjects will be provided with additional pertinent information after participation.
These conditions cover a lot of research supported by the National Science Foundation.
Original Agencies, Departments and Offices approving the Common Rule (1991)
Agency for International Development
Consumer Product Safety Commission
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Centers for Disease Control
Food and Drug Administration
National Institutes of Health
Department of Housing and Urban Development
Department of Justice
Department of Veterans Affairs
Department of Transportation
Environmental Protection Agency
National Aeronautics and Space Administration
National Science Foundation
In addition, the Central Intelligence Agency and Social Security Administration are required by Executive Order and statute, respectively, to follow the DHHS regulations (including all subparts).
What parts of the regulations are applicable to my institution?
The Common Rule (subpart A of the DHHS regulations) has been adopted by many federal agencies involved in research.
NSF has not adopted subparts B, C and D of the DHHS regulations, and they are not necessarily applicable to NSF awards. (See Vignette: Child language studies in "Freedonia")
Specific institutions may have adopted policies that go beyond NSF's requirements. In general, institutions are free to adopt policies as they see fit, above and beyond the Common Rule. IRBs or researchers with specific questions about projects should contact the relevant agency program officer for guidance. (See FAQ: What are the Subparts of the regulations?)
My institution's assurance is with DHHS through OHRP, which has adopted subparts B, C & D. Does this mean that all research conducted through this institution must comply with the particulars of these subparts?
Not necessarily, if the research project is supported by an agency which has not adopted the particular subpart. The new Federalwide Assurance authorizes an institution to follow the regulations as interpreted by the most relevant agency or department. In NSF's opinion, a rote application of subparts B, C, and D may not always respect the autonomy of respondents, reduce risk or insure justice, and NSF urges flexibility with the goal of protecting human subjects and advancing research. (See Vignette: Child language studies in "Freedonia") (See FAQ: What are the Subparts of the regulations?)
What are the overall goals of the federal policy (the Common Rule)?
The policy is designed to ensure minimal standards for the ethical treatment of research subjects. The major goal is to limit harms to participants in research. That means that no one should suffer harm just because they became involved as subjects or respondents in a research project. Institutions engaged in research should foster a culture of ethical research.
ETHICAL RESEARCH rests on three principles:
- RESPECT for persons’ autonomy, meaning the researcher gives adequate and comprehensive information about the research and any risks likely to occur, understandable to the participant, and allows them to voluntarily decide whether to participate.
- BENEFICENCE, meaning the research is designed to maximize benefits and minimize risks to subjects and society.
- 3. JUSTICE, meaning that the research is fair to individual subjects and does not exploit or ignore one group (e.g., the poor) to benefit another group (e.g., the wealthy). (cf: The Belmont Report)
Research produces benefits valued by society. Regulatory oversight seeks to ensure that any potential harm of the research is balanced by its potential benefits.
How can oversight be matched to risk in order to achieve the goals of the Common Rule?
The level of oversight should be matched to the level of risk. This implies that:
- Projects should be preliminarily assessed for the possibility of harm to subjects greater than what is normally encountered in daily life.
- IRBs should distinguish the probability of harm from the magnitude of harm. It is possible that a project can be "minimal risk" with a high probability of a trivial harm. Proposals with extremely low probabilities of serious harm should be carefully examined to minimize risks and ensure that appropriate informed consent is obtained.
- In these guidance statements, "minimal risk" is used to refer to research where the magnitude of harm is low, whether the probability of harm is low or high.
What does "minimal risk" mean in research?
The Common rule defines minimal risk as: "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (§ 690.102 (i))
- Note that the probability of harm should be distinguished from the magnitude of harm. It is virtually certain that we will suffer minor transient harms in normal every-day life (transportation delays; inclement weather; embarrassment; fatigue; etc.). Such high-probability, low-magnitude harms are within the definition of "low-risk" research. Researchers might be asked what the probability of transient harm occurring is; whether the harm is likely to be lasting in any way; and what steps will be taken to ameliorate the harm.
- "More than minimal risk" means that the degree of physical or psychological discomfort is above that which is ordinarily encountered in daily living or during the performance of routine physical or psychological examinations or tests. This could include disclosure of confidential information to individuals who could use that information to harm a subject in some way.
Researchers who gather such information are obligated to take all reasonable measures to provide a secure environment for data and to assure that it does not come into the wrong hands (See FAQ: What are the major techniques for protecting confidentiality?). The regulations refer to serious harm:
- Most social science data, even if revealed, would not put subjects at serious risks. The mere fact that data might be disclosed does not mean that subjects will be seriously harmed; the critical question is whether disclosure would be potentially damaging.
Most social and behavioral scientists, however, subscribe to a strict standard involving confidentiality:
- Confidentiality should be guaranteed, unless the respondent explicitly agrees to disclosure. The release of any information that can be linked to an individual, potentially damaging or not, should be agreed upon.
- "Delayed harm": It is conceivable that as a result of participating in a social science study a subject may experience some longer term psychological reaction, such as depression. It is also conceivable that material covered in the course of an interview may lead subjects to re-examine past experiences in a different light, to reevaluate themselves in less than positive terms, or to seek additional information that may lead to other difficulties. This process may take days or even weeks. Researchers might be asked to indicate what the probability of such harm is and what might be done to ameliorate it should it occur. (For example, counseling referral information can be made available for participants.)
What does the Belmont Report have to do with IRB reviews?
