Table 12.7 Information to be provided to study subjects before obtaining consent to participate
in clinical studies
The information sheets and consent forms should contain the following items:
1.Information about the consent procedure:
Consent to be given by the study subject’s free will
Adequate time (which should be defined in advance in the protocol) must be allowed for the study
subject to decide on participation in study
Adequate time must be allowed to ask questions
Statement that participation is entirely voluntary
Statement that refusal to participate will involve no penalties or loss of usual benefits
Description of circumstances under which participation would be terminated
Right to withdraw at any time without prejudice or consequences
Study subject is allowed to keep the written explanation (information sheet and consent form) for future
reference
2.Information about the study and medications/devices:
Instructions on use and storage of study medication/device, if relevant
Name of sponsor/CRO
Explanation that the study is a research procedure
Description of study type and research aims
Description of study medications/devices
Description of procedures to be followed
Description of experimental procedures to be followed, if any. Experimental procedures might include
those which are not normally used for the presentation under consideration or procedures which are new or
have never been used before
Comparator treatments (including placebo) described. It is important to explain ‘placebo’ in simple terms
Randomization procedures. Randomization is not easily understood by many subjects and should also be
explained in simple terms
Expected duration of participation
Required number of visits
Reason for selection of suitable subjects
Approximate number of other study subjects participating in the study
3.Information about the risks/benefits:
Foreseeable risks, discomforts, side effects and inconveniences
Known therapeutic benefits, if any. The benefits must not be ‘oversold’
Availability of alternative therapies. If there are other treatments, this must be explained so that the subject does
not feel the new treatment is the only option
Any new findings, which might affect the safety of the study subject, and that become available during
participation in the study, will be disclosed to the study subject
Assurance of compensation for treatment-induced injury with specific reference to local guidelines (it must
not be expected that the study subject is familiar with the guidelines, and therefore the guidelines must be
explained and/or attached)
Terms of compensation
Measures to be taken in the event of an AE or therapeutic failure
Financial remuneration, if any. Patients, whether receiving therapeutic benefit or not, are not usually paid for
participation in clinical research, except for incidentals such as travel costs. Healthy volunteers are usually paid a
fee for participation, but this payment should never be offered to induce the prospective subjects to take risks they
would not normally consider
Explanation of additional costs that may result from participation, if any (this normally only occurs in the United
States)
(continued)12.4 MONITORING AND SAFETY ASSESSMENT 147