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Part III

Chapter 16





Chapter 16: Results

In this section, we present the results of the SIS. We begin with a description of the demographic characteristics of the patients we interviewed, as well as the basic characteristics of the research projects in which some of these patients were or had been participating. We then review what we learned about patients' general attitudes toward, and beliefs about, research and their understanding of some of the terms commonly used to describe research to potential subjects. This is followed by our results concerning patients' perceptions of whether they are, or are not, participants in research and the extent to which we were able to compare these perceptions with documents and other sources. We then discuss what patients said about the distinctions between research and treatment, and their reasons for deciding to participate. We also describe the characteristics of patients who reported that they declined to be research participants. Our discussion of results closes with what we learned from the SIS about the consent process and issues of voluntariness of participating in research.

Demographic Information

Brief Survey

A total of 1,882 patients completed the Brief Survey. The overall response rate was 95 percent. Patients predominantly were Caucasian (80%), more than sixty years old (53%), and male (59%). Other relevant demographic features are found in table 2.

In-Depth Interview

A total of 103 patients, representing fourteen of the sixteen institutions included in the overall study sample, were interviewed.[1] This sample also was predominantly Caucasian (74%) and male (54%) (see table 2). Due to technical or administrative difficulties with four interviews, only ninety-nine transcripts were available for analysis.[2]

Characteristics of the Research Projects

The characteristics of the projects in which patients participated are described in table 3. The expert panel categorized the disease burden associated with the projects reviewed as low (11%), medium (38%), and high (51%). Approximately half (48%) involved minimal incremental risk from research.

Table 2. Demographic Characteristics of SIS Patients
 Brief Survey
(N = 1882)
In-Depth Interview
(N = 103)
Female 41.3 46.0
Age Category
Under 303.6 5.0
30 to 5943.353.0
Over 59 53.142.0
African-American16.3 23.0
Less than high school 21.59.0
High school graduate plus those with additional schooling 53.7 52.0
College graduate plus those with additional schooling24.939.0
Annual Household Income
Greater than $75,00010.921.0
$50,000 - $74,99914.4 15.0
$25,000 - $49,99928.725.0
Less than $25,00041.0 34.0
Not reported5.15.0
Veterans Administration 26.620.0
Not reported1.412.0
Type of Institution
VA Medical19.717.0
University28.5 17.0
Government/Military 24.132.0
*A detailed breakdown, in schematic format, of the procedures and results reported in this section are found in a supplemental volume to this report.

Table 3. Characteristics of Research Projects
Type of ResearchPatients' Report*Expert Panel Report
ReportN = 476N = 236§
Did not know3%N/A
* Patients' Report refers to the patient's understanding of the type of research in which they were participating. Expert Panel Report refers to the expert panel's assessment of the type of research in which the patient was participating.
§ Because of time constraints, the remaining consent forms were not reviewed.

General Attitudes Toward and Beliefs About Biomedical Research

Brief Survey

In the Brief Survey, patients were asked a series of questions concerning their attitudes toward, and beliefs about, "medical research." Almost all the patients had positive impressions of medical research. Specifically, 52 percent reported a "very favorable" attitude toward research and 37 percent a "somewhat favorable" attitude. Only 5 percent of patients described themselves as having an unfavorable attitude. Controlling for multiple factors, the characteristics associated with more favorable general attitudes toward research included being older (age greater than sixty), being male, being a patient in radiation oncology rather than cardiology, and having reported currently being or having been a participant in research.[3]

More than two-thirds of the patients reported that they believed medical research usually or always advances science. More than 80 percent of the patients agreed that medical research does not involve unreasonable risks (86%). Nevertheless, some patients (9%) believed that research usually or always poses unreasonable risks to people. Controlling for multiple factors, the characteristics associated with holding this belief included being younger, being African-American, not having a college education, being in fair or poor general health, and not having any experience as a research participant.[4] Seven percent of patients believed that participants in medical research are usually or always pressured into participating. Patients more likely to believe that people are pressured into research were African-American and had an annual income of less than $25,000.[5]

Thirty-seven percent of patients believed that patients who participate in medical research are usually or always better off, medically, than similar patients who are not in medical research. Patients with a more positive view about research tended to be older, have incomes of less than $50,000 a year, and have had some experience as a research participant.[6]