The Belmont Report (1979) was prepared by a government commission convened to frame "Ethical principles and guidelines for the protection of human subjects of research." The report described three ethical principles that should be adhered to when conducting research: respect for persons, beneficence, and justice. This document provides the philosophical foundation for the Common Rule. It explicitly focused on biomedical research, however the regulations that stem from it cover behavioral and social as well as biomedical research. Quoted material here is from that report.
- Respect for persons. This means that "individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection." Informed consent is the key element:
- "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall and shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied."
- Sufficient information should be provided to subjects so that they may make an informed decision about whether to participate. Information provided to potential subjects should be clear and understandable.
- "An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence."
- "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall and shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied."
- Beneficence. Researchers are obliged to protect subjects from harm; "maximize possible benefits" of the research while "minimizing possible harms."
- Justice. The principle of justice concerns the distribution of the burden of research and the reaping of possible benefits of the research as well as the procedural fairness of the research as experienced by the participants. It is relevant to the selection of subjects; the burden of risky research should not fall disproportionately on stigmatized or institutionalized persons.
Potential risks and benefits of the research project need to be assessed. "The term 'risk' refers to a possibility that harm may occur. However, when expressions such as 'small risk' or 'high risk' are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm." "The term 'benefit' is used in the research context to refer to something of value related to health or welfare." … "Risks and benefits may affect individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society)." Risks and benefits are usually described in the informed consent process for clinical research; for many social and behavioral science projects where risks and benefits are minimal (e.g., many surveys) an extensive statement is not appropriate.
"Do I make myself clear?" (Vignette)
Dr. Strunk prides himself on his ability to communicate clearly, in terms appropriate to his audience. Strunk feels special responsibility to communicate clearly when he solicits subjects for his research on children's responses to literature. He follows the principle of respect for the autonomy of human subjects, as enunciated in the Belmont Report. In Strunk's view, that means, among other things, that the informed consent must be understandable to these parents and to their children. He realizes that comprehension is influenced by emotional as well as cognitive factors. Unusually formal or legalistic language will obscure meaning that otherwise would be clear if friendly, informal and familiar forms of address and vocabulary were used.
Accordingly, Strunk prepared parental permission and child assent forms in clear friendly language. Since he was a member of the school's PTA, served on various PTA committees and was generally known to the teachers and other parents as Bill Strunk, he signed his correspondence with parents as "Bill Strunk." Strunk was flabbergasted when his IRB sent him back a very long "corrected" version of his assent and permission letters, rewritten in complex "legalese," to be signed as "Dr. William Strunk." Who was right?
Strunk was right. The federal regulations require an explanation that subjects can understand. In fact, the University of South Florida recently was sued by subjects (successfully for $3,800,000) claiming that the consent form was not written in a manner they could understand. (http://www.researchroundtable.com/usfcase.htm). University lawyers who rewrite such documents may fail to realize that clear communication (in terms the subjects can understand) is what the law requires. Language that is unclear, alarming, and incomprehensible to the subject does not protect the institution and is not in fact "legally correct."
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).
Does this mean that I cannot collect or record personal identifying information?
IF you collect information on individually identified participants from publicly available sources, the project may be in the exempt category as long as that information would not cause harm to the individual if it were known. For example, recording observations of everyday public behavior, or interviewing people about non-controversial opinions or preferences.
Does this mean that I cannot collect or record personal identifying information when studying sensitive topics?
IF the personal identifying information could harm the participant, then the project would need to be reviewed by the IRB. The IRB might require informed consent to be obtained including a description of the confidentiality procedures to be used. The IRB should be convinced that the subject can understand the procedures for confidential handling of the information as communicated in the consent process.
Child language studies in "Freedonia" (Vignette)
Professor Jones, a sociolinguist, received a prestigious CAREER Award from the National Science Foundation funding five years of her research on how elementary school children in "Freedonia" learn grammatical categories. Her research involved asking children how they say normal phrases on subjects that were not sensitive in Freedonian or US culture, thus the research was deemed to be low risk by her institution and NSF.
In the fourth year of her research Professor Jones changed institutions to "Academic" University. Professor Jones expected her IRB approval for her continuing research to be simple, since this was the fourth year of research on this minimal risk project. She was surprised to learn, three weeks before she was due to leave the country, that the new University's IRB wanted her research to be reviewed by a Freedonian IRB. Freedonia does not have social science IRBs and using a Freedonian medical IRB to review this project would not be an ideal situation.
The new University's IRB also said that following Subpart D, pertaining to research involving children, she would need to get prior written consent from parents of all children she would involve in her research, using language which mentioned "risks" that are biomedical in nature and inapplicable in the context of her research. Professor Jones called her NSF program officer for help. The program officer, together with the NSF human subjects research officer, affirmed that the research was low risk. However the position of the University administrators was that the regulations required both a foreign IRB and the application of Subpart D's additional oversight for children. The University pointed out that their Federalwide Assurance with DHHS specifically included Subpart D.
After additional conversation with NSF staff, University administrators and legal advisors, and OHRP specialists, the University finally gave its approval to the project and Professor Jones was able to leave for Freedonia to continue her research as approved originally by her previous institution, without written consent. Most of the conversation dealt with formal requirements of the process and did not focus on issues related to potential risks of harm to the human subjects in the study.
- Research in foreign countries does not always need to be reviewed by a foreign IRB if none exists, or when such a review would not be appropriate or feasible under local conditions. The US institution's review is always primary and often sufficient. The review will ensure that at least equivalent protections apply to both subject populations.
