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Related Concept Videos

Blinding01:11

Blinding

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Blind Procedures02:07

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Randomized Experiments01:13

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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

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Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
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Related Experiment Video

Updated: Nov 14, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Unblinding in Randomized Controlled Trials: A Research Ethics Case.

Ayesha Bhatia1, Paul S Appelbaum2, Katherine L Wisner3

  • 1Research study coordinator in the Department of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine.

Ethics & Human Research
|March 8, 2021
PubMed
Summary

Should research participants be told which treatment they received in a clinical trial? This summary explores the ethical considerations of unblinding participants after a randomized controlled trