22-04728

Submitted by fratecm on Fri, 06/17/2022 - 18:06
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Cellular Basis for Differential Hormone Sensitivity in Women with Peripartum Mood Disorders – Documentation of Updated Consent
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Cheryl
Leone
cleone@mail.nih.gov

Secondary Contracting Officer

Dionne
Draper
dionne.draper@nih.gov
NAICS Code Number
541990
All Other Professional, Scientific, and Technical Services
Estimated Period of Performance
1 year from award
Delivery of Goods
n/a
Competition Status
Non-Competitive
Vendor Name
Erasmus University Medical Center
Single-Sole Source Determination
determine that the documentation of the updated consent form listed herein is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.

This acquisition is restricted to: Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, Netherlands. The point of contact is Astrid Kamperman a.kamperman@erasmusmc.nl

The essential characteristics of the updated consent documentation that limit the availability to a sole source is to maintain involvement with the same personnel from the original study and ensure compatibility with a previous set of consents from this study. Only this suggested source can furnish the requirements, to the exclusion of other sources, because of the following:
Originally, the Bench to Bedside (BtoB) proposal built on access to two unique samples of women with peripartum mood disorders as follows: 1) to create human-induced pluripotent cells (h-iPSCs) and neuronal progenitor cells whose transcriptional responses to ovarian steroids in vitro will be assessed; and 2) to create lymphoblastoid cell lines (LCLs). In women with postpartum psychosis (PPP), peripheral blood samples were obtained from women who met criteria for PPP and who additionally had no prior history of affective disorder. This carefully selected sample included participants from the Netherlands and from the United States to capitalize on the availability at these two sites of subjects with first onset PPP and no past Axis I psychiatric illness and to thereby ensure the adequacy of our sample size. Blood samples from matched (age, race, and parity) control women with no history of affective disorder including PPP also were obtained. All women are otherwise healthy and medication free.

Given recent scientific advances in the potential use of cell lines such as those in this study and the recent ethical issues related to the assignment of ownership of immortalized cell lines, we feel a stronger and more clear written informed consent statement should be documented in this study. Therefore, using personnel from a different institution would jeopardizes the findings from the above-mentioned study. Different personnel are not familiar with the subjects nor the complexities of the ongoing study.
Background/Description of Requirement

1) A member of the EMC clinical team will contact by telephone those thirty-nine women who previously were enrolled and provided peripheral blood samples for this BtoB award (both those women with previous postpartum psychosis and those women who served as asymptomatic controls);

2) Schedule a visit during which an updated and revised consent document for this study will be reviewed with each woman; and

3) Obtain written informed consent from each woman employing the revised consent document.

The women from whom blood samples were obtained participated in “Research Program Postpartum Psychiatry Erasmus MC Rotterdam (OPPER),”. The Principal Investigator is Dr. V Bergink.

Experimental Plan: This Bench to Bedside (BtoB) proposal built on access to two unique samples of women with peripartum mood disorders as follows: 1) to create human-induced pluripotent cells (h-iPSCs) and neuronal progenitor cells whose transcriptional responses to ovarian steroids in vitro will be assessed; and 2) to create lymphoblastoid cell lines (LCLs). In women with postpartum psychosis (PPP), peripheral blood samples were obtained from women who met criteria for PPP and who additionally had no prior history of affective disorder. This carefully selected sample included participants from the Netherlands and from the United States to capitalize on the availability at these two sites of subjects with first onset PPP and no past Axis I psychiatric illness and to thereby ensure the adequacy of our sample size. Blood samples from matched (age, race, and parity) control women with no history of affective disorder including PPP also were obtained. All women were otherwise healthy and medication free.

Given recent scientific advances in the potential use of cell lines such as those outlined in this study and the recent ethical issues related to the assignment of ownership of immortalized cell lines, we feel a stronger and more clear written informed consent statement should be documented in this study.  

The project will involve drafting correspondence between investigators at the EMC under the supervision of Dr. Bergink and the EMC IRB, contacting participants, scheduling a meeting with each woman, and obtaining written informed consent. 

Staff in EMC will need to travel to perform in-person visits in order to review the consent documents and obtain written informed consent. Costs of travel are included in this contract.

Travel will be within a 100-mile radius of EMC and will be by motor vehicle or train.

Staff in EMC will need to travel to perform in-person visits in order to review the consent documents and obtain written informed consent. Costs of travel are included in this contract.

Travel will be within a 100-mile radius of EMC and will be by motor vehicle or train.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.