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Everyone be welcome to the 4th paper discussion of our Bioethics Journal Club. This essay by C D Herrera was not published in a journal but appeared on this website as a bioethics topic.

Most of the bioethics topics on this website deal with medical science and clinical medicine where the ethics involve the relationship between medical researcher and the subject /patient or the physician and his or her patient. Informed consent is now a major ethical requirement associated with either of these relationships. In the area of social science research, which involves the researcher studying human behavior and not the effects of drugs or procedures on disease, there is valid questioning whether all the ethical requirements of the medical or clinical research should also be applied in this field. Particularly interesting is the matter of informed consent. With informed consent in the clinical experiments, there is always the matter of harm; will the experiment possibly harm the subject and if so shouldn't the subject be aware of that possibility in order to decide whether to participate or not? In social science research, it is less clear how to define research-related harm. Also in social science research, there is a question of whether the subject knowing that an investigation is being performed and the nature of the investigation will alter the spontaneous behavior of the subject and thus degrade the experiment. Writing to this issue, C.D. Herrera from Montclair University in New Jersey has presented a formal essay which is reproduced below. He concludes his writing with his viewpoint about informed consent.

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Few things are more pressing than the need to understand human behavior and culture. There's good news, though: social science offers to help us in that regard, and researchers are eager to observe you or even talk to you. The bad news? Critics warn that those same researchers sometimes don't give you the information that you need to mull over your service in their cause (1). It seems that a few social scientists aren't telling research subjects enough about why and how they'd like to observe them. That psychologist who wants you in his experiment may not give honest answers to questions that you have about it. The more you know, the more likely he might think you'll be to react unnaturally. The sociologist who sits next to you and your friends in a mall, recording your conversations, might not let on that research is in progress, not at first anyway. She might have similar concerns about disturbing your natural behavior by informing you. She might even claim that she can't possibly seek the consent of everyone she studies (imagine her studying crowd behavior at a soccer game). Lastly, those anthropologists who summer with villagers in a distant land might not reveal plans to write a thesis about the local table manners. Their defense? Since people are hardly strangers to manipulation and deception, there's no real sin in the researchers keeping a few details to themselves. And in any event, doesn't research involve engaging people in ordinary interaction?

The Informed Consent Ritual

Critics would prefer "informed consent" to this incomplete disclosure. Being something of a ritual, the seeking of informed consent is supposed to work like this. Prospective subjects volunteer only after they fully understand what awaits them, why their participation is needed, and so on. Volunteers so informed are able, the thinking goes, to rationally weigh all of the risks and benefits. Potential recruits would also be told that they can opt out of a study without penalty. Where researchers meet these criteria, the consent is said to be ethical, mainly because it is autonomous and informed (2).

The associations that represent the various social sciences generally support this model of informed consent (3). The trouble, say critics, is that the associations' Codes of Ethics are vague when it comes to incomplete disclosure, and researchers who bypass codes altogether may only risk difficulties in publishing their work or obtaining financial backing (4). In addition, the codes are interpreted by oversight committees that usually pass final judgment on proposed research (5). This means that, although codes provide broad rules on informed consent, determination of what's ethical hinges on the committee's take on those rules.

In fairness, researchers aren't exaggerating when they argue that strict informed consent rules would invalidate some of their studies (6). They also reply that they can usually come clean after the research (when disclosure will no longer jeopardize their work). Nearly always, researchers promise that no significant or extraordinary harm will come to their subjects (7).

Objections to Incomplete Disclosure

Still, critics have for some time not considered these defenses sufficient (8). Perhaps researchers seem too casual when they describe the researcher-subject relationship. By varying the information that they provide, researchers unilaterally decide what risks the subjects are "willing" to take. This represents substantial power. The risks we are talking about do not arise in the course of an ordinary relationship. These relationships involve motives that may be foreign to everyone but the researcher. Thus, we needn't dwell on research that places subjects in stressful situations. Incomplete disclosure could sweep subjects up in relatively stress-free projects that they have no interest in (e.g., research into political sympathies).

Critics are probably correct when they allege that researchers don't always explain how their work is beneficial enough to offset the deviation from informed consent. Critics ask why yet another study on gender attitudes, for example, is important enough to justify the manipulation of trusting subjects (9). Claims about informed consent precluding a particular study seem to wrongly presuppose that the study must be conducted. What of the promise that subjects won't be harmed? Researchers have yet to explain what they are protecting subjects from. As for the claim that deception is rampant in society, and incomplete disclosure is common in relationships, this may not prove much about the ethics of incomplete disclosure. The critic can hold researchers to a higher standard. One suspects that researchers don't like being misled when they drop off their dry-cleaning, visit with a child's teacher, or engage in other mundane activities that involve trust and communication. Why believe that the manipulation takes on a different ethical tone because research is involved?

Are the Critics Right?

Before rushing to prohibit incomplete disclosure on these grounds, there are a few questions to consider from researchers. For starters, what is so wrong with incomplete disclosure, and why is informed consent the proper response to it? If researchers aren't sure what harm they are protecting subjects from, critics don't seem to know either. Researchers might also challenge the habit that critics have of summarily dismissing promises about balancing risk against benefit. Critics are fond of saying that the "the ends don't always justify the means," yet utilitarian calculation is so central to all other areas of human reasoning that it is hard to see why it should not apply to research. At least some social problems appear important enough that the need to obtain reliable data about them could override ethical concerns about incomplete disclosure (10).

Researchers grow especially impatient with controversial examples that critics cite from the history of research. Critics refer to the experiments that Nazis conducted, and to the research conducted by Americans some time later (11). Critics mention the psychology experiments run by S. Milgram in the early 1960s, where subjects were misled into thinking that they were punishing others with electric shocks (12). Critics remind us of L. Humphreys, a field researcher who concealed his interests and identity, and observed homosexual acts in public restrooms (13). In another often-mentioned study, researchers feigned symptoms of schizophrenia and gained admittance to a mental hospital, where they secretly observed the staff and other patients (14). Few critics seem interested in explaining what these examples reveal about incomplete disclosure. (Lack of informed consent was only one of the things that may have been wrong with these studies.) More importantly, has such research anything in common with the average sociological study or psychology experiment?

Reforming Research Cont(r)acts

We may be left with uncomfortably weak arguments for or against incomplete disclosure. This should not, however, suggest that we can't improve the treatment of subjects. Researchers in medical experiments often tell subjects they may receive a placebo. Social scientists could offer verbal "placebos" by telling subjects not to expect complete, honest disclosure. Subjects could then decide if they know enough to consent, and those interested could "barter" with researchers for more information. Social research hinges on communicative give-and-take, as researchers admit; why not the consent phase as well?

To that end, ethnographers and other field researchers could give subject greater power over the review of reports that are written about their lives (15). The subjects might not get the chance to prevent or control the research, but giving them partial authority over what becomes of the details about them might force researchers to reconsider the ethical balance. What if subjects had to "consent," in some sense, to the publication of research results? Researchers do routinely use pseudonyms in these reports, to prevent readers from recognizing their subjects. Yet anonymity by no means equals confidentiality, and catering to both may still not set things right with all subjects. Some subjects would surely prefer to control which aspects of their lives make it into print, regardless of how they are identified. And the fact that researchers are willing to alter the names may not soothe feelings of having been manipulated in the first place.

Also needed are better definitions of the key terms and concepts. It is one thing to ask how much research subjects should know, and when should they know it. It is another to say what counts as informed consent, or what qualifies as "deception," or "harm," for instance (16). Here it is important to consider how the subjects themselves understand these concepts. Ethical debate should also reflect the generally positive evidence that researchers have about their subjects' experiences. It has to be worth something, that is, when critics have trouble finding many former subjects who resent their treatment during field research. Even Milgram's subjects were reportedly glad to have served in his project (something few critics acknowledge)(17). Subsequent research has documented similar attitudes among subjects who are deceived in psychology experiments. I don't suggest that the absence of clear complaints be taken as evidence of no harm done. But of what relevance is such information?

Why not Take the Ethical High Ground in Research Ethics?