- The additional protections involved in the Common Rule's subparts are not automatically relevant to NSF-funded projects and should not serve to impede research when minimal risk of harm is involved. The IRB should follow the guidance of the federal agency supporting the research.
The general lesson:
- The purpose of the regulations is to prevent or minimize harm, given informed consent, while ensuring the quality of research. The degree of oversight should be scaled to the level of risk.
- Other guidelines may be applicable and provide guidance including ethical standards of professional associations as well as certain journals that require assurance that research has been conducted with ethical standards.
Are third parties human subjects in research?
The Common rule defines a human subject as: "...a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (§ 690.102(f))
When respondents give information about other people who are not directly interviewed these others are known as "third parties".
The goals of the Common Rule apply to any person who has the potential to be harmed because of a research project, whether or not the person is directly interviewed or identified through an interview with someone else.
The research project should be assessed for the likelihood that third parties could be harmed. If the project is low risk then no special oversight is required.
If the data are stripped of identifiable private information (http://www.icpsr.umich.edu/), then no "human subjects" are involved. The IRB records should retain information about the process leading to this determination.
The project information should be kept confidential; the level of confidentiality (applicable to all identified persons, not just interviewed subjects in the research) should be commensurate with the level of risk.
Additional provisions may apply in the case of health information privacy and confidentiality (HIPAA). These provisions generally require securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them.
The regulations do not automatically mandate informed consent from third parties. If the potential risk is serious and not ameliorated by confidentiality procedures, then consent is necessary.
Is secondary analysis of data human subjects research?
Much research in the social sciences deals with the re-analysis of data often available in a "public-use data file". This is known as "secondary analysis". The goals of the Common Rule apply to any person who has the potential to be harmed because of a research project, whether or not the person is directly interviewed or identified through data collected by another researcher for a different purpose. Public use data files are normally stripped of identifiable private information or "de-identified.” In this case, the research is exempt since no identifiable human subjects are involved. (§ 690.102.f.2) When identifiers are included in the data, several issues should be considered:
- The research project should be assessed for the likelihood that identified respondents could be harmed or easily identified. If the project is low risk then no special oversight is required. If the data is de-identified, then no "human subjects" are involved in the research.
- The project information should be kept confidential; the level of confidentiality commensurate with the level of risk applicable to all identified persons.
- The regulations do not mandate informed consent from identified persons in secondary data sets although it may be required. If the potential risk is serious and not ameliorated by confidentiality procedures, then consent is necessary. Medical records may be subject to additional regulations.
What about merging public data files or enhancing a public data file?
This activity requires IRB review to verify that the risk of identifiability has not occurred or increased. It also requires that an adequate data protection plan for confidentiality is in place.
What if the project intends to link data from a new survey to existing individual-level data from public data sources?
Whenever appropriate, the subjects will be provided with additional pertinent information about the use of their data. The researcher should inform the research participants of efforts to link their data to public data sources in the process of obtaining consent.
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?
If the level of confidentiality in the new data set created by the linkage is less than that in either of the pre-existing sets, then the change in research design must be examined by either the IRB official or fully convened IRB depending upon whether the initial review was exempt. Following that review, after evaluating the level of risk involved, a waiver of informed consent may be recommended if risk of harm is low and adequate confidentiality procedures are in effect.
What sorts of harm can arise from social and behavioral science research?
Here are some typical examples:
Harms commensurate with daily life, requiring no special protection:
- Mere inconvenience when a survey or other research interaction is administered at an inconvenient time or place or simply takes a long time to administer.
Harms that have the potential for serious effects, which IRBs should examine:
- Emotional or psychological harm, for example when a research interaction causes upset, or worry about breach of confidentiality.
- Social harm due to stigma or other negative social outcomes of breach of confidentiality.
- Physical harm if revelations about others get back to those persons, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, or other phenomena concerning violence-prone individuals.
- Financial harm if revelations result in loss of employment or insurance coverage.
- Legal harm when illegal activities are disclosed.
- Moral harm when participation in research strengthens subjects' inclinations to behave unethically.
Informed Consent in Social and Behavioral Science
- Informed consent should take the form of a friendly, easily understood communication process with competent participants. Ideally it should be a verbal exchange between researcher and subject, with a written summary of the information for the subject to keep as appropriate. When written, it should be brief, and simply phrased at a reading level that the least literate subject can understand.
The informed consent process should involve a friendly discussion that provides a basis for subjects to decide about participation. Subjects should be able to think about what they have been told and to ask any questions. IRBs and researchers should not defeat the purpose of informed consent by substituting a legalistic consent form for an effective communication process. If signed forms are appropriate, signing the form should not be perfunctory, unreflecting and automatic. When written informed consent would be the only identifiable link to research participants, it may increase risk and in some circumstances should be avoided.
- When there is likely to be some risk of harm or inconvenience to certain subjects, they should receive enough information to judge whether the risk is at a level they can accept. If more than minimal risk is involved the consent form should state the subject's rights and the researcher's responsibilities.
Research participation in most social-behavioral research involves time and possibly some inconvenience and discomfort. An adequate informed consent process can sort out those who would gladly participate from those who wish to opt out. Persons may agree to undertake some risks or inconveniences, which they would reject if unilaterally imposed upon them.
- Researchers and IRBs should distinguish between the process of informed consent, the documentation of informed consent, and written documentation of informed consent.
