- My research involves the use of human biological materials. What do I need to do to obtain research ethics clearance for my studies?
- What do I need to include in the information-consent letter for my potential participants?
- Are there any sample information-consent letters that I could look at to give me some guidance in writing my own letter?
- What do I need to include in the information-consent letter if I intend to create a biobank or biorepository?
As outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS, 2nd edition), “the use of materials originating from human bodies for research contributes greatly to the advancement of knowledge” (p. 169).
The sources of biological materials collected from humans may come from a variety of places but mainly the materials will come from patients following diagnostic or therapeutic procedures, autopsy specimens, donations of organs or tissue from living or dead humans, body wastes (including urine, saliva, sweat) or abandoned tissue. Not only are biological materials used in specific research projects, but they may also be held in a biobank to be used in future research.
Research involving human biological materials may include: tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, or other bodily fluids. An individual whose data and/or biological materials used in research is a study participant and they may agree to provide a biological sample for a particular project or donate organs, tissue, or their entire body for research that occurs after their death; individuals then become a study participant through their donation. In other instances, researchers may use human biological materials for secondary use in research.
Human biological materials may be obtained by researchers in several different ways as outlined in the TCPS2 (p. 171):
- “they may be collected expressly for a specific research purpose”,
- “they may be collected incidentally to medical or diagnostic procedures with no initial intent to be used in research”; or
- “they may be collected for research or medical or diagnostic purposes with some expectation that they may, or will, also be used in future research, although the precise research project(s) may not be known at the time”.
The Office of Research Ethics and the two Research Ethics Boards at the University of Waterloo, the Human Research Ethics Board (HREB) and the Clinical Research Ethics Board (CREB), recognize that there are ethical issues that researchers need to specifically take into consideration when planning a study that involves human biological material (e.g., saliva, blood, tissue, cells). These considerations apply whether the biological material will be transferred from another institution or collected from members of the University of Waterloo community or by members of the University of Waterloo community.
This guideline applies to any form of human biological material which will be used by University of Waterloo researchers, whether this biological material will be received from another institution, for example, by using a Material Transfer Agreement, or whether it will be collected by Waterloo researchers themselves. The same ethical considerations must also be considered when researchers intend to create either biobanks or biorepositories.
These guidelines are meant to be a living document. Changes or revisions may be required as the collection of biological materials or the use of biobanks at the University of Waterloo increases and evolves.
The ethical considerations that researchers need to consider when conducting research involving human biological materials, as noted in the TCPS2, are:
- “acceptable access to, and use of, the materials”,
- “potential privacy concerns arising from the handling of information derived from such materials”, and
- “the special status some individuals and groups accord to the human body and its parts” (p. 169).
The TCPS2, states that “human biological materials that may reasonably be expected to identify an individual, alone or in combination with other available information, are considered identifiable biological materials (or biological materials that are identifiable)” (p. 169). As a researcher, please review the following categories as these will provide guidance for assessing the extent to which human biological materials could be used to identify an individual:
- Identified human biological materials
- The materials are labelled with a direct identifier (e.g., name, personal health number).
- Materials and any associated information are directly traceable back to a specific individual.
- Coded human biological materials
- Direct identifiers are removed from the materials and replaced with a code.
- Depending on access to the code, it may be possible to re-identify specific individuals (e.g., a principal investigator retains a key that links the coded material with a specific individual if re-linkage is necessary).
- Anonymized human biological materials
- The materials are irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.
- Anonymous human biological materials
- The materials never had identifiers attached to them and risk of identification of individuals is low or very low.
My research involves the use of human biological materials. What do I need to do to obtain research ethics clearance for my studies?
You will need to complete and submit a research ethics application form. If you will be using biological samples which you have received from another institution (e.g., by means of a Material Transfer Agreement) which are anonymous or have been anonymized as outlined above under Types of Human Biological Materials, please complete the 'Use of tissue or bodily fluids for research purposes'. In all other cases, complete the Standard application.
What do I need to include in the information-consent letter for my potential participants?
If your study is a specific research project with a specific duration and you intend to “use and destroy” the materials and no biobank or biorepository is intended to be created, the information and consent letter needs to include the following elements:
- Specific type and amount of biological materials to be taken from study participants
- The manner in which biological materials will be taken and the safety and invasiveness of the procedures for acquisition
- The intended uses of the biological materials, including any commercial use
- The measures employed to protect the privacy of and minimize risks to participants (note: ensure specific reference is made to the University of Waterloo’s data security guidelines and requirements)
- The length of time the biological materials will be kept, how they will be preserved, location of storage, and process for disposal, if applicable
- Any anticipated linkage of biological materials with information about the participant, if applicable
- Right to withdraw the samples (or not) and what will happen to data already obtained or aggregated into the existing analysis
- Assurance of independent review by HREB/CREB and contact information for the HREB/CREB if questions or concerns were to arise for a participant
- Prohibition of financial gain (i.e., researchers will not be able to sell the actual samples obtained for financial gain but may commercialize).
- The researchers’ plan for handling results and findings, including clinically relevant information and incidental findings
- Rules governing transfer of samples to other laboratories
- Any anticipated future use of this data for other research objectives (i.e., secondary use of data). Please refer to p. 173 of TCPS 2 for the specific conditions under which secondary use of biological material is allowed.
Are there any sample information-consent letters that I could look at to give me some guidance in writing my own letter?
Please refer to the sample information and consent letters available from the University of Michigan or the wording below from Western University. The following has been adapted from Western University, London, Ontario. This wording should be inserted into the information-consent letter:
- Any specimen(s) [specify type, e.g., tissue, blood, urine] obtained for the purposes of this study will become the property of the researchers/sponsors and once you have provided the specimens you will not have access to them. They will be kept in [specify where and detail security and privacy controls] for [specify length of time].
- The specimen(s) will be discarded or destroyed [and specify how] once they have been used for the purposes described in the protocol.
- The specimens will be used for research and such use may result in inventions or discoveries that could become the basis for new products or diagnostic or therapeutic agents. In some instances, these inventions and discoveries may be of potential commercial value and may be patented and licensed by the researchers/sponsor. You will not receive any money or other benefits derived from any commercial or other products that may be developed from use of the specimens.
Samples of biobank and biorepository information-consent letters:
What do I need to include in the information-consent letter if I intend to create a biobank or biorepository?
If your study involves the creation of a biobank or biorepository, and the human biological sample is intended to be added to a biobank or biorepository, the information and consent letter needs to include the following elements:
- Location of the biobank/biorepository
- Type and amount of materials to be stored
- Research scope for the stored biological materials
- Indicate clearly if participation in the biobank is an option to participation in the main/related study (usually it will be)
- Overview of the scientific relevance of biobanks and their importance to human well-being
- Participants should be specifically asked to participate in creating a biobank
- Specific health and personal data to be collected, if applicable
- Nature of the research activities in the field of biological materials
- Choice in advance of whether or not to be contacted in the case of discovery of meaningful personal information
- Statement that researcher has moral duty to contact donor to be informed of results and given an opportunity to decide whether or not to be informed at that time.
- Risks related to the collection of the sample
- Voluntary character of the donation (i.e. an assurance that you are donating this sample voluntarily)
- Right to withdraw your material and duration of storage
- Identifiability of biological materials, if applicable
- The physical, administrative and technical safeguards which will protect the human biological materials and any information about participants from unauthorized handling. This may include information about the governance structure of the biobank or repository.
- Prohibition of financial gain such that participants should not receive any payment for the gift of biological material and the biobank/biorepository should be forbidden to sell the collected biological samples.
- Assurance of independent HREB/CREB review