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Informed Consent Considerations . Office for the Protection of Research Subjects (OPRS) June 28, 2006. OPRS: Who we are…. Who we are…. Director, Michele Russell-Einhorn (9/05) Deputy Director, Amanda Hammond (10/05) Five new positions during our time Part-time oncologist (5/06)
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Informed Consent Considerations Office for the Protection of Research Subjects (OPRS) June 28, 2006
Who we are… • Director, Michele Russell-Einhorn (9/05) • Deputy Director, Amanda Hammond (10/05) • Five new positions during our time • Part-time oncologist (5/06) • Consultants • 23 total staff
OPRS: Who we are… • Systems Administration Team • Pre-Review Team • Post-Activation Team • On-Line/Communications Team
OPRS: Institutions we work with… • DF/HCC Member Institutions: • Beth Israel Deaconess Medical Center • Brigham and Women’s Hospital • Children’s Hospital Boston • Dana-Farber Cancer Institute • Harvard Medical School • Harvard School of Public Health • Massachusetts General Hospital • Affiliated Institutions
What We Do… • OPRS receives the protocols from the time the disease leader signs off on the protocol until the time the first subject can be enrolled. • OPRS is functioning as the clinical trials office for the DF/HCC. Research is refined and developed throughout the processes managed and coordinated by OPRS.
What we do in a nutshell… • New Protocols • Amendments • Adverse Events • Deviations/Violations/Exceptions • Continuing Reviews • Single Patient IND requests • Posting to OncPro
What we do… • Manage three scientific review committee meetings a month • two adult SRC meetings • one pediatric SRC meetings • Manage eight IRB meetings a month • two Panel A meetings • two Panel B meetings • two Panel C meetings • two Panel D meetings
What we do… • Manage protocol approval to activation through all DF/HCC institutions • Coordinate review of protocols with institutional offices such as pharmacy, nursing, bio-stat, radiation, pathology, cell manipulation, at all five institutions
OPRS Statistics • November 1-30, 2005 • 32 new protocols received • 111 continuing reviews • 289 amendments • 50 internal adverse events • 160 deviation reports • 300+ IND safety reprots TOTAL = 900+ action items
2004 New protocols: 394 Deviations: 1267 Amendments: 2180 Continuing Reviews:1208 Conditional Approvals: ? Adverse Events:2568 2005 New protocols:457 Deviations:1836 Amendments:3114 Continuing Reviews:1400+ Conditional Approvals:? Adverse Events: 4000+ OPRS Statistics: 2004-2005
New Initiatives • Revised model consent for biomedical research • First model consent for social and behavioral research • OPRS Information Sheets (single patient INDs, repository research, etc.) • Open office hours on Mondays for new staff
Additional New Initiatives include: • Ownership of the OPRS website • OPRS Alerts • OPRS News • Revision of all OPRS forms (in progress) • Revision of IRB Manual and the Guide to Human Research
Regulatory Requirements • Federal Policy for the Protection of Human Subjects (56 FR 2008) • DHHS Protection of Human Subjects (45 CFR Part 46) • FDA Regulations (21 CFR Part 50 –Protection of Human Subjects; 21 Part Part 56-Institutional Review Boards)
Informed Consent • 45 CFR Part 46.116 General requirements for informed consent. • “Except as provided elsewhere by this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.”
Informed Consent[45 CFR Part 46] • “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
Informed Consent [45 CFR Part 46] • “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”
Informed Consent [45 CFR Part 46] • “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.”
