by Claire Carbary

Consent for Future Research

Addressing the “Unknown” in the Consent Form

Increasingly, participants in clinical trials are asked to allow their samples to be stored for future research. Often these requests are embedded in the main consent form for a study and the description of the plans for samples may be limited to a few sentences. When requests are framed in this way it is unlikely they meet the regulatory requirements for informed consent. Moreover, it’s unlikely that participants really understanding the request, how it is different than their involvement in the main study, and whether it is optional.

Although there is industry-wide recognition of the need for simplified consent documents and processes, consent for research must comply with current legal and regulatory requirements and should be meaningful to participants. Below we’ve provided some tips and considerations relating to each element of consent when asking individuals to bank samples as well as some sample language.[1]

Purpose, Duration & Procedures

angioplasty-diagramIt is important to keep the “understandability” requirement in mind. Take a sentence or two to define terms like “angioplasty” or “catheter” when explaining the type of research that may occur with the samples. Consider using images to help define terms.

Although the procedures are typically straightforward, the consent form should clearly state whether additional procedures are needed if the request is an add-on to an existing study. Whether or not the purpose of the future research is known, it is important to tell people the scope of the plans.

As far as the expected duration of research, there is generally not a limit to the time samples will be stored. However, that does not mean the consent form should remain silent on this issue.

Example Statements

Example 1: Purpose The purpose of this project is to collect tissue samples and some health information from many people. We will store these samples and information in a biobank so they can be used for research now and in the future.[2]

Example 2: Purpose We would like to keep the samples we collect as part of this research to be used by researchers that want to conduct research about people with your condition.

Example 3: Duration There is no limit on the length of time we will store your samples and information. We may keep using them for research indefinitely unless you decide to withdraw from the project.[3]

Risks & Discomforts and Unforeseeable Risks[4]

Typically the main type of risk that is foreseeable in the context of sample storage for future research is the loss of confidentiality or “informational risk”. Physical risks tend to be negligible for providing samples: Often requests are for continued storage and use of a sample that would already be drawn. Depending on the type of information collected or generated for future research, the risks could extend to family members or members of a group to which the subject belongs. These risks are generally unforeseeable as far as what might be known or could be revealed and should be addressed.

Discussion of risks may need to address the risks posed by the combination of biological material and clinical information from other sources or other information that is publicly available about the individual. It is a good practice to include a statement that as technology advances informational risks will likely grow.

Example Statements

Example 1: Informational Risks [I]t may be possible that genetic information from them could be used to help identify you. Similarly, it may be possible that genetic information from you could be used to help identify [your blood relatives].[5]

Example 2: Informational Risks Because your samples contain genetic information that is unique, there is a chance that someone could trace your samples back to you. The risk of this happening is small, but may be greater in the future.[6]

Example 3: Data Breach There is always a possibility that information could be accessed by individuals without authorization. We have security systems and procedures in place to try to prevent this, such as password protection and data encryption.[7]

Example 4: Unforeseeable Risks We will take many steps to protect your privacy, but because your DNA is unique to you, it is possible that someone could trace it back to you. There is also a risk that someone could get access to the data we have stored about you. There may also be other unforeseen privacy risks.

Benefits[8]

An individual who contributes samples for storage and future research will not likely receive an individual benefit. There are certainly possible benefits to others if researchers are able to gain a greater understanding of diseases and conditions and that can be stated.

 Example Statement

 Example 1: Benefits You will not get direct benefit from taking part. The main reason you may want to take part is to help researchers make discoveries that might help people in the future.[9]

Alternatives and Voluntariness of Participation[10]

The alternatives section for a typical study discusses alternative treatment options; however, with sample storage- the alternative is not to participate. The participants should also be clearly informed as to whether the banking is optional if it is being asked in the context of another study.

Example Statements

Example 1: Optional Banking The alternative to participating is not to participate, and the decision about whether to participate is completely up to you.[11]

Example 2: ‘Required’ Banking If you do not agree to have your tumor sample stored for future research you cannot participate in this study.[12]

Example 3: Voluntariness The choice to participate in this research by donating your tissues and medical information is completely up to you.[13]

confidentiality imageConfidentiality[14]

The description of how confidentiality will be maintained is often quite complicated and unclear. It is important to keep the “understandability” requirement in mind when describing plans for storing samples. Terms such as “coded”, “anonymous”, and “de-identified” should not be used without further explanation as there is not a single definition for these terms and they can be interpreted differently. This section should explain how entities and researchers will have access to information and samples and explain what type of information and samples could be obtained by researchers.

Example Statements

Example 1: Confidentiality We will remove your name and other identifiers from your sample and information, and replace them with a code number…[Researchers] must also sign an agreement that they will not try to find out who you are…We will not give information that identifies you to anyone, except if required by law.[15]

Example 2: Confidentiality Your samples will be “coded”, meaning the biobank will have a code that links to all of the information collected about you. Researchers will only have access to certain information, such as dates and your diagnosis, but will never receive your name.