In closing, one might try to resolve these issues by adopting a strict, universal standard of informed consent. As things stand now, a subject from a medical study who walks across the hall to serve in a psychology experiment will experience something quite different in terms of disclosure. In theory, a strict, universal version of informed consent would make any two forms of research ethically indistinguishable. My hunch is that this would be a mistake. In practice, a generalized code would be useful only where we could locate a uniform type of research that involved indistinct, generic subjects. The risks and rewards vary from one study to the next (and across disciplines). The makeup of the researchers and the subject pool can vary even between two experiments that otherwise appear identical. A generalized or universal standard would therefore only sidestep questions about what type of informed consent, if any, should govern the relationship between researcher and subject in social science (18).

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1 I refer to "researchers" and scientists in general here, recognizing that only some rely on incomplete disclosure, and that many do not conduct human studies.

2 Recently, researchers have tried to expand on this list of criteria, though the basic ritual remains unchanged for now. For details on where the standard informed-consent ritual might be improved, see the essays in King, M. P., Henderson, G. E., Stein, J. (Eds.) 1999. Beyond Regulations: Ethics in Human Subjects Research. Chapel Hill, NC: University of North Carolina Press.

3 Readers might like to compare the ethical standards of these scientific associations: http://www.apa.org/ethics/code.html; http://www.asanet.org/members/ecoderev.html; and http://www.sfaa.net/sfaaethic.html.

4 This raises questions about disciplinary ethics: how often do investigative or undercover journalists worry about informed consent? Is what the social scientist wants to do that much different?

5 In the U.S. these committees are called I.R.B.s, and in Canada, R.E.B.s. For an interesting account of research oversight, see McNeill, P. M. 1993. The Ethics and Politics of Human Experimentation. NY: Cambridge University Press.

6 For example, see the remarks in Goode, E. 1996. "The ethics of deception in social research: A case study", Qualitative Sociology, 19, 1, 11-33; and Wax, M. L. 1995 "Informed Consent in Applied Research", Human Organization 5, 4 (3): 330-1.

7 Interestingly, ethnographers occasionally claim that they can protect subjects from risk only by not informing them.

8 For early perspectives on these issues, see, e.g., Erikson, K. T. 1967, "A Comment on Disguised Observation in Sociology," Social Problems, 14, 366-373; and Vinacke, W. E. 1954, "Deceiving Experimental Subjects," American Psychologist, 9, 155.

9 I recognize that much evidence suggests that subjects are often suspicious of the researcher's explanations, when they are given. For an elaboration of this issue, see Clarke, S. 1999. "Justifying Deception in Social Science Research," Journal of Applied Philosophy, 16, 151-166.

10 This defense assumes, of course, that we are able to distinguish between trivial and critical research.

11 For brief but readable descriptions of this research, see Brandt, A. (1978), "Racism and Research: The Case of the Tuskegee Syphilis Study," Hastings Center Report 8, 21-29; and Pellegrino, E. D. (1997), "The Nazi Doctors and Nuremberg: Some Moral Lessons Revisited," Annals of Internal Medicine, 127, 4, 307-308.

12 The "shocks" were fake, part of an elaborate charade that only Milgram and his assistants knew about. Milgram describes his research in Obedience to Authority (NY: Harper & Row, 1974).

13 Read Humphreys' account of his work in Tearoom Trade: Impersonal Sex in Public Places (Chicago: Aldane Publishers, 1975).

14 See Rosenhan, D. L. (1973), "On Being Sane in Insane Places," Science, 179, 250-258.

15 For a nice introduction to ethical issues related to this, see When they read what we write: The politics of ethnography, edited by C. B. Brettell, Westport, CN: Bergin & Garvey, 1993.

16 The few attempts that have been made at defining key concepts are not very encouraging. See, for instance, Sieber, J. E. 1982. "Deception in Social Research I: Kinds of Deception and the Wrongs They May Involve." IRB: A review of human subjects research, 1, 2, 12.

17 See, e.g., Smith, C. P. & Bernard, S. P. (1982), "Why are Human Subjects less Concerned about Ethically Problematic Research than Human Subjects Committees?" Journal of Applied Social Psychology, 12, 209?221.

18 I thank Jackie Sawicki for providing insightful help with this essay.

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Homan, R. (1991), The Ethics of Social Research. NY: Longman.

