Last Updated on June 16, 2022
Overview:
Consent for research participation involves an informed consent process. This procedure entails sharing information and ongoing communication between the investigator (researcher) and the possible research participant (subject). There is great importance of Informed Consent in research.
The consent process begins with the initial presentation of the research to a participant. It continues with a discussion and information exchange between the researcher and the participant and concludes with consent obtained. The approach may also continue throughout the research activity until the participant decides to discontinue participation or the study concludes.
What is Informed Consent?
There is an importance of informed consent in research. Informed consent is a fundamental belief of research ethics. Its goal is for participants to voluntarily participate in studies, fully understand what it entails, and grant consent before participation.
Freedom is given to individuals to make their own decisions and all of the knowledge is provided that they need to make the right decisions. Conducting research when participants lack the capacity to make an informed decision is a breach of ethics and human rights. Community representatives can help in recognizing the distinct decision-making processes of individuals and communities and recommending the best strategies to empower participants to make voluntary decisions.
General Data Protection Regulation (GDPR):
Researchers should ensure that they follow the General Data Protection Regulation (GDPR) both during and after the consent procedure, especially if they will be collecting particular category (i.e. sensitive) data or personal data as part of their research (also refer to the advice on consent in research involving children).
An effective informed consent process includes the following components:
- Conducting the process in a way and place that protects participant privacy.
- Allowing the potential topic enough time to examine all choices.
- Give appropriate information about the study in a language that the potential subject can understand.
- Answering probable subject inquiries and/or concerns.
- Assuring that the intended subject understands the information supplied.
- Obtaining the potential subject’s voluntary participation agreement.
- Adequately documenting consent.
- Giving the subjects copies of the consent paperwork.
- Providing information when the subject or investigation requires it.
Why is Informed Consent Important?
There is equal importance of informed consent in research as other parameters. Informed consent is an important ethical requirement in research because it demonstrates respect for personal autonomy (“Respect for Persons”). This collaborative decision-making process is both an ethical and legal requirement for healthcare providers.
Informed consent obtained effectively promotes patient autonomy, builds trust and confidence in medical professionals, and reduces the risk of unnecessary legal claims based on incorrect assumptions about appropriate medical care.
The consent process makes it clear to participants that research differs from clinical care in that the goal is to benefit society rather than just the individual. Researchers should consider what information should be provided to ensure participant autonomy, even if consent is not legally required in certain situations.
Informed, Written, or Verbal Consent:
Obtaining consent entails discussing the study and measuring participant comprehension while using a consent document, typically a written consent form or information sheet, as a reference for the spoken explanation of the study. Before beginning any study activity, including screening processes, informed consent from the participant and/or their legally authorized guardian is acquired.
Step 1: Summarize the Research.
Explain the study verbally to the potential subject:
offering all important information (purpose, methods, risks, benefits, and alternatives to participation), and providing the potential participant sufficient time to ask questions or express concerns. Instead of reading the permission paperwork directly, paraphrase it, testing for comprehension and allowing for questions throughout the process. Some studies would benefit from the participation of family members or close friends.
After a verbal discussion, hand over the written consent form or information sheet to the potential subject:
Following a verbal explanation, give the potential subject the written consent form or information sheet (as required by the IRB), and give them enough time to absorb and appreciate the information before deciding whether or not to participate in the research.
The amount of time required will vary according to the complexity and/or nature of the research. Participants, especially those in high-risk studies, may require a waiting period. We also encourage them to discuss their participation with family members, close friends, or trusted advisers.
Meet with the potential participant and address any concerns or questions:
Allow the potential participant time to read the consent form/information sheet before meeting with him or her to address any additional questions or concerns.
Step 2: Assessing Subject Understanding.
The investigator, not the potential subject, bears the primary responsibility for ensuring that a possible subject understands the importance of informed consent in research and the risks and rewards involved.
Ask and respond to questions:
Answer questions and ask questions to advance the topic and elicit inquiries from potential participants. This will cause the prospective subject to reconsider the study.
Ask open-ended, non-directive queries:
“Who,” “what,” “when,” “where,” “why,” “how frequently,” or “please describe…” are all examples of open-ended questions.
Open-ended inquiries include the following:
- “Could you please briefly explain what you’ll have to do if you think of taking part in the study?”
- “Explain the research’s purpose in your own words.”
- “Could you please let me know if you have any other options available if you decide not to take part in this study?”
- “Do you have any other questions regarding this study?”
- “Could you please tell me for how long I will have to participate in this study?”
- “How did you get to decide you were eligible to take part in this research?”
- “Are there any risks of participating in this research?”
- “How is the research conducted?”
- “Who should you contact after the study begins if you have any questions or experience any side effects?”
