Institution Newsletter Volume 2, Issue 1
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The document discusses challenges faced by U.S. researchers in initiating clinical trials, highlighting regulatory burdens and institutional oversight that hinder research effectiveness. It also outlines new draft guidance from the FDA and OHRP concerning exculpatory language in informed consent, indicating a shift in policy regarding subjects' rights over biospecimens. Quorum Review emphasizes its commitment to ethical review and adapting its practices in light of these changes while encouraging communication for any assistance needed.
![February 24, 2012 | Volume 2, Issue 1
New Draft Guidance on “Exculpatory Language” from FDA and OHRP
On August 19, 2011, OHRP and FDA issued a joint Draft Guidance document: “Guidance on Exculpatory Language in
Informed Consent.” When finalized, the Guidance will replace guidance on this topic from both OHRP2 and FDA3.
The Draft Guidance provides an updated interpretation of the regulatory restriction on “exculpatory language” in informed
consent documents.4 The Draft Guidance specifically addresses the issue of a subject’s rights with respect to a biospecimen
provided for research purposes, stating: “a subject’s waiver of any rights…with respect to a biospecimen…would not be
exculpatory.” This conclusion is based on two factors: (1) the practice of not compensating research subjects who provide
biospecimens for research purposes, and (2) the absence of federal or state laws or policies that recognize a legal right to
compensation if a subject has voluntarily signed an informed consent form stating they would not be paid for biospecimens.
The position is a departure from previous guidance documents, which will be replaced when this Draft Guidance is
finalized. The 1998 Frequently Asked Questions Guidance from FDA advised that it was acceptable “for [a] consent to say
that specimens are to be used for research purposes” but not to say that they were donated because “the word ‘donation’
implies abandonment of rights to the property [and] 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive
any rights as a condition for participation in the study.”5 The 1996 Guidance from OHRP took the same position with
respect to sample ownership, providing the following examples of “exculpatory” language:
By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.
I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and
interest to said items.
By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the
research.6
In contrast with the position taken in the previous guidance documents, the Draft Guidance provides several examples of
“acceptable language” as follows:
By agreeing to this use, you are giving up all claims to any money obtained by the researchers from commercial or other use of these specimens.
I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] and hereby relinquish all property
rights, title, and interest I may have in those samples.
By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples collected during this
research.7
Quorum Review’s practice, based on the existing guidance, has been to modify language that explicitly or implicitly
indicated subjects were “donating” samples or otherwise giving up ownership rights with respect to samples. Given the
updated interpretation of “exculpatory language”, Quorum Review anticipates making a change to our policies. Quorum
Review will not make a formal change until the Final Guidance is issued; however, please feel free to contact us with
questions about consent language addressing sample ownership in the interim. Questions can be addressed to your study
manager or sent to our Site Support Team at sitesupport@quorumreview.com.
2
Exculpatory Language in Informed Consent, OHRP (November 15, 1996).
3
Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).
4
45 CFR 45.116 and 21 CFR 50.20 state: “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.”
5
Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).
6
Exculpatory Language in Informed Consent, OHRP (November 15, 1996).
7
Draft Guidance, Guidance on Exculpatory Language in Informed Consent, DHHS (August 19, 2011).](https://image.slidesharecdn.com/institution-newslettervolume2issue1-120502123531-phpapp02/85/Institution-Newsletter-Volume-2-Issue-1-2-320.jpg)
Institution Newsletter Volume 2, Issue 1
- 1. The Quorum Review: Institutional Edition Letter from the CEO How can we help each research site initiate clinical trials as effectively as possible? A recent article by researchers at Duke University1 concludes that U.S. researchers face impediments from many sources, including: Aging regulations Broad risk management by trial sponsors Layers of oversight by institutions Health system incentives that do not favor research The researchers describe the current clinical trials process as “unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing treatments.” As this article makes clear, there is no easy fix to streamline the clinical trials process. Even so, here at Quorum Review we will continue to do our small part – to provide ethics review carefully, promptly, accurately and courteously. To help you with your mission, we’ve enclosed several articles regarding the ethics review of proposed clinical research. Please contact us if we can be of additional assistance. Sincerely, Cami Gearhart, CEO Quorum Review IRB 1 Kramer, Smith & Califf, Impediments to Clinical Research in the United States, Clinical Pharmacology & Therapeutics (February 2012), http://www.nature.com/clpt/journal/v91/n3/full/clpt2011341a.html
