Ethics of biotechnologyUnderstand what the IRB is and why it was established. Be able to give examples of research that needs IRB approval vs that which does not.

Describe the 3 principles of the Belmont Report.

Autonomy: Respect for a person. Making sure they recognize all their rights to make choices and decisions. (informed consent). Beneficence: Protection from harm. Physician is responsible for the participants mental, physical, and social well being Justice: Benefits and burden distributed equally. Special protections put in place for vulnerable populations

Describe biobanks and understand why they are use

Biobanks: Repositories that assemble, store, and manage collections of human specimens and related data for future research use. Typically these biobanks are disease specific. They collect blood, tissues, plasma, etc. Why they are used: Government Academia

Know the requirements of informed consent and what community consent involves

Capacity to consent: understand the purpose, practice, and procedure. Appreciation of how research can affect their own situation. Reasoning, balancing risk and benefits. Voluntary choice Community Consent: when research is done on a community. Risks and benefits are weighed. Structural intervention. Additional protection on vulnerable groups.

Know and give examples of vulnerable populations

Economically disadvantaged, racial and ethnic minorities, uninsured, the elderly, prisoners, homeless, children.

Understand the risks associated with research in terms of harms that have serious effects

Emotional or psychological Social Physical Financial Legal

Describe the common rule and know why it is important

General requirements for informed consent Shared regulations governing human subjects It defines what constitutes research as well as defines "human subjects" Additional protection for certain vulnerable subjects (pregnant women, prisoners, children.)

Understand what the IRB is and why it was established. Be able to give examples of research that needs IRB approval vs that which does not.

Institute review board was established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the sponsorships of the institution with which it is affiliated. Needs approval: collecting specimens, obtaining samples from biobank, obtaining samples from investigation if investigator has access to results, prospective collection for future research Doesn't need approval: collection/use of specimen obtained through clinical care that are not for diagnosis purposes, use of investigation specimen when investigator will not have access to results, specimen from deceased individual where conclusions are not submitted to the FDA

Understand the ethical issues discussed in regards to germline gene therapy (cost, inequality, etc.)

Insurance does not cover germline therapy: this means wealthier people can afford out of pocket treatment while less wealthy people would not be able to get this treatment done. This would also only be available in wealthier countries which would create a gap between first and third world countries If all countries don't ban this it can become a medical tourism issue meaning people can just fly to get the treatment done which is unfair because puts rich at an advantage

Know the principles of medical ethics

Principle of Respect for Patient Autonomy Principle of Non-maleficence Principle of Beneficence Principle of Justice

Describe the differences between somatic and germline gene therapy

Somatic Gene Therapy: gene therapy done to an individual that is living. Treats single cell diseases (cystic fibrosis) unlikely to really eliminate the entire disease though Germline Gene Therapy: extremely controversial, edits embryo after in vitro and before implantation in the uterus. This is controversial because many embryos die eventually (would have become babies if they didn't get discarded and died). Can change a person's genes