In-Depth Interview

In the In-Depth Interviews, patients' general attitudes about research often seemed to be shaped by what their own research experiences had been, and patients generally had very positive things to say about their own experiences. Typically, they believed that the projects in which they were or had been participants had been explained thoroughly, that they had been treated kindly, and that they had received at least as much benefit as could have been expected. Moreover, the more experience people had with research, the more positive was their attitude. In addition, a few patients admitted that they had held a rather negative impression of research until they themselves had participated, at which time their impression changed. One respondent said, "I didn't know what to expect. In the beginning I was worried, you know. I was a little upset, a little frighten[ed] and everything. Once I got here, I found that the people were very nice, very professional, and they care about their patients . . . [Y]ou think that you are going to be a number, that they just may be cold and calculating, they['ll] just be thinking about just the data itself and you are just a number or something. But once I got here I found that . . . the doctors and nurses and everybody are very concerned about the individual and you find that out because they take the time to know your name."[7] These findings are consistent with those from the Brief Survey, in which patients who currently were, or once had been, research participants had significantly more positive attitudes about research than those who had never participated.

When asked for their attitudes and beliefs about medical research generally (rather than about their own experiences), patients, again, had very positive things to say. Research was thought of as a promising endeavor, something that would advance knowledge and help other people: "[Research is] the only way advancement is made in the medical field particularly. . . [I]t's gotta be done at some point in time on human beings . . . and there are people who are alive today because of the people [who] did research projects."[8] Another respondent strongly endorsed research activities: "Overall I have to say clinical trials, medical experiments are the only way we're going to find any type of results . . . because you can . . . practice on guinea pigs, monkeys, or whatever, but the only way you're going to find out if any of these drugs are going to work is you're going to have to do it on a human being."[9] While patients articulated the necessity of conducting research, a few reiterated the importance of looking out for the interests of the human participants: "I think that . . . research is awfully important in all fields and . . . the more it involves human life the more guarded one has to be about it."[10]


Brief Survey

In the Brief Survey, patients were asked to compare the term medical research with one of four alternative terms: clinical trial, clinical investigation, medical study, or medical experiment. The term medical experiment evoked the most striking and negative associations. It was the only term to be evaluated as worse than the term medical research on all of the dimensions considered. Specifically, patients who were asked to compare medical experiments with medical research reported that patients in "medical experiments" were more likely to get unproven treatments and be at greater risk than patients in "medical research" and also that they were less likely to do better medically. By comparison, patients thought those in "medical research" were more likely than those in either "clinical investigations" or "clinical trials" to get unproven treatments and to be at greater risk, but they were more likely to do better medically. The term medical study got better ratings than the term medical research in every respect; medical studies were viewed as less risky, as less likely to involve unproven treatments, and as offering a greater chance at medical benefit.

In-Depth Interview

Distinctions in meaning among different terms for biomedical research also emerged from the In-Depth Interview. Elaborating on the findings of the Brief Survey, the terms experiment and experimental, for the vast majority of participants, meant that something was unproven, untested, or in the first stage of testing and was thereby riskier and perhaps scary. Some patients said they would become a participant in an "experiment" only if they were terminally ill. A few participants described quite explicit images of what experiments involved: "I envision all kinds of weird things done to the body and I assume that's not true, but also I envision a medical experiment maybe . . . done in a laboratory sealed up somewhere where no one even knows what [is] going on."[11] Another respondent said, "Medical experiment--almost sounds like Frankenstein to me."[12] When asked to explain the term experiment, patients often invoked the term guinea pig to convey the sentiment of being the "victim" of an experiment. For example, one respondent, when asked to define the term medical experiment, said, "That's where you get down to the human guinea pig . . . where they may be injecting medication or whatever they want to inject in someone and watching them for a reaction."[13]

In comparison with the term experiment, clinical trial and clinical investigation were not such evocative terms. Some patients gave hesitant or stumbling definitions or said they were not familiar with these terms. On the other hand, some patients did attach meaning to these terms, defining them as endeavors that were at an intermediate stage of inquiry, where researchers already know something about the topic and they are now trying the next step.

