Bio-Law Group

Services for IVF Clinics, Institutions, and Biotech

Overview

A. Services for IVF Clinics

Jaeger represents fertility clinics on a variety of critical issues. She works with clinics to develop the numerous documents that are necessary for patients undergoing infertility treatments. This includes updating and writing informed-consent documents, gamete and embryo storage agreements, gamete and embryo directives, gamete and embryo known and anonymous donor agreements, carrier agreements that are separate from medical consent documents, and clinic procedures and policies, including genetic testing of embryos (PGD). She also guides clinics through the myriad of regulatory issues so they comply with both federal and state laws. She develops SOPs and ethical guidelines for clinics.
Talk to someone who's knowledgeable in reproductive law and knows the trends in ethics, law, science, and policy. BioLaw Group can help you with the following:

Legal Information

Legal parenthood of your patient's baby
The law in your state impacting your practice
Ensuring that the clinic has defined legal boundaries with donors or carriers to reduce liability to the participants in collaborative reproduction.

Documenting Consent

Embryo and Gamete Directives
Storage agreements
Documentation of control over storage, use, donation, destruction, and protection of gametes and embryos
Consent for donating embryos for research
Using embryos in research at your facility

Donor Programs

Affidavits for collaborative reproduction
Information requirements about donors, including long term identity release programs
Supporting a relationship with a donor or carrier for patients and their children that serves everyone's best interests
Donor Egg Program consents, releases, and disclosures
Donor Embryo Program consents, releases, and disclosures
Identity Release, Directed Donor, and Known Donor Programs and services

Confidentiality

Disclosure of private health information in collaborative reproduction
Consent and disclosure of genetic test results

Liability and Financing

Payment plans
Shared risk programs
Insurance

Compliance with State and Federal Rules

HIPPA
FDA regulations
State regulations
CLIA

Policy and Legislative Affairs

Press relations
Legislative efforts to support ARTs
Legal and Bioethics programs for staff and researchers
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B. Services for Tissue Banks and Storage Facilities

Jaeger offers knowledgeable legal assistance to tissue banks. Drawing on her years of work in this area, she is able to ensure thorough, defensible legal documentation of the acceptance, transfer, storage, and release of both gametes and embryos. She works with storage facilities to develop documents, policies and procedures to ensure quality assurance and recordkeeping standards. She also assists facilities to meet federal and state regulations, and internal and national ethical standards.
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C. Services for Genetics Research and Biotech

Jaeger provides legal services to academic centers, research foundations, and companies that are on the frontier of scientific investigations. She helps institutions and companies with legal issues in obtaining stem cells for research, and communicating research objectives with funders and policymakers. She aids researchers to consider the implications of their research on the reproductive health and choices of the participants. Other experience includes:
Jaeger has extensive experience in developing and implementing protocols involving special populations due to her experience with the Native American Institutional Review Board.
She has consulted with cancer researchers and the Fred Hutchinson Cancer Research Center on the legal and ethical parameters of reproductive disclosures in genetic cancer research.
* Jaeger's groundbreaking policy research has been cited as the basis for President Clinton's recognition of genetic discrimination in the workplace.
* Jaeger has conducted training sessions for the American Society of Clinical Oncology on the legal and ethical issues in bringing cancer genetic testing to clinical practice.

Whether it is considering the obligations of a researcher to disclose, or making informed consent forms understandable yet complete, you will have the benefit of Jaeger's abilities and experience.

BioLaw Group provides professional support for small to medium-sized biotech companies facing complex legal and ethical issues.

Jaeger helps these companies develop their protocols and informed consents, and assists them in obtaining Institutional Review Board approvals. She also helps companies negotiate sponsored research agreements at academic centers, including access to and protection of data.

Jaeger provides general contract and business advice for companies including contract review and negotiations including service agreements with contract research organizations or hiring independent contractors on research protocols.

BioLaw Group engineers agreements for sponsored-research and licensing. Jaeger has represented both non-profit and for-profit entities for technology-licensing projects. She offers particularly broad experience in issues related to ownership and sharing of intellectual property, publication review, and patient-records access, including HIPAA compliance. She also provides services in securing and licensing trademarks and copyrights.
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D. Considerations in Reproductive Genetics and Preserving Fertility

Assisted Reproductive Technologies (ART) are no longer just for people experiencing infertility. ART techniques are for persons at risk of genetic disease, or those undergoing treatments that may impair their fertility, and even for people that want to ensure that they have a healthy baby. Understanding assisted reproduction and reproductive genetics, including the legal details that must be addressed is important for all medical professionals. ART is unique because physicians are not just extending or improving life, they are creating life. Thus, ART raises unique legal and ethical issues that demand the broader involvement of professionals, including legal professionals, as the physician provides care to his or her patients.

For example, the retrieval and storage of gametes and embryos are no longer limited to infertility practice. Anytime a patient undergoing treatments or surgery that may affect their fertility or quality of gametes, the physician must present information to the patient on gamete retrieval and storage issues before any treatment is commenced. Physicians have a duty to consider and counsel on the impact of the treatment on the patient's fertility, including legal options for retrieval, storage and use of gametes and embryos. These are sophisticated legal issues that are inherently intertwined with medical treatment choices!

BioLaw Group can provide counsel around the legal issues listed below. These include the following:

* Physicians must counsel patients on the options associated with assisted conception and various cancer treatments or surgical options. For example, the physician must discuss the possibility of involving a gestational carrier as a pregnancy option for a woman with cervical cancer. Again, the legal issues of parentage, controlling the use of embryos is important information to discuss with a legal authority.

* With gamete or embryo storage, there are additional issues regarding the medical screening of patients and related confidentiality. Physicians need to comply with both FDA and HIPAA regulations, and with the requirements of storage facilities.

* Emerging egg or oocyte freezing services will change choices for women and potential parents. BioLaw Group provide legal and ethical support for clinics, companies and individuals using these technologies and services.

* Physicians need to counsel and explain options for patients at-risk of inherited disorders. Options include preimplantation genetic diagnosis of the embryo (combined with IVF), prenatal screening, or donated gametes. Legal considerations are a large part of a patient's choice in selecting a treatment plan.

* In addition to counseling on contraception, physicians need to counsel on fertility. For example, women of all ages need to be informed on the risks of STDs, as well as the impact of delaying childbirth, the connection between age and egg condition.
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