The goal of the consent process is to facilitate a prospective participant’s or legally authorized representative’s understanding of the reasons why an individual might or might not want to participate in a research study. The responsibility for the investigator in the consent process is to:
- Provide more information when requested by subjects
- Make sufficient time and opportunity to discuss the research
- Answer questions to improve a subject’s understanding
For certain types of research (e.g., research for which there is reason to believe some subjects will find the research controversial or objectionable), a robust description of the research will be required.
The informed consent process and consent form must encompass key information, be well organized, and presented in a way that facilitates comprehension and include a concise explanation of the following (excerpted from www.citiprogram.com):
- Consent is being sought for research and that participation is voluntary
- A description of the reasonably foreseeable risks or discomforts to the prospective participant
- An explanation of the purposes of the research, expected duration of participation, and procedures to follow in the study
- The benefits to the participant or others that may reasonably be expected from the research
- Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to participants
This approach provides “key information” [46.116(a)(5(i))] essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Investigators are reminded to present informed consent information in sufficient detail and in a way that helps with subject comprehension, not just running down a list of risks and procedures. Investigators are advised to review the general instructions and helpful hints to create a consent form, choosing from the below list of templates.
Depending on the research, the above “information” elements of consent may require the use of three other requirements:
- 46.116(c)(7) -A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
- 46.116(c)(8) -A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
- 46.116(c)(9) -For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Confidentiality
Provisions for confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. If data are to be in the form of audio/video tape recordings or photographs, procedures protecting confidentiality should be described. Be sure to describe to participants the steps used to preserve confidentiality. In the course of certain protocols, confidentiality may not be absolute or perfect. This must be expressed to participants. There are some circumstances where research staff might be required by law to share information provided by participants.
Anonymity
An anonymous study means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including the investigator). Even if data is coded, it can be de-coded and become identifiable. A confidential study means that while their identity potentially could be determined from the information they give, steps will be taken to insure that they will not be identified. Be sure to describe to participants the steps used to preserve anonymity. A study cannot be both confidential and anonymous.
Use of Consent Documents
Federal regulations at 45 CFR 46.117 require written informed consent, one that is approved by the IRB and signed by the participant or the participant’s legal representative and the principal investigator (or his/her delegate).
Consent forms are signed at the time the consent conversation concludes and by the person actually administering consent, attesting to the informed consent conversation. The delegate acts as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective participants; this person should be listed in the “Offer to Answer Questions” section of the consent form, as well as a member of the research team on the protocol application. At no time should the consent forms be pre-signed by the members of the research team.
Please choose the appropriate consent templates for your study and upload draft versions to Kuali using your Kuali protocols dashboard:
UMBC Consent Templates
Consent Documents – Instructions || Adult Consent Template
Consent Documents – Instructions || Adult Assent Template
Consent Documents – Addendum to Prior Consent Template
Consent Documents – Instructions || Email Consent Template
Consent Documents – Instructions || Information Sheet Template
Consent Documents – Instructions || LAR Consent Template
Consent Documents – Instructions || Parent/Guardian Consent Template
Consent Documents – Instructions || Webpage Consent Template
Consent Documents – Instructions || Minor (Child) Assent
Consent Waiver – All Consent Elements
Consent Waiver – Alteration of Consent Elements
Consent Waiver – Documentation of Signature
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Waivers of consent
Depending on the circumstance, investigators may request a “waiver of consent” that waives certain requirements of consent documentation. The IRB will expect you to document how and when consent was obtained. This may be in the form of a consent log (paper based, spreadsheet, etc.) that tracks the consent conversation and may be used as part of protocol file. The consent waiver process and forms required to request a waiver are found here. For investigators to use, here is an example of a consent tracking log.
Revisions and updates to approved consent documents
Revisions to previously approved consent forms may occur during a protocol period due to changes in procedures or identification of serious or adverse events. These revisions must be documented using the protocol modification process. In all cases, all participants who had previously signed a consent form must be provided this new information with the option of remaining in the study. Investigators will upload draft versions of an Addendum to Informed Consent Form to Kuali using your Kuali protocols dashboard.
Guidance for the Use of Electronic Signatures for Documenting Informed Consent
When the IRB reviews the study, it will consider how the electronic signature is being created, whether the signature can be shown to be valid and/or legitimate, and how the research team plans to provide a version of the consent form to the potential participants for their review and retention. Click on this link for additional IRB guidance.
Consent Forms Approved at Other Institutions
Many human research protocols conducted at UMBC involve collaboration with researchers from other institutions. At times, UMBC faculty members, masters and/or dissertation students are listed as a co-investigator on a collaborative protocol with that institution’s IRB reviewing and approving the research protocol. External IRB institutional approval is accepted by the UMBC IRB; however, while the faculty member or student is listed on the consent documents as a co-investigator, no information is provided to potential participants of whom to contact at UMBC in the event of asking questions or addressing issues or problems. The purpose of this addition will provide complete and full information to participants about who is involved with the study and whom to contact with questions and concerns. Investigators are reminded to add a statement to the Whom to Contact section of the consent documents such as “In addition, this study has been reviewed and approved by the UMBC Institutional Review Board (IRB). A representative of that Board, from the Office for Research Protections and Compliance, is available to discuss the review process or my rights as a research participant. Contact information of the Office is (410) 455-2737 or compliance@umbc.edu”.
Certificates of Confidentiality
Certificates are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research protocol. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Additional information and directives for Certificates of Confidentiality may be found at http://www.hhs.gov/ohrp/policy/certconf.html