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- 4 Enhancing Informed Consent INFORMED VOLUNTARY CONSENT iS one of the bedrock principles of ethical research with human participants. The 1947 Nuremberg Code affirmed the principle of voluntary consent to participate in research, and U.S. and international policies and regulations from the beginning incorporated informed consent as a key element of ethi- cal research (see Chapter 31. Following the Belmont report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979), which articulated the principle of respect for persons, and as that principle gained in importance, federal regu- lations elaborated the requirements for informed consent and its doc- umentation. By "informed consent," we mean that a person's decision to partic- ipate in research is made by the individual (or by his or her legally au- thorized representative), without pressure to hurry the decision, with- out coercion or undue influence from the investigator to participate, and with relevant information about the research that is provided in understandable language (see Faden and Beauchamp, 19861. For mini- mal-risk research, a process that allows consent to be truly informed chiefly respects individual autonomy (voluntariness). For more-than- minimal-risk research, such a process is critical not only for autonomy, but also to allow the individual to make reasoned judgments related to potential harms and benefits of participation. In the Common Rule provisions for human participant protection, two of the seven criteria for institutional review board (IRB) approval of research (45 CFR 46.111 see Box 1-1 in Chapter 1) are that in- formed consent will be sought and that it will be appropriately docu- mented, usually by a participant's signing a written consent form in advance of participation. Other sections of the regulations specify el- ements of informed consent and special conditions when consent ele- ments may be waived (see Boxes 4-1 and 4-21; and required documen- tation of informed consent, including when advance written consent may be waived (see Box 4-31. 81

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82 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX 4-1 Basic Elements of Informed Consent (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject: (1 ) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (3) a description of any benefits to the subject or to others which may reasonably be expected from the research; (4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related in jury to the subject; and (8) a statement that participation is voluntary, refusal to participate will involve no penally or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. SOURCE: Verbatim quotes from 45 CFR 46.116 (a) (bolt/face added for ease of reference). Over time, changes to federal regulations have expanded and mod- ified the provisions on informed consent (see Boxes A-7 through A-10 in Appendix A). New items were added to the list of basic information that must be provided to participants; a list was added of informational items that can be provided to participants when appropriate; language was added about circumstances under which required elements of in- formed consent can be modified or waived; and language was clarified about the circumstances under which documentation of informed con- sent can be waived. In this chapter we begin with a review of the available evidence on the ways in which IRBs interpret the informed consent provisions of the Common Rule and the problems, often unintentional, that a nar-

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ENHANCING INFORMED CONSENT 83 row interpretation can cause for research that uses such methods as surveys, interviews, observations, laboratory experiments, and anal- yses of existing data. Such methods are commonly used in the so- cial, behavioral, and economic sciences (SBES) and are also frequently used in biomedical research. We also review the available evidence on how consent procedures may affect comprehension of risks and bene- fits and participation in research and recommend a research program to improve consent procedures and forms for different types of SEES research and populations studied. The remaining sections of the chapter present our analysis and rec- ommendations on useful guidance the Office for Human Research Pro- tections (OHRP) should develop for IRBs (which can also aid research- ers) on applying the Common Rule provisions on informed consent. We consider four topics: informed consent issues for certain vulnerable and special populations (e.g., language minorities); issues regarding consent of third parties (i.e., people who are not being directly inter- viewed or observed in a study); when it is appropriate and good prac- tice to waive written signed advance consent; and when one or more elements of informed consent may be omitted from the consent process and documentation. We stress that informed consent is best thought of as a process, whereby an investigator interacts with potential participants to inform them about study goals, harms, risks, and benefits, and other pertinent information about the project (see Institute of Medicine, 2002:Ch. 41. The process should be designed to respect individuals' rights and to allow them to make informed choices about the risks and obligations they are willing to accept to participate in a research project. Depend- ing on the nature of the research, the consent process may require explaining and obtaining consent for the research in advance, or at the time when data collection actually begins, or repeatedly throughout the project to be sure the participant understands the steps in the research and their implications. In contrast, documentation of consent, while important, should be viewed as secondary to the consent process. Doc- umentation should be tailored to facilitate and not impede or confuse the actual process of obtaining informed consent, which may often- but not always include obtaining a signed written consent form. We urge OHRP to begin immediately to work with relevant pro- fessional associations, IRBs, investigators, and representatives of re- search participants to develop detailed guidance, with examples for types of research and populations studied, on informed consent pro- cesses and to add to and modify the guidance as needed in the future (see discussion in Chapter 71. Without authoritative guidance on such topics as when it is appropriate to waive written consent and in a cli-

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84 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX 4-2 Additional Elements of Informed Consent and Provisions for Waiver or Alteration (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (1 ) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; (2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) any additional costs to the subject that may result from participation in the research; (4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) the approximate number of subjects involved in the study. (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that: (1) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit service programs; (ii) procedures for obtaining benefits or services under these 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; and (2) the research could not practicably be carried out without the waiver or alteration. (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1 ) The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the sub jects; (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation. SOURCE: Verbatim quotes from 45 CFR 46.116 (b), (c), (d) (bolt/face added for ease of reference).

