Clinical research involving human subjects is crucial for the development of new treatments, drugs, and therapies, but it must be conducted in an ethical manner that protects the rights and well-being of the participants. Informed consent is the cornerstone of ethical research, requiring that participants or donors are provided with sufficient information about the study to make an informed decision about whether to participate or not. This involves explaining the study in a language that participants can understand and allowing them to provide written consent indicating their voluntary participation.

Informed consent is not only an ethical requirement but also a legal one, with specific guidelines outlined in the Common Rule and FDA regulations. Other informed consent regulations include: The Office of Human Research Protections (OHRP) regulation 45 CFR 46.116, General Data Protection Regulation (GDPR) in Europe, and the National Statement on Ethical Conduct in Human Research in Australia. These regulations ensure that participants are fully informed about the risks and benefits of the study, as well as any alternative treatments or procedures. The regulations also require researchers to minimize the risk of harm to participants and to protect their confidentiality and privacy.

However, creating an informed consent document can be a complex and challenging task. The guidelines for Informed Consent Forms (ICFs) can use technical jargon that may be difficult for participants to understand, and researchers may struggle to balance the requirements of the regulations with the need for clear and concise information. Preparing an informed consent document is a crucial step in conducting ethical and responsible research, and understanding the basics can help researchers navigate the process with greater ease. In this blog, we shall delve into the intricate art of crafting informed consent documents that comply with the exacting standards of the FDA and Common Rule guidelines.

FDA and Common Rule: Basic Elements for Informed Consent Writing

The FDA and Common Rule require nine fundamental elements to be included in informed consent documents:

1. Introduction: The introduction should identify the research project, explain its purpose, and describe the procedures that will be performed.
2. Purpose of the research: The purpose of the research should be clearly explained, including the scientific goals, the procedures involved, and the expected duration of the study.
3. Foreseeable risks and discomforts: The potential risks and discomforts associated with the research should be described in detail, including any physical, psychological, social, or economic harm that may result.
4. Possible benefits: Any potential benefits of participating in the study should be explained, including direct benefits to the participant, benefits to others, and benefits to society.
5. Possible alternatives: The participant should be informed of any available alternative treatments or procedures and the benefits and risks associated with each.
6. The Extent of confidentiality: The extent to which confidentiality will be maintained should be described, including any exceptions to confidentiality.
7. Terms for compensation for injury: The terms for compensation for any injury that may result from participation in the study should be explained.
8. Statement of voluntary participation: The participant should be informed that participation is voluntary and that they can withdraw from the study at any time without penalty.
9. Clinical trial disclosure statement for Phase II studies: If the study is a Phase II clinical trial, a statement disclosing whether the drug or device being tested has been approved by the FDA for any use should be included. A Phase II study must also include the following statement as mentioned on the FDA website:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”

FDA and Common Rule: Additional Elements for Informed Consent

In addition to the 9 basic elements of informed consent required by the FDA and Common Rule, there are 10 additional elements that are essential to ensure that research participants are fully informed before deciding to participate in a study. These additional elements address specific concerns and considerations that may arise in certain types of research studies and provide important information for participants to make an informed decision about their participation.  In this section, we will discuss each of these 10 additional elements in detail.

1. Potential risks to pregnant subjects or developing fetuses: If the study involves pregnant women or women of childbearing age, this element informs them of the potential risks to their own health or that of their developing fetus.
2. Possibility of termination of participation: This element outlines the process for terminating participation in the study, including the participant’s right to withdraw at any time without penalty.
3. Costs to the participant: This element explains any costs that the participant may incur as a result of participating in the study, such as travel expenses or medical procedures that are not covered by insurance.
4. Procedure for terminating participation: This element explains the steps that the participant must take to terminate their participation in the study.
5. Commitment to update the subject on study findings: This element outlines the researcher’s commitment to keeping the participant informed about any significant findings that emerge during the course of the study.
6. Estimate of the total number of participants: This element provides an estimate of the total number of participants in the study, which can help the participant understand the scope of the research.
7. Description of the “Certificate of Confidentiality” for NIH-funded studies: This element explains the purpose and significance of the Certificate of Confidentiality, which is intended to protect the participant’s privacy and confidentiality.
8. Information on the Genetic Information Nondiscrimination Act (GINA) for genetic testing studies: This element explains the implications of GINA for genetic testing studies, including the participants’ right to privacy and protection against discrimination based on their genetic information. For infectious diseases or epidemics, this element requires including a statement that results are required by law to be reported to local health authorities.
9. Statement on reporting results for infectious diseases or pandemics: This element explains the researcher’s obligation to report any positive test results for infectious diseases or pandemics, such as HIV or COVID-19.
10. Additional statements for Common Rule studies: This element may include any additional statements or disclosures that are required under the Common Rule, which is a set of federal regulations governing research with human subjects.

