What about consent?

Ethics committees have determined that explicit informed consent for Lynch Syndrome screening is NOT necessary. View an example of one decision on informed consent.

In August 2013, the Lynch Syndrome Screening Network conducted a brief, informal survey* of members regarding consent practices. The results, summarized below, show that the majority of the responding institutions do not obtain specific written informed consent. The one institution reporting utilization of a written consent indicated this was through the standard surgical consent obtained at the time of surgery.

*The survey and results were provided by:
Maria J. Baker, Ph.D., FACMG, M.S., CGC
Associate Professor of Medicine
Division of Hematology/Oncology
Penn State Hershey Medical Center

What method of informed consent (if any) do you use?

  1. No informed consent – 73.33% (33 respondents)
  2. Information sheet provided in advance – 24.44% (11)
  3. Verbal consent – 0.0% (0)
  4. Written consent – 2.22% (1)

Total Responses = 45


No Informed Consent

  • Consent forms are signed for all medical diagnosis, treatment, management at first visit. If surgery follows, there is this form already in the chart.
  • IHC performed at time of surgery. Surgical consent obtained and felt to encompass IHC.

Information Sheet

  • Our informed consent info is included in the surgical information prior to surgery. The patient is informed that, in the case of colon or endometrial cancer, IHC is routinely done on the tumor. We also do BRAF and methylation on abnormal results as appropriate; these screening tests are also included in the informed consent process (i.e., I only call the patient after all testing has been completed–IHC, BRAF, and methylation).
  • The physicians are instructed to provide the information sheet (which I provide to their offices) prior to surgery. I have not checked on their compliance with this policy.
  • The information sheet provided at the patient’s pre-op visit does not really constitute “informed consent,” but our physicians feel that since we are just using IHC for universal screening, it is similar to other pathology tests done for treatment purposes. Any screen-positive patients are referred to genetic counseling and that is where the real informed consent to proceed with germline testing occurs.

Written Consent

  • Standard surgical consent at surgery

Chubak B, Heald B, Sharp RR: Informed consent to microsatellite instability and immunohistochemistry screening for Lynch Syndrome. Genet Med 2011; 13:356-360.

Chubak B, Heald B, Sharp RR. Informed consent to microsatellite instability and immunohistochemistry screening for Lynch Syndrome. Genet Med. 2011;13:356-360. [Abstract]

Letter to the Editor: Williams JL, Williams MS. Informed consent and immunohistochemistry screening for Lynch Syndrome. Genet Med. 2011;13;848-849. [Abstract]

Chubak et al. conclude that there is no ethical obligation to obtain informed consent from patients who undergo universal CRC tumor screening with MSI, comparing to other routine tests in oncology such as receptor typing in breast cancer, and that it characterizes only the tumor, not the germline. However, the authors argue that informed consent for IHC testing may be considered because such testing is strongly predictive of germline abnormalities and is more similar to a traditional genetic test. The authors acknowledge that obtaining consent for universal IHC testing would represent a deviation from standard practices and research is needed to understand the implications of population-based testing. The authors recommend that newly diagnosed CRC patients should be prepared for and educated about the tests performed and possible follow-up that may ensure if results are abnormal.

Responding to the article, the letter to the editor reported on the authors’ experience implementing universal screening with IHC within Intermountain Healthcare. After thorough exploration and discussion the issues, the group screened more than 200 patients and provided educational materials and an “opt out” option instead of formal informed consent. Based on their program’s positive experiences, the authors concluded that informed consent is not required for IHC screening, but that further empirical studies should be undertaken.

Manne SL, Meropol NJ, Weinberg DS, et al. Facilitating informed decisions regarding microsatellite instability testing among high-risk individuals diagnosed with colorectal cancer. J Clin Oncol. 2012:28:1366-1372. [Abstract]

Hall MJ, Manne SL, Winkel G, et al. Effects of a decision support intervention on decisional conflict associated with microsatellite instability testing. Cancer Epidemiol Biomark Prev. 2011;20:249-254. [Abstract]

These two studies, performed by the same group, assessed the effect of informational interventions in more than 200 newly diagnosed CRC patients meeting Bethesda criteria. Participants were randomized to receive a brief education session with a health educator (E) or E plus a CD-ROM decision aid to address issues related to MSI and IHC testing. The E + CD-ROM participants had significantly increased knowledge about testing, and had an improved experience in multiple domains with respect to decision making about testing, and the intervention did not adversely affect psychological outcomes. Since more than 90% of participants consented to the tumor test, and there was no control group in the study, it is not possible to conclude what effect the interventions had on test uptake. However, the authors conclude that a multimedia-based intervention may be a valuable adjunct to the informed consent process and may facilitate informed decision making about taking the test.