Feature Article
Documenting Informed Consent: What’s Required and Why
January 2014 Issue
By Mary-Tara Roth, RN, MSN, MPH, Russell Gontar, and Thomas J. Moore, MD
Authors has nothing to disclose with regards
to commercial support.
All human researchers know that study participants must thoroughly understand a research study, including its risks and benefits, before agreeing to participate. Some well-known examples where informed consent was not obtained serve to remind us of the importance of this required step in the research process. For example, until the latter part of the twentieth century, research without any informed consent was commonly done with vulnerable populations such as prisoners, children and very sick patients. There is the Tuskegee Syphilis Study, where the researchers withheld penicillin treatment from men with syphilis so they could observe the natural history of the disease.
Of course, informed consent is more than the printed informed consent document. It is a process. It includes all of the communication between the investigator and the potential subject. Subjects are encouraged to ask questions so that they can be as informed as possible about what they are signing up for. It is impossible to routinely monitor the quality of these researcher-participant conversations, so we rely on the written consent document to confirm that key elements of the consent process were discussed. The subject’s signature on the consent form confirms that the subject agrees to participate in the trial.
Despite the fact that informed consent is one of the ethical cornerstones of human research, regulations around informed consent are often misunderstood or misinterpreted. As part of our human research quality assurance program, we perform audits on randomly selected human studies that have recently been approved by the IRB. We review study procedures and documentation in the early phases of the research so that modifications, if needed, can be applied sooner rather than later.
During these quality assurance audits a number of important issues related to the documentation of informed consent were identified. In some cases, if there is improper documentation of informed consent, the IRB may insist that study subjects be re-consented and in other cases the IRB may not allow the data from subjects where consent was improperly documented to be used.
In this article, we would like to highlight some of the issues with informed consent that we have encountered so that our entire research community can be clear on what type of documentation is necessary.1. The proper version of the consent form must be used
Audits commonly find that the incorrect version of the consent form has been used. When the IRB initially approves a protocol that includes a documented consent process, it also approves a matching consent form. If the consent form is subsequently modified in an amendment to the protocol, then the newly-approved consent form will be validated with a new date stamp at the bottom (see image below); and the former consent form is marked invalid and should no longer be used.
The consent form is also approved at each continuing review; so even if there are no changes to the consent form at that time, a new approval date stamp with the new study approval date range will appear at the bottom of the consent form. Using the incorrect version of the consent form can have important safety implications for participants. For example, in one case, a study was amended to give a larger dose of the study drug, and the amended consent form stated the new higher dose. However, some subjects signed the old consent form with the incorrect lower dose. In many cases, the reason subjects sign outdated consent forms is because researchers print many copies of the consent form to conveniently have on hand when subjects come for their consent study visits, and then fail to discard the obsolete versions. Best practice: Print the current version of the consent forms daily on an as-needed basis instead of printing many copies monthly or yearly!
2. Subjects must personally sign and date the consent form.
Study teams might – mistakenly and with good intentions – implement a process of writing in the date when consent was obtained for the subject. However, this practice is in conflict with regulatory requirements and BUMC IRB policies which require that the consent process be documented by having the subject (or subject’s legally authorized representative) personally sign and date the consent form.
3. The consent form should be signed and dated before any research procedures take place.
The subject’s own signature is documentation that the subject received the information about the study. The subject’s dating of the consent form allows for verification that the consent process took place prior to research procedures. The study documentation of the informed consent process should clearly indicate that the research began after the consent form was reviewed with the subject, and signed by the subject and investigator. If research procedures begin on a date after the consent is signed, then this is clear by just the date on the consent form. It’s not as clear when the consent form is signed on the same day as research procedures begin. Best practice: There is no regulation that requires that the time of consent be noted on the consent form. However, the regulation does clearly state that informed consent should happen before taking part in the research. Thus, if research procedures begin directly after the consent is signed (i.e., on the same day), then some method should be used which makes it clear that the consent process took place prior to any study procedures beginning. One way to do this is to supplement the consent form by adding a progress note which documents that the consent process took place before any research procedures. FDA guidance recommends that “…if consent is obtained the same day that the subject’s involvement in the study begins, the subject’s medical records/case report form should document that consent was obtained prior to participation in the research.”
4. The investigator or designee conducting the consent process must personally sign and date the consent form.
This is a requirement in Good Clinical Practice (GCP) guidelines. This signature and date affirm that the person who conducted the consent process did so on the day that the subject signed the consent form. It also allows verification that this individual was approved to obtain informed consent by the IRB-approved protocol (see below for more on this topic).