Patients were most likely to consider "study" a benign endeavor, akin to studying something in school: "Study brings to my mind more of using documentation for analysis. . . . With a study . . . you're looking at records. You look at past histories and so forth. . . . It is mostly paperwork, documents, or the books and things."[14]

Of the four terms offered, patients usually said they would prefer to be in a study. It was reported to be the least harmful because it was believed to be the least invasive. In comparison to experiments, which many patients believed involved "trying things out" on animals and/or humans, "studies," they felt, usually entailed gathering information and reviewing paperwork.

Personal Experience With Research

Brief Survey

Thirty percent (570) of the 1,882 patients interviewed reported that they were or had been participants in research (see table 4).[15] We were able to review records or consult other sources for 541 of these 570 cases. By these reviews, we were able to confirm research participation in 302 of 541 cases (56%). In another 203 of the 541 cases (38%), we were unable to find documentation to suggest whether or not the patient was participating or had participated in research. In the remaining 36 cases, the review by health professionals on the Advisory Committee staff concluded that these patients were probably in error and that they were not, indeed, research participants.[16] In summary, 16 percent (302 of 1,882) of the total sample, consistent with their reports, were former or current research participants. Also, assuming that most of the patients for whom research participation could not be verified but, consistent with their own reports were probably truly former or current participants (11%, or 203 of 1,882), then a total of 27 percent of the Brief Survey respondents were former or current research participants. By contrast, 2 percent of the total sample (36 of 1,882), were likely incorrect in their perception of themselves as being participants in research.

Table 4. Personal Experience With Participation in Research: Results of the Record Review*
Result of record review Subjects who reported they were in research
N = 570
Subjects who said they were not in research
N = 1,223
In research53% (302)5% (69)
Couldn't tell36% (203)2% (23)
Probably not in research6% (36)88% (1,080)
No record review5% (29)4% (51)
*The numbers in this table should be interpreted in the context of the explanation and limitations presented in the text.

Sixty-five percent (1,223 of 1,882) of the patients interviewed reported that they were not and never had been participants in research. We were able to review records or consult other sources for 1,172 of these cases. In 23 of the cases, relevant records were unavailable to confirm participation. In our review of records and other sources, we did not find evidence of research participation for 1,080 of 1,149 patients. In 69 of these 1,149 cases, however, Advisory Committee health professional staff was able to confirm patients' participation in research. In 61 of these 69 cases, the preliminary evidence for participation had included an informed consent form signed by the patient for enrollment in the research project. In summary, then, 60 percent of the total sample (1,080 of a total of 1,882) appear never to have been research participants--in the sense that there is no evidence to the contrary--and in another 1 percent of the sample (23 out of 1,882) it is unclear. By contrast, 4 percent (69 of 1,882) of the total sample were apparently incorrect in believing they never had been participants in research.

Although the Committee could not return to the 69 subjects to determine whether the apparent discrepancy was due to true lack of awareness or perhaps to other factors like confusion, misunderstanding of the question, or poor memory, we did attempt to take a closer look at these cases. These 69 patients came from all five geographic sites sampled in the SIS and were receiving care at every type of institution participating in the study (that is, university hospitals, government or military hospitals, Veterans Affairs medical centers, and community hospitals). These patients were interviewed in radiation oncology, medical oncology, and cardiology clinics. Their ages ranged from twenty-one to eighty-nine years of age; 30 were women and 39 were men; and the majority (53) were white (12 were African-American and 4 were of other ethnicities). Their educational background ranged from less than eighth grade to those with graduate or professional degrees. The records of these 69 patients, who reported that they were not in research but for whom evidence of research participation was found, were subjected to extensive review and analysis by Advisory Committee health professional staff. According to this review, about half of these patients had been enrolled in research during the previous year.[17] The consent forms of 42 of the studies in which these patients were enrolled had been included in the sample of consent forms reviewed by our expert panel. According to the panel, the disease burden for those recruited for these 42 studies ranged from low (5 studies) to high (18 studies), with the remainder being medium (19 studies). Most of these studies involved the evaluation of treatment (23 studies), while some were diagnostic (13) or other types of studies (5).[18] Finally, of these 42 studies, 25 were determined by our experts as posing minimal incremental risk to subjects and 17 as posing more than minimal incremental risk.

