Get the free Recombinant DNA Research Protocol Renewal/Amendment - odu

This document is used for the renewal or amendment of research protocols involving recombinant DNA at Old Dominion University, requiring details of the principal investigator, project title, and any

How to fill out recombinant dna research protocol

How to fill out Recombinant DNA Research Protocol Renewal/Amendment

1. Review the existing Recombinant DNA Research Protocol for relevance and compliance.
2. Gather necessary documentation, including previous approval details and any changes in research.
3. Complete the renewal/amendment form, specifying the changes or updates to the protocol.
4. Include any new personnel involved in the study and their qualifications.
5. Submit all required supporting documents, such as safety assessments and relevant permits.
6. Ensure all changes comply with institutional and federal guidelines.
7. Obtain signatures from all principal investigators and necessary institutional officials.
8. Submit the completed protocol renewal/amendment to the appropriate oversight committee for review.

Who needs Recombinant DNA Research Protocol Renewal/Amendment?

1. Researchers working with recombinant DNA who have an existing protocol that requires renewal or amendment.
2. Any institution conducting ongoing experiments involving recombinant genetic material.
3. Principal investigators who have made changes to their research methods or personnel related to recombinant DNA.

People Also Ask about

What is a major action as defined by the NIH guidelines?

An experiment may be considered a Major Action if: 1) it involves the use of recombinant or synthetic nucleic acids to introduce drug resistance into a microorganism, and 2) the drug in question is used to treat disease caused by the organism in humans, veterinary medicine, or agriculture.

Which investigators who conduct research involving recombinant or synthetic nucleic acid molecules must comply?

Question: Investigators who conduct research involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. As part of this general responsibility, the needs toObtain Institutional Biosafety Committee (IBC) approval before initiating or modifying non-exempt research.

What is Section 4 B 2 A of the NIH guidelines?

Section IV-B-2-a-(1) of the NIH Guidelines states that at least two members of the IBC shall not be affiliated with the institution. These individuals are supposed to represent the interests of the surrounding community with respect to the environment and public health.

How does NIH guidelines define recombinant and synthetic nucleic acids?

The NIH Guidelines define recombinant and synthetic nucleic acids as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including

What is a major action as defined by the NIH guidelines?

An experiment may be considered a Major Action if: 1) it involves the use of recombinant or synthetic nucleic acids to introduce drug resistance into a microorganism, and 2) the drug in question is used to treat disease caused by the organism in humans, veterinary medicine, or agriculture.

Why did the NIH form the recombinant Advisory Committee?

The US NIH formed the Recombinant DNA Advisory Committee (RAC) in 1974 in response to the emerging technology of linking genes from different organisms. This powerful recombinant DNA technology, initiated by the Cohen-Boyer experiments at Stanford, spread rapidly.

What are recombinant and synthetic nucleic acids?

Recombinant or synthetic nucleic acid (r/sNA) molecules are constructed outside of living cells. They are made by joining DNA or RNA segments (natural or synthetic) to DNA or RNA molecules that can replicate within a living cell. They may also result from replication of previously constructed recombinant molecules.

What are recombinant or synthetic nucleic acids ing to the NIH guidelines?

ing to NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as (1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or

For pdfFiller’s FAQs

What is Recombinant DNA Research Protocol Renewal/Amendment?

Recombinant DNA Research Protocol Renewal/Amendment is a formal process that allows researchers to update or extend their approved research protocols involving recombinant DNA. This process ensures compliance with regulations and can involve changes to methodologies, personnel, or goals of the research.

Who is required to file Recombinant DNA Research Protocol Renewal/Amendment?

Any researcher or institution engaged in recombinant DNA research that has previously submitted a protocol is required to file for a renewal or amendment when the research is set to continue beyond its original approval timeline or if any significant changes occur.

How to fill out Recombinant DNA Research Protocol Renewal/Amendment?

To fill out a Recombinant DNA Research Protocol Renewal/Amendment, researchers typically need to provide details such as the original protocol number, a description of the proposed changes or continuation details, the rationale for these changes, updated risk assessments, and any revised consent documents, if applicable.

What is the purpose of Recombinant DNA Research Protocol Renewal/Amendment?

The purpose of the Recombinant DNA Research Protocol Renewal/Amendment is to ensure that any ongoing or amended research adheres to current ethical, safety, and regulatory standards. It allows for continuous oversight and minimizes potential risks associated with recombinant DNA research.

What information must be reported on Recombinant DNA Research Protocol Renewal/Amendment?

Information that must be reported includes the protocol's original approval date, any changes to the research scope, methodologies, personnel involved, safety measures, funding sources, updated risk assessments, and any adverse events encountered during the initial research period.