Informed consent should endure throughout the interaction between investigators and participants, rather than only at the beginning. The initial agreement to participate can be documented in various ways. When appropriate, usually where risks of harm are substantial, individually signed forms are the "gold standard" of informed consent.
- When the research procedure is long and complex, the researcher should take extra precaution to make clear that the subject is free to ask questions at any time.
Informed consent as a conversation needs to be available throughout the research, as subjects may develop questions or concerns when they are well into the research experience. For example, a discussion of confidentiality may not be really understood until they are asked very personal questions in the research experience. Subjects should feel free to raise questions at any point in the research. The elements of informed consent include:
- A statement that the study involves research and an explanation of its purpose.
- A description of any reasonably foreseeable risks to the subject.
- A description of any benefits to the subject.
- A disclosure of appropriate alternative procedures of courses of treatment.
- A statement describing the extent to which confidentiality of identifying records will be maintained.
- An explanation as to compensation or treatment available if injury occurs, when the research involves more than minimal risk.
- An explanation of whom to contact for answers to pertinent questions about the research and subjects’ rights.
- A statement that participation is voluntary and that the subject may withdraw their participation at any time for any reason.
Detailed recitation of irrelevant information demeans the communication and is slightly insulting. People are capable of deciding whether to participate in surveys and ethnographic research. Assurances that there are no risks and descriptions of measures taken to assure confidentiality can be irrelevant, irritating, misleading, and may not decrease the risk of harm.
- When subjects are peers or superiors of the researcher, extremely detailed verbal informed consent is often unnecessary, and written consent may not be appropriate, unless the research is concerned with sensitive personal information.
Normal interaction among peers or with persons of higher status than the researcher is not respected by "reading subjects their rights" or by formal or written consent procedures. Common sense, courtesy and standard social norms should dictate what is communicated when asking such persons to participate in research.
- The cultural norms and life-styles of subjects should be considered in deciding how to approach informed consent. Issues such as whether to present material in printed form, deal with subjects individually or in groups, seek the consent of gatekeepers or superiors in lieu of or in addition to individual subjects' consent, and whether to treat underage persons differently should be dictated by the culture and context of the research and the level of risk.
Persons should be treated respectfully in accordance with their culture and circumstances. People who are functionally illiterate, who are suspicious of persons who proffer documents or require signatures, or from non-industrialized cultures should be approached in the style that is most comfortable to them. Protocols for research on such populations should show evidence that the researcher is informed about the culture of the intended research population and has arranged the informed consent and other research procedures accordingly.
- IRBs should be flexible in considering a wide range of media as possibly appropriate for administering informed consent given varying degrees of risk. Video tapes, brochures, group discussions, web sites, and so on can be more appropriate ways of communicating with potential subjects than the kinds of legalistic formal consent forms that have often been used.
The emphasis should be on effective communication with appropriate opportunity for exploration, asking questions, achieving clarity and understanding, reflecting and making reasoned decisions. (§ 116, §117)
- The IRB may approve a consent form that does not include, or alters some or all elements of informed consent, or waive the requirement to obtain informed consent.
There are different circumstances, which might be reasonable for the IRB to consider. For example, if the research involves no more than minimal risk the IRB may waive requirements to obtain informed consent.
- An IRB may waive the requirement for the researcher to obtain a signed consent form for all subjects.
When documentation by written consent forms is required (§ 117 (a)) then the regulations discuss two forms: a long and a summary, short form (§ 117 (b) (1) & (2))
When a Signed Consent Form can Harm a Participant (Vignette)
A social scientist proposed a study in which subjects would be asked to discuss privately with their romantic partner a past disagreement. Because the questions are embarrassing, the researcher proposed that complete anonymity, including to the researcher, be preserved. This was aimed to encourage participation and protect the subjects. The IRB instead required the collection of signed informed consent forms, thereby eliminating the anonymity.
- The risk in this project is the harm resulting from a breach of confidentiality. The regulations allow the IRB to waive documentation of informed consent ((§ 116 (d)), and ethical considerations mandate that they do so, in order to reduce the risk to the subjects. Here a misreading of the rules actually increased the risk to subjects.
- Documentation of informed consent is not an end in itself, but should be a tool to decrease risk of unexpected harm to participants.
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 FAQ Does research conducted as a classroom exercise count as human subjects research?), 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.
The Beach versus the Airport (Vignette)
Two parts of a study were proposed to the Maven University IRB, one to be conducted at the beach, where subjects were to be offered compensation, another to be conducted at the airport, where they were not. The IRB demanded an explanation of why subjects should be paid at the beach but not the airport. They agreed to the study after the investigator explained that that people at the beach are busy having fun, so you have to offer to pay them to get them to take the time to help you; but people at the airport are bored, and they are often quite happy to have something to fill the time.
"Research-Like Tools Used as Teaching Tools" (Vignette)
Professor Speakwell teaches undergraduate courses in linguistics in which he demonstrates variability in both the syntax and vocabulary of spoken expression across individuals and cultures. Professor Speakwell involves his students in active learning in the classroom. He brings recordings of spoken English to class and calls on students to say whether they find the example grammatical and to explain or guess what the utterance means. He also requires students to code narratives to show the part of speech that various words occupy in utterances.
Professor Researchit, a colleague of Speakwell's, uses these same techniques with undergraduate student volunteers to do research on variables that predict understanding of utterances. Dr. Researchit develops a protocol, and obtains IRB approval and students' signed informed consent. Professor Researchit tells Speakwell that he had better get IRB approval and student informed consent since he is doing the same thing. Is Researchit correct?