- 2. February 24, 2012 | Volume 2, Issue 1 New Draft Guidance on “Exculpatory Language” from FDA and OHRP On August 19, 2011, OHRP and FDA issued a joint Draft Guidance document: “Guidance on Exculpatory Language in Informed Consent.” When finalized, the Guidance will replace guidance on this topic from both OHRP2 and FDA3. The Draft Guidance provides an updated interpretation of the regulatory restriction on “exculpatory language” in informed consent documents.4 The Draft Guidance specifically addresses the issue of a subject’s rights with respect to a biospecimen provided for research purposes, stating: “a subject’s waiver of any rights…with respect to a biospecimen…would not be exculpatory.” This conclusion is based on two factors: (1) the practice of not compensating research subjects who provide biospecimens for research purposes, and (2) the absence of federal or state laws or policies that recognize a legal right to compensation if a subject has voluntarily signed an informed consent form stating they would not be paid for biospecimens. The position is a departure from previous guidance documents, which will be replaced when this Draft Guidance is finalized. The 1998 Frequently Asked Questions Guidance from FDA advised that it was acceptable “for [a] consent to say that specimens are to be used for research purposes” but not to say that they were donated because “the word ‘donation’ implies abandonment of rights to the property [and] 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation in the study.”5 The 1996 Guidance from OHRP took the same position with respect to sample ownership, providing the following examples of “exculpatory” language: By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances. I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items. By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.6 In contrast with the position taken in the previous guidance documents, the Draft Guidance provides several examples of “acceptable language” as follows: By agreeing to this use, you are giving up all claims to any money obtained by the researchers from commercial or other use of these specimens. I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] and hereby relinquish all property rights, title, and interest I may have in those samples. By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples collected during this research.7 Quorum Review’s practice, based on the existing guidance, has been to modify language that explicitly or implicitly indicated subjects were “donating” samples or otherwise giving up ownership rights with respect to samples. Given the updated interpretation of “exculpatory language”, Quorum Review anticipates making a change to our policies. Quorum Review will not make a formal change until the Final Guidance is issued; however, please feel free to contact us with questions about consent language addressing sample ownership in the interim. Questions can be addressed to your study manager or sent to our Site Support Team at sitesupport@quorumreview.com. 2 Exculpatory Language in Informed Consent, OHRP (November 15, 1996). 3 Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998). 4 45 CFR 45.116 and 21 CFR 50.20 state: “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.” 5 Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998). 6 Exculpatory Language in Informed Consent, OHRP (November 15, 1996). 7 Draft Guidance, Guidance on Exculpatory Language in Informed Consent, DHHS (August 19, 2011).
- 3. February 24, 2012 | Volume 2, Issue 1 method for maintenance of confidentiality of data The Importance of Addressing Local language(s) understood by prospective subjects Research Context method for minimizing the possibility of coercion or undue influence in seeking consent, and, safeguards to protect the rights and welfare of vulnerable An important consideration for the IRB is commonly subjects10 referred to as the “local research context.” Local research The OHRP memorandum includes a number of methods context may include community attitudes towards research, by which an IRB may obtain necessary information, the literacy rate, subject recruitment, or other community including personal knowledge of the research context by factors, such as: geographic, socioeconomic, gender, one or more IRB members, consultants, and an exchange of cultural, and moral backgrounds of the proposed human information between the IRB and the research site. subject population. Quorum Review IRB recognizes the importance of the local In January, 2010, the Office for Human Research research context for institutions. We have incorporated a Protections (OHRP) withdrew two policy documents number of steps within our standard process to obtain suggesting that OHRP favored local IRB review over review knowledge about the research context in your community. by a non-local IRB.8 OHRP has clarified that it no longer Quorum solicits information about the local population, holds this position.9 Although OHRP’s policy has shifted, site privacy and confidentiality practices, and local laws and the reviewing IRB, whether local or central, still must requirements from investigators on our required obtain appropriate knowledge of the local research context. submission forms. In addition, Quorum maintains information about unique local requirements related to The OHRP policy memorandum “IRB Knowledge of Local research, such as state law, or institution-specific Research Context” outlines the necessary information an requirements. Quorum’s IRB members come from a variety IRB should obtain as follows: of backgrounds, professions, and geographic regions. If needed, our specialty consultants are available to field the anticipated scope of the institution's research activities questions for the IRB members regarding specific scientific the types of subject populations likely to be involved and local context issues. the size and complexity of the institution institutional commitments and regulations For further information or to obtain a copy of Quorum’s applicable law Institutional Start-Up Package, please contact Quorum’s standards of professional conduct and practice Business Development Team at method for equitable selection of subjects busdev@quorumreview.com. method for protection of privacy of subjects 8 (Archived) OPRR Policy Memorandum, Local Institutional Review Board (IRB) of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) Nat’l Institute of Allergy and Infectious Diseases (NIAID), Sept.13,’93,, http://www.hhs.gov/ohrp/archive/humansubjects/guidance/hsdcsep93.htm (Archived) OPRR Policy Memorandum, Local IRB Review of Multicenter Clinical Trials, Nov.9, ‘92, 93-01, http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-01.htm. 9 10 OHRP April 30, 2010 Response, Use of a Central Institutional Review Board, OPRR Policy Memorandum, IRB Knowledge of Local Research Context, August 27, 1998 (updated http://www.hhs.gov/ohrp/policy/Correspondence/mcdeavitt20100430letter.html 2000), http://www.hhs.gov/ohrp/policy/local.html