Biological Material Use and Storage Consent Form

State:
Multi-State
Control #:
US-70266NMS
Format:
Word; 
Rich Text
Instant download

Description

Consent form for storage of biological materials collected in a research study for use in current research studies.
A Biological Material Use and Storage Consent Form is a document used to record the informed consent of a patient for the use of their biological material in research or clinical trials. It is typically used in medical research and clinical trials involving the collection of biological tissue samples from a patient and their subsequent storage in a laboratory or other repository. The form is designed to ensure that the patient is aware of the purpose of the collection and storage of their biological material and that they have given their informed consent for it. It also serves to ensure that the material is used in accordance with the ethical and legal guidelines governing research and clinical trials. There are two main types of Biological Material Use and Storage Consent Forms: ‘Generic’ and ‘Specific’. A Generic Consent Form is a generic document that is used for any type of research or clinical trial involving the collection and storage of biological material. This document typically lists the purpose of the research or trial and outlines the rights of the patient. A Specific Consent Form is tailored to the specific research or clinical trial and is designed to provide more detailed information on the purpose of the collection and storage of the biological material. It also outlines the rights of the patient in greater detail and may include other details such as the duration of storage of the material.

A Biological Material Use and Storage Consent Form is a document used to record the informed consent of a patient for the use of their biological material in research or clinical trials. It is typically used in medical research and clinical trials involving the collection of biological tissue samples from a patient and their subsequent storage in a laboratory or other repository. The form is designed to ensure that the patient is aware of the purpose of the collection and storage of their biological material and that they have given their informed consent for it. It also serves to ensure that the material is used in accordance with the ethical and legal guidelines governing research and clinical trials. There are two main types of Biological Material Use and Storage Consent Forms: ‘Generic’ and ‘Specific’. A Generic Consent Form is a generic document that is used for any type of research or clinical trial involving the collection and storage of biological material. This document typically lists the purpose of the research or trial and outlines the rights of the patient. A Specific Consent Form is tailored to the specific research or clinical trial and is designed to provide more detailed information on the purpose of the collection and storage of the biological material. It also outlines the rights of the patient in greater detail and may include other details such as the duration of storage of the material.

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FAQ

Biological Sample Storage: Industry Applications Biobanks: Biobanks, or biorepositories, are used for biological sample storage and preserving biological specimens. Biospecimens are collected and stored for future research. The types of samples stored include human tissues for DNA analysis.

Biologic materials like blood, tissues, and reproductive specimens, as well as clinical trial materials, should be stored in cryogenic containers that can be maintained at -150 degrees Celsius for at least 10 days. Under those conditions, this type of storage is really the only viable option.

Biologic materials like blood, tissues, and reproductive specimens, as well as clinical trial materials, should be stored in cryogenic containers that can be maintained at -150 degrees Celsius for at least 10 days. Under those conditions, this type of storage is really the only viable option.

Handling of Biological Materials on the Open Bench Disinfect the bench and equipment surfaces regularly. Do not leave sharp objects out. Change absorbent materials frequently. Clearly define all waste streams and have disposal bins readily available. Keep things in order.

Maintained thermostatically between 15.5°C and 24°C (60°F and 75°F) with less than 60% humidity. equal to the ambient temperature of its surroundings; storage area may lack temperature and humidity control methods.

Cryogenic freezer storage is often deemed the gold standard for long-term storage of biological samples. At these extremely low temperatures all biological activity is suspended and no degradation occurs. Cryogenic freezing is ideal for sensitive samples and specimens which cannot be suspended in a preservative.

Vaccines and biologics should be stored in a refrigerator that can maintain constant temperatures between +2ºC and +8ºC and the refrigerator should be in a secure location away from unauthorized personnel and public access.

The consent form must include: A statement that the study involves research.Purpose of the research.Procedures.Risks or discomforts to the subject.Benefits of the research to the subject.Treatment Alternatives.Costs of Participation.Confidentiality.

More info

The consent form for storage and future use of biological materials from your current study offers several options. Information and Informed Consent template for participation of human beings for using biological samples of human origin.The guidelines do not apply to tracking and reporting of biological materials that were obtained from commercial sources for use as "reagents". This institution is responsible for the practical aspects, such as data collection and secure storage of samples and data. Under the HIPAA Privacy Rule separate permission is required for the storage of biological materials as well as each research use of identifiable materials. This form is a resource that you may use to assist you in completing your consent forms. Consent for the Use and Storage of IDENTIFIED Human Biological Material- investigators planning to use data or specimens may use this consent form. The Recommendations are presented in the form of Model Regulations covering air, rail, road, sea and also include international mail. Permission to retain microorganisms with participant identifying information after the study is completed must be included in the consent form document. Effective Date: ______.

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Biological Material Use and Storage Consent Form