Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects.
What is Informed Consent?
ALL human subject research activities conducted at RIT and by RIT investigators must provide a prospective subject with the information necessary to make an informed decision about participating, and an opportunity to discuss that information with the investigator and trusted individuals in the subject’s life if necessary.
Before involving an adult in research, an investigator must obtain informed consent of the subject or the subject’s legally authorized representative. Obtaining informed consent is an educational process that takes place between the Investigator and the prospective subject. The goal is to provide information so that prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Informed consent is one of the primary ethical requirements of research with human subjects as it reflects the basic principle from the Belmont Report of respect for persons.
Federal regulations (45 CFR 46.116) provide the framework for the type of information (i.e., the “elements”) that must be included as part of the consent process. Additionally, the circumstances are important too, and investigators may seek consent only under conditions that:
provide the prospective subject (or representative) enough time to discuss and consider whether or not to participate,
minimize the possibility of coercion (intimidation) or undue influence,
present the information in a language that is understandable to the subject or representative (the person who signs the consent form must have access to a copy as a reference and reminder of the information conveyed), and
the information that is presented must be what a reasonable person would want to have in order to make their decision. The goal is to help people process the complicated information they’re being given and make it easier for them to make a more informed decision. Your discussion and materials should help them in their decision-making.
Modes of Information
The consent process includes providing a written document containing the required elements of informed consent at 45 CFR 46.116 presented in a way that will make it easy for subjects to comprehend. The informed consent may also be delivered in other modes, such as ASL, video, or spoken word. In most cases, investigators are expected to obtain a signature from the participant unless the IRB modifies or waives the consent requirement or the documentation (signature) requirement. Waivers are rare and granted only when specific requirements are met and documented by the IRB or HSRO.
A successful consent process presents detailed information which is organized and presented in a way that helps the prospective subject understand why a person might or might not want to participate. There are specific elements that must be included in the consent information.
Exempt research and non-exempt research have different requirements for informed consent. If you are not sure which category of research your project falls under, you can develop a document following the guidance for exempt research and submit that with your proposal. If review indicates your project falls into a non-exempt category, the HSRO will contact you and provide guidance for revising the document.
Before involving a subject in exempt or non-exempt research, the investigator must obtain the informed consent of the individual or their legally appointed representative.
Research procedures that meet the categories set forth in 45 CFR 46.104(d); 21 CFR 56.104(d) may qualify for exemption. The HSRO or IRB reviews, and when the only involvement of human subjects falls within one or more of the exempt categories, provides a determination.
Expedited Category Research
The HSRO and IRB use an expedited review process for initial review of studies that meet the expedited categories adopted by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA), and that involve no greater than “minimal risk.” Under DHHS revised Common Rule regulations, the research is deemed to be eligible for expedited review if the study involves activities on the list, unless the reviewer determines and documents that the study involves more than minimal risk. (“Expedited” refers to the type of review — despite the name, it does NOT mean you can request this to make the IRB process go more quickly.)
Expedited category research requires a Key Information section at the beginning of the consent form.
The Key Information section is to provide subjects with a concise and focused presentation of the research activity. How the information is presented will depend on the nature of the specific research study and in most cases can probably be expressed in a paragraph or two. This section of the consent could, in appropriate circumstances, include a summary of relevant pieces of information that are explained in greater detail later in the consent form. It should be written in everyday language and could be similar to what you’d say to someone who is not familiar with your research if they asked you what it would be like to be in your study.
Key Information could include information on these elements:
What is the study about and how long will it last?
What kinds of things will happen during the study, what will a subject do?
What are the key reasons a person might choose to take part in the study? (DO NOT include the incentive or compensation as a benefit.)
What are the key reasons a person might not choose to take part in the study?
Information on voluntary participation
Contact information for the PI and HSRO if there are questions
And anything else you think would help a subject get a quick picture of what participating will be like.
How you apply the “key information” requirement, and to what level of detail, will depend on the complexity of the research project. Many social/behavioral research projects already employ a brief informed consent document, so including a “key information” section may be redundant. The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.
The collection of identifiable private information or identifiable biospecimens
A statement indicating whether:
identifiers may be removed, and
de-identified information or biospecimens may or may not be used or shared for future research
Additional Optional Elements that may not be relevant to all studies but should be included when appropriate
Use of biospecimens
A statement indicating whether:
biospecimens may be used for commercial profit, and
the subject will share in that profit
Clinically relevant results
A statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions
Constructing the Consent Process and Form
The information provided to potential subjects will be evaluated in light of the risks and benefits of the proposed research procedures.
Review is from the subject’s perspective: what facts would a prospective subjects want to know before deciding whether or not to participate in the research?
Does the information inform prospective subjects as clearly as possible? Are there any coercive (intimidating) aspects which might impede free choice? In cases where there is reason for special concern about pressure (e.g., when students or employees are asked to participate in research conducted by their professors or supervisors), the researcher may be required to provide some form of monitoring (such as the presence of an impartial observer).
Obtaining informed consent is an educational process; researchers should do everything they can to enhance the prospective subject's understanding of the information presented.
Review of Informed Consent Process
Review of the Informed Consent Process considers:
the characteristics of the subject population,
the type of information that will be given to the subjects, and
the circumstances under which the consent process will take place (e.g., method, timing, place, and personnel involved).
After considering all of these items, the HSRO may suggest changes in the wording of the consent documents or in the timing or location of an investigator's contact with potential subjects. These requests are made to provide subjects with as much relevant information as possible to ensure they take part as informed and voluntary participants.
For NIH-funded research or other research with a Certificate of Confidentiality (CoC), the potential subjects must be told about the protections afforded by the certificate and any exceptions to that protection and in the informed consent form.
There may be circumstances where studies can be conducted without obtaining informed consent. In addition, when children are involved in a research activity, it is necessary to obtain their assent and the permission of their parents. There are also special considerations around using RIT students as research subjects.