In-Depth Interview

Patients completing the Brief Survey were recruited for the In-Depth Interview if they reported that they currently were or once had been participants in research. Through the review process described above, however, research participation could not be verified for 9 of the 99 In-Depth Interview patients, nor did the transcripts of these 9 patients suggest that they were research participants. Two of these 9 patients told stories about research participation that were confusing or unclear. Another 7 of the 9 seemed to believe that anything new or unknown, or, in a few instances, any tests, were research. One such respondent, with a rare medical condition without a known efficacious treatment, described the interventions she received and said, "Everything is experimental, they don't know how to cure it."[19] These 9 transcripts were excluded from further analysis.

Distinctions Between Research and Medical Care

While the Brief Survey did not address distinctions between medical treatment and research, this issue arose during the In-Depth Interview. Here, patients' descriptions of their research experiences often included descriptions of their physical conditions, their own health care providers, or the hospitals at which their research projects were conducted. Research experiences, particularly for those patients who reported being in research evaluating potential treatments, were inextricably interwoven with their medical care experiences. One respondent described her research experience "as a means of treating what I have."[20] Another respondent, when asked what she disliked about the project in which she was a participant, replied: "Nothing other than the fact that nobody likes to be sick and nobody likes to go to doctors."[21]

While patients, if asked, were quite able to identify which procedures, tests, and staff were associated with their research, they did not themselves readily make distinctions between research and medical treatment. Particularly for patients with serious medical diagnoses, research often was viewed as one of the treatment options for their medical conditions. Not surprisingly, then, some participants evaluated their research experience in terms of whether they believed it would provide them with clinical benefit. One respondent noted, "I see results that indicate that the chemotherapy that I'm taking is working, and therefore, that is adequate enough to satisfy me."[22]

Despite the tendency for some patients to fuse discussions of research and treatment, some clearly differentiated the two.[23] This was especially true for those who reported that they were in diagnostic, epidemiologic, or survey research.[24]

Deciding to Participate

Brief Survey

When asked whether specific factors contributed a lot, contributed a little, or did not contribute to their decision to participate in particular research projects, patients typically identified multiple motivations. Most patients reported that they had joined a research project to get better treatment (contributed a lot, 67%; a little, 11%) and because being in research gave them hope (contributed a lot, 61%; a little, 18%). Patients who cited the desire for better treatment as a reason for agreeing to be in research were more likely than other patients to be in a study that they viewed as "therapeutic," that related to the patient's medical condition, and that involved radiation.[25]

In addition to this emphasis on the possibility of better treatment and the bolstering of hope, 135 patients agreed with the statement that they "had little choice" but to participate and that this belief contributed a lot to their decision. While it is difficult to ascertain precisely what these patients understood this statement to mean, patients elaborated on this motivation in the In-Depth interviews, often saying that because of the serious nature of their medical condition and/or because other interventions had not been successful, they believed they had "little choice" but to try research. Patients reporting that they had little choice tended to categorize the projects in which they were subjects as treatment projects (compared with diagnostic or epidemiological), tended to report that the projects involved radiation, that they did not feel they had enough information, and that the research was related to their medical condition.[26]

Altruistic reasons also played a part in many patients' decisions to participate in research. Specifically, most patients reported that they looked at participation as a way to help others (contributed a lot, 76%; a little, 18%) and as a way to advance science (contributed a lot, 72%; a little, 21%). Patients also frequently said that they had joined research projects because it seemed like a good idea (contributed a lot, 48%; a little, 17%), the project sounded interesting (contributed a lot, 53%; a little, 24%), and they had no reason not to participate in medical research (contributed a lot, 56%; a little, 15%).

In-Depth Interview

In reporting how they had decided to participate in research, In-Depth Interview patients described many different processes, ranging from the very deliberate weighing of risks and benefits to the quicker decision of just taking action. Doctors (e.g., "my doctor," "the doctor," a particular doctor, or referring physician) were frequently identified as the key agent in the respondent's decision to participate in research.