No, Speakwell is not doing the same thing. Speakwell is teaching, not doing research. Even if Speakwell or some of his students record systematic data and treat this as a classroom experiment, it is being done for teaching and demonstration purposes. It is part of what students signed up for when they enrolled in Speakwell's class. Just as Speakwell is entitled to give exams, require homework, grade students on classroom participation, and so on, he is entitled to employ this kind of classroom activity as part of his teaching.
The requirement of IRB review would be an inappropriate infringement on Speakwell's academic freedom. There is no point in having students sign a consent form. Participation is part of the coursework for which they enrolled. Moreover it would add inappropriately to the IRB workload. The Federal Regulations are entirely clear on this point. 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.
Researchit's project in fact fits the criteria for exemption, because it uses interview procedures that involve no risk of harm.( § 690.101.b.2)
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"?
The regulations specify exempt research at § 101 (b) and expedited review at § 110. Your university requires that the IRB or some other non-involved person, and not simply the investigator, must confirm that the project is in the exempt category. In order for that determination to be made, the project must be examined by an independent authority. Exempt projects are usually free from continued oversight by the IRB unless the nature of the project changes.
On the other hand, your university may have simply collapsed the exempt and expedited categories of research together. In an expedited review, typically only one experienced member of the IRB committee, or the chair of the committee, will review the project and confirm that the project is indeed minimal risk, or a minor change to a previously approved protocol, and meets the criteria for expedited review.
Where can I get authoritative and expert interpretation of the regulations?
Many agencies support the Common Rule, meaning they follow the same regulations. Each agency has special expertise in the application of the regulations for relevant research.
For example, NSF funds research in the area of experimental economics. An IRB asking how to apply the regulations to experimental economics research could seek guidance from the funding agency supporting those research activities.
The most knowledgeable advice comes from the agency funding the research.
Although all agencies follow the same regulations, each agency has different expertise on the application of the regulations to specific cases. For NSF research, the first person to call is the Program Officer, who will answer questions directly or get authoritative advice from NSF's Human Subjects Research Protections Officer.
But my institution's assurance is from OHRP. Doesn't that mean that I must get that office's response to my question?
No, OHRP will direct inquiries from requestors to the appropriate officials at the funding department or agency. The response of the agency funding a specific research project is the most appropriate government interpretation of the regulations with respect to that project.
What flexibility does the IRB have in applying the Common Rule?
The purpose of the federal regulations is to obtain the benefits of research for society while minimizing the risks of harm to human research participants. To further this goal the regulations encourage IRBs to make independent informed judgments, using common sense and expertise to apply a standard set of rules to diverse research situations, and to document the procedure followed in arriving at its judgment.
For example, sections §…116 (c), (d), and §…117 (c) discuss flexible procedures that may be used to administer informed consent, depending on the specifics of the research project. Informed consent is the procedure by which the researcher respects the autonomy of research participants (as discussed in the The Belmont Report). Since written documentation of informed consent can create harm for research participants in some circumstances, it should not be routinely required in all cases. For example, research should not use signed forms when the focus is on illegal behavior, or on partisan political activity in violent areas, where signed forms may potentially increase risks to the participants. Here the respondent's signed form could expose him or her to harm from state authorities or private vendettas.
- Your IRB can authorize a waiver of written consent forms or other formal consent procedures under specified conditions. (See 45 CFR Part 46 §116)(See 45 CFR Part 46 §117)(See FAQ Informed Consent in Social and Behavioral Science)(See FAQ When a Signed Consent Form can Harm a Participant
What if the researcher and the IRB disagree about the risk and appropriate action to be taken in the project?
The regulations do not discuss procedures for resolving conflicts between IRBs and researchers. Each institution should develop a written set of procedures for resolving differences of opinion. For example, perhaps a conversation could be scheduled between the research office administrator, the IRB chair, the researcher, outside consultants if deemed appropriate, and the funding agency representative. The major principles to be respected in any mediation procedure should include:
- Limitation of risk of harm to human subjects.
- Reasonable implementation of informed consent.
- Avoidance of conflicts of interest.
- Advancement of knowledge through research.
- Oversight commensurate with the level of risk.
- Adherence to the Common Rule.
Ultimately, however, authority to approve the research must rest with the IRB.
Advice to IRBs on Dealing with Researchers
The advance of scientific research is a vital interest of the United States of America. Your institution is by definition an important part of the US research effort. The institution should provide enough resources to enable the IRB to:
- Act in a timely way on research protocols. Expedited reviews should take no longer than five working days.
- Incorporate sufficient expertise to review the research presented to you (§…107 (a)). The institution should provide a roster of experts to the Office of Human Research Protections of HHS, without conflicts of interest with the research, willing to contribute to the IRB discussion of every proposal.
- Seek ways to streamline the process. Proposals may be reviewed on-line to minimize paper clutter; departmental representatives could be included in the IRB to triage the reviews.
- Give talks and workshops for departments (and especially for their graduate students) whose protocols are often problematic; make handouts or on-line materials that suggest useful procedures for handling human subjects issues that frequently arise.
- Make sure that your institution's library carries books and articles that offer useful guidance on sensitive issues such as research on children, procedures for assuring confidentiality of research data, state laws concerning mandated reporting of child or elder abuse, etc.
- Offer to consult with researchers as they design their research and as they prepare their protocols.
