Data on consent for research with biological samples: toward a uniform

approach

The views and opinions expressed in this talk are my own. They do not reflect any position or policy of the NIH, or U.S. government.

Informed Consent

Much of the debate over informed consent for research with biological samples has focused on what information individuals should be provided, and choices they should be asked to make.

Consent for New Samples

Most endorse offering a variety of choices: What diseases can be studied? Will the samples be shared? Can they be used in commercial research?

However, there is disagreement regarding which choices should be offered.

Range of Ethical Approaches

General ethical considerations seem consistent with several options.

Respect for autonomy and protection from risks do not determine whether individuals should consent to research on all diseases, or consent specifically to research on their disease and research on other diseases.

Need for Data

When general considerations do not support one approach, data on individuals’ views can help identify a best approach.

In particular, data on individuals’ views can provide evidence of what individuals care about, the views of the ‘reasonable’ person, and which approaches have the broadest social support.

Identified Studies

Literature search identified 30 studies published in English which provide empirical data on the views of over 33,000 individuals.

The studies were from England, France, India, Japan, Singapore, Sweden, Uganda, UK, and the US.

Views of Subject DonorsAuthor Year Population Donate? Other

diseases?

Matsui 2005 5361 Japanese >90.0% N/A

Hoeyer 2005 1200 Swedes N/A N/A

Chen 2005 1670 US 90.8% 87.1%

Wendler 2005 347 Ugandans 95% 85.0%

McQuillan 2003 3680 US 85.3% 85.3%

Stegmayr 2002 1409 Swedes 93.0% N/A

Malone 2002 7565 US 93.7% 86.9%

Wendler 2002 814 US N/A 91.9%

Nakayama 1999 120 Japanese 98.5% N/A

Patient/Public Donors and Patient non-Donors

Author Year Population Donate? Other diseases?

Jack 2003 3140 English 98.8% N/A

Moutel 2001 170 French 100% N/A

Hamagima 1998 583 Japanese 95% N/A

Womack 2003 106 U.K. 100% N/A

Kozlowski 2002 3383 US 18% N/A

Start 1996 450 UK 83% N/A

Goodson 2004 100 English 82.0% N/A

Public non-Donors

Author Year Population Donate? Other diseases?

Roberts 2005 63 US N/A N/A

DeCosta 2004 59 Indians 86.0% N/A

Hoeyer 2004 1000 Swedes N/A N/A

Wong 2004 708 Singaporeans 49.3% N/A

Ashcroft 2003 155 UK 100% N/A

PSP 2002 16 UK focus groups N/A N/A

Stolt 2002 21 Swedes N/A N/A

Asai 2002 21 Japanese N/A N/A

Schwartz 2001 1383 US Jewish Am. >80.0% >80.0%

Wang 2001 3130 US 79% 79%

Welcome 2000 16 UK focus groups N/A N/A

NBAC 2000 7 US hearings N/A N/A

Merz 1996 99 US 60% 87%

Phan 1995 21 US N/A N/A

NIH Subjects

N=1298

Decline all Future Research 7%

Consent to Future Research on Same Condition

91%

Consent to Future Research on ANY Condition

87%

Ugandan Parents

Provided sample for future research 95%

Allow research on any condition 80%

Allow HIV research 85%

Share sample with Tanzania or Kenya 94%

Share sample with U.K. or U.S. 95%

Swedes

93% (1311/1409) gave consent for samples to be used for future “academic genetic research” provided ethics committee approved the project.

A significant percentage wanted to be contacted concerning each new project.

English Patients

Oct 1998-Aug 2002: Only 1.2% (38/3140) refused to donate a sample, with 2 citing commercial involvement as the main reason for refusal.

Willingness to Donate

Of the 20 studies that assessed willingness, 17 found that at least 80% of respondents were willing to donate their samples.

Most unwilling respondents were appear to concerned with factors other than research use, especially the method of obtaining the samples. In Wong 2004, 38% of those who were unwilling to donate cited as their reason a fear of needles or injections.

Choices

The majority of individuals asked were willing to provide one-time general consent and rely on IRBs to determine when their samples would be used in future research projects (Hoeyer 2005 85.9%; Wendler 2005 95%; McQuillan 2003 85.3%; Stegmayr 2004 93%; Malone 2002 93.7%; Hoeyer 2004 79.4%).

Findings

The data yield consistent findings, despite being conducted around the world, over a 10 year period, in different groups, using different methods.

The studies reveal that the vast majority of individuals want to decide whether their biological samples are used for research purposes.

Findings II

The studies also reveal that, when asked, the vast majority of individuals are willing to donate a sample for research purposes.

Preferences to Policy?

Current data suggest, in addition to risks, most individuals care whether their samples are used for research, but not what diseases will be studied nor who will use them.

Consent for New Samples

The data suggest that consent forms need not detail all the different diseases that might be studied.

Instead, subjects should be offered a binary choice of allowing all future research or not, with the provision that future studies will be approved by an IRB.

Six Elements of Consent

1) Request to obtain samples

2) Risks, if any

3) Absence of direct benefits

4) Information, if any, to be provided

5) Reliance on IRB to review and approve future research provided research is important and ethical, and risks are minimal

6) Solicitation of individual concerns/questions

Example Wording

We would like to use your blood (tissue) sample in future studies to learn how to improve people’s health. The researchers conducting these studies will not contact you for more information. Your sample will be used only when an independent group, called an IRB (REC), determines that the research is important and ethical, and poses no more than minimal risk to you. These future research projects will not benefit you personally, and are not needed for your medical care. All information you provide will be kept confidential as far as possible. However, there is always a very small chance that some information may be released.

Additional Considerations When Relevant

Optional provision: The choice of whether you provide a sample is up to you. No matter what you decide, it will not affect how we treat you.

Individual information: We will provide you with any information from future studies that may have an impact on your health.

Study information: Information on the nature (findings) of future research projects will be posted on our website (provided in some other way).

Future removal: If you decide in the future that you longer want to allow your sample to be used for research, please contact the study doctors and any remaining sample will be removed.