Table 3 Awareness points and recommendations for communication in relation to type of research

Randomized Controlled Trials (RCT)

Confidentiality and privacy

The potential for a therapeutic

misconception:

- differences between clinical research

and standard care

- potential conflict between research

and treatment goals

Consent to treatment does not imply

consent to an RCT

Provide information about collection of data and measures

taken to protect confidentiality and privacy.

Clarify how the physician-investigator/patient-subject

relationship differs from the traditional physician-patient

relationship.

Mention alternatives to research participation explicitly.

Discuss clinical and parental equipoise.

Mention voluntariness.

Indicate research interventions that are solely

performed to measure trial outcomes.

Assure freedom to withdraw from the study.

Discuss research participation with subjects

before, during and after the study.

Ask explicit consent with a separate consent form than the

consent form for treatment. Ask consent for treatment first,

and for research later, preferably by a different person than

the treating physician, for example a research nurse (with the

opportunity to consult with the treating physician)

Clinical Controlled Trial (CCT)

Confidentiality and privacy

Consent to treatment does not imply

consent to collect patient data

Provide information about collection of data and measures

taken to protect confidentiality and privacy.

Ask explicit consent with a separate consent form than the

consent form for treatment. Ask consent for treatment first,

and for research later, preferably by a different person than

the treating physician, for example a research nurse (with the

opportunity to consult with the treating physician)

Laboratory research using tissue from patients

Confidentiality and privacy

No therapeutic goal; completely distinct

from therapeutic interventions

The obligation of non-maleficence in this

setting differs from that in clinical

medicine

Consent to treatment does not imply

consent to using or storing human

tissues for research purposes

Provide information about collection of data and measures

taken to protect confidentiality and privacy.

Mention voluntariness.

Indicate that all research interventions to gain tissues are

solely performed to gain scientific knowledge.

Indicate that risks to a patient are justified not because they

are outweighed by potential benefits to the patient, but

because they are outweighed by the value of the knowledge

to be gained from the research.

Ask explicit consent with a separate consent form than the

consent form for treatment. Ask consent for treatment first,

and for research later, preferably by a different person than

the treating physician, for example a research nurse (with the

opportunity to consult with the treating physician)