Compensation and Medical Treatments in Case of Injury[16]

As sample collection procedures tend to be minimally invasive- or may not even be required- a statement about compensation for injury might not be needed as it is only required in the event the procedures pose a greater than minimal risk to the subject. It is important to make a distinction, however, if the banking is an additional request as part of a main study if there is any difference in policies for compensation. Costs associated with procedures are unlikely or tend to be quite minimal. This should be clearly stated as well. A good example addressing both costs and compensation for injury in just three sentences is provided below.

Example Statement

Example 1: Compensation You will not be paid to participate in this project. You will not incur any expenses from participating in this project. If you are physically injured as a result of participating in this project, emergency medical treatment for your research-related injury will be provided to you at no cost.[17]

Question-Exclamation_icons-200x-197Contact for Study-Related Questions[18]

This is another element that may require differentiation from a main study if sampling is requested as part of the study. While the individual participant would typically contact the study doctor for questions regarding the main study, they may need to contact the sponsor or another entity in the case of sample storage or banking protocol.

Example Statement

Example 1: Questions For questions about this project, contact [name], the Biobank Director, at [number]. For questions about your rights as a research participant, contact the [IRB] at [(XXX) XXX-XXXX].[19]

one_of_many-1Withdrawal and Number of Subjects[20]

The issue of withdrawal is an important one to address so that people don’t have the wrong expectations about whether they can request the removal or destruction of their samples and data. The consent should explain whether samples and data can be withdrawn, whether there is a time limit, and also address the issue of withdrawal after samples or data have been shared or used for research and the inability to retrieve them at that point. Another issue to be addressed as part of consent, number of subjects planned, may not be known, this should be explained so that people have an understanding of the scope of the planned sample storage or biobank project.

Example Statements

Example 1: Withdrawal You can also tell us to stop using your medical records. However, you cannot withdraw your samples and information from studies that have already begun. We cannot get samples and information back once they are shared with other researchers. Also, it may not be possible to remove your genetic information from scientific databases once it has been distributed.[21]

Example 2: Number of Subjects This biobank is planned to continue for many years, we do not know how many people will contribute samples; however, we hope that at least XXX people will join.

New Findings[22]

“New findings” is another topic the regulations require consent to address. In the context of sample storage and future research, the issue of new findings, and particularly incidental findings, need to be thought-out. Policies are needed to guide the handling and possible dissemination of incidental findings and the language in the consent form should reflect the policy of the organization that is asking to bank the samples. Often participants may be given options as to whether they would like results returned. Make sure there are systems in place to ensure that an individual’s wishes are respected if they were given the choice to opt-in or out of receiving information related to their health.

Example Statement

Example 1: New Findings You should not expect to get individual results from research done using your sample. We will offer to tell you something we discover only if it is about a disease that is likely to cause early death if not treated. You can get general news about the kinds of studies being done through the Biobank at [URL].[23]

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References

[1] Sample language is from consent templates developed by various groups and is cited throughout.

[2] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking Annotated Consent Document for the Texas Cancer Research, Baylor College of Medicine, available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample4.pdf

[3] Id.

[4] 21 CFR 50.25(a)(2); 45 CFR 46.116(a)(2)

[5] Genomics (eMERGE) Network model consent language for biobanking Annotated Consent Document for the Texas Cancer Research, Baylor College of Medicine, available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample4.pdf

[6] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking, NHGRI Medical Sequencing Project (MSP) DNA template available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample2.pdf

[7] Id.

[8] 21 CFR 50.25; 45 CFR 46.116(a)(3)

[9] Beskow LM, Friedman J, Hardy C, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010; 5(10): e13302, available at: http://dx.plos.org/10.1371/journal.pone.0013302

[10] 21 CFR 50.25(a)(4), (a)(8); 45 CFR 46.116(a)(4), (a)(8).

[11] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking, Reconsent for a Genome-wide Association Study with Broad Data-Sharing, available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample1.pdf

[12] Id.

[13] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking, NHGRI Medical Sequencing Project (MSP) DNA template available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample2.pdf

[14] 21 CFR 50.25(a)(5); 45 CFR 46.116(a)(5).

[15] Beskow LM, Friedman J, Hardy C, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010; 5(10): e13302, available at: http://dx.plos.org/10.1371/journal.pone.0013302

[16] 21 CFR 50.25(a)(6); 45 CFR 46.116(a)(6)

[17] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking, NHGRI Medical Sequencing Project (MSP) DNA template available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample2.pdf

[18] 21 CFR 50.25(a)(7); 45 CFR 46.116(a)(7)

[19] Beskow LM, Friedman J, Hardy C, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010; 5(10): e13302, available at: http://dx.plos.org/10.1371/journal.pone.0013302

[20] 21 CFR 50.25(b)(5)-(6); 45 CFR 46.116(b)(5)-(6)

[21] Electronic Medical Records & Genomics (eMERGE) Network model consent language for biobanking, Annotated Consent Document for the Texas Cancer Research, Baylor College of Medicine, available at: http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormExample4.pdf

[22] 21 CFR 50.25(b)(5); 45 CFR 46.116(b)(5).

[23] Beskow LM, Friedman J, Hardy C, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010; 5(10): e13302, available at: http://dx.plos.org/10.1371/journal.pone.0013302.

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