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ENHANCING INFORMED CONSENT 85 BOX 4-3 Documentation of Consent and Waiver Conditions (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. (b) Except as provided in paragraph (c) of this section, the consent form may be either of the following: (1 ) A written consent document that embodies the elements of informed consent required by 46.1 1 6. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or (2) A short form written consent document stating that the elements of informed consent required by 46.1 16 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall Sian both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: - (1 ) That 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. Each subject will be asked whether he or she wants there to be documentation linking the subject with the research, and the sub ject's wishes will govern; or (2) That 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. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. SOURCE: Verbatim quotes from 45 CFR 46.117 (boldface added for ease of reference).

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86 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH mate of fear in which IRBs may be blamed for any harm that occurs to research participants, IRBs will have no incentive to use the flexibil- ity in the Common Rule to develop the most beneficial consent proce- dures for particular research protocols (see discussion in Chapter 61. OHRP guidance, informed by research on effective informed consent procedures, will also help researchers improve practice on this vitally important element of human research participant protection. IRB FOCUS ON INFORMED CONSENT Data from the available studies of IRBs indicate that issues of in- formed consent account for a large share of the time and resources that IRBs devote to reviewing research protocols and that investigators, in turn, devote to revising their protocols in order to secure IRB approval. The 1975 Michigan survey carried out for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research found that 40 percent of research protocols reviewed by the sampled IRBs between July 1974 and June 1975 were modified as a result of the IRB review process: the most common modification, re- quired for 24 percent of protocols, concerned informed consent (Gray, Cooke, and Tannenbaum, 1978:1096-10971. Almost all such modifi- cations involved the content of consent forms; less than 1 percent in- volved the consent process (e.g., timing or setting of consent, who ob- tained consent). The 1995 Bell survey (Bell, Whiton, and Connelly, 1998) reported data on protocol modification in terms of IRBs, not protocols; those data show clearly that, by 1995, IRBs were more likely to modify pro- tocols and to require changes to informed consent documents than they had been in 1975. Thus, 34 percent of IRBs in 1995 required modifica- tions to every protocol in their workload (Bell, Whiton, and Connelly, 1998:61), compared with only 14 percent of IRBs that required modi- fication of every protocol in their workload in 1975 (Gray, Cooke, and Tannenbaum, 1978: 10961.2 ~OHRP provides access to an IRB Guidebook on its website at http://ohrp.osophs. dhhs.gov/irb/irb guidebook.htm [4/10/03]. The guidebook was originally developed in 1981 for the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and updated in 1993; it has useful information and guidance on such topics as informed consent, but the guidance is quite general for the most part. 2The 1995 Bell survey data are not consistent as reported. As reported, 73 percent of IRBs disapproved 75 percent or more of protocols as submitted, another 10 percent dis- approved between 50 and 75 percent, and 6 percent disapproved fewer than 50 percent.

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ENHANCING INFORMED CONSENT 87 As of 1995, IRB chairs were most likely to report deficiencies in protocols involving the language of consent forms 60 percent said such a deficiency occurred often; the next highest percentages were 13 percent of chairs reporting that cost information was often omitted from consent forms, and 11 percent of chairs reporting that consent forms often omitted or understated risks of participation. Investigator reports of most commonly required protocol modifications confirmed the IRB focus on consent forms: 78 percent of investigators said they were required to change the consent form, and 21 percent said they were required to change consent procedures.3 Applying Common Rule Consent Provisions Few quantitative data are available on how IRBs apply the informed consent provisions of the Common Rule. The 1975 Michigan survey does report that informed consent was obtained in almost 90 percent of projects, usually in writing. For the remaining projects, investigators said that the return of questionnaires implied consent, that the project used only routine procedures, or that it used existing records gathered for other purposes.4 The 1975 survey also reported that some informa- tion was withheld from participants in 15 percent of studies, usually to eliminate sources of bias or because of the belief that the participant would not understand the information. Omitted information usually pertained to a specific medication or treatment (e.g., in a double-blind study) or the purpose of specific procedures. In 2 percent of studies, participants were given false information, usually concerning the pur- pose of procedures and usually to avoid bias in the results. Although quantitative data are lacking, anecdotal evidence suggests that IRB practices with regard to informed consent particularly doc- umentation of consent are one of the sorest points for researchers who are engaged in minimal-risk research. For example, Sieber, Platt- ner, and Rubin (2002) conclude: These numbers add up to 89 percent, not 100 percent. However, this discrepancy does not invalidate a conclusion that IRBs were more likely in 1995 than in 1975 to require modifications to protocols. 3 The large percentage of protocols for which modifications were required to consent forms suggests that IRBs could provide clearer guidance to researchers on appropriate content and language (see Chapter 7). 4 Gray, Cooke, and Tannenbaum (1978: 1 101) conjecture that "in some cases investi- gators who reported that they did not obtain informed consent may have meant only that they did not use a consent form. The confusion of the substance of consent with its doc- umentation is not an uncommon error and may have negative implications for informed consent."

