ReachBio Research Labs' Ethical and Legal Standards for Primary Human Cell Products & Contract Services Utilizing Primary Human Cells

ReachBio Research Labs is committed to operating under the highest ethical and legal standards for the acquisition of human cells used in our Human Primary Cell Products and Contract Assay Services. As such, all primary human cells used and sold by ReachBio Research Labs are sourced within the USA under protocols that have obtained Institutional Review Board (IRB) approval. IRB are also known as Independent Ethics Committees (IECs) or Ethical Review Boards (ERBs) and are governed by Title 45 of the Code of Federal Regulations (CFR) Part 46.  IRBs are federally empowered by the US Food and Drug Administration (FDA) and the Department of Health and Human Services who authorize and task them to review, modify, approve or disapprove proposed research involving human subjects under the regulations of 45 CFR Part 46. Fundamental to obtaining IRB approval is that the important ethical tenets outlined in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) are adhered to.  These basic tenets are:

1.  Respect for Persons

• The privacy and autonomy of all donors is protected.
• All donors are treated with courtesy and respect.
• Written informed consent is obtained from all donors prior to their donation.

2.  Beneficence

• A risk/benefit assessment has been performed and the principles “Do No Harm” and minimizing risks to the donors are upheld.

3. Justice

• Reasonable, non-exploitative, and well-considered procedures are administered fairly and equally.
• Due care is taken in the selection of donors.

The tenets of the Belmont Report are very similar to those of the World Medical Association’s Declaration of Helsinki, and IRBs routinely use both sets of ethical principles to guide their decisions regarding approval or disapproval of research utilizing human subjects

Utilizing cells that are only obtained within the USA from IRB-approved protocols thus assures ReachBio, our customers and our clients that the highest ethical and legal standards are always adhered to.

 

Ethical Statement last updated: May 1st, 2012