Korn, J. H. (1997), Illusions of Reality: A History of Deception in Social Psychology. Albany, NY: State University of New York Press.

Lee, R. M. (1993), Doing Research on Sensitive Topics. London: Sage Publications.

Mitchell, R. G. (1993), Secrecy and Fieldwork. Newbury, CA: Sage.

Rosnow, R. L. & Rosenthal, R. (1997), People Studying People: Artifacts and Ethics in Behavioral Research. NY: W. H. Freeman and Company.

Schuler, H. (1982), Ethical Problems in Psychological Research. NY: Academic Press.

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COPYRIGHT 2001 C.D. HERRERA

I just finished working on a medical sociology project with a professor of USC. I did most of the fieldwork myself; I interviewed about 95 individuals (all Latinos over 18) on different aspects of their health seeking behavior. The interviewed lasted about 45 minutes and it was recorded. The questionnaire was long and it covered a lot of questions that encouraged a great deal of personal information. Through the project I came across different groups of people. Some people were very suspicious and were reluctant to give me the interview at first, especially after they saw the tape recorder. But as I explained to them the nature of the questions, the reasons for the interview, how the information would be used, and the consent form, they seemed more comfortable and agreed on letting me interview them. With this group of people, I really used a strict version of informed consent. However, there was another group of people that really did not care much about my reasons for the interview. They were excited that I would interview them and that they would give their point of view on the issues under study. Even though they were very cooperative, I did try to inform them about the study, but to be honest, many of them did not really understand exactly why I wanted to interview them (due to lack of education). They did know, however, the nature of the questions that I would ask them, but they did not understand what the final outcome of the interview would be. In this case, I could not use the strict version of informed consent because the subjects did not want to hear the explanation. It was enough for them to hear that the questions dealt with their health and that their identity would be protected.

Mr. Herrera has a very strong point when he says that "the risks and rewards vary from one study to the next, and across disciplines." I would even go further to say that it varies within the same study. A relationship develops between the researcher and each subject, and as the study is being conducted, the researcher learns how many details should be disclosed to the subjects. It is not a matter of being secretive about the study; sometimes it is not necessary to go into all the details because the subjects do not require it. They trust the researcher. The trust comes from the nature of the study. The subjects know that they won’t be harmed by giving some of their information so they are not much concerned about where the information will end up. I am not saying however, that just because the study won't hurt our subjects that we should not exercise informed consent. What I am saying is that sometimes, it is not necessary to go into all the details because our subjects do not require it; there is a special rapport between the researcher and subject. I believe that in studies like this one, as long as the researcher is not malicious and does not misled his subjects, if informed consent is not fully exercised, the researcher should not be held as unethical or liable. Sometimes, as I started informing the interviewee about the research, the interviewee would cut me off and say something like "Miss, let's move on, I don't have much time; I trust you."

My overall understanding is that incomplete disclosure is a dangerous practice. Incomplete disclosure used by an unethical (or ethically unaware) scientist can lead to damage to theirs subjects. However, it seems to be a necessary practice for some studies that would be invalidated by a complete informed consent.

The million dollars question is: how to regulate the ethically dangerous practice of incomplete disclosure to avoid its malpractice. Some comments:

Is it possible to predict the implications of a research study?

Dr. Herrera says "Claims about informed consent precluding a particular study seem to wrongly presuppose that the study must be conducted."

I do not feel comfortable with the underlying idea that the implications of a given study should be predicted in advance in order to allow/disallow the use of informed consent.

In science it is frequently the case that the most relevant implications of a given study appear after the experiment is done and the data analyzed. So, in many cases, predicting the implications of a given experiment would involve a sort of black art.

Not only the results but the study process might be harmful

Dr.Herrera discusses the possibility of letting the research subjects decide whether their experimental results should be published or not. I agree with Dr.Herrera's opinion that this "might force researcher to reconsider the ethical balance."

I still find fundamental problems with incomplete disclosure.

Suppose a social scientist wants to study the sexual behavior of young couples. He mentions to every couple that they are going to be asked personal questions and the couples agree to participate in the experiment. The study is performed and by the end the different couples are asked if their results can be published.