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88 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH In the current regulator climate, many IRBs treat all social and behavioral research as if it were very risky. They interpret the Common Rule as literally as possible, ignor- ing any cultural or procedural inappropriateness this may entail, and generating an extensive paper trail to prove that they have done what they construe the Common Rule to re- quire.... Some results of this environment of fear include: (a) a self-defeating quest for entirely risk-free research in a world where nothing is entirely risk free, (b) long delays in ap- proving protocols, and (c) extremely bureaucratic interpre- tations of the requirement of informed consent. These three problems are intertwined. The focus on very minor or un- likely risks has resulted in lengthy negotiations between IRBs and investigators, and overly detailed, insultingly paternal- istic informed consent procedures. Sieber, Plattner, and Rubin (2002) cite the following examples pro- vided to them by researchers of inappropriate IRB actions with respect to documentation of consent: requiring participants who are members of a preliterate society to read and sign a consent form; requiring written consent of members of cultural groups who consider it insulting to sign an agreement, as if their word were not to be trusted; requiring written consent in situations when oral consent or im- plicit consent is adequate (e.g., answering a survey question) and requiring written consent only serves to discourage otherwise willing participants; requiring written consent in advance of a mail survey of individu- als who had previously agreed to be contacted for such research; and requiring written consent of students who are asked by their in- structor to make judgments and discuss their reasons as a peda- gogical exercise in which no data are collected and no research is conducted. Is the IRB Focus on Informed Consent Effective? Given the intense focus of IRBs on informed consent, particularly consent forms, three key questions are relevant: First and foremost,

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ENHANCING INFORMED CONSENT 89 does it increase the protection that is afforded to human research par- ticipants? Second, does a focus on consent result in improved con- sent forms? Third, does it help or hinder research in other ways? The available data suggest that consent forms are not understood by many participants and that IRB-required revisions to consent forms do not improve their readability or understandability. There is no evi- dence on whether IRB attention to consent forms improves the level of protection for participants, but there is some evidence that requiring advance signed written consent inhibits participation for some people who would otherwise not hesitate to join a minimal-risk research study. Readability of Consent Fowns The 1975 Michigan survey devoted considerable attention to eval- uating the consent forms that were used by the research projects in- cluded in the study. Only 18 percent of the forms were complete or nearly complete when measured on an index consisting of six elements required by the 1974 regulations: the purpose of the research, the pro- cedures involved, the risks, the benefits, a statement that participants can withdraw from the research, and an invitation to ask questions. The purpose was omitted from 23 percent of the forms, and risk was omitted from 30 percent (however, 70 percent of this 30 percent were said by the investigators to involve a very low probability of minor harm to participants). The Michigan survey also developed a "reading ease score" in which the "standard" was the language used in Time magazine. Only 6 per- cent of the consent forms analyzed were as easy or easier to read than Time; 17 percent were "fairly difficult" (at the level of Atlantic Monthly); 56 percent were "difficult" (scholarly); and 21 percent were "very difficult" (scientific or professional). This distribution was similar across types of institutions universities, medical schools, hospitals, and otheralthough university consent forms were somewhat easier to read than others (13% were at the level of Time or below). There was almost no correlation between the completeness of consent forms and their readability.5 Turning to the effects of IRB review, there was no significant dif- ference in average completeness or readability scores between con- sOf course, the appropriate readability level relates to the population to be studied. Informed consent materials for research involving university faculty would not need the same degree of readability as research involving the general population. Other issues of readability include type size, which may need to be larger for older people, and appro- priate translation for people who are not literate in English (see "Informed Consent for Special Populations" below).

