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:
- 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
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 projects, 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.
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.
If confidentiality or anonymity cannot be assured, clearly state this under the “risk” section of the consent form.
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 consent template(s), found on the ORPC Documents and Forms page (scroll to Human Participant Use (IRB) Forms. The originally signed and dated consent document is valid for the approved time period stated in the protocol approval letters. Consent documents will have an “Approval Date” indicating when an investigator can begin using the form.
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 (LINK TO WAIVER PAGE). 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 project period due to changes in procedures or identification of serious or adverse events. These revisions must be documented using the protocol modification process (LINK TO MOD 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.
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 project, 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 firstname.lastname@example.org”.
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 project. 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