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Genetic Research

In addition to the guidelines for research involving stored biological material, the following must be considered for genetic research: 

  • The researcher must ensure that the results of genetic testing and genetic counseling records are protected from access by third parties (e.g., insurers, employers), unless free and informed consent to do so is given by the participant (TCPS 2, Article 13.2). For example, for some projects CHIPER may request that there be no mention of the project in the participant’s medical charts. 
  • Children may be at particular risk for stigmatization both within and beyond the family because of knowledge gained through genetic projects. The investigators, REB and substitute decision makers must carefully weigh the risks and benefits of participating in genetic research for the child. In general, children should not undergo carrier testing or predictive testing for adult-onset conditions that do not have any management recommendations in childhood (e.g., it may be appropriate to offer testing to children in a family for an early onset condition such as polyposis coli, for which the knowledge affects treatment options, but inappropriate to test children for an adult-onset condition such as Huntington Disease for which no effective prevention yet exists). 
  • Where appropriate, researchers and CHIPER shall ensure that the research project makes provision for access to genetic counseling for the participants (TCPS 2, Article 13.3). 
  • Gene alteration (including “gene therapy”) that involves human germline cells or human embryos is not ethically acceptable. Please see TCPS 2, Chapter 13, Section G and the Assisted Human Reproduction Act for additional guidance.  
  • Gene alteration for therapeutic purposes and involving human somatic cells may be considered for approval. 

Informed Consent Form for Genetic Research 

The following additional requirements for informed consent should be addressed for genetic research: 

  • Discuss potential harms (to the participant, family, group or community) that may result from the genetic research. For example, receiving information regarding susceptibility to genetic disease or identification of blood relationships may cause distress to the participant. Describe how such harms will be dealt with as part of the research project (e.g., genetic counseling, TCPS 2 Article 13.3). 
  • Plans for disclosure of the results of genetic research (to the participant and to family members) must be addressed in the Harmony application, project protocol and the informed consent forms. 
  • With the exception of the cases provided by law, no genetic information should be transmitted to insurers, employers, educational institutions and other public institutions without express consent from the participant. 

Genetic Research Q&A

Question: Can the current guidelines (for example with respect to length of storage, or informed consent) be applied to research involving samples that were collected prior to the existence of these guidelines? 

Answer: Yes, the current guidelines may be applied. RITHIM will address such projects on a case-by-case basis.

Question: Do researchers need to specify length of storage for research that does not involve genetic analysis? If not, what is the justification for specifying length of storage for genetic research (other than the fact that it is asked for in the TCPS 2)? 

Answer: Regardless of the type of sample, genetic or otherwise, length of storage should be specified if the samples are not anonymized. While there is no ‘upper limit’ for the length of storage, the length must be justified. In certain circumstances it may be necessary to maintain the link to the participant, for example if the results of the research may be beneficial to the participant.  If the samples are anonymized, storage for an indefinite period of time is acceptable.  The informed consent form should specify the length of storage and whether the samples are anonymized.

Question: Should ‘minimal risk’ research involving human biological materials qualify for delegated review? For example, some research involving anonymous or anonymized tissue may qualify for delegated review. 

Answer: ‘Minimal Risk’ research may qualify for delegated review. This is to be determined by the CHIPER chairs on a case-by-case basis. 

Question: Would CHIPER accept informed consent forms that refer to future use of the samples in general terms, rather than specifying, at the very least, the category of future research (e.g., “research about cardiovascular disease”)? 

Answer: Such informed consent forms are only acceptable when the samples are anonymous. If the samples are not anonymous, the informed consent forms need to be more specific with respect to the type of research. 

Question: How should our local researchers address ethical concerns with regard to storage and access when other parties (e.g., the sponsor) are banking the samples? 

Answer: The informed consent form should detail who has access and under what circumstances. The recipient researcher’s/institution’s policies governing storage and access to stored samples should be provided in the Harmony application along with the request for approval.