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90 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH sent forms as proposed to IRBs and consent forms as approved by IRBs. Moreover, looking only at consent forms that were modified in response to an IRB, there was also no significant difference in com- pleteness or readability scores before and after IRB review for these forms either. Finally, the less readable or less complete forms were no more likely than the more complete or more readable forms to be singled out for change by IRBs. Whether the effects of IRB review of consent forms are still as neg- ligible as found by the 1975 Michigan survey is not known. One study of all approved consent forms at two universities in 1988 and 1991 sug- gests that IRBs were no more effective in that period than 15 years ear- lier (Goldstein et al., 1996~. This study found that the average reading score of 284 consent forms was 12.2, or roughly a 12th grade reading level, which is above the average reading level of the general popula- tion (about 10th grade). Fewer than 10 percent of all consent forms were written at a 10th grade level or below. Readability scores were not related to whether the consent form was revised at the behest of the IRB, the year of the study, or the university. However, survey studies had more readable consent forms than clinical drug trials, and having a higher number of female than male IRB members related to more readable forms. Research on alternative consent forms in biomedical research has found that readability is not the only issue. For example, a study in which participants had low levels of literacy were given a standard can- cer trial consent form (written at a college level) and a simplified form (written at a 7th grade reading level). The participants overwhelmingly preferred the simpler form and found it easier to read. However, their comprehension was low regardless of which form was used (Davis et al., 1998~. It is clear that even after years of research on informed consent, largely covering written consent forms for biomedical research and treatment (see bibliographies in Sugarman, McCrory, and Hubal, 1998; Sugarman et al., 1999), there are still no agreed-upon procedures that are demonstrated to provide adequate, comprehensible information to prospective research participants. Furthermore, it is clear that, on av- erage, IRB efforts to improve participant protection by focusing on consent forms have had relatively little effect and, as such, have di- verted scarce time and resources of IRB members and investigators alike, particularly when empirical information is lacking about effec- tive ways to improve consent forms and procedures.

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ENHANCING INFORMED CONSENT Effects of Consent Requirements on Participation 91 There is a small literature that helps illuminate the effects of in- formed consent requirements on willingness to participate in research. For research that is of minimal risk, understanding how information presented in certain ways could discourage participation of individuals who would otherwise be willing to volunteer is important for develop- ing consent procedures that inform participants but do not unneces- sarily degrade the research by adversely affecting the size or compo- sition of the sample. Such understanding is also helpful for determin- ing when it may be appropriate and good practice to waive elements of informed consent. For research that is of more than minimal risk to participants, understanding the effects of different informed con- sent procedures is critical for developing the most effective means for clearly communicating the risks and benefits of participation. Data exist on participation in surveys and laboratory experiments, primarily in the SEES domain, as well as the desires and concerns of participants regarding the consent process. Singer (1993) reviews the literature published before 1993;6 Singer's (2003) is the first relevant empirical study to be reported since then. With regard to the detail provided in survey introductions, Singer (1993:363) sums up early practice as follows: Prior to the spate of studies on informed consent procedures in the late 1970s (National Research Council, 1979; Reamer, 1979; Singer, 1978a, 1978b, 1984; Singer and Frankel, 1982), conventional survey wisdom had advocated keeping the in- troduction short, so as not to lose the respondent's interest or attention; and some evidence from experiments with mail questionnaires had suggested that a general explanation of purpose was preferable to a more detailed one, which might antagonize some respondents (Blumberg, Fuller, and Hare, 19741. At the same time, some investigators supported fuller disclosure of research purposes to respondents.... Some support for the efficacy of fuller disclosure came from a study by Hauck and Cox (1974), in which refusals were re- duced after respondents had been given a more nearly com- plete and accurate description of the study's purpose. Singer's review (1993:365) of studies conducted from 1978 through the early l990s of the effects on survey participation of providing dif- 6Work on informed consent issues in survey research was initially stimulated by en- actment of the 1974 regulations for protection of human research participants (see Chap- ter 3) and by enactment of the Privacy Act of 1974 (Dalenius, 1983). Declining response rates also played a role (Steeh, 1981).

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102 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH methods of SBES research involve activities that would rarely require signing a written consent form outside the research context (e.g., be- ing observed in social activities by random bystanders, being asked to respond to a market survey, etc.~. We review below types of survey, un- structured interview, observational, and secondary analysis research for which it is appropriate to waive signed written consent and note other consent issues such research poses. Survey Research Survey research using probability samples of households or individ- uals who represent a specified universe (e.g., the U.S. civilian noninsti- tutionalized population, people aged 55 and older, college graduates, or likely voters) has been a mainstay of SBES research in many disci- plines since the 1940s. In order to obtain generalizable valid results, it is critical that a high percentage of sample cases respond to a survey. Sample cases who do not respond cannot be replaced without affecting the ability to make population estimates from the survey and to esti- mate the sampling error of those estimates. Furthermore, the failure to obtain responses from most sample cases may introduce systematic biases in the survey estimates for which reweighting and other meth- ods do not compensate. These properties of survey methodology mean that recruitment procedures should be designed to inform prospective participants about the research, but the procedures should not raise unwarranted fears about the possible risks of participation or impose barriers to participation. For this same reason, namely, to maximize response, investigators often provide financial incentives, such as cash or small gifts, to survey participants, and such incentives are generally appropriate. At a time when people have many demands on their attention and receive a large volume of unsolicited mail and telephone calls, it is becoming standard survey practice to recognize the burden on respondents by providing some type of reimbursement. Surveys may be lengthy, they may in- volve the cost of travel to the interview site or parking fees, or they may require special arrangements to accommodate family and work responsibilities such as babysitting costs. Normally, incentives include monetary reimbursement commensurate with respondents' opportu- nity costs for time and direct costs for travel, gift certificates, or small gifts such as vitamins or refreshments. The form and value of the in- centive will vary, depending on the nature of the study and the potential burdens for respondents. To facilitate survey research, we conclude that signed written con- sent should be waived, as a matter of standard practice, for minimal-

