Discussion

CHAPTER 16 ENDNOTES

2 . . One audiotape of poor quality was never transcribed. Transcripts for three patients who stated clearly during the In-Depth Interview that they had never participated in research and who were inappropriately selected were also excluded.

3 . All models were developed using multiple logistic regression, and the results are reported here as the baseline probability of a given response along with the approximate absolute difference due to a given factor. Each factor either adds to or subtracts from this baseline probability. Note that the baseline probability used in the models is not equal to the overall probability of corresponding response reported in the text. It is only a "baseline" within the context of these models.

4 . Baseline probability of saying that medical research usually or always involves unreasonable risks was 19%; Age > 60, -6%; African-American, +11%; College degree, -6%; Good health, -8%; Research participant, -6%.

5 . Baseline probability of feeling that potential subjects are usually or always pressured was 5%; African-American, +9%; Income=$25,000-$50,000, -2%; and Income > $50,000, -3%.

6 . Baseline probability or saying those in research usually or always do better was 31%; Age > 60, +7%; Income > $50,000, -8%; Research experience, +9%.

7 . Subject No. 335216-8, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 27 March 1995, lines 40-43, 170-175 (Research Project Series, Subject Interview Study).

8 . Subject No. 551334-6, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 706-714 (Research Project Series, Subject Interview Study).

9 . Subject No. 335213-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 28 March 1995, lines 1663-1668 (Research Project Series, Subject Interview Study).

10 . Subject No. 442107-9, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 29 March 1995, lines 458-460 (Research Project Series, Subject Interview Study).

11 . Subject No. 552106-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 311-315 (Research Project Series, Subject Interview Study).

12 . Subject No. 442107-9, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 29 March 1995, line 432 (Research Project Series, Subject Interview Study).

13 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 745-748 (Research Project Series, Subject Interview Study).

14 . Subject No. 333256-6, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 16 March 1995, lines 361-366 (Research Project Series, Subject Interview Study).

15 . A detailed breakdown, in schematic format, of the procedures and results reported in this section is found in a supplemental volume to this report.

16 . A variety of reasons suggested that although patients reported that they were research participants, review of their medical records suggested that they were not. For [instance, in comparing patients' self-reports with their records, what they had called "research" actually was standard clinical care that they were receiving.]

17 . Data for this analysis were available for 54 of 69 individuals with discordant responses: 54% had enrolled after 1 January 1994; 65% after 1 January 1993; and 72% after 1 January 1991.

18 . Data regarding type classification are missing for one study in this group.

19 . Subject No. 552212-3, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 13 March 1995, lines 34-35 (Research Project Series, Subject Interview Study).

20 . Subject No. 335227-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 March 1995, lines 226-227 (Research Project Series, Subject Interview Study).

21 . Subject No. 552126-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 13 March 1995, lines 186-187 (Research Project Series, Subject Interview Study).

22 . Subject No. 221202-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 403-405 (Research Project Series, Subject Interview Study).

23 . One respondent remarked, "Wouldn't it be great" if this particular protocol "that treats you for [a] shorter period of time [with] high doses of chemotherapy" proved as beneficial as treatment over "years and years" (Subject No. 335215-0, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 24 March 1995, lines 536-539 [Research Project Series, Subject Interview Study]). It was clear that this respondent conceptualized research as an endeavor aimed at increasing knowledge about unproven interventions, rather than understanding research as a form of medical care.

24 . Research experience for these patients tended to be described more dispassionately as a one-time event that stood apart from their therapeutic needs. Indeed, the patients tended to minimize the effect that the research experience had for them personally: deciding to join required little deliberation, and participating required little effort. One respondent made it clear repeatedly that her research experience was "just" an interview (Subject No. 334148-4, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 3 March 1995, lines 73, 105, 143-144 [Research Project Series, Subject Interview Study]). A respondent who participated in survey research agreed out of a willingness to help: "If I can help on anything, I want to be able to do it . . . . 'course my wife thinks if we can help in any research, we're both willing to do it" (Subject No. 443321-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, lines 108-109, 125-126 [Research Project Series, Subject Interview Study]). Finally, in notes kept by interviewers and in debriefing sessions with interviewers, interviewers reported that most patients who had participated in survey research simply did not have a lot to say compared with other patients.