I wonder how should a couple feel when they realize that their sexual behavior is far below the normal. The damage to this couple cannot be repaired by not publishing their data; the damage occurred in a research experiment of whose details they were not aware.

An alternative to incomplete disclosure

When a child is requested for an experiment that requires consent, the consent is not requested from the child but from his parents who are supposed to guard the child interests.

Why not applying the same protocol for adults. Every subject should designate his/hers person of confidence and the scientist should obtain approval from this person prior to the experiment. This practice would force the scientist to explain in detail the implications and dangers of the experiment to a person acting on behalf of the interests of the subject. This practice could be combined with the post-study approval/disapproval of the subject to publish the results of the study, as mentioned in the paper.

Miscellaneous comments

As Dr. Herrera mentions in his paper informed consent is not the panacea. How much information should the scientist give to the subject in order to get the informed consent? The scientist should have an impossibly deep ethical understanding in order to judge the risks of the study. Even worse, what does it mean a "yes" from the subject; perhaps he was influenced by the scientist.

I believe in the autonomy of the subject been research, much like patient in a medical situation, the subject been researched should have complete information. The complete information will allow the subject to ponder all aspects of the research, possible implications post-research, and application of his/her contribution to the research. When "yes" portion of the research if given under partial information that "yes"should also be considered a partial "yes" to the researcher from the client.Can the research be done with a partial yes? If the answer is no! then full information should be given at all times. Rose A.

What if subjects had to "consent," in some sense, to the publication of research results? Retrieving consent from test subjects for the publication of test results would allow two things to happen. First, it would cause researchers to think very carefully about the balance between the neccesity to withold information from subjects and the possibility of performing a fruitless study. If a test subject feels mislead and manipulated by researchers and they feel that the relationship formed is now nonexistent, the chances are high that will not want to help the research team by allowing them to publish there information. Second it would allow the test subject to determine for themselves if what is being written and published about them is correct. On the other hand, these results may not happen all the time. Even if informed consent is given,the test subject still may not like the result of the research and decide that they do not consent to the publication of the study. Jackie

I agree with Rapela that "Incomplete disclosure used by an unethical scientist can lead to damage to their subject". I think that incomplete disclosure, when used by an ethical scientist only, is necessary in many studies. One that comes to mind is Mead's study of adolescents in Samoa. Critics of Mead's study have argued that her findings were not accurate because the girls knew of the study. I do not think, however, that research subjects should be allowed to decide whether the research is published.

There may be no question that researchers and subjects can form relationships. And as Ms. Rivera notes, in these relationship subjects may care little about what happens to information about themselves. This is setting aside the question, which perhaps we shouldn't, of whether the subjects truly understand what might happen if/once the world learns about them. It is also setting aside the fact that researchers aren't positioned to make too many claims about the effect that research participation might have on those subjects who readers can identify. But perhaps the real question is, what kind of "relationship" are we talking about? Informed consent rules are in my view nearly always imperfect at best. They seem destined to err by being over-restrictive or blur important distinctions in social science. Still, informed consent rules have this virtue: they set out in fairly clear terms just what the relationship will involve. That's what kind of relationship we're talking about, the one spelled out in the informed consent rules.

I agree with Ms. Rivera that subjects might be put off by detailed explanations about the research objectives, potential risks, and other things. The researchers can make a good case that such procedures diminish the naturalness of the research setting. This doesn't mean that there is nothing to be said for insisting that potential subjects understand that theirs is no ordinary relationship (if it is a "relationship" at all). A number of things can go wrong in ordinary, personal relationships, despite one person's saying "trust me," and the other doing so. People who ask for trust, along with people who promise it, can misjudge, fail to appreciate circumstances, and simply change their minds. True, people in a personal relationship usually do not, upon greeting each other, renew their agreement to be involved, specify the terms of their relationship, and ensure that the other is still committed. That fact may not resolve anything, however, unless we want research relationships conducted with all of the ambiguity, posturing, and risk that personal relationships involve. Supposing that we do not, there could be something of significance for research ethics in that corny line from TV courtroom dramas, where the attorney says to the witness, ". . . and before you answer, let me remind you that you are under oath... ."