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ENHANCING INFORMED CONSENT 103 risk mail, telephone, and in-person surveys of the general adult popu- lation that do not involve unusual incentives for participation and do not raise serious third-party consent issues (see "Third-Party Consent," above; see sections below for specific issues for risk assessment and consent in mail, telephone, and in-person surveys). Traditionally, sur- vey research has not had a practice of obtaining signed consent for par- ticipation, and there is no evidence that the absence of written consent has jeopardized the rights or welfare of human participants. Indeed, the evidence reviewed above is that requiring written signed consent for minimal-risk surveys will discourage participation by some people who otherwise are willing to participate. IRBs should carefully review survey protocols to be sure that the information that investigators provide to respondents by such means as interviewer scripts, advance letters, informational leaflets, and the like adequately fulfills the Common Rule requirements, particularly with regard to procedures for respecting privacy and protecting confi- dentiality. Documentation of consent to provide an audit trail can be assured in such ways as requiring that interviewers' presentation of scripts in telephone surveys are recorded or monitored; requiring that interviewers in personal surveys sign a statement that appropriate in- formation was provided to respondents for their (tacit) consent; and calling back a sample of respondents to confirm that appropriate in- formation was provided. Such procedures as callbacks and telephone monitoring are commonly used to validate that interviewers in fact ad- ministered the questionnaire and did not make up the information. It would be straightforward to add validation of the consent process to these procedures, if the protocol does not already provide for their use for this purpose. Mail Generally, mail surveys of the general population should be treated as minimal risk and, hence, not require written consent, even if the subject matter appears to be sensitive. The reason is that there is no interaction between the investigator and the participant and therefore no danger that a participant will feel threatened the participant can simply toss the survey in the trash.~ It is possible to imagine scenarios it However, mail surveys of specific populations (e.g., cancer patients, people on .her- apy for HIV or AIDS) should have procedures to minimize the risk that respondents might be embarrassed or otherwise put at risk if someone other than the intended recip- ient opened the questionnaire package. Usually surveys to specially defined populations will be preceded by a letter or telephone call regarding participation and specifying pro- cedures to protect privacy.

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104 PROTECTING PARTICIPLE ED FACILITATING SOCIAL ED BEHAVIOR SCIENCES SEARCH in which a respondent could have an adverse psychological reaction to a mail survey question. However, unless the study universe is known to include people who are likely to have serious adverse reactions to the question content (in which case a mail survey is probably not appro- priate for the research in the first place), highly improbable scenarios should not drive the requirements for informed consent. Because there is no opportunity in a mail survey to interpret in- formation needed for informed consent (unless a respondent calls to ask for more information), it is critical that all materials mailed to re- spondents are appropriately targeted to the study universe in terms of reading level and language used. Because breach of confidentiality is almost always the only risk that could accrue to mail survey respon- dents, the survey materials should be clear about the level of confiden- tiality protection that will be provided and the purposes for which the respondent's data will be used (e.g., whether the data will be made available for any research purposes, including matching studies). Telephone Surveys conducted by telephone, unlike mail surveys, involve inter- action between the interviewers and participants.) ~ However, they are almost always minimal risk because the interaction is at arm's length, there is no intervention involved (the respondent is not subjected to any treatment), and the respondent may break off the interview at any time by hanging up the telephone. Thus, as for mail surveys, signed con- sent is rarely, if ever, necessary for participants in telephone surveys of the general population and for the same reasons such documentation does not provide any added protection to the respondent, and it will likely reduce participation. The interviewer's script should provide information the respondent needs in order to decide whether to participate, such as provisions for protecting confidentiality and the right of the respondent to refuse to answer questions and to break off the interview at any time. The IRB should determine that the interviewer script is understandable for the population of interest. The IRB should also establish that the investiga- tor has procedures in place for quality control of interviewing, includ- ing a procedure to check that interviewers are adhering to the portion of the script that pertains to informed consent. ~ ~ Mail surveys often use telephone follow-up for people who did not mail back a com- pleted questionnaire; the comments on telephone surveys apply to telephone follow-up as well.

