Informed Consent Process
Informed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.
In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement.
- Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
- It is an ethical best practice to include an informed consent process for most exempt research.IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself. A suggested consent template for exempt research can be found below under the References and Resources section. A companion protocol template for exempt research may be found in the feature box, Related Information (top right).
Even in situations where the IRB may waive the documentation (signature) requirement (e.g., telephone interview, online survey), investigators are expected to present participants with the required key elements of informed consent and with a copy of the written consent document.
Informed consent documents
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. 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. New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study.
Key Information Elements
The image below displays the five elements identified in the preamble to the revised Final Rule as suggested key information.
Note: Element number 5 (alternative procedures) applies primarily to clinical research.
General Information & Tips for Preparing a Consent Document
Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level. A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application. Always:
- Tailor the document to the subject population.
- Avoid technical jargon or overly complex terms.
- Use straightforward language that is understandable.
The informed consent document should succinctly describe the research as it has been presented in the IRB application.
- Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I).
- Include a statement of agreement at the conclusion of the informed consent document.
- The consent doucment must be consistent with what is described in the IRB application.
Document Formating for Uploading into eResearch
- Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
- Use a consistent, clearly identified file naming convention for multiple consent/assent documents.
Informed Consent Templates
IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per 45 CFR 46.116), as well as other required regulatory and institutional language. The templates listed below include the new consent elements outlined in the 2018 Common Rule.
If you choose to create an informed consent document without utilizing an IRB-HSBS template, you must ensure that all required elements are included and that the recommended language (found in the templates) is utilized appropriately.
The Informed Consent Template here is meant to provide guidance; it is not a required format. Please review Basic Elements of Informed Consent for additional information.
Informed Consent Document Tips
Informed consent documents explain to potential participants:
- the nature of the research project,
- why they are candidates for the research,
- what risks, benefits, and alternatives are associated with the research, and
- what rights they have as research subjects.
The consent form is one part of the dialogue that investigators have with each subject.
It is recommended that forms for adult subjects be written at a 6thgrade reading level or lower, which means:
- sentences and paragraphs are short,
- terms and concepts are simple, and
- technical information is explained in non-technical ways.
Information should be accurate and precise. The consent form should be easy to look at, with:
- a clear layout,
- white-space borders, and
- easy to read fonts.
In the beginning of the consent form, investigators describe what they will do and what will be asked of participants. Subjects are directly addressed as “you;” investigators are referred to as “we.”
Informed Consent Document Template
You are invited to join a research study to look at ________________. Please take whatever time you need to discuss the study with your family and friends, or anyone else you wish to. The decision to join, or not to join, is up to you.
In this research study, we are investigating/testing/comparing/evaluating __________________.
The information here should be a clear and short description of the “bottom line” of the study. Hold details of the study until later in the document. Briefly give the subjects some background information about why this study is being done, this can inclue information about what is already known and what you hope to learn.
WHAT IS INVOLVED IN THE STUDY?
If you decide to participate you will be asked to ___________________. We think this will take you ___________minutes.
Refer to the subjects as “you.” Tell subjects exactly what to expect. Explain what will happen during the study and how the study will work. Include everything that subjects will be asked to do. Describe all surveys and data collection instruments that subjects will experience. Indicate how long each survey or procedure will take and state how long (e.g. minutes, hours, days, months, until a certain event or endpoint) the subjects will be part of the study.
The investigators may stop the study or take you out of the study at any time they judge it is in your best interest. They may also remove you from the study for various other reasons. They can do this without your consent.
If appropriate, list any additional reasons why subjects might be taken off the study.
You can stop participating at any time. If you stop you will not lose any benefits.
This study involves the following risks __________________.
There may also be other risks that we cannot predict.
List the physical and non-physical risks of participating in the study above.Non-physical risks may include social, psychological, or economic harm; risk of criminal or civil liability; or damage to financial standing, employability, or reputation.
BENEFITS TO TAKING PART IN THE STUDY?
It is reasonable to expect the following benefits from this research: _______________________. However, we can’t guarantee that you will personally experience benefits from participating in this study. Others may benefit in the future from the information we find in this study.
List all the benefits that might reasonably be expected from participating in the study. First describe benefits to subjects, then describe benefits to others. If there are no benefits from participating in the research, state that fact.
We will take the following steps to keep information about you confidential, and to protect it from unauthorized disclosure, tampering, or damage: ___________
List all individuals and agencies who will have access to the data and records, and how data will be described if published or shared with others.Will you be using direct quotes which could be traced to an individual? Will you be aggregating the data?
Describe confidentiality protections here. Explain how you are protecting the subject’s information. Give details as appropriate: for example, are data files kept in locked cabinets, are the data kept on a computer, is a password required for getting onto the system; who has access to the data, etc.
Indicate if subjects will receive anything for participating.
YOUR RIGHTS AS A RESEARCH PARTICIPANT?
Participation in this study is voluntary. You have the right not to participate at all or to leave the study at any time. Deciding not to participate or choosing to leave the study will not result in any penalty or loss of benefits to which you are entitled, and it will not harm your relationship with _______________.
Describe procedures for withdrawing and any follow-up that you will request for subjects who withdraw early. Follow-up such as questionnaires that are part of the research cannot be forced upon subjects who wish to withdraw.
CONTACTS FOR QUESTIONS OR PROBLEMS?
Call ____________________ at ___________________ or email___________ at ___________if you have questions about the study, any problems, unexpected physical or psychological discomforts, any injuries, or think that something unusual or unexpected is happening.
Contact Heather Foti, Associate Director of the HSRO at (585) 475-7673 or email@example.com if you have any questions or concerns about your rights as a research participant.
Provide the name of one or more researchers who can be reached for assistance.If you are a student provide your advisor's contact information too.
Consent of Subject (or Legally Authorized Representative)
Signature of Subject or Representative Date
Upon signing, the subject or the legally authorized representative will receive a copy of this form, and the original will be held in the subject’s research record. Unless otherwise required by the HSRO, Exempt research does not require a signature. For all other research, in some cases it may be in the best interest of the subject not to collect a signature and the HSRO will advise you if that is the situation.