Informed Consent and Clinical Trials

NCT01635842 | Completed

• 2 other identifiers: 11073Informed Consent Project
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To understand the patients' meaning of the informed consent process in clinical trials. Objective of the study is:

• to assess, in a cohort of subjects included in clinical trials, whether the information and the informed Consent Forms conveyed to the patients have been understood
• to assess whether the choice to participate in a clinical trial is informed and aware

Conditions

Informed Consent

Keywords

Patient; information leaflet; informed consent; awareness

Outcome Measures

Primary Outcomes (4)

• Therapeutic misconception cases among participants

  The question N° 18 has 4 answers. The patients who will answer "yes, for sure" will be considered cases of "therapeutic misconception". The study is qualtative. The assessment needs a multidimensional evaluation through many primary outcomes.

  From the 31st to the 40th day since the ICF signature of the clinical trial

• Time required to release the informed consent signed

  The question N. 7 wants to verify the time passed between the release of information by the investigator and the signature of the informed consent (Less than 1 hour, more than 1 hour, more than 1 day, more than 1 week).

  From the 31st to the 40th day since the ICF signature of the clinical trial

• Understanding of the possibilities / alternatives to experimental therapy

  The questions N. 15 and N. 16 want to verify the awareness of possible alternatives to the experimental therapy.

  From the 31st to the 40th day since the ICF signature of the clinical trial

• Comprehension of the significance of the informed consent

  The question N. 11 want to verify the patient's awareness about the significance of the informed consent.

  From the 31st to the 40th day since the ICF signature of the clinical trial

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects or legal representatives (care givers, parents) who have signed the ICF during the last 30 days for participation in an interventional clinical trial

You may qualify if:

• subjects or legal representatives (care givers, parents) who have signed the IC during the last 30 days for participation in an interventional clinical trial
• release an authorization to be contacted by the Ethics Committee of AUSL Bologna.
• able to read Italian

You may not qualify if:

• subjects enrolled in observations studies
• not release of authorization to be contacted by the Ethics Committee

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Ethics Commitee AUSL of Bologna

Bologna, Bologna, 40100, Italy

Location

Study Officials

• Paola Mosconi, Biology

  Ethics Committee AUSL of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 3, 2015

Record last verified: 2015-03

Locations

IT (1)