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ENHANCING INFORMED CONSENT In-Person Pros Surveys conducted in face-to-face interactions may represent mini- mal-risk or more-than-minimal-risk research depending on the nature of the study, the setting in which the research is conducted, and the vulnerability of the study population. Most often, written informed consent should be waived for in-person surveys involving minimal-risk research. In these situations, verbal consent is usually adequate. In studies involving more than minimal risk to the participants, written consent may be appropriate, but if research participants could come to harm because of potential stigmatization, emotional distress, or phys- ical injury should there be a breach of confidentiality, it may be better to obtain consent verbally rather than create a paper record that could intentionally (e.g., by subpoena) or accidentally become public. In many research studies involving face-to-face interviews, investi- gators must contact prospective participants prior to conducting the in-person survey. In these situations, investigators often send a letter requesting the individual's participation, indicating how he or she was identified, and describing the purpose, procedures, risks, and harm involved in the study, along with information about voluntariness of participation, protection of confidentiality, and incentives (if relevant). In some studies, it may be appropriate to have the initial contact made by a person known to the participant. For example, in a study involv- ing face-to-face surveys with a population of student athletes, it would be appropriate for the athletes' coaches to send a letter or to verbally describe the study and inform the prospective participants whom they should contact if they are interested. Unstructured or Semistructured Interviews Unstructured or semistructured interviews are used by research- ers conducting focus groups, oral histories, and some forms of eth- nographic studies. They also may be used as one methodological tool in a study involving the application of several approaches to data col- lection. In some situations, interviews may be audiotaped and then transcribed. The primary characteristic of an unstructured interview is its allowance for informal discussion of particular topics. Investigators who use unstructured or semistructured interviews confront unique ethical challenges when the study sample involves vulnerable populations or the interview addresses sensitive informa- tion about an individual. Deciding whether informed consent elements should be waived or whether to seek written or verbal consent requires a judgment based on the nature of the research, the population of in-

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106 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH terest, and the seriousness of the risks involved for participants in sign- ing an informed consent document. For example, verbal consent may be appropriate if participants are illiterate or vulnerable because of their legal status or involvement in illicit activities. Verbal consent may also be appropriate if the research is conducted in a cultural setting- nationally or internationally in which signing a document to partici- pate in research is viewed as inappropriate. Ethnographers often work in field settings in which they have fre- quent informal interactions with study participants. It would be bur- densome for both the researcher and the study participants to contin- ually obtain consent under these conditions. Verbal or written consent for semistructured interviews conducted during focus groups, oral his- tories, or ethnographic research should clearly identify strategies in place to protect the confidentiality of individuals. If audiotapes are used, individuals should be informed how the tapes will be stored, who has access to them, and when they will be destroyed or permanently archived. As in all cases, the process of informed consent should be evaluated against the standard of assuring participant respect and pro- tection and not adherence to a particular consent procedure. Observational and Ethnographic Studies Observational studies include those in which the investigator is ob- serving public situations when participants are anonymous and un- aware of the researcher, in which case consent is not relevant (see street-crossing observation example in Box 2-3 in Chapter 2), and those in which the researcher is known to the participants. Ethnographic re- search may involve direct, sustained observation of group behavior or the use of participant observation, in which the researcher is both a member and observer of a group. In both cases, the observation typi- cally involves a period of intense social interaction and engagement be- tween the ethnographer and individuals involved in the study. During this time, data (e.g., field note observations, interview results, archival materials) are systematically collected. In ethnographic research involving direct observation of group ac- tivities, arrangements should be made before the implementation of the project to inform group members that the ethnographer will be present in the course of routine activities. In closed systems such as a hospital unit or an office or school setting, informed consent should be obtained from all those who are at the facility on a regular basis. Deciding whether to obtain written or verbal consent depends on the specific situation, including the vulnerability of the population being studied and the sensitivity of the information being collected. For ex-

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ENHANCING INFORMED CONSENT 107 ample, in an ethnographic study of an intensive care unit in a hospital, verbal informed consent should be obtained from all staff members. Patients, their visitors, and other individuals who are not present on a regular basis but whose behavior may be observed in public activities should be alerted to the presence of an ethnographer if it is feasible to do so. Informed consent should always be obtained from individuals who are interviewed. In some group observations, it may not be possible or necessary to obtain written or verbal informed consent from every person present. For example, at informal gatherings of visitors and staff at a nurse's station in a busy unit of a medical center, it would be intrusive to intro- duce the ethnographer, explain the study to every person who passed by, and obtain consent. In contrast, an ethnographer's presence at a family conference to discuss patient care and treatment decisions should be explained and permission obtained to observe the proceed- ings; if anyone is uncomfortable with the observation, it cannot pro- ceed. If individual informed consent is going to be obtained from the participants in small group interactions, they should be advised about the methods designed to protect confidentiality. Participant observation differs from other kinds of ethnographic re- search in that the researcher is a participant in the group for exam- ple, a member of the local chapter of a political party in a study of grassroots politics while at the same time the researcher observes the group. Often, other members of the group are not aware that they are being observed, and this technique raises a variety of ethical issues (see Wax, 1979; Bernard, 2000, 2001~. For example, although the in- tent is to avoid altering the behavior of the group that might occur if the presence of an observer were known, it is possible that the behav- ior of the participant observer intentionally or unintentionally alters the behavior of other members of the group. If participant observation is designed to involve deception by not telling other members of the group that they are being observed, the IRE must decide whether it is permissible to waive some of the elements of informed consent (see "Omitting Elements of Informed Consent," below). Analyses of Existing Data Economists, sociologists, political scientists, psychologists, and other analysts often conduct research using existing data sets of indi- vidual records of variable size. When publicly available microdata sets are studied that were collected from research participants who gave consent for the original data collection for research purposes, no con- sent is required for secondary analysis. Indeed, IRBs should routinely