- Ensure that the IRB includes members who are, themselves, researchers and who are knowledgeable about research design and human subjects protections. Have a directory available to researchers to identify which IRB staff or member to consult with for any given type of problem.
- Be willing to work with researchers to help them improve their protocols rather than rejecting problematic protocols.
Remember that the time you spend being helpful before a protocol is finished saves everyone's time, creates goodwill, and earns the IRB a reputation that will make it easier to recruit top notch researchers to your institution and to the IRB membership.
Advice to Researchers on Dealing with IRBs
Researchers can do several things to avoid problems with IRB review:
- become familiar with the federal policies and regulations and with the local IRB procedures,
- provide the IRB with sufficient information to allow them to accomplish their job,
- volunteer to serve on the IRB.
- Consult with the IRB as soon as you begin to consider doing sensitive research or research on a vulnerable population; learn their concerns and recommendations; ask them the best ways to solve the problems they mention. If they suggest "solutions" you cannot live with (e.g., getting written consent when you know this would be virtually impossible, or would compromise your sample, rendering the research invalid) let them know their requirement means you can't do the research. If they cannot respond in a way that is helpful, consult with the following and provide written documentation of what you learned from them.
- Refer to your scientific society's code of ethics or discuss the issue with representatives of your scientific society. Official representatives of your scientific society may be unwilling to give advice, but may refer you to members who are knowledgeable and who might advise you.
- Consult with the agency (actually or potentially) funding your research.
- Consult with researchers who have worked on this kind of sensitive research and learn how they and their IRB resolved the problem.
- Consult the ethics/methodology literature on this issue.
- • Check the Federal Regulations to see what options they allow, but which your IRB may not wish to follow. Remember that your IRB has the option of being stricter than the Regulations, but it may be useful to remind them that you are operating within the Regulations.
- Consult OHRP guidance at http://www.hhs.gov/ohrp/policy/index.html#irbs.
How should IRBs deal with research in foreign countries?
The US institution administering the research has the primary responsibility, normally codified in an Assurance, to ensure that the project complies with US regulations. The Common Rule § 101 (h) discusses foreign human subjects regulations and procedures for substituting them for US regulations. When an appropriate foreign IRB exists the regulations foresee involving it in reviewing the research. The US institution’s IRB chair determines that the procedures prescribed by the foreign IRB afford protections that are at least equivalent to those provided in the Common Rule.
This regulation is most germane to biomedical research, as few foreign countries apply human subjects regulations to social and behavioral science. In many foreign countries IRBs deal only with biomedical research and will refuse to extend their purview to cover social and behavioral science. In other foreign situations there will be no analogue to an IRB and the concept may be irrelevant. When this situation occurs, the US institution remains the responsible authority and the services of a foreign IRB might not be necessary.
Can research proceed at a foreign institution if no foreign IRB has reviewed the research?
The Common Rule discusses cooperating research institutions at § 114, which envisions each institution reviewing the research through its IRB. When institutions are in foreign locations with no tradition of IRB review of the relevant research, the review of the US institution may be sufficient. If the IRB has concerns about the risk of harm to research participants, the IRB should make a serious effort to involve appropriate cultural expertise in its review by soliciting the cooperation of persons knowledgeable about the customs and language in the society where the research will occur.
There are options that can be considered in order to ensure that research proceeds even in the absence of a foreign IRB. Some foreign IRBs have FWAs, and can be used for the review of research to be conducted in that country. Alternatively, a foreign IRB or ethics board in the country where the research is to be conducted can review the research.
Compensation and Disguising Cessation of Participation (Vignette)
An investigator submitted a proposal to the Maven University IRB for an anonymous paper-and-pencil study of attitudes toward a hypothetical case of incest. Due to the sensitive nature of the topic, the IRB wished to ensure that subjects could discontinue their participation at any time. The survey was to be administered simultaneously to numerous subjects in a group setting. The IRB felt that individuals who began the survey, but then changed their minds, would experience undue pressure to continue participating, since leaving early would call attention to the individual's withdrawal from the study. The IRB therefore instructed the investigator to attach a paper-and-pencil puzzle to the survey packet, along with instructions indicating that, if subjects wished to discontinue their participation at any time, they could work on the puzzle if they so chose.
This created a dilemma for the researchers: they felt no obligation to pay compensation to subjects who choose not to participate. Such payments would be costly in research funds, and raise the problem that subjects might chose to participate solely to be compensated for doing puzzles. On the other hand, inspecting the survey forms to pay compensation to only those who completed the survey would defeat the goal of disguising withdrawal.
The researchers argued that there was no harm to subjects who choose not to participate and left the location early, and no need to provide an alternative activity. The notion that there would be undue pressure to continue participating invented a risk where none existed.
Deception in research involves lying to or intentionally misleading subjects. Withholding information may or may not be deception. For example, telling subjects that an urn contains an unspecified number of red and blue balls, and inviting them to participate in an experiment by guessing the number, would not involve deception because the subjects "know what they don't know". Concealing the fact that there is a hidden camera would be deceptive. The distinction is whether subjects have the information to make an informed choice about whether to participate in the research. Secretly filming their behavior denies them the opportunity to consider whether or not they want to be filmed for research. Not telling them how many balls are in the urn is part of the accepted framework for a participant to guess the number.
It may be important in some research to withhold the specific theoretical purpose of the research from subjects, in order not to bias their opinions. If done in a neutral way, it would not be deceptive. If subjects are intentionally led to believe that the research is for a purpose different than the actual purpose, this would be deceptive.