In order to safeguard the rights of subjects in research that is governed by the Common Rule, it is crucial to incorporate certain essential statements. Firstly, a statement should be included regarding the possibility of removing identifiers from collected data for future research purposes without the need for further informed consent to maintain subject privacy and prevent unauthorized use of their personal information. Alternatively, a statement should be added that obtained biological samples cannot be utilized for future research without the explicit consent of the subject, particularly for sensitive or personal data such as genetic information, to protect their privacy. Thirdly, it is necessary to incorporate a statement that specifies whether the subject’s biological samples may be commercially reused. This is important to allow the subject to make an informed decision regarding the potential commercial usage of their samples. Fourthly, a statement must be included to explain the circumstances under which clinically relevant research findings will be disclosed to the subject. This is important to ensure that the subject understands the possible benefits and risks associated with participation and can make an informed decision. Finally, a statement should be added indicating if the investigator intends to perform whole genome sequencing to inform the subject about any associated risks and allow them to make an informed decision.

By including these statements in research governed by the Common Rule, researchers can ensure that they adhere to ethical and industry standards, protect the privacy of subjects, and respect their rights during the research process.

 3 Ways Laboratory Software for Clinical Research Supports Informed Consent Management

 Utilizing laboratory software for clinical research, also known as Laboratory Information Management System (LIMS), can aid clinical researchers in automating and simplifying the handling of informed consent procedures. This not only decreases the chances of human error but also eliminates the possibility of tampering with the Informed Consent Forms (ICFs).

Let’s look at 3 ways a LIMS helps support clinical researchers in consent management.

1. Manage Documents  A LIMS manages all internal and external documents including consent forms, standard operating procedures (SOPs), and quality management manuals. The system keeps track of each document’s revision history to ensure that employees only access the most recent version. Additionally, a LIMS assigns role-based access rights to staff, allowing controlled access to confidential documents. With the document management feature, users can manage the latest version of the consent form. A LIMS can also associate filled-out consent forms with individual participant records for proper tracking and consent management.
2. Protect the Privacy of Participants  A LIMS ensures the anonymity of sensitive participant data and grants role-based access rights to protected health information (PHI) of participants. Only authorized personnel can view the masked data, and any changes or views of PHI are logged in the audit trail. This feature is beneficial for audits as external auditors can request a PHI audit report at any time
3. Associate Participants with a Study  A LIMS allows users to create a clinical research study and associate participants with it. In this way, all participants are associated with the study. Thus, all the consent forms, participant data, and all SOPs that apply to a study can be organized in one place.

A clinical LIMS helps automate and streamline the management of informed consent. It minimizes human error associated with manual paper-based processes and also eliminates ICF tampering risks. What’s more, a clinical LIMS can be integrated with digital tools used for the collection of informed consent.

Conclusion

Creating an informed consent document is a complex and challenging task that requires balancing regulatory requirements with the need for clear and concise information. Laboratory software for clinical research streamlines the process of managing informed consent documents to help researchers comply with the standards of the FDA and Common Rule guidelines. Using a LIMS can be a differentiator for clinical research labs, as it can make the consent management process a breeze, leading to better participant satisfaction and improved research outcomes.

About CloudLIMS

CloudLIMS.com is an ISO 9001:2015 and SOC 2-certified informatics company. Their SaaS, in-the-cloud Laboratory Information Management System (LIMS), CloudLIMS, offers strong data security, complimentary technical support, instrument integration, hosting and data backups to help biorepositories, analytical, diagnostic testing and research laboratories, manage data, automate workflows, and follow regulatory compliance such as ISO/IEC 17025:2017, GLP, 21 CFR Part 11, HIPAA, ISO 20387:2018, CLIA, ISO 15189:2012, and ISBER Best Practices at zero upfront cost. Their mission is to digitally transform and empower laboratories across the globe to improve the quality of living.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.