5. The investigator or designee conducting the consent process and signing the consent form must be listed in the IRB-approved protocol.
The protocol may have requirements for who may be involved in the consent process. For example, the protocol may explicitly state that the person must be an MD, PhD, and/or RN. Even if there is no specific requirement in the protocol, regulatory requirements dictate that the individuals involved in human subjects research have documented and up-to-date training in human subjects protection. Regulations also require that the investigators have appropriate training to do the protocol-specific tasks assigned to them. Also, the IRB approves not only the consent form, but also the consent process, including who is able to obtain consent. Thus, the name of the investigator enables verification that the individual obtaining consent is approved to do so by the IRB and has fulfilled all the appropriate regulatory requirements, including having sufficient training to do the job. Best practice: Ensure that the person obtaining consent is listed on the IRB-approved protocol, and is approved and appropriately trained to conduct the consent process!
6. Written alterations to the consent form, even if initialed and dated by the subject and the investigator, are not acceptable.
The IRB approves the consent process and the content of the consent form. Investigators are required to use only the current, approved consent form to consent and enroll subjects. Changes to the consent form that are not approved by the IRB invalidate the consent form. Any changes to the consent form must be reviewed and approved by the IRB. If the revisions involve changes to the risk or to the procedures, then the subjects who would be affected by the changes (currently active subjects) may have to be re-consented. Best practice: Ensure that study staff are trained and know that altering the consent form invalidates the consent document.
7. The entire signed consent form must be kept by the study team in the study records.
Although one might think it’s a good idea to streamline study records or save paper by keeping only the signed last page of the consent, this particular streamlining process is not acceptable. Maintaining the full consent form provides documentation that the subjects were provided with all of the information about the study. If the entire consent form is not present in the study records, then it is impossible to verify what the subjects received to make their decision to take part in the study. Best practice: Keep the full, signed form and give a copy to the subject.
“When you know better, you do better.” – Maya Angelou
“An ounce of prevention….” – Benjamin Franklin
Most of the items described above are easy to implement. One barrier to proper documentation of informed consent is that investigators and research team members are not clear about what is required to properly conduct and document the consent process and/or are not sufficiently trained on the appropriate processes. Any person involved in any aspect of the consent process should receive training on all aspects of the consent process prior to carrying out any of the tasks (in addition to being added to the IRB-approved protocol). Best practices dictate that the training of any study staff also be documented as proof that the training was completed. The study team can develop processes to ensure that new staff obtain the appropriate training for their roles (which may include obtaining consent). One great way to track the training of study staff is using the templates developed by the Clinical Research Resources Office (CRRO) available here (see Staff Member Training Log and Task Delegation log). Using such templates can help to document and verify that the individuals designated by the Principal Investigator to carry out certain tasks received the appropriate training, education, certifications, etc. to adequately carry out these tasks at the time they were assigned to do them.
Another means by which study teams can evaluate their consent process is to implement a procedure for doing self-audits by critically assessing completed consent forms. The self-audit technique is simple, can be extremely informative, and can help study teams know where their processes should be improved to ensure proper conduct moving forward. The CRRO has a self-review template for consent forms, available here. Study staff should choose the frequency of these self-audits depending on the rate of participant enrollment. Staff should systematically review every consent form (since the last self-audit) for the following:
- Was the appropriate version of the consent form used?
- Did the person obtaining consent have IRB approval to do so (at the time the consent was obtained)?
- Did the subject personally sign AND date his/her own consent form?
- Is it clear from the documentation that the consent was signed prior to any research procedures taking place?
- Did the investigator or designee personally sign and date the consent form?
- Did the investigator or designee date the form on the same day as the subject? If not, is there appropriate documentation as explaining why?
- Are there any handwritten modifications to the consent form?
The data you collect for your research study are used to test your study hypothesis. It is the written documentation—the data, and the study procedures and documents that describe how you collected those data—which supports the validity of the data as well as the safety and ethical treatment of study subjects. It takes some simple steps to ensure that the informed consent documentation is properly done, starting with the training of study staff to the appropriate procedures so that consent forms are correctly signed and dated by the subject and the investigator; confirming that the current versions of the consent form are used; and understanding that no alterations can be made to the consent form without IRB approval. Informed consent is a fundamental tenet of ethical human subjects research. Thus, it is essential that we get this right.
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