Deception potentially poses ethical problems and should be dealt with by weighing the benefits of the research against the harm (if any) from the deception. Aside from any potential harm to participants, deception can also harm the institution by building the perception among potential subjects that "researchers are liars." The IRB should follow the regulations in § 690.116.d.
What issues arise concerning compensation
The common rule does not address the compensation of subjects for participation in research. Good ethical practice suggests some guidelines:
- Researchers should be careful about paying compensation to subjects who are placed at risk, so that the payment is not seen as coercive. A high payment may induce a needy participant to take a risk that they normally would clearly prefer not to take. That concern would not exist when the risk is minimal.
- Advertising the amount of compensation, in order to give information to potential subjects, poses no risk or ethical problem.
- Sometimes compensation can take the form of a lottery. Provided that subjects do not risk their own money, this is not gambling. Lotteries are often part of the research design, for example in studies of attitudes towards risk. In assessing whether lotteries involve appropriate levels of compensation, the expected value (the prize amount divided by the number of contenders) of the lottery should be assessed, not the size of the largest prize.
- Compensation may depend on circumstances or performance, for example, when participants are paid on the basis of the choices they and other participants make. The common rule does not suggest that this is improper, and researchers have not reported ethical or practical problems arising from these circumstances.
Use of Lottery as Compensation (Vignette)
A study was proposed at Maven University to conduct a survey using a dietary questionnaire, a motion sickness history questionnaire, and a "disgust sensitivity" survey. To protect participants, and to preclude any bias, the researchers preferred that participation in the study be anonymous, even to them. To assure anonymity while paying compensation, a lottery for $500, with odds depending on number of entries, was proposed, together with a carefully developed scheme for preserving the anonymity of the winner.
Prior to this, the Maven IRB had argued that that a lottery could not be used as compensation, first because it is gambling, and second because it is unfair that not all subjects are paid the same amount. However, they ultimately agreed that a lottery is an acceptable form of compensation. In response to this proposal, they ruled that the amount of the prize could not be advertised, because $500 is "coercive".
The researchers argued that a lottery is not gambling, because subjects do not risk their own money. They further argued that it is not unfair to pay subjects differentially, because all have an equal opportunity to win the prize and know that beforehand.
- The use of a lottery to compensate subjects should require no special justification.
Because of the voluntary and anonymous nature of participation, the research is minimal risk, and so the size of the prize should not matter. The researchers argued that the size of the prize is not as relevant as the expected value. With ten participants, the expected value of the prize would be only $50, which can hardly be viewed as coercive. The researchers further argued that the subjects, as Maven U. undergraduates, were adults who could legally participate in state operated lotteries. The students would be briefed that a lottery with a $500 prize is worth substantially less than $500 to the average participant.
"Unexpected Risk in Classroom Research"
Dr. Goodbar, a professor of sociology, was in the habit of surveying students on their experiences, as both a classroom exercise in survey research techniques as well as a source for his published articles. While he recorded the identity of student respondents (sometimes on videotape, other times on paper records), he foresaw no risk because the questions did not deal with sensitive topics.
During one exercise he was astonished to see a student's response describe some sanctioned behavior-plagiarism on the part of the student. He had recorded the student's identity.
What to do?
- There are 2 issues here. First, to the extent that Dr. Goodbar is using students’ survey responses for his published scholarly articles, he is conducting research CFR 46.112 (d). In conducting research, he would have submitted an IRB proposal and obtained permission to survey the students. The second issue concerns confidentiality, and if Dr. Goodbar promised this within the IRB proposal and promised this to students on the consent form, then he is obligated to maintain that confidentiality.
- To protect the student, the record should be erased immediately.
- To respect the academic institution and tradition, the student should be counseled on the impropriety of plagiarism.
- In general, in the case of a serious matter (a threat of violence, a criminal act, a serious breach of academic discipline, e.g., the theft of a test) the professor should inform institutional authorities provided that confidentiality was not promised.
- The professor should routinely point out to students, before the research takes place, to consider before responding that their responses will be recorded. They should be told not to say anything they would not want others to see and hear on tape.
Doesn't the Common Rule demand confidentiality in research records?
The Common Rule addresses privacy of information about persons and confidentiality of data. A research project involving individual information about respondents can be exempt under two conditions:
- if the information either is not linked to the respondents' identity (§ 101 (b) (2)), e.g., it is anonymous, or
- the information is linked to the respondents' identity, but the nature of the information is such that disclosure will not be reasonably expected to cause harm (§ 101 (b) (2)). Non-anonymous data recording can be exempt if any breach of confidentiality will not cause harm beyond that encountered in everyday life. Historical or other research where the respondent is fully aware that publication will involve names, or where the information is in public records, is not of concern here.
The Common Rule thus explicitly allows social and behavioral science research involving minimal risk to record the identity of respondents in the data. Whether or not the research is exempt, professional ethics and respect for persons mandate confidentiality unless the participant agrees to release the information. (§ 111 (a) (7)).
What's the difference between privacy and confidentiality?
The Common rule defines "identifiable private information" as:
"information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)." (§690.102(f))
- PRIVACY refers to persons; and to their interest in controlling the access of others to themselves.
- CONFIDENTIALITY refers to data; and to the agreements that are made about ways in which information is restricted to certain people.
- Identifiable information collected through research should be kept confidential as much as possible, as a matter of professional courtesy, no matter whether there is an identified harm or not in accordance with any promise made in the consent form (unless the research is such that respondents clearly understand that identities will be published, as in historical studies).