Documenting Informed Consent:
The informed consent is documented once details about the research have been discussed and the participant comprehends what will occur. At the very least, it entails getting the signatures of both the participant (or the legally-authorized representative or parent(s), if granted) and the person requesting consent. The individual getting consent certifies that he or she has explained the research to the participant, established that the participant understands the importance of informed consent in research and that the subject freely consents to participate.
Documentation of Consent:
Make use of the approved version:
Print the stamped copy from iRIS to ensure subjects sign the currently approved consent form (not required, but strongly encouraged).
Signatures required:
- Once a participant accepts (or a legally authorized representative [LAR] or parent(s) agrees on their behalf) to participate in the study, they should sign and date the permission form.
- After the participant signs, the person who has orientated and secured consent must sign and date the consent form.
- Except in rare cases, a witness signature is not necessary.
Give a copy and keep a copy:
Give signed copies to subjects and maintain the original signed copies in your study file.
Notes from the research file:
Note in the study file when and with whom the consent discussion occurred, as well as any concerns that arose.
Documentation of medical records:
Include a copy of the consent form in the medical record where the study may have an impact on the subject’s health or treatment. It would be beneficial to share research-related treatment information with UCSF clinicians who may be unaware of the volunteer’s study participation. Document when the consent process occurred in the medical record as well, as they keep the same importance of informed consent in research.
Important:
Without clearance from the IRB, no changes to the documents can be made. This includes crossing out or striking through the consent form text or changing the content.
Witness signature required:
According to Federal Regulations, witness signatures are a requirement in special cases. This might also be a requirement from the IRB for specific studies to ensure an effective informed consent process.
Examples:
- The person has decision-making ability but is unable to read, write, speak, or is blind.
- The participant’s guardian/legally authorized representative is unable to read, write, or speak, and is also blind.
When there is a need for a witness, he or she must be without bias. This may include an adult who is not a member of the study team and, preferably, is not a family member of the subject (unless the person is a health professional or otherwise knowledgeable about research). At the moment of consenting, the witness must sign and date the consent form. A witness’ signature denotes:
The informed consent criteria have been met. Consent is granted freely and voluntarily by the participant, guardian, or legally authorized representative.
HIPAA Authorization form:
HIPAA allows researchers/UCSF personnel access to, use of, creation of, and disclosure of an individual’s protected health information (PHI) for research purposes. Check your approval letter (either initial or ongoing review) to learn if participants must sign a HIPAA authorization form!
Template phrasing for consent forms:
Include HIPAA-specific template language in the consent form’s “Consent” section.
Send it to the IRB:
This form should be submitted to the IRB as another Study Document.
Make a copy and keep a copy:
Examine the information on the HIPAA research authorization form and have the subject sign it. Give the subject a signed copy, and save the original signed form in the study file.
FDA Informed Consent Requirements:
- The IRB determines that the additional disclosure elements that are required and appropriate are included in the consent process.
- The consent form includes a statement indicating that the FDA may check the records submitted to each participant.
- If relevant, the consent form includes a declaration that, as required by US law, a description of the clinical experiment will be available on the Clinical Trials database. The website will not contain any information that can be used to identify the participant. The webpage will only contain a summary of the results. The participant has access to the website at all times.
- When a participant withdraws from a study, the data of the participant up to the point of withdrawal remains in the study database. The consent document cannot provide the participant with the option of withdrawing their data.
- A researcher may ask a withdrawing participant if they want to continue on the follow-up and if they allow the collection of the data after they leave the interventional portion of the study. For this limited participation in the study, the researcher must obtain the participant’s permission.
The consent document must be approved by the IRB.
- If a participant withdraws from the interventional portion of a study and refuses to consent to continued follow-up of associated clinical outcome information, the researcher must not access the participant’s medical record or other confidential records requiring the participant’s consent for study-related purposes. However, researchers can evaluate study data pertaining to the participant that was obtained previously to their withdrawal from the study. They can access public records, such as those used to determine survival status.
In the course of continuing research, situations may arise that need researcher to confirm or re-obtain consent. For instance:
- Researchers are recommended to frequently invite participants’ inquiries and confirm continuous involvement in the research when investigations are of extended duration (e.g., participant involvement lasts two or more years), or entail long-term follow-up or repeated contacts/interactions.
- When new information emerges that may affect participants’ willingness to continue in the research (e.g., from interim research findings, or communication/reports from the study sponsor), researchers must notify the IRB. They must obtain IRB approval for the materials used in informing participants of the new information, and re-obtain consent from enrolled participants.
- Following IRB approval, consent is re-obtained by utilizing modified consent document or an amendment to the original consent document.
Takeaway:
In order to undertake clinical research, it is important to obtain Informed Consent. Informed consent is a crucial part of any research study that educates participants about the research study and their rights. Once the participant is at ease with the information provided, they then sign the Informed Consent form. However, in certain situations when obtaining consent is not possible, and the research does not violate the principle of self-determination and still provides clinical value, the researcher is permitted to proceed without informed consent.
