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BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

18 Years
Open (Enrolling)
Cancer, Oncology Problem

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Trial Information

BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

Obtaining informed consent as part of a clinical study is a cornerstone of current day
medical ethics; however, this has not always been the case. The development of the informed
consent has been necessitated out of abuses committed in the name of medicine.

Informed consents have become increasing lengthy and complex. It is not unusual for an
Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will
utilize the QuIC-A survey to evaluate patient understanding of the basic elements of
informed consent required by federal regulations. The QuIC-A survey has been condensed from
20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining
14 questions are designed irrespective of phase and address the basic elements of informed

Investigators hypothesize that as informed consents have become more lengthy and
complicated, in part due to required regulatory language and legal clauses inserted to
protect the institution performing research, patient comprehension of the basic elements of
informed consent has been hindered.

Inclusion Criteria:

- Patients > 18 years of age

- Patients are receiving active treatment on an oncology clinical trial that utilizes
chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy

- Patients must have been consented in English to an oncology treatment clinical study

Exclusion Criteria:

- Not meeting all eligibility criteria

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Understanding of all elements of informed consent via questionnaire

Outcome Description:

Comprehension of the important elements of the informed consent forms using questionnaire

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Andrew Schumacher

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • Oncology Problem
  • questionnaire
  • prior therapy
  • prior study volunteer
  • prior study patient
  • cancer
  • oncology



Rhode Island Hospital Providence, Rhode Island  02903
The Miriam Hospital Providence, Rhode Island  02903