Patients expressed a broad range of reasons they decided to participate in biomedical research. As in the Brief Survey, for people in therapeutic research, the primary reason for participating in research was to obtain benefits either through an experimental treatment they hoped would be better than standard treatment or through the closer medical attention they believed they would receive through research. One woman reported that she was participating in a treatment trial specifically to obtain an experimental drug that she believed looked promising. Furthermore, she wanted to receive it in a controlled environment where she could receive good follow-up and where researchers would document the drug's effects.[27] Another respondent commented that since doctors at the military hospital where he received his care were very busy, he could receive closer attention and obtain appointments more easily by enrolling in research.[28] Some patients who reported being in therapeutic research hoped that the research would give them more "time": "[A]ll I wanted at that point was five years to get my boys through high school";[29] "I want longevity . . . I don't see myself wanting to just pass away."[30] Some patients decided to be in research because they believed that newer therapies might inherently be better: "If there's something new on the market that might be better than the traditional program they've been using, why not try it?"[31]

Mirroring the Brief Survey finding that 31 percent of patients felt they had little choice in joining a research project, many In-Depth Interview patients who participated in therapeutic research remarked that they had joined because they believed they had "no choice," meaning they had no medical alternatives: "My doctor told me if I do not take the drug, in a couple of months I . . . [will] . . . die. So, I had no choice. Who wants to die? Nobody."[32] Another respondent said, "I had one more option as he [the doctor] put it."[33] Hope and desperation pervaded the remarks of many terminally ill patients. Patients said they wanted to "try anything" or that this was their "last resort." One man explained, "Well, what was driving me to say 'yes' was the hope that this drug would work. . . . When you reach that stage . . . and somebody offered that something that could probably save you, you sort of make a grab of it, and that's what I did."[34] This same patient noted that he had first declined what he had considered a very aggressive therapy, "because at that point everything was pretty okay and there was no need for me to do any wild things."[35] Later, when his condition worsened, he decided to participate in the research.

One of the most influential forces in patients' decisions to enroll was doctors' recommendations. One patient described the process of her enrollment: "He [the doctor] asked me if I wanted to go on it, and I said, 'If it's what you think I should do, yes, because you know more about it than I do.' . . . [H]e said, 'I think it would be a good idea to try it.'"[36]

Along these lines, a theme of trust overwhelmingly emerged. Patients trusted specific physicians, medical professionals more generally, or the overall research enterprise. Trust in specific physicians was straightforward: "Basically, y[ou] know, we trust Dr. [So-and-so] . . . [There] was no reason to, . . . get a second opinion from another doctor."[37] Another respondent exclaimed "Oh, I love that man. He has kept me alive and I obey him and I do what he tells me to do. . . ."[38] Some patients also communicated trust in the medical profession more generally: "I have this attitude. They know what they're doing. They wouldn't have you to do this if they didn't know what they were doing and . . . that's my attitude. . . ."[39] Finally, there were a few patients who expressed trust in the overall enterprise of medical research as well as its oversight. One respondent stated: "I do not feel like the drug would be on the market if it were going to harm me, and if it would help in any way . . . I'm very willing to participate in this and perhaps other studies."[40] Related were patients who said they decided to participate because of their trust in the institution where the research was being conducted. "I think I've got the best treatment down there [named hospital]. I don't think I could get any better."[41] Rare were the patients who had less "blind trust" and considered themselves to be more of a consumer: "I sort of take my own treatment in my head and tell them that I'm his client. It's not the other way around. . . ."[42]

Elaborating on responses to the Brief Survey, the majority of patients mentioned altruism as a reason to participate. This desire to help others took many forms, including helping others who had the same medical condition, advancing medical science more broadly, and contributing to society. Most frequently, those in therapeutic research seemed to voice a combined motivation of seeking benefit for themselves and hoping to achieve benefit for others. Very representative was the comment, "I was hoping, if not for me, at least for the next people coming along. . . ."[43]

For some patients who faced a life-threatening illness, participating in research seemed to offer them a greater sense of personal worth, a chance to contribute something of value to society. One woman said, "[I]f I can help find a cure for what seems to be so common [that is, cancer] these days, I would love to think I was part of finding that cure."[44] For a small number of patients, this notion of helping others went further, to be a duty or obligation: "[I thought], well, I don't have to do this, and then I thought, well, here I am benefiting from literally thousands and thousands of experiments that have gone before and that are helping to save my life and this one sounded [very] reasonable to me and I was happy to participate."[45] Similarly, one respondent replied, "I feel like that [participating in research and giving blood] is a moral obligation as a citizen. You put back into your community. . . . [O]pportunities to not only help yourself but other people are real important to me. . . ."[46]

