Notice Number: NOT-AI-05-006

Key Dates
Release Date: October 29, 2004

Issued by
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
Health Resources and Services Administration (HRSA) (http://www.hrsa.gov)

The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH), in collaboration with the Health Resources and Services Administration (HRSA), are planning to establish a consortium of institutions to conduct research on the outcomes and medical needs of live organ donors. This research will expand the Institutes' current support of basic and clinical research in organ transplantation. The proposed cooperative agreement program would support epidemiologic research focusing on the medical and functional outcomes of individuals who have donated a kidney or a lobe of liver or lung for transplantation into an individual with end-stage organ disease. The NIAID, NIDDK, and NHLBI plan to issue a Request for Applications to establish this consortium.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a cooperative agreement on the basis of responses to this RFI nor otherwise pay for the preparation of any information submitted or for the Government's use of such information.

Background

Less than one third of individuals currently registered for organ transplant in the U.S. can expect to receive a transplant in the coming year and one in fourteen of those waiting will die before an organ becomes available. Efforts to increase the donor pool have led to an increase in the number of organ transplants from live donors. The number has more than doubled over the last 10 years, and, since 2001, the number of living donors has been greater than the number of deceased donors. Most live donors give a single kidney (94.3%), with the remaining donors giving a lobe of donated liver (5.4%) or lung (0.3%).

There are benefits associated with live donor organ transplant. These include elective scheduling of transplantation, minimization of organ ischemic time and, in many cases, reduced waiting list time. Recipient and graft survival are better after live donor kidney transplantation, whether from a related or unrelated donor, than with deceased donor transplantation. Living donor liver transplantation in children has reduced waiting list mortality and there are data that suggest that obliterative bronchiolitis may occur less frequently in recipients of lung lobes from living donors.

There may be psychological benefits to the donor associated with the altruistic satisfaction of having assumed a risk to help a loved one or a stranger. However, there is limited information about the risks to and outcomes of those who chose to become living donors. The mortality rate of living donor nephrectomy has been estimated at 0.03% with morbidity between one and ten percent. The medical risks associated with live donor liver and lung transplants are higher: the mortality rate associated with partial hepatectomy is estimated in the range of 0.2%, and the rate of morbidity at about ten percent. Living donor lung transplantation places two donors at risk for each recipient. While there has been no reported mortality in association with lobar lung donation, the perioperative morbidity is high, with complication rates ranging from 20-50% of donors.

In 2003, the Secretary of Health and Human Services, in response to recommendations made by the Secretary's Advisory Committee on Transplantation, requested that a database of health outcomes for all live donors be established and funded through and under the auspices of the U.S. Department of Health and Human Services. To facilitate the achievement of that goal, the NIH plans to support a consortium of institutions that have accumulated experience in this area. A research consortium will be established to develop and implement a scientific agenda to address issues relevant to living organ donors, including survival and health outcomes, risk assessment, and medical care needs. Existing registries or cohorts of living organ donors will be the basis for a merged dataset of demographic and clinical information that will allow exploratory research into the risks to and outcomes of living organ donors. Participating centers will have access to funds and resources to support database infrastructure, patient follow-up, and data collection. Prospective cross-sectional clinical research conducted in the identified cohorts of organ donors will also be supported.

Research topics to be addressed by the consortium include, but are not limited to:

1. Risk stratification for immediate or long-term complications of organ donation: donor characteristics, center characteristics, and surgical approaches

2. Prevalence of renal insufficiency, hypertension, proteinuria and other morbidities late after renal transplantation

3. Incidence and outcome of hepatic malignancy, viral hepatitis, and other morbidities that might be linked to liver regeneration

4. Health-related quality of life and functional outcome after organ donation

5. Psychological outcomes of organ donation, and

6. Evaluation of the informed consent process

Information Requested

Information in the following areas will aid the NIAID, NIDDK, and NHLBI, in collaboration with HRSA, to design the initiative. Interested institutions and individuals should identify key criteria that should be included in the announcement, and should describe their interests as well as their current and potential capabilities to meet these criteria. Information need not be limited to the areas listed below. Single institutions or consortia may be considered in the final initiative. Academic, private, and government groups are encouraged to respond.

Please restrict your response to 10 pages or less.

1. Identify the issues and questions of highest priority in this area of research.

2. Briefly describe the cohort of living donors whose whereabouts are known to your center: number of individuals, follow-up time from organ donation, organs donated. Estimate the number of such individuals who you believe would be willing to participate in research into the outcomes of live organ donation.

3. Describe your ability to provide a repository of information (dataset) on living donors. The description should include number of donors, organs donated, titles of the data fields, average frequency of follow up, and proportion of donors who have complete survival data (that is, who are known to be alive or known to be deceased).

4. Describe how you might obtain data that are currently missing from donor datasets.

5. Describe the resources you feel would be required to substantially improve the quality of the data set you currently have, i.e., infrastructure funding, bioinformatics support, etc.

6. Briefly describe your interest in participating in the epidemiologic research and describe ways in which, in the absence of a prospective long-term study, a valid current assessment of the outcome, risks and benefits of live organ donation, and the medical needs of those who donate organs, might be evaluated.

Responses

Responses should be identified with this Notice identifier (NOT-AI-05-006), and are due by November 22, 2004 Please submit them by e-mail to:

Nancy D. Bridges, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3039
6610 Rockledge Drive
Bethesda, MD 20892-6601 (use 20817 for express mail)
Telephone: 301-451-4406
Fax: 301-480-0693
E-mail: nbridges@niaid.nih.gov

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's assessment of the information received. No basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Responses will be held in a confidential manner. Any proprietary information should be so marked.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.