DOE Human Subjects Resources

DOE-NHGRI (National Human Genome Research Institute) Model Consent for Use of Tissue Samples for Human Genome Project Cell Lines

This document was developed by DOE and NHGRI staff, in consultation with Dr. Ellen Wright Clayton. It is intended for donors whose tissues will be used to prepare the cell lines and DNA libraries that will be used to sequence the human genome as part of the Human Genome Project. This model consent may be used by those who seek to comply with the NHGRI-DOE guidance on human subjects issues in large scale DNA sequencing, issued August 23, 1996.

It is offered as a model to be adopted as investigators and Institutional Review Boards (IRBs) see fit. We encourage you to use the document and to distribute it to all who may be interested. You are invited to discuss details, including improvements, modifications, or implementation issues, with DOE or NHGRI staff.

Consent for Use of [Tissue] Samples to Make a Cell Line and a DNA Library for the Human Genome Project

This research is part of the Human Genome Project, the principal goal of which is to map and sequence all of the genes contained in human DNA. You are being asked to provide samples of [tissue] to create a "cell line" and a "library" of DNA to be used in research as part of the Human Genome Project. This form describes the research that will be done and what providing samples would mean, so that you can decide whether or not you want to donate samples. The choice is completely up to you.

What we will do with your [tissue] samples, what they will be used for, and who will use them.

We will divide your sample into two parts. We will take cells from one part of your sample and treat them so that they become a permanent "cell line," which means that they can be grown in the laboratory whenever they are needed. [N.B. In the case of sperm donors, this language will obviously need to be changed to indicate that a blood sample will also be taken in order to construct a cell line] Creating a cell line will allow us to have a source of your DNA to use for research in the future, without having to come back to you to ask for another [tissue] sample.

From the other part of your [tissue] sample, we will isolate the DNA and prepare it for "cloning," which means making multiple copies of it. To do this, we will cut the DNA up into pieces. These pieces will then be joined with a "vector," which is a kind of DNA that allows your DNA to be grown in [host] and to make millions of copies, or clones, of each piece. The collection of all of the cloned pieces of your DNA is known as a "clone library." The library we make will consist of a complete collection of all your genetic material.

Clone libraries, like the one we will make from your [tissue] are very useful for genetic research. At present, clone libraries are used for two purposes. One is to map genes, which means finding out on which chromosome, and where on that chromosome, an individual gene is located. The second is to determine the sequence of the bases in those genes, which means finding out how the DNA sentences (genes) are spelled; this process is called DNA sequencing. In the future, the clone libraries may be used for other types of research.

Because of its usefulness, the clone library we plan to construct from your DNA will be shared with researchers around the world for gene mapping and DNA sequencing research. Some of these researchers work in universities and research institutions; others work in commercial organizations. The results of the mapping and sequencing of genes carried out by the Human Genome Project will be put in databases that are available to the public. Other results, particularly those obtained by researchers from commercial organizations, may not be made public but may make important contributions to the development of useful medicines, diagnostic tests, and other products that will be available to the public. It is also possible that some companies may restrict the use of the information they obtain to those who pay a licensing or royalty fee.

Benefits of allowing your [tissue] to be used to create DNA libraries.

We expect that this new knowledge about human genetics will provide many benefits for human health. This knowledge will increase our understanding of disease, promote the development of more effective diagnostic tools and therapies, and determine the most effective use of already existing treatments. The first of these is already beginning to happen, but much work remains to be done. If you participate by contributing your DNA, you may feel good about your role in advancing knowledge to help others. It is extremely unlikely, however, that you will receive any tangible benefits from allowing your [tissue] to be used.

You will not be given any information about your own DNA.

There are four reasons why we will not tell you anything about your own DNA. First, we believe that a person has the right to keep his/her DNA sequence information private. Therefore, apart from the signed informed consent document, we will not retain any records that link your identity to the DNA sequence information. Second, if we were to give you specific information about your DNA, and you were then asked by someone (such as an insurer or employer) to provide that any information, you would likely be required to, whether or not you wanted to at that time. It is possible that such information could then be used to deny you insurance or employment, even in the absence of a known disease. Third, at present, the health implications of specific DNA sequences often are unclear; therefore, in most circumstances it would be very difficult to provide you with any specific information about what your DNA sequence might mean for you or your relatives. Finally, the purpose of this project is to develop new knowledge about the genetic makeup of human beings, not to provide clinical information to you.

What we will do to reduce the possibility that someone will find out who you are and what your DNA sequence is.

This signed consent form will be stored in a locked file that will be accessible only to [consent/contact person]. No one working in the [investigator's] laboratory at [investigator's institution] will be told who you are. You will deal only with [consent/contact person] when you provide the [tissue] sample and when you have any questions about this research.

