Basics of Informed Consent (Part 1). Paula Bistak, DMH, RN, MS, CIP, CHRC Executive Director, HSPP Donna Hoagland, LPN, BS, CIP, CCRC, CHRC IRB Director, New Brunswick/Piscataway and Stratford/Camden Carlotta Rodriguez, BS, CIP, CHRC IRB Director, Newark Campus IRB
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Paula Bistak, DMH, RN, MS, CIP, CHRC
Executive Director, HSPP
Donna Hoagland, LPN, BS, CIP, CCRC, CHRC
IRB Director, New Brunswick/Piscataway and Stratford/Camden
Carlotta Rodriguez, BS, CIP, CHRC
IRB Director, Newark Campus IRB
Cheryl Forst, RN, BSN, CCRP
HSPP Analyst Director
Christine Asmann-Finch, DMH, MS
Program Development Specialist/Medical Humanist
* Ethical and Regulatory Aspects of Clinical Research
45 CFR 46.116 Common Rule
21 CFR 50. 25 FDA
ICH E-6 Section 4.8.10 (GCP)
Informed consent is a process, not just a signed document.
If the study is a clinical trial, the following must be included:
"A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time."
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
Privacy & Confidentiality :
Source Documents :
45 CFR 46.116
10. Subject signature and person obtaining consent on different dates
9. Subject consented with wrong version of consent/expired consent
8. Subject consented by individual not named on the IRB protocol
7. Check boxes within consent incomplete (future use of samples)
6. Crossed out or white out anywhere on the consent document
5. Unable to locate consent(s) for subject(s) on study
4. Subjects not re-consented with revised consent
3. Ineligible subjects enrolled
2. Wrong contact telephone number listed in consent
1. Copy of the consent document NOT provided to the subject
What terms and ways of writing are difficult to comprehend?
What does participation mean in the context of a person’s life?
Key Concepts, Procedures & Rights
Health & Research Literacy
“Experiment”, “research”, “new treatment”, “study”, “investigation”
“We are experimenting with this drug to determine if it will lengthen time to disease progression.”
“Some ‘side effects’ of the experimental drug are…”
“We would like to keep track of your medical condition for x years.”
“You can withdraw from the clinical trial at any time.”
Active v Passive verbs: “Improving the Treatment of Disease X with Drug Y” v “Drug Y in the Treatment of Disease X”
Point of View Phrases