Human subjects research is research that involves living individuals about whom an investigator obtains data through intervention or interaction with the individual.
Office for Human Research Protections (OHRP), which is an office within the U.S. Department of Health and Human Services (HHS) that oversees the implementation of the Common Rule, which is a set of federal regulations that governs human subjects research in the U.S. OHRP can provide you with guidance and assistance on how to protect your rights and interests as a research participant, especially if you have been involved in any unethical or harmful human experimentation. You can also request that your data be destroyed or removed from the study records if you want to withdraw from a research study.
Human subjects research is research that involves living individuals about whom an investigator obtains data through intervention or interaction with the individual, or identifiable private information¹. The Common Rule is a federal policy that regulates the ethical conduct of human subjects research funded or supported by the U.S. government². The Common Rule has eight categories of research that may be exempt from the requirement of obtaining informed consent from the participants, depending on the level of risk and the nature of the research³. Some examples of exempt research are:
- Research involving educational practices in established or commonly accepted settings
- Research involving benign behavioral interventions with adult subjects who can provide verbal consent
- Research involving secondary use of identifiable private information or biospecimens that have been collected for non-research purposes
- Research involving public benefit or service programs conducted by or subject to approval by federal agencies
- However, even if a research study is exempt, it still must comply with the ethical principles of respect for persons, beneficence, and justice, and follow the relevant federal, state, and institutional regulations⁴.
Human experimentation in the United States refers to various experiments that have been performed on human subjects without their informed consent or knowledge, often violating ethical and legal standards. Some of these experiments involved exposure to harmful substances, infections, radiation, surgery, torture, and mind-altering drugs. Many of these experiments targeted vulnerable populations such as prisoners, minorities, children, and mentally disabled individuals. Some of these experiments were conducted by government agencies or private corporations with military interests⁶.
If you are a participant in a human research study and you want to withdraw your participation, you have the right to do so at any time, without penalty or loss of benefits. You should inform the research team that you want to withdraw and follow any instructions they give you for ending your participation safely and orderly. You may also ask for the reason why you want to withdraw, but you do not have to provide it if you do not want to. You should also be aware of the consequences of withdrawing from the study, such as how your data or biospecimens will be handled, and whether you will receive any follow-up care or monitoring⁷⁸⁹.
(1) Federal Policy for the Protection of Human Subjects ('Common Rule. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.
(2) Revised Common Rule Q&As | HHS.gov. https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html.
(3) Exemptions from IRB Review and the Revised Common Rule: What Has .... https://ohsrp.nih.gov/confluence/download/attachments/38961209/OHSRP%20ES%20Changes%20to%20Exemptions%20Presentation%206_13_19.pdf?api=v2.
(4) Guidance and Procedure: Level of Review - Certification of Exemption .... https://ora.research.ucla.edu/OHRPP/Documents/Policy/4/Exemption.pdf.
(5) Unethical human experimentation in the United States. https://en.wikipedia.org/wiki/Unethical_human_experimentation_in_the_United_States.
(6) 346. Consent and Early Withdrawal or Cessation of Participation. https://www.unr.edu/research-integrity/human-research/human-research-protection-policy-manual/346-consent-and-early-withdrawal-or-cessation-of-participation.
(7) Guiding Principles for Ethical Research | National Institutes of Health .... https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research.
(8) Withdrawing from a Research Study | Human Research Protection Office .... https://hrpo.wustl.edu/participants/withdrawing-from-a-study/.
(9) Changes to the Common Rule | Research and Innovation. https://research.uoregon.edu/manage/research-integrity-compliance/human-subjects-research/changes-common-rule.
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