25 . Groups for which there was marginal statistical evidence for increased frequency for this belief were African-Americans (versus Caucasians) and those who were retired or unemployed. In this model, the baseline probability of contributing a lot to the decision was 13%; Treatment study +27%; Involved radiation 13%; African-American +8%, Employed -5%; and Research related to condition +20%.

26 . Baseline probability of contributing a lot to their decision was 11%; Treatment study +10%; Radiation +6%; Had enough information 7%; Research related to condition +25%.

27 . Subject No. 335215-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 March 1995, lines 11-72 (Research Project Series, Subject Interview Study).

28 . Subject No. 553109-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 10 March 1995, lines 252-269 (Research Project Series, Subject Interview Study).

29 . Subject No. 441227-6, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 10 March 1995, lines 542-544 (Research Project Series, Subject Interview Study).

30 . Subject No. 221202-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 350-352 (Research Project Series, Subject Interview Study).

31 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 30-32 (Research Project Series, Subject Interview Study).

32 . Subject No. 333215-2, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 3 March 1995, lines 194-195 (Research Project Series, Subject Interview Study).

33 . Subject No. 114229-8, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, line 119 (Research Project Series, Subject Interview Study).

34 . Subject No. 332250-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 28 March 1995, lines 105-109 (Research Project Series, Subject Interview Study).

35 . Subject No. 332250-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 28 March 1995, lines 208-210, 188-193 (Research Project Series, Subject Interview Study).

36 . Subject No. 552264-4, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, March 1995, lines 432-434 (Research Project Series, Subject Interview Study).

37 . Subject No. 114229-8, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 194-198 (Research Project Series, Subject Interview Study).

38 . Subject No. 114217-3, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 10 March 1995, lines 50-51 (Research Project Series, Subject Interview Study). A powerful instance of the finding of trust in physicians' recommendations and requests was the participant who said, "He [a physician] asked me would I do it and I told him, 'Yeah.' I didn't think that he would harm me [in] any kind of way, hurt me in any kind of way, so I told him, 'Yeah.' He couldn't get I don't believe . . . anybody else to do it" (Subject No. 441311-8, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 155-158 [Research Project Series, Subject Interview Study]).

39 . Subject No. 332324-3, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 March 1995, lines 309-311 (Research Project Series, Subject Interview Study). Another reported, "There's not a lot that you can control when you're sick so you have to rely on your doctor . . . if he suggests that you should go into a research project, I think you should really take his advice or her advice, whatever it may be . . .[B]ecause if you take the time to get yourself a good doctor and they're involved in research, they would never steer you wrong" (Subject No. 552244-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 5 March 1995, lines 617-675 [Research Project Series, Subject Interview Study]).

40 . Subject No. 443241-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 2 March 1995, lines 67-70 (Research Project Series, Subject Interview Study).

41 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 381-383 (Research Project Series, Subject Interview Study).

42 . Subject No. 552143-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 15 March 1995, lines 327-329 (Research Project Series, Subject Interview Study).

43 . Subject No. 223212-2, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 16 March 1995, lines 233-234 (Research Project Series, Subject Interview Study). A few patients had very specific others in mind. One respondent, for instance, enrolled in a genetic study of colon cancer, said, "Because if it's hereditary and it sure seems [so] in my situation . . . I'm concerned about my daughter. I'm concerned about her kids, and [it] goes on and on and on . . . " (Subject No. 221240-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 15 March 1995, lines 334-337 [Research Project Series, Subject Interview Study]). As patients became sicker, altruism played a larger note for some. For example, one respondent explained that over the course of his disease and enrollment in numerous research projects, his reasons for participating in research had become more altruistic: "[I]t will never cure me . . . I'll be dead in the next couple of years . . . but if they can find something that can save someone else [I'll be happy] . . . [W]hen you first go in . . . you're kind of dealing with whatever . . . disease you're dealing with. . . . There's this hope factor that's there, that you think, 'Well, maybe this is going to work. Maybe I'm going to--it's going to help me. . . .' [But now] I don't have the expectations that . . . I did . . . seven or eight years ago . . . I'm realistic. It might help. It might not. But, you know, they're going to find out something that's going . . . to help somebody else and you have to think of it that way" (Subject No. 335213-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 598-600, 1234-1238, 1294-1299 [Research Project Series, Subject Interview Study]).

