Research ethics and consent

Why it matters

Life science research often involves people (blood samples, medical records, clinical trials) or animals. History shows what happens when researchers decide for themselves what is acceptable. Today, research involving humans or animals must be reviewed and approved before it starts, and everyone on the team, including technicians and students, must follow the approved protocol. You will complete ethics training before working on such projects; this lesson gives you the background.

Lessons from history

• The Nuremberg Code (1947) came out of the trials of Nazi doctors who experimented on prisoners. Its first principle: the voluntary consent of the human subject is absolutely essential.
• The US Public Health Service syphilis study at Tuskegee (1932-1972) followed hundreds of Black men with syphilis without telling them their diagnosis, and withheld effective treatment (penicillin) even after it became standard. Public exposure in 1972 ended the study and led directly to US research protections.
• Henrietta Lacks (1951). Cells taken from her tumour at Johns Hopkins without her knowledge became the HeLa cell line, used in countless discoveries. Her family was not told for decades. The case still shapes discussion of consent, privacy and the use of biological samples.

The Belmont Report's three principles

In 1979 a US national commission published the Belmont ReportThe 1979 US report setting out the three research ethics principles: respect for persons, beneficence and justice., which still underpins research ethics:

1. Respect for persons: treat people as autonomous; get informed consentAn ongoing process in which participants learn the purpose, risks and their rights, and voluntarily agree, free to withdraw any time.; protect those with reduced autonomy (children, people with cognitive impairments, prisoners).
2. Beneficence: do no harm, and maximise benefits while minimising risks.
3. Justice: distribute the burdens and benefits of research fairly; do not target vulnerable groups because they are convenient.

IRBs and the Common Rule

In the US, most federally funded research with human subjects follows the Common Rule (45 CFR 46), and FDA-regulated studies follow FDA's human subject rules. Both require review by an Institutional Review BoardA committee of scientists, non-scientists and an outside member that must approve and oversee research with human subjects. (IRB): a committee including scientists, non-scientists and at least one member not affiliated with the institution. The IRB:

• Reviews the protocol before research begins.
• Weighs risks against benefits.
• Checks the consent process and documents.
• Can require changes, approve, or disapprove, and continues oversight while the study runs.

Some low-risk studies qualify for exempt or expedited review, but the decision belongs to the IRB, not the researcher.

Informed consent

Consent is a process, not just a signature. Participants must be told, in language they understand:

• The purpose, procedures and how long participation lasts.
• Foreseeable risks and discomforts, and possible benefits.
• Alternatives, and how their data and samples will be kept confidential and used.
• That participation is voluntary and they can withdraw at any time without penalty.
• Whom to contact with questions.

Animal research: IACUCs and the 3Rs

Research with vertebrate animals at US institutions is reviewed by an Institutional Animal Care and Use Committee (IACUCThe Institutional Animal Care and Use Committee that reviews research with vertebrate animals at US institutions.) under the Animal Welfare Act and Public Health Service policy. Researchers must justify the use of animals and follow the 3RsReplace animals where possible, reduce their number to the minimum, and refine procedures to minimise pain and distress.:

• Replace animals with alternatives (cell culture, computer models) where possible.
• Reduce the number of animals to the minimum needed for a valid result.
• Refine procedures to minimise pain and distress.

Research misconduct

Separate from consent, US agencies define research misconductFabrication, falsification or plagiarism in research; honest error is not misconduct. as fabrication (making up data), falsification (manipulating data or images) and plagiarism. These end careers. Honest error and differences of opinion are not misconduct; hiding errors can become it.

A worked example

A technician in a lab studying a blood biomarker is asked to "just run a few extra samples" from the freezer for a new side project. The samples were collected under a consent form that covered only the original study. What should happen?

The technician should pause and ask whether the IRB-approved protocol and the consent cover the new use. If not, the PI needs to seek IRB approval (and possibly new consent) first. Doing the work without it would breach respect for persons, regardless of how harmless it seems.

Quick recap

• History (Nuremberg, Tuskegee, HeLa) explains why research protections exist.
• Belmont principles: respect for persons, beneficence, justice.
• IRBs review human research before it starts; consent is an informed, voluntary, ongoing process.
• IACUCs review animal research using the 3Rs; fabrication, falsification and plagiarism are misconduct.
• Official sources: HHS Office for Human Research Protections (hhs.gov/ohrp) and NIH Office of Laboratory Animal Welfare (olaw.nih.gov). Checked on 2026-10-23.