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108 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH exempt such research from review, given that the data have been pro- cessed using good practices to protect confidentiality (see Chapters 5 and 61. Increasingly, secondary analysis involves abstraction and use of ex- isting records as well as or instead of research microdata for exam- ple, analysis of administrative records (e.g., state unemployment in- surance records or food stamp case records), medical records, or aca- demic records. Waiver of informed consent is appropriate when par- ticipants agreed to the use of their records for research when those records were originally collected and adequate confidentiality safe- guards are in place. However, consent may not have been obtained at the time of collection, often because many records were collected in years past when research use of the data was not considered or when consent for such use was not a common practice. In some of these cases, it may be possible to obtain consent, and consent may be neces- sary to protect the study participants, so consent should be obtained. In cases when it is not possible to recontact participants to obtain con- sent, whether their records can be used without consent will depend on judgments about the researcher's ability to assure appropriate protec- tion of the participants. If protection is believed to be adequate, then the records may be used. If protection is believed to be compromised, then the records may not be used. The decision must be made on a case-by-case basis. However, given evolving views about informed con- sent and increasingly complex issues surrounding confidentiality pro- tection, greater effort must be made to find ways to respect and protect people whose records may be used for research in the future than was done in the past. Greater effort must be made to obtain consent at the time of original data collection. OMITTING ELEMENTS OF INFORMED CONSENT Recommendation 4.5: The Office for Human Research Pro- tections should develop detailed guidance for IRBs and re- searchers, including specific examples, on when it is accept- able to omit elements of informed consent in social, behav- ioral, and economic sciences research. The Common Rule acknowledges the appropriateness, under some circumstances, of omitting or modifying some of the required elements of the consent process. Although issuance of a waiver may seem to require extraordinary circumstances, the federal guidelines regarding waivers are quite straightforward. Some or all elements of informed consent may be altered or omitted if the research meets four criteria:

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ENHANCING INFORMED CONSENT 109 it is minimal risk; the waiver or alteration would not adversely affect participants' rights and welfare; the research could not practicably be carried out otherwise; and whenever appropriate, participants will be provided with additional pertinent information after participation (see Box 4-2, section d). Furthermore, when a basic element of informed consent is clearly inapplicable to the proposed research, we argue that such an element should be omitted as a matter of common sense. For example, ele- ment (4) (see Box 4-1), which requires disclosing appropriate alterna- tive procedures or courses of treatment, if any, that might be advanta- geous to the participant, is clearly oriented to biomedical or behavioral clinical research. Including that element in the consent form for, say, a study using structured or semistructured interviews would just add length and confusion to the form. Some SEES research may purposefully manipulate a condition of the research environment by deceiving participants about aspects of the research- passively by withholding information about the true pur- pose of the research, or actively by presenting information that is not correct in order to observe reactions to the condition created by that information. Deception should only be used when the welfare of par- ticipants has been carefully considered and judged to be protected and when other methods for studying the phenomenon of interest have been considered and judged not to be feasible. Research involving deception is most often conducted in laboratory experiments in which the experimenter wants to create some belief or psychological state (deception is also sometimes used in participant ob- servation and in field experiments; see the employment discrimination example in Box 2-2 in Chapter 21. In a conformity study, for example, a participant may be asked to write down a position and then be told that a specified proportion of other people in the room hold the op- posite opinion. The intent of the research is to determine the effects of varying the proportion in opposition on the willingness of a partici- pant to stick with his or her original position. The deception is judged not to put participants at risk of physical or psychological harm, and the study results could not be valid if participants were aware that the experimenter was manipulating the proportion of people with the op- . . posmg view. Four review of IRB websites at 47 major research institutions found that 28 percent of these IRBs do not indicate that statements about irrelevant elements of informed con- sent can be omitted from the consent document, and 9 percent require that statements about all of the basic elements be included in the consent document regardless of the nature of the research.

