Human research or research involving human biospecimens necessitates the participant’s or donor’s advance consent. The researcher must explain the research in a language that participants can comprehend, and the participants must then provide a written statement indicating their understanding and voluntary participation. This is known as informed consent and is subject to specific requirements outlined in the Common Rule, Office of Human Research Protections (45 CFR 46.116), and FDA regulations (21 CFR 50.25). However, researchers are only required to include regulatory elements that apply to their particular study. For instance, a study regulated by the FDA may not have to comply with Common Rule requirements unless the study receives DHHS funding.
Creating informed consent documents can be challenging due to the many requirements involved. Many guides for Informed Consent Forms (ICFs) use technical jargon that can be confusing and contradictory, leading researchers astray. Nonetheless, preparing an informed consent document should be a straightforward task once you understand the basics.
While the FDA does not specify the precise language that should be used in the informed consent document, it does specify certain fundamental elements that must be included. To assist researchers in this process, we have developed a cheat sheet consisting of 19 points for consent writing in clinical research.
FDA and Common Rule Cheat Sheet for Informed Consent: 9 Basic Elements
- Begin with an introduction explaining why the prospective participant might want or not want to participate in the research; applies to research subject to the Common Rule
- Outline the purpose of the research
- Outline any foreseeable risks and discomforts that the participant might experience
- Outline possible benefits to the prospective participants
- Outline possible alternatives if any that might be advantageous to the prospective participant
- Outline the extent of confidentiality that will be accorded to the prospective participant. Where applicable, this should include the possibility of having the FDA inspect the study records
- Outline terms for compensation for injury if and where applicable
- Include a statement of voluntary participation stating that the subject can withdraw from the study at their own pleasure without being penalized
- Clinical trials in phase two must include the following statement: “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 Web site will include a summary of the results. You can search this website at any time.”
FDA and Common Rule Cheat Sheet for Informed Consent: 10 Additional Elements
The application of these additional elements is at the discretion of the Institutional Review Boards (IRB). It is recommended that clinical trial sponsors and other stakeholders liaise with the IRB to know which of the following elements are applicable to their studies and which are not.
- A statement informing prospective participants of potential risks to themselves or a developing fetus should they be pregnant
- Possibility of termination of participation in the study, regardless of the informed consent and willingness to participate
- Any costs that the participant might incur in relation to the study
- The appropriate procedure for terminating willful participation in the study, and consequences where applicable
- A statement affirming commitment to update the subject on periodic findings from the study that may help the subject decide where to continue or terminate participation from the study
- A statement indicating an estimate of the total number of participants involved in the study
- NIH-funded studies must include a description of the “Certificate of Confidentiality”
- Provide information on the Genetic Information Nondiscrimination Act (GINA) where genetic testing is involved and results are to be provided to the subject or site where the genetic specimen was collected
- For infectious diseases or pandemics, include a statement indicating that the results will be reported to local and national health authorities
- For research regulated by the Common Rule:
- Include a statement indicating that identifiers can be removed from the identifiable biospecimens to allow the biospecimens to be used for future research and this will not require additional informed consent
- OR include a statement indicating that biospecimens collected cannot be used for future research even when identifiers have been removed
- Include a statement indicating whether the subject’s biospecimens (even when identifiers have been removed) can be reused commercially and in that case, whether the profits will be shared with the subject
- Include a statement indicating conditions under which clinically relevant research results will be disclosed to subjects whenever applicable
- Include a statement indicating whether whole genome sequencing will be carried out by the researcher whenever applicable
How Does a Laboratory Software for Clinical Research Support Informed Consent Management?
Informed consent is an integral part of clinical research and it sets the stage for mutual collaboration between the research team and the prospective research participants. In a nutshell, informed consent should explain to the subjects the purpose of the study, how it will be carried out and the procedures involved, as well as any potential risks or benefits that might accrue. It should also stipulate that participation or withdrawal from clinical research should be voluntary and that there should be no coercion at any stage whatsoever.
Informed consent must always be in written form and should be collected from all prospective subjects whether or not they go ahead with participating in the research. This makes managing informed consent an arduous task for any clinical research team. A Laboratory Information Management System (LIMS) can help clinical researchers to automate and streamline the management of informed consent. This will not only minimize human error but it will also eliminate risks of tampering with the ICFs. A clinical LIMS can also be integrated with digital tools used for the collection of Informed Consent in clinical research, enabling laboratories to manage laboratory data and participant consent in one place, eliminating data silos.
A cloud-based laboratory software for clinical research helps researchers meet regulatory requirements while optimizing operational efficiency and reducing operational costs with the overall aim to boost the productivity of the clinical research process.