Table 2.
Coding for Elements of Consent
| Element of Consent | n= | % agree |
Definition | Example |
|---|---|---|---|---|
| Purpose | 54 | 92.6 | A statement of the scientific question of the research (NIH, 2008). |
And I’ll go through one of the research studies we’re doing here, trying to figure out some new ways to mix and match. |
| Risks | 56 | 80.4 | A statement of the probability and magnitude of harm or discomfort that may arise from participating in research (45 CFR 46, 2005/1999), including both side effects and negative outcomes (NIH, 2008). |
The consent form has all the information that is about the trial, what the drug is, why we are using it, and what its potential side effects are. Or if it’s [the tumor] against the blood vessel and the blood vessel can rupture, so that’s always a small risk. It’s a small risk with Gleevec, it’s been a small risk with this [experimental drug]. |
| Benefits | 59 | 88.1 | A statement of the direct benefits to the patient, including access to the treatment, care, and education patients receive on the trial, as well as their feelings of autonomy and altruism derived from participating in the research; a statement of indirect benefits to others or society, including the likely importance of the scientific knowledge resulting from the clinical trial (NIH, 2008). |
And, um, it’s one pill a day and … the … early information that we have is that the combination-- th-this combination might be one and a half or two times more effective than the older one that I was telling you about. OK. PH: But the information that’s derived will go on to further help medical research -- PT: And other people. PH: -- may be able to help others in the future know if there’s a difference or not. |
| Alternatives | 43 | 83.7 | Disclosure of appropriate alternative treatments, if any, that might be advantageous to the patient (45 CFR 46, 2005/1999). |
So among the drugs that we can give to you there are three options. Either the standard chemotherapy drugs, which have a ten to fifteen percent chance of working. And they are—they could have some potential side effects. The second option is to try one of the newer, more selective drugs … which has the same probability of working, same chance it works but [is] easier to take. |
| Vol. Part. | 42 | 92.8 | A statement that participation is voluntary (45 CFR 46, 2005/1999). |
This is also voluntary. And if you decide either now or later that you don’t wanna participate we’ll still take care of you, we’re not gonna chase you away for it. |
| Total | 254 | 87.4 |