44 . Subject No. 443252-2, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 1 March 1995, lines 198-200 (Research Project Series, Subject Interview Study).

45 . Subject No. 442107-9, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 29 March 1995, lines 120-124 (Research Project Series, Subject Interview Study).

46 . Subject No. 443218-3, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 February 1995, lines 545-553 (Research Project Series, Subject Interview Study).

47 . Only one respondent noted that he participated simply because he wanted the money that was being paid to participants in his research project (Subject No. 551145-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 11 March 1995, line 60 [Research Project Series, Subject Interview Study]). Another respondent with breast cancer stated plainly that she, as someone without health insurance, had enrolled in research to get treatment and "didn't have to worry about trying to pay something back later on" (Subject No. 335216-8, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 27 March 1995, lines 30-33 [Research Project Series, Subject Interview Study]).

48 . Subject No. 335227-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 March 1995, lines 47-48 (Research Project Series, Subject Interview Study).

49 . Subject No. 333256-6, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 16 March 1995, lines 332-333 (Research Project Series, Subject Interview Study).

50 . Subject No. 221240-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 15 March 1995, lines 359-370 (Research Project Series, Subject Interview Study).

51 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 407-409 (Research Project Series, Subject Interview Study). Another respondent had a similar response: "[T]o me they are the doctors and once I had gotten those doctors and I trusted them. It was pretty much up them. I wanted to know what I was going to be going through as far as what to expect . . . physically . . . [b]ut a lot of the little nitty-gritty detail, I did not even want to know" (Subject No. 114250-4, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 10 March 1995, lines 274-283 [Research Project Series, Subject Interview Study]).

52 . Subject No. 332324-3, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 24 March 1995, lines 156-161 (Research Project Series, Subject Interview Study).

53 . Subject No. 441204-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 8 March 1995, lines 171-172 (Research Project Series, Subject Interview Study).

54 . Subject No. 552365-9, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 399-401 (Research Project Series, Subject Interview Study).

55 . There were a number of people who said that the written material was difficult to read: "I read some of the literature and it didn't mean a hill of beans to me because I didn't know anything about medical science . . . but . . . like I say, if it's to help me, I'll go in . . ." (Subject No. 332324-3, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 24 March 1995, lines 189-192 [Research Project Series, Subject Interview Study]). One respondent drew attention to the overly technical language used in forms: "You kind of think, 'Hmmmm. What do these things really mean?'. . . [You hear that] your follicles might fall. . . . you're thinking, 'follicles fall?' My hair . . . [T]hey're slick at . . . [how] they present stuff . . . " (Subject No. 335213-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 742-748 [Research Project Series, Subject Interview Study]). A few patients said the forms were unnerving: "[I]t'd be more reassuring for the person . . . that's going to be involved in the research to receive some positive, more positive language in the protocol itself. . . . [C]ertainly in a way it's good that they let you know these things. . . . on the other hand, it just scares people sometimes" (Subject No. 335227-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 24 March 1995, lines 89-92, 114-116 [Research Project Series, Subject Interview Study]).

56 . One respondent noted that cancer patients such as herself receive a deluge of technical information to digest: "We were sorta bombarded with information and I just made my mind up at that one appointment to go with the study" (Subject No. 443311-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 February 1995, lines 212-214 [Research Project Series, Subject Interview Study]). Another replied, "[T]hey do give you all the available information, almost too much, because you can't absorb it all at once, and I brought home all these little books and the books are good and you just get sick of it . . ." (Subject No. 333250-9, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 8 March 1995, lines 84-87 [Research Project Series, Subject Interview Study]).

57 . One respondent, approached in his hospital room the night before scheduled brain surgery to consider enrolling in a clinical trial for anesthesia, felt that the timing of consent was poor: ". . . I felt the timing could have been a little better, because I was . . [I]t might have been better a day earl[ier] . . ." (Subject No. 442107-9, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 29 March 1995, lines 155-157, 174-175 [Research Project Series, Subject Interview Study]).

