17 
Dr. W&lters called the attention of the working group to Section I-D, Informed 
consent , of the points to consider document. 
Ms. Witherby felt the points in this section of the document should be statements 
rather than questions. Dr. Anderson felt this section of the document should 
be in the form of questions; individuals involved in clinical studies perform 
these types of activities as a matter of course. Mr. Mitchell said the working 
group would like to ensure, however, that this information is given to the 
patient. 
Mr. Capron suggested the points in this section be questions but suggested they 
be prefaced by the ward "hew." The working group agreed to modify Sections 
I-D-l and I-D-2 by adding the word "how." 
Mr. Capron felt Section I-D-5 should be a declarative sentence. He thought 
specific language should draw attention ‘to the working group's concern about 
the periods vhen the patient could withdraw from the protocol. Dr. Temin said 
the points to consider document should permit the investigator to discourage 
subjects fran withdrawing from the protocol. Dr. Anderson suggested these 
important concepts be stated at the beginning of the section dealing with 
informed consent. 
Mr. Capron said moral determination clauses exist, but the investigator has no 
means of forcing people to abide by an informed consent agreement even if a 
contract exists. Nonetheless, the investigator should convey to the patient 
the difficulty or danger of withdrawing fran the study. The investigator 
might discuss vhy it would be difficult or inadvisable to withdraw fran the 
study, and convey to the patient and guardians the moral responsibility the 
patient assumes in becoming part of these research protocols. 
Dr. McCarthy said the consequences of withdrawing from a research protocol 
should be explained with moderation to the patient and the guardians. These 
consequences could be to the individual, to the institution, or to society as a 
vhole . 
Dr. Mot ul sky suggested the investigator should have the option of presenting 
this type of information to the patient. 
Mr. Capron said the points to consider document could ask the investigator 
vhat information would be given to the subject on the topic of withdrawing 
fran the protocol. 
Dr. Mahoney said most current informed consent forms used with research protocols 
explicitly state these considerations. Pie said generally in clinical care, 
patients withdraw from care at their own risk. 
Ms. Witherby suggested the following language be included in the points to 
consider document to read: "How will patients and/or their parents or guardians 
be informed of their right to withdraw from the proposed study, or the possibility 
that at certain times it will be medically inadvisable to withdraw." 
[102] 
