Genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results.

In addition, myriad operational concerns exist for sponsors and sites, ranging from finding patients to test and identifying which genes and mutations to test for, to designing appropriate protocols and managing the resulting data and results.

Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

To begin, genetic counselors can provide pre-test genetic counseling for candidates who need to take a genetic test to determine eligibility for a clinical trial.

Not only does the pre-test counseling make patients aware of the possibility of unwelcome and unexpected results, it can also help determine if a different genetic test would be more appropriate — or if genetic testing is necessary at all. In addition, pre-test counseling allows counselors to address concerns related to genetic discrimination; alleviating those concerns can increase the pool of potential trial participants.

Genetic counselors can play a significant role here, helping patients understand the results and what they mean.

The research is clear: Genetic counseling can be beneficial to patients and study partners by helping them understand the implications, and facilitating decision-making and informed consent. Once a genetic risk is identified, patients then need to be counseled to know how to proceed.

Research — and need — notwithstanding, genetic counseling has yet to be integrated into most clinical trial protocols.

So that raises the question: Who will do the counseling? Clinical investigators often lack the experience in speaking to patients about the results of genetic tests, and many fail to understand the disconnect between the scientific community’s understanding of genetics and the general population’s grasp of the topic.

Healthcare professionals in the clinical setting may have a better grasp of what the patient needs to know, but they often lack the time or expertise to discuss findings in depth.

Essential to the process is deciding how to obtain informed consent. That can be a challenge because, sometimes, risks are impossible to quantify. Moreover, each patient brings to the table values and cultural contexts. Counselors also help control expectations: No one benefits if participants pin unrealistic hopes on a particular study.

The notion of informed consent becomes particularly problematic when there’s potential cognitive decline and/or memory loss. Decisions about how investigators will obtain informed consent need to be made at the design level, not in the field.

Genetic counselors can help investigators anticipate questions as they are designing the protocol so they can be addressed, systematically, in advance — not in an ad hoc manner once recruiting has begun.

Among the issues to consider when incorporating genomic or genetic data into a clinical trial:

• How do you obtain patient consent for trials incorporating genetic/genomic data?
• How do you manage multiple consents?
• What do you explain during the consent process?
• How do you handle consent when diminished cognitive function is — or will be — an issue?
• How will you assess decisional impairment?
• How will you handle incidental genetic test results? What are the ethical and clinical considerations?
• What subsequent conversations and follow-up will you have with patients?
• How do you manage patient expectations of a clinical trial?
• How do you address patient misconceptions about genetic testing?
• Who will be responsible for each of the above?

Until CROs and sponsors are able to develop that expertise themselves, they need outside experts to help them design protocols and appropriate genetic test panels, provide genetic counseling and test interpretation to potential participants. This ultimately improves the success of CNS clinical trials, allowing sponsors to bring urgently needed therapies to market faster.

Jill Johnston is president of site activation solutions for WCG Clinical Services. Jill also is an instructor for clinical monitoring at Mercer County College, supporting Drexel University’s Clinical Development Master’s degree program.

Tricia See, ScM, GCG, is the cardiac and neurogenetics team lead at InformedDNA. Formerly, Tricia was a genetic counselor at Children’s Hospital Boston, University of California San Francisco Memory and Aging Center, and Children’s National Medical Center’s Center for Prenatal Evaluation.