Eight Required Elements[45 CFR 46.116(a) & 21 CFR 50.25] • Statement that study is research and information on purposes / duration / procedures / experimental procedures • Reasonably foreseeable risks or discomforts • Reasonably expected benefits • Alternative procedures • How confidentiality will be maintained
Eight Required Elements[45 CFR 46.116(a) & 21 CFR 50.25] • Information on compensation for injuries (unless minimal risk) • Contact persons for information on research, injury, subject’s rights • Voluntary participation, no penalty or loss of benefits for refusal or withdrawal
Six Additional Elements • Statement that there may be risks which are unforeseeable • Under what circumstances investigator could terminate subject’s participation • Additional costs to subjects • Consequences of subject’s withdrawal from research • Statement that will be told of new findings • Approximate number of subjects in study
Informed Consent • There is no such thing as “passive consent” • Consent is required unless formally waived • Documentation is required unless formally waived • There is no such thing as “secondary subject” • If an investigator obtains “identifiable private information” about a living individual, the individual is a human subject, regardless of the sources • Deception Research • Requires a formal waiver of consent
Informed Consent Document and Risks to Subjects • Adverse events vs. unanticipated problems • A risk or problem is unanticipated if it is not in the protocol or consent document • Risks discussed in the protocol should be included in the consent document • Questions raised as a result of an unanticipated risk: • Does the informed consent form need to be amended? • Do previously enrolled subjects need to be re-consented? • Does a report need to be made to any government office?
Waiver of Informed Consent(not permitted in FDA-regulated studies) • IRB must find and document that four (4) criteria have been satisfied: • Minimal risk research • Waiver or alteration will not adversely affect the rights and welfare of the subjects • Research could not practicably be carried out without the waiver or alteration • Subjects will be provided with additional pertinent information
Documentation of Informed Consent • Written consent document • Language understandable to the subject or the subject’s Legally Authorized Representative (LAR) • Signed by subject or subject’s LAR • Copy SHALL be given to subject • Opportunity to read before signing
Documentation of Informed Consent (short form) • Short form written consent document requires: • Oral presentation • Witness to oral presentation • An IRB approved written summary • Given to subject • Signed by witness • Signed by person obtaining consent • Short form documenting oral presentation • Signed by subject or LAR • Signed by witness
Waiver of Documentation of Informed Consent(not permitted in FDA-regulated studies) • Signed consent document provides the only link to the subject’s identity and principal risk is breach of confidentiality • Research presented no greater than minimal risk of harm to subjects and involves no procedures requiring consent in a non-research context • IRB may require a subject information sheet
Model Consent Template:Biomedical Research • Located at: http://www.dfhcc.harvard.edu/clinical-research-support/office-for-the-protection-of-research-subjects-oprs/investigator-resources/
Model Consent Template:Social and Behavioral Research • Located at: http://www.dfhcc.harvard.edu/clinical-research-support/office-for-the-protection-of-research-subjects-oprs/investigator-resources/
Common Findings:Substantive Issues • Benefits of the research are over-stated • Not all the objectives set out in the protocol are set out in the consent form • The alternatives section does not describe specifically other drugs that could be used to treat subject’s cancer
Common Findings:Substantive Issues • Cost section does not specifically state what subjects will have to pay for • Section describing what procedures are involved in the research is too complicated • No clear line between screening procedures and the study procedures
Common Findings:Substantive Issues • Procedures do not accurately describe all relevant issues – for example: • Consent may state that 1 teaspoon of blood will be drawn but the consent does not continue to state that this will happen 9 times over the course of two days
Common Findings:Substantive Issues • Certain procedures are stated as optional (e.g., optional blood draws), but there is no optional signature line for the subjects at the end of the consent form • Risks are duplicated • Risks are not complete
Common Findings:Substantive Issues • Consent contains exculpatory language, for example: • We will not compensate you unless it is proven that your injury is the result of negligence • The sponsor will be the sole owner of the specimens and you give up any and all commercial rights to any developments resulting from this research
Common Findings:Formatting Issues • Orphan headings • Schemas are not formatted to fit one page • Tables run across more than one page without repeating the column headings • Fonts are not consistent throughout • No header and/or footer
Recommendations • Use the most current version of the model consent (available at the OPRS website) as your starting document. • Follow the instructions and guidance in the document • As you complete the procedures and risks section, think about the end user – the subject! Will the language make sense to someone who is not in the medical profession?