Only three patients cited monetary reasons for participating in research.[47]

Deciding Not to Participate

It is also clear from the Brief Survey that not all patients approached to participate in a research project agree to do so. In fact, 191 (10%) of the 1,882 patients we spoke with told us that at some point they had made a decision not to participate in research. While 112 (59%) of these 191 patients had never decided to be in research, the remainder reported that at some time or other they had (39 were current research participants, and 40 were former research participants), suggesting that some patients discriminate between projects they are willing to participate in and those they are not. Patients who declined to participate in research ranged in age from twenty-one to eighty-three, with a median age of fifty-six. The patients were of both genders (53% male, 47% female), predominantly white (69%, with 27% African-American and the remainder being of other ethnicities), with wide educational backgrounds ranging from less than eighth grade to those with professional degrees.

We asked the 112 patients who had never been in research why, when they had been offered the chance, they had decided not to participate. The reasons that "contributed a lot" to their decision were that they wanted to know what treatment they were getting (64%); they wanted their medical decisions to be made by their doctors and themselves, not by researchers (56%); they believed that being in the medical research project was not the best way for them to get better (45%); and taking part in the medical research project would have been inconvenient (43%).

Consent and Voluntariness

Brief Survey

Overall, 83 percent of patients who told us they were current or former research participants remembered signing a consent form agreeing to take part in research. This was true for 88 percent of current research participants and 80 percent of former research participants. Most (90%) of the patients who believed that they were current or former participants in research reported that they felt they had enough information to make a good decision about whether to participate. This was the case for 95 percent of current research participants and 87 percent of former research participants.

Fewer than 2 percent of current or former research participants felt pressured by others in making a decision to participate. Six patients specifically said that they had been pressured by someone in the medical field (e.g., "my doctor"; "the hospital"); four patients reported having been pressured by someone in the military (e.g., "the military"; "Admiral on ship").

When patient-subjects were asked what they thought the policy was for dropping out of the study in which they were participating, 78 percent thought, correctly according to current research standards, that they could drop out at any time. A variety of other responses were also offered, ranging from not knowing the policy, to expressing that it was irrelevant (e.g., the entire project consisted of a single survey or blood test), to believing they had to stay in the research project.

In-Depth Interview

On the whole, patients who granted In-Depth Interviews recounted that the staff involved in conducting research explained research projects, gave participants time to read over the consent forms and confer with family and friends, and responded to participants' questions. One patient said explicitly, "It seemed to me that they were well prepared to answer any questions I would ask them."[48] Asked if research staff had provided her with as much information as she needed, one patient replied that they used "terminology . . . that I could relate to. They spoke in my language. That was a plus."[49]

The consent process, in general, and the consent form, in particular, held varying degrees of importance for patients. Most patients enrolled in survey or noninvasive projects did not attach a great deal of meaning to the consent form. One respondent, whose experimental procedure consisted of "just drawing some blood," thought, in fact, that his consent form went overboard.[50] For those patients who reported being in research evaluating potential treatments, the value of the consent form varied. For many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality. For a few, signing a consent form symbolized the first step on the path to getting better. Others, however, relied heavily upon the content of the form when deliberating about whether to participate. In addition, several patients noted that they held on to their consent forms, a few even offering them up for the interviewers' review.

The notion of trust also accompanied accounts of the consent process. For some participants, the consent form was the means by which patients could authorize trusted health professionals to do what they think is best. One respondent remarked, "[W]hatever the doctor was doing, well, that was all right. I consented to this and let the experts take over then."[51] This authorization for treatment meant abdicating attention to detail for some patients: "I'm the type of person, I don't read all this fine print and all this stuff and so forth. The lady said that we would like to experiment on your body to see what can be done . . . and it's to help me and so far, so good. . . . "[52]

While patients attached different levels of personal interest to the consent process, they were clear that the type of information typically conveyed in a consent process is exactly what they would need in order to decide about participating in research in the future. Patients overwhelmingly said that they would participate in a research project again if they had enough information and if the project were explained in sufficient detail by research staff: "I'd have to know the what fors, ifs, whys, what they're gonna do. . . ."[53] Or, "if somebody can't explain what they're going to do to me good enough, I wouldn't [do] it."[54] Furthermore, several patients stated that they would like to know why a particular study was being conducted and why certain procedures or techniques were necessary. "Communication," "information," and "honesty" were frequently identified by participants as essential in considering participation in any future research project.