- Successful confidentiality begins from the top, and implies a research culture which involves everyone, whether they normally have access to project files or not, being aware that identifiable private information must be kept confidential.
- There are many techniques of insuring confidentiality and of de-identifying data, from simple to complex. (See FAQ: What are the major techniques for protecting confidentiality? The level of confidentiality should match the level of risk inherent in the project and with any promise made in the consent form.
What are the major techniques for protecting confidentiality?
The following techniques for assuring confidentiality are listed on a continuum according to the degree of prospective harm that may occur.
- The simplest procedure to insure confidentiality is to substitute codes for personal identifiers and to store the key in a different locked physical location.
- Another simple procedure is to remove the face sheet, which typically contains personal identifying information such as name, telephone, address.
- Data with personal identifiers should be kept in locked files, and access to the data should be controlled by the researchers with specified procedures.
- Research assistants should be educated in the importance of confidentiality and the potential risks of harm to subjects. In situations of serious risk assistants could be asked to sign confidentiality agreements.
- Access to the data can be controlled electronically, perhaps by storing very sensitive data on computers not attached to a network where hackers could penetrate the files. Electronic files can be protected with key-words, and portable computers should be appropriately secured.
- The data can be manipulated electronically, for example by encrypting data files. The data can also be recoded to eliminate identifiers by collapsing it into categories.
- Research involving many data files on the same person can use anonymous linkage systems.
- CERTIFICATES OF CONFIDENTIALITY: If research is contemplated on a topic which is likely to be subject to legal proceedings, the federal government can issue a "Certificate of Confidentiality" which shields the data from required disclosure by the researcher. The Secretary of DHHS has the authority to: authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs), to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals. (42 U.S.C. 242a(b)(1989))
- Information on certificates of confidentiality is available at http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm
- Note that certificates are available from DHHS irrespective of the source or even the existence of funding for the project.
Where can I find information about confidentiality in data?
The National Research Council's Committee on National Statistics, part of the Division of Behavioral and Social Sciences and Education has a publication, "Improving Access to and Confidentiality of Research Data: Report of a Workshop" edited by Christopher Mackie and Norman Bradburn.
The U.S. Department of Justice, Office of Justice Programs, Bureau of Justice Statistics has a paper by Joan Sieber on its web site, "Summary of Human Subjects Protection Issues Related to Large Sample Surveys" which gives a comprehensive discussion and bibliography of these issues.
The Federal Committee on Statistical Methodology (FCSM), sponsored by OMB, has produced 2 reports on statistical methods to limit disclosure. "Report on Statistical Disclosure and Disclosure-Avoidance Techniques", 1978 (NTIS PB86-2115/AS) and 22, "Report on Statistical Disclosure Limitation Methodology", 1994 (NTIS PB94-165305) respectively). They can be found them on the FCSM's web site at http://www.fcsm.gov.
FCSM has a standing "Confidentiality and Data Access Committee" (CDAC) which has produced several useful documents. In particular, CDAC's "Checklist on Disclosure Potential of Proposed Data Releases" is a useful resource.
The U.S. Bureau of the Census has recently cooperated with a private press to publish "Confidentiality, Disclosure, and Data Access, Theory and Practical Applications for Statistical Agencies". The book is also based on work by the Committee on National Statistics at the National Academy of Sciences-National Research Council. The book is edited by Pat Doyle, Julia Lane, Jules Theeuwes and Laura Zayatz, and published by Elsevier-North Holland, 2001.
"What is Private Information?" (Vignette)
Professor Studyphud obtained a prestigious grant for longitudinal research on the outcomes of graduate training in the physical sciences. She will assess student values and ethics upon admission to graduate school, the kinds of scientific and personal values imparted in doctoral training, and ethical decisions made in career choices and performance as measured five years post-Ph.D. An important part of Studyphud's longitudinal research design is to recruit volunteers when they are admitted to the university's Ph.D. program in any of several major physical science departments. Studyphud plans to obtain from each program the list of graduate students admitted that year. After the student has enrolled, she plans to send the student, via campus mail, an introduction of herself (a professor of psychology), a description of her longitudinal study, an invitation to participate, and a standard consent form.
Studyphud showed her research protocol to a colleague who is on the IRB to inquire whether the format was correct. She was surprised when her colleague objected to her obtaining a list of students admitted to the Ph.D. program. Her colleague claimed that Studyphud has no right to that list since the fact of students' admission to Ph.D. programs is a private event. The colleague said that the only way Studyphud could contact the students is by placing a more general solicitation in all doctoral students' mailboxes asking them to contact her if they qualified (as new students) and were interested in participating. Was Studyphud's colleague right?
Studyphud's colleague was wrong. A list of names of students admitted to a graduate program is not normally private. With students’ permission, departmental newsletters will list and briefly describe these students to welcome them to the program. Lists of their names and a few other identifying characteristics will be distributed to faculty, staff and existing doctoral students.
The distinction between public and private information can be ambiguous in some cases. Some information that becomes part of university records, such as students' financial status or that of their parents, would arguably be private and covered by the federal law called the Family Educational Rights and Privacy Act, also known as FERPA or the Buckley Amendment. And clearly if Studyphud were seeking volunteers who had smoked marijuana as undergraduates or who had certain medical conditions, she would be dealing with private information.
The Common Rule provides a general and satisfactory description of identifiable private information whose confidentiality should be discussed with the respondent, such as medical records (§ 102 (f) (2)).
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.