Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration

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Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Grace Gartel, Heather Scuderi, Christine Servay
Ochsner Journal, March 2020; 20(1) pp 76–80
Open Access
Abstract
Background
The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.
Methods
This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.
Results
Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.
Conclusion
Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.

Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal.

Revised Common Rule Changes to the Consent Process and Consent Form

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Revised Common Rule Changes to the Consent Process and Consent Form
Leah L LeCompte, Sylvia J Young
Ochsner Journal, March 2020; 20(1) pp 62-75
Open Access
Abstract
Background
The Federal Policy for the Protection of Human Subjects—the Common Rule—was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process.
Methods
We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non–federally funded studies.
Results
Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects’ understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation.
Conclusion
The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.

Understanding Broad Consent

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Understanding Broad Consent
John W Maloy, Pat F Bass III
Ochsner Journal, March 2020; 20(1) pp 81–86
Open Access
Abstract
Background
The 2018 revisions to the Common Rule that were effective in January 2019 introduced a new category of informed consent: broad consent.
Methods
Investigators and institutional review board (IRB) members need to understand (1) what broad consent is, (2) the role of broad consent under the revised Common Rule, (3) how and when broad consent can be used, (4) exempt research categories that relate to broad consent, and (5) the scope of limited IRB review as it relates to broad consent.
Results
Under the prior regulations, researchers had two consent options: obtain study-specific informed consent or request the IRB to waive the requirement to obtain informed consent. The revision to the Common Rule introduced the third option of broad consent, but its applicability is limited. Broad consent can only be used to obtain an individual’s consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. The regulatory authority for broad consent is at 45 CFR §46.116(d). None of the required elements of broad consent can be omitted or altered because each element is considered essential. Broad consent shares many of the requirements for study-specific informed consent, but several elements are unique: a description of the types of secondary research that may be conducted; statements describing the private information or biospecimens that might be used in research, whether sharing of the information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the information or biospecimens; information on how long the information or biospecimens may be stored, maintained, and used; a statement that subjects will or will not be informed of the details of any subsequent research; a statement that research results will or will not be disclosed to subjects; and contact information for obtaining answers to questions about the subjects’ rights regarding storage and use of information or biospecimens and whom to contact regarding research-related harm.
Conclusion
Broad consent provides flexibility that did not exist prior to the revision, giving researchers the option to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. With an understanding of the regulations, an investigator can plan how best to organize his or her research plan and decide whether to obtain study-specific informed consent, to apply for a waiver of consent, or to obtain broad consent.

Material risk: a review of informed consent in the UK

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Material risk: a review of informed consent in the UK
Thomas Walton
Orthopaedics and Trauma, 24 April 2020
Abstract
Consent is a requirement for any medical or surgical intervention to be deemed appropriate. For such consent to be considered valid, it must be given voluntarily, by an individual with capacity, who has the appropriate information available to make an informed decision in line with their values. Following the Montgomery vs. Lanarkshire ruling in 2015, the legal basis from which informed consent is measured has changed. The law now reflects pre-existing professional guidelines, and advocates a patient-centred approach to informed consent. The previously paternalistic focus of informed consent, whereby it was deemed a matter for clinical judgement, has been firmly abandoned in favour of the provision of information pertaining to ‘material risks’, as determined by the significance attached to these risks by the patient themselves. This paper serves to provide an overview of consent within the medical profession, and gives an account of the implications of this landmark ruling.

A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria

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A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria
Chinemelum Nelson Arinze-Umobi, Godwin N Okeke
African Journal Of Law And Human Rights, 2020; 4(1)
Open Access
Abstract
Today, the fundamental principle of medical law and ethics is that a medical professional should obtain the informed consent of a competent patient before administering any form of treatment on such a patient. This is in tandem with the principle of autonomy (self-determination) which is intrinsic in every individual save for circumstances wherein the observance of this principle can legally be departed from. In clinical context, ‘autonomy’ connotes a patient’s ‘right to refuse and right to participate in every decision regarding medical treatment’. This study reviewed the socio-cultural factors inhibiting patients’ right to autonomy in medical practice in Nigeria. The study found that striking a balance between the opposing interests may be a difficult tasks as patients’ right to autonomy is case-specific and that a whole lot of factors operate in the social space and as a result, alter, from time to time, the standard, such that it becomes nearly impossible to apply the same standard in all instances. The study found that certain circumstances exist in the doctor-patient relationship wherein a patient lacks capacity to grant such consent to the medical professional – hence the need for such consent to be given on his/her behalf towards his/her best interests.

Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit

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Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Rohi Shah, Sharan Sambhwani, Awf Al-Shawani, Christos Plakogiannis
Annals of Medicine and Surgery, 8 April 2020
Open Access
Abstract
Background
The Montgomery case in 2015 resulted in a pivotal change in practice, leading to a patient-centric approach for informed consent. Neck of femur fractures are associated with a high rates perioperative morbidity and mortality. Using guidelines highlighted by the British Orthopaedic Association we performed a multi-loop audit within our department to assess the adequacy of informed consent for NOF fractures.
Methods
Two prior cycles had been performed utilising a similar framework. Prior interventions included ward posters, verbal dissemination of information at Doctor’s induction and amendments to the JD handbook. For the latest audit loop, a retrospective analysis of 100 patients was performed. Risk factors were classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation in the signed Consent Form-1s.
Results
Infection, bleeding risks, clots and anaesthetic risks were documented in all patients(100%). Areas of improvement included documentation of neurovascular injuries(98%), pain(75%) and altered wound healing(69%). There was no significant change in the documentation of failure of surgery(83%) neurovascular injuries(98%). Poorly documented risk factors included mortality(21%), prosthetic dislocation(14%) and limb length discrepancy(6%).
Conclusion
Following the latest cycle, the trust has now approved the use of 2 consent-specific stickers(arthroplasty/fixation), amendable on a patient-to-patient basis. As part of the multi-loop process, the cycle will be repeated every year-in line with Junior Doctor rotations. Medical professionals have an ethical, moral and legal obligation to ensure they provide all information regarding surgical interventions to aid patients in making an informed decision.

Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking

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Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking
Brief Communication
C Tortorella, C Solaro, P Annovazzi, L Boffa, M C Buscarinu, F Buttari, M Calabrese, P Cavalla, E Cocco, C Cordioli, G De Luca, M Di Filippo, R Fantozzi, D Ferraro, A Gajofatto, A Gallo, R Lanzillo, A Laroni, S Lo Fermo, S Malucchi, G T Maniscalco, M Moccia, V Nociti, D Paolicelli, I Pesci, L Prosperini, P Ragonese, V Tomassini, V L A Torri Clerici, M Rodegher, M Gherardi, C Gasperini, RIReMS Group
Neurological sciences, 2 Apr 2020
Abstract
In the last years, change in multiple sclerosis (MS) therapeutic scenario has highlighted the need for an improved doctor-patient communication in advance of treatment initiation in order to allow patient’s empowerment in the decision-making process. AIMS: The aims of our project were to review the strategies used by Italian MS specialists to inform patients about treatment options and to design a multicentre shared document that homogenizes the information about disease-modifying treatment (DMTs) and the procedure of taking informed consent in clinical practice. RESULTS: The new resource, obtained by consensus among 31 neurologists from 27 MS Centres in Italy with the supervision of a medico-legal advisor, received the aegis of Italian Neurological Society (SIN) and constitutes a step toward a standardized decision process around DMTs in MS.

Mainstream consent programs for genetic counseling in cancer patients: A systematic review

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Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Review
Tahlia Scheinberg, Alison Young, Henry Woo, Annabel Goodwin, Kate L. Mahon, Lisa G. Horvath
Asia-Pacific Journal of Clinical Oncology, 29 February 2020; pp 1–15
Open Access
Abstract
As demand for germline genetic testing for cancer patients increases, novel methods of genetic counseling are required. One such method is the mainstream consent pathway, whereby a member of the oncology team (rather than a genetic specialist) is responsible for counseling, consenting, and arranging genetic testing for cancer patients. We systematically reviewed the literature for evidence evaluating mainstream pathways for patients with breast, ovarian, colorectal, and prostate cancer. Medline, EMBASE, and Cochrane Library were searched for studies that met inclusion and exclusion criteria. Article references were checked for additional studies. Trial databases were searched for ongoing studies. Of the 13 papers that met inclusion criteria, 11 individual study groups were identified (two study groups had two publications each). Ten of the 11 studies evaluated the acceptability, feasibility, and impact of BRCA testing for patients and/or clinicians in different clinical settings in breast and ovarian cancer, while the final study explored the attitudes of colorectal specialists toward genetic testing for colorectal cancer. None involved prostate cancer. Overall, mainstream pathways were acceptable and feasible. Medical oncologist and nurse-driven pathways were particularly successful, with both patients and clinicians satisfied with this process. Although the content of pretest counseling was less consistent compared with counseling via the traditional model, patients were largely satisfied with the education they received. Further research is required to evaluate the mainstream pathway for men with prostate cancer.

The Importance of Physician Directed Informed Consent

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The Importance of Physician Directed Informed Consent
Neena Oza
Journal of Health Care Finance, 2020
Open Access
Abstract
The process and scope of procedural/surgical informed consent has changed dramatically with emerging technologies, expanding medical knowledge, updated outcomes data and increased recognition of patient autonomy.  With the paradigm shifting towards ethical considerations of patient care and active involvement of patient’s in their treatment, medical practices and laws have evolved to guide communication standards between the patient and physician.  The delivery of all relevant information should enable the patient to make an informed decision regarding the procedure, while preserving the core principles of patient understanding and free consent, devoid of coercion or manipulation.[1],3  Additionally, education and counseling delivered during the informed consent should relieve the patient’s safety concerns related to procedures and to address patient knowledge deficiencies, present other alternative plans or procedures, as well as any possible perceived coercion related to noninvasive and invasive procedures.  The intent of this article will be to further explain the rationale for the performing provider, attending physician or surgeon, to be the sole person ultimately responsible for providing the patient with the goals, risks and benefits of the proposed treatment or intervention; and for the words and actions of any other medical team member (such as medical students or residents) that may assisting during the informed consent process.

Information Disclosure in Informed Consent

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Information Disclosure in Informed Consent
Review Article
Lydia Aiseah Ariffin
Malaysian Journal of Medicine and Health Sciences, May 2020
Open Access
Abstract
Informed consent has been recognised as an essential part of clinical practice, giving ethical and legal legitimacy to medical intervention. There is no universal standard on the amount and type of information that a patient is entitled to and needs to be adequately disclosed. This article proposes nine information that will assist the doctor in providing adequate information for a patient to evaluate whether to authorise medical intervention. The recommended information are: (i) diagnosis, prognosis and its uncertainties; (ii) nature of proposed medical intervention; (iii) the expected benefit of proposed medical intervention; (iv) the potential risk of proposed medical intervention; (v) alternative to proposed medical intervention; (vi) progress of proposed medical intervention; (vii) opportunity for a second medical opinion and to seek further details; (viii) costs of proposed and alternative medical intervention; and (ix) the person responsible for implementing medical intervention.