For patients who described their own consent process, experiences generally were positive. A few patients reported problems, however. Three general problems were identified: (1) too much technical information that was difficult to read and understand,[55] (2) an overwhelming amount of information,[56] and (3) discussions occurring at stressful or inappropriate moments.[57]concerned about sleeping and being rested. . A few patients reported that during discussions with physicians or investigators they relied upon family members to help process the information conveyed.[58]

A few patients remarked upon the importance of contact among participants in research projects evaluating treatments. One respondent contrasted the type of information one research participant can provide to another versus that which a doctor can provide: "[It's] always nice to be able to . . . see somebody in the same boat or talk to [that person]. . . . because even though a doctor is very good in explaining thing[s]. . . . there are certain things that . . . only somebody who's going through the thing can really know what you're talking about."[59]

Consistent with findings from the Brief Survey in which 98 percent of patients reported that they were not pressured into participating in research, almost all the patients who gave In-Depth Interviews believed that the decision about whether to participate in research had been theirs to make and that they had not felt pressured into that decision. Indeed, many patients mentioned that they participated "voluntarily." One respondent said, "They wanted to know if I would be interested in this. Nobody was pushy. Nobody, they just said, 'Here it is, would you like to be involved in this program[?]'"[60] No one interviewed identified pressure from family members. More often, patients remarked that while they conferred with families and friends, the choice was ultimately their own: "My family. The people I work with . . . [E]verybody tells you you have to make up your own mind. . . . [N]obody's going to tell you what to do because it wouldn't work anyway. So nobody tried to influence me one way or the other. . . ."[61]

There were only a few patients who suggested that doctors tried to exert what was viewed as unwelcome or inappropriate influence. One respondent, who remarked in one portion of the transcript that she did not feel pressured, later reported, "[The doctor] sorta made a plug. He said, 'you know, if people like you refuse to get into this . . . we're never going to get anywhere.'"[62] Another respondent indicated that he felt pushed by one doctor to sign a consent form for a particular type of infusion treatment. "[T]hey say, well . . . go ahead and sign it . . . so we can . . . start you on the process, and I said, well, I want to read it. . . . And he said, have you signed it yet? And I said, 'I haven't read it yet. Oh, okay, well . . . we need you to sign it and then . . . make a copy and we'll just let you read it afterwards and I thought, what is going on? I mean, they had never ever kind of pushed it like that."[63]

Almost all patients reported that they had been told they could leave the research project at any time and that they believed that they could leave at any time. One respondent said, "[T]hey always told us all the way along, anytime you don't feel happy with this, we can quit . . . they said if you don't feel like you want to continue, you can quit anytime. There was no pressure on or nothing. . . ."[64] Similarly, "[I]t was made very clear up front[,] and then in the original package of material that they had, at any point in time for any reason in time any reason I wanted, you know, I didn't even have to have a reason, I could withdraw with no problem."[65] For some participants, the question of withdrawing seemed almost foreign because there was such trust in the research process. One respondent said, "[The thought of withdrawing] never entered my mind. I was going to let them make the decision because they were the ones that were watching the cancer. . . . I wasn't the expert. If they thought it was working, that was fine."[66] One respondent who was in the military believed that continued participation was required.[67] Another respondent, about to undergo a bone marrow transplant, reported being pressured both to enroll and to continue participation in a clinical trial. "They were really pushing this procedure [a drug to help raise white blood cell counts]. . . . It was very obvious to me that they wanted people to sign up for this bad, and I did not want to upset my doctor. . . . Y'know I'm totally helpless. I'm in his hands and, so part of it was, I wanted to keep him happy and, uh, there was some pressure."[68]

As described earlier, several patients in therapeutic research identified an intense desire to have some type of treatment. This not only influenced their decision to enroll, but also to remain in a research project. One respondent stated that participating in research "was through necessity. . . . [T]he thought never entered my mind that I would withdraw from this program."[69] Such sentiments also seemed to influence patients' desires to find research projects for which they might be eligible. "I said if something comes up that you think will benefit me, let me know . . . I wanted to be on that trial bad enough to where I gave [in to] the pressure."[70]

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