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110 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH Because, historically, deception has been used in social psychologi- cal research it is not surprising that the American Psychological Associ- ation (APA) wrestled with issues of deception as early as the 1 940s and 1950s. The topic took on increasing importance in the 1 960s and 1 970s in light of the controversy about such experiments as those conducted by Milgram and others (see Faden and Beauchamp, 1986:167-187; see also Box 3-1 in Chapter 31. In 1963, 38 percent of articles in journals in personality and social psychology reported uses of deception, as did 47 percent of articles published in the Journal of Personality and Social Psychology in 1971 (Faden and Beauchamp, 1986:172, 179~.~3 In 1973 the APA adopted a major revision of its code of ethics, which attempted to balance two concerns: the recognition "after al- most 20 years of debate and self-study" that informed consent is a "moral ideal" for psychological research; and a view that the "strict application of informed consent would invalidate valuable research findings and would compromise the psychologist's ability to conduct meaningful research" (Faden and Beauchamp, 1986:185~. The 1973 code was fairly general in its prescriptions. In the early l990s, APA adopted a more explicit code in addition to a statement of principles. The code (revised in 2002, see http://www.apa.org/ethics L4/10/031) es- sentially incorporates the Common Rule provisions: It explicitly and strictly limits the use of deception to research for which deception is necessary for valid results and the research is likely to have significant scientific, educational, or applied value; the research is not expected to cause physical pain or severe emotional distress; and participants are debriefed about the deception as soon as possible after data collection. Discussion of deception needs to recognize that the term does not have a clear definition and can take on many meanings (see Smith, 1979), including deception about one or more aspects of a research protocol with the intention for full debriefing at the conclusion of the research; consent to participate in research in which participants are not fully informed; and consent to participate in research not knowing which of several treatments one will receive. Deception can also vary in the salience of the omitted or misleading feature, the extent of risk posed by the deception, and the extent of likely benefit from obtaining valid research results consequent on the deception. It is not always clear where the boundary lies between deception and abbreviation of information about the study in order to reduce cog- nitive burden (e.g., informing prospective survey respondents of the main topics of the survey rather than showing them the entire ques- i3This journal specializes in research using deception designs; it is not typical of psy- chological journals.

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ENHANCING INFORMED CONSENT 111 tionnaire). Similarly, it is not always clear where the boundary lies between deception that is justified and necessary to produce valid re- search and deception that is so disrespectful of participants that it can- not be justified. In considering research protocols that involve one or another form of deception, IRBs and researchers should take care not to use the term pejoratively: deception is often well justified on scien- tific grounds, but, at the same time, a researcher should not make that decision in isolation. The Common Rule and professional codes of ethics recognize the complexity of the issue and permit deception in appropriate circum- stances, although the Common Rule restricts its use to minimal-risk research.~4 As with other aspects of informed consent (e.g., waiving written documentation or allowing proxy response for third parties), a key decision is the determination that a study is not of more than minimal risk, taking account of the research setting, method used, and population studied. For this reason, we recommend that OHRP pro- vide guidance, with specific examples, to help IRBs make these judg- ments and to improve research practice. CONCLUSION Informed, voluntary consent is a critically important principle of human research participant protection and one of the most difficult to implement in an effective manner. We hope that a combination of sys- tematic research on consent procedures and development of detailed guidance for IRBs and researchers will raise the standard of practice for seeking and documenting consent to participate in research in ways that increase the protection and respect for human participants and are commensurate with the risks of the research. Hit would be useful for IRBs, researchers, and participant representatives to debate the ethics of high-benefit research that requires deception for valid research results and is of more than minimal risk. Such research may be justified in some instances, but is unlikely to be approved given the current regulations and climate of fear in which IRBs operate.

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112 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH is that requiring written signed consent for minimal-risk surveys will discourage participation by some people who otherwise are willing to participate. IRBs should carefully review survey protocols to be sure that the information that investigators provide to respondents by such means as interviewer scripts, advance letters, informational leaflets, and the like adequately fulfills the Common Rule requirements, par- ticularly with regard to procedures for respecting privacy and pro- tecting confidentiality. Documentation of consent to provide an au- dit trail can be assured in such ways as: requiring that interviewers' presentation of scripts in telephone surveys are recorclecl or moni- tored; requiring that interviewers in personal surveys sign a state- ment that appropriate information was provicled to respondents for their (tacit) consent; and calling back a sample of respondents to confirm that appropriate information was providecI. Such proce- clures as callbacks and telephone monitoring are commonly used to vaTiclate that interviewers in fact actministerect the questionnaire and did not make up the intonation. It would be straightforward to adcI validation of the consent process to these procedures, if the protocol does not aIreacly provide for their use for this purpose. Mail . - Generally, mail surveys of the general population shouic! be treated as minimal risk and, hence, not require written consent, even if the subject matter appears to be sensitive. The reason is that there is no interaction between the investigator and the participant and therefore no danger that a participant will fee! threatener! the participant can simply toss the survey in the trash.~ It is possible to imagine scenarios in which a respondent could have an adverse psychological reaction to a mad! survey question. However, unless the study universe is known to include people who are likely to have serious adverse reactions to the question content (in which case a mail survey is probably not appropriate for the research in the first However, mail surveys of specific populations (e.g., cancer patients, people on therapy for HIV or AIDS) should have procedures to minimize the risk that respondents might be embarrassed or otherwise put at risk if someone other than the intended recipient opened the questionnaire package. Usually surveys to spe- cially defined populations will be preceded by a letter or telephone call regarding participation and specifying procedures to protect privacy.