58 . One respondent who spoke only broken English reported that she relied upon her husband to gather and make sense of information that staff relayed about her therapeutic research project.

59 . Subject No. 114229-8, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 14 March 1995, lines 481-486. Similarly, another respondent argued that "it's important that the people who are on the protocol talk," particularly since in this forum participants can more quickly exchange information about what "is going to happen. . . . " Talking can convey the information "quicker than if it's on a piece [of paper] . . ." (Subject No. 335213-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 1403-1404, 1417-1420 [Research Project Series, Subject Interview Study]).

60 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 27-29. Even when some patients noted that a doctor's recommendation had influenced them, they did not construe this as "pressure": "[D]on't misunderstand me, [my doctor] didn't influence me in [any] way . . . [but] he thought it would be a good program for my type of cancer" (Subject No. 552126-5, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 13 March 1995, lines 125-127 [Research Project Series, Subject Interview Study]). Another respondent noted that she thought that the staff wanted her to enroll, "but they [were] not pushing anything" (Subject No. 113122-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 11 March 1995, line 462 [Research Project Series, Subject Interview Study]).

61 . Subject No. 552126-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 13 March 1995, lines 102-105 (Research Project Series, Subject Interview Study).

62 . Subject No. 223201-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 13 March 1995, lines 136-138 (Research Project Series, Subject Interview Study).

63 . Subject No. 335213-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 28 March 1995, lines 687-700 (Research Project Series, Subject Interview Study). Another respondent, who did not remember signing a consent form reported, the doctor "just recommended me to go [on the drug]" (Subject No. 441311-8, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 63 [Research Project Series, Subject Interview Study]). Another respondent reported that although she did not recall signing a consent form, she later discovered that she had. One procedure to which she had consented in written form was not something she wanted to go through, however. This respondent explained the confusion in part to the fact that she . . . "never thought about the study" . . . because she was worried about . . . "[having] to be cut again . . ." (Subject No. 443226-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 16 March 1995, lines 246-255, 348-361, 446-448 [Research Project Series, Subject Interview Study]).

64 . Subject No. 223212-2, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 16 March 1995, lines 195-200 (Research Project Series, Subject Interview Study).

65 . Subject No. 552143-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 15 March 1995, lines 205-208 (Research Project Series, Subject Interview Study).

66 . Subject No. 333208-7, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 6 March 1995, lines 250-252, 256-257, 260-261 (Research Project Series, Subject Interview Study).

67 . This respondent described that others in the study had been "on orders to leave here" (i.e., to go to another military base), . . . and were "not allowed to [leave]. The doctor told them that they could not . . . [and] . . . had the orders changed because they were enrolled in an intense medical program research program" (Subject No. 333301-0, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 9 March 1995, lines 779-783 [Research Project Series, Subject Interview Study]).

68 . The respondent went on to identify sources of overt and covert pressure for him to remain in the trial: "[T]he response was kind of like trying to convince me to just finish it up and that was always the response, anytime I had reservations there was somebody there to . . . talk about those reservations, but in the course of doing it really trying to convince me that it's ok[ay]. . . . " The respondent also said, "When they asked for a bone marrow biopsy I said I'm not gonna do it, so I just dropped out at that point, and she says, you know if we don't do that then I mean, it's not valid . . . it defeats all those days . . ." (Subject No. 551334-6, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 14 March 1995, lines 303-305, 326-328, 330-332, 562-566, 652-656, [Research Project Series, Subject Interview Study]).

69 . Subject No. 553215-5, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 10 March 1995, lines 96-99, 205-206. Another respondent explained, ". . . I knew that I could stop at any point and time. I was aware of that . . . I knew that I could, but I didn't have anything else . . . I didn't know what stopping was going to do either . . . then I thought well, if I stop, what do I do[?]" (Subject No. 334110-4, interview by Subject Interview Study staff [ACHRE], transcript of audio recording, 28 March 1995, lines 483-488 [Research Project Series, Subject Interview Study]).

70 . Subject No. 552143-0, interview by Subject Interview Study staff (ACHRE), transcript of audio recording, 15 March 1995, lines 37-38, 217-218 (Research Project Series, Subject Interview Study).