However, we cannot guarantee that your identity as a DNA donor will always remain unknown to others as genome science progresses. Every person's DNA is unique; therefore it may be possible some day that someone could find out who you are just from knowing your DNA sequence. At that future time, the ease with which an individual donor could be identified would increase as more of that person's DNA sequence is known. To minimize the chance that someone would be able to find out who you are just from looking at the sequence in the public databases, several other DNA libraries are also now being created using DNA from other people for use in DNA sequencing. This means that even when the whole human DNA sequence is known, it will have not been determined from any single individual, but rather from several people. In other words, only a part of the whole sequence will come from each of the donors. As a result of all of these precautions, we believe that the chances of someone being able to find out who you are just from knowing the DNA sequence will be very low.

In summary, we believe that all these steps will make it unlikely that someone will find out your identity or your DNA sequence . But, you should understand that we cannot absolutely guarantee that you will not be identified or that someone will not be able to find out something about your genetic makeup from the material you have donated.

Risks of allowing your [tissue] to be used to create a cell line and a DNA library.

[The risks of providing blood samples are those associated with drawing blood, namely, pain or bruising at the site as well as a very small possibility of infection.] [The actual process of providing sperm poses no health risks.] There are, however, some other risks of providing [tissue] for this project that you should know about that could occur in the unlikely event that your identity were to become known.

Although every effort will be made to ensure that this does not happen, someone may find out that you are donating [tissue] for this project. There has been public interest in whose DNA is being sequenced in the Human Genome Project. If someone found out that you are one of the DNA donors, representatives of the media or other people might want to interview you or represent you. Some people are opposed to this type of research and may criticize you for your participation. These responses could be embarrassing or annoying to you. Other things could happen if someone found out which DNA sequences were obtained from your DNA, particularly if one or more of the sequences showed a mutation or change in the DNA that caused or predisposed you to have a particular disease. If your particular DNA sequence were to become known:

  • You could be distressed if you found out about a risk of illness that you had not known about before.
  • You might have a harder time than you otherwise would have had in getting or keeping a job or health insurance if you were found to have a disease-causing or disease-promoting mutation. Some laws have already been enacted, and others are being considered, that attempt to protect people from such job and insurance discrimination. You should know, however, that the laws that are currently in place do not provide people with complete protection from being discriminated against on the basis of their genetic information.

There may be other risks that we do not yet know about. This makes it hard to say for sure whether any new risks may arise in the future.

Optional: [Payment for your donation.

You will be paid $_____ when you provide a [tissue] sample for your time and inconvenience. To help protect your confidentiality, you will not get checks directly from the [the investigator=s institution]; rather, [consent/contact person] will pay you out of a separate fund.]

Compensation for your contribution and for any injuries that may result from your participation.

If you suffer from unwanted media attention, emotional distress, or discrimination in the unlikely event that your identity or genetic makeup became known in the absence of negligence or malfeasance, you will not be compensated (by [the investigator], by the [investigator=s home institution], by the [Department of Energy /National Human Genome Research Institute], or by any other person or entity that is using or storing the DNA for sequencing the human genome).

You will not receive economic gain from commercial products.

It is likely that some of the research that would be done using your DNA will lead to the development of commercial products. However, your DNA would represent only a very small contribution to the development of a successful product. Even though the law in this area is not completely clear, you should not expect to get any part of these profits.

What will happen if you were to decide in the future that you no longer wish to have DNA from your [tissue] used in this project?

If you provide samples and then later decide that you want to withdraw from participation, we will try to honor your request to the extent possible. Should you decide this, the [investigator=s home institution] would destroy all the clones [and cell lines] derived from your DNA that are in [the investigator=s] possession at that time. You should know, however, that once they have been disseminated, both your and our ability to control the use of the clones made from your DNA will be limited. Because the clone library will have been widely distributed to other researchers, it will be impossible to retrieve all copies of it. Similarly, the transformed cell line made from your cells will also have been distributed to other researchers and it will not be possible to retrieve all copies of it. [Investigators please note: While it seems unlikely, it would be worth attempting to get companies which will distribute the clones, libraries, and/or cell lines to sign an agreement that they will destroy any clones and cell lines in their possession if the donor changes his/her mind.] Finally, once the DNA sequences have been put in the public data banks, this information will also be very widely disseminated and therefore cannot be retrieved. Sources of information. If you have any questions or concerns about this project, you can ask [consent/contact person] or [ ], the Chair of the Committee for the Protection of Human Subjects at the [investigator's home institution and phone number].

Consent for Use of [Tissue] Samples to Make a Cell Line and a DNA Library for the Human Genome Project

I agree to the use of DNA obtained from my [tissue] to create a clone library to be distributed for research. This consent applies only to the samples I provide now.

I have read this form and understand the possible consequences for me and my family of allowing my DNA to be used in this way. I understand that , while I am free to decide in the future that I no longer want my DNA to be used, there are significant limitations on my ability to prevent future use.

I have had my concerns and questions addressed and know that I can ask more questions if they come up. I have been given a copy of this form for my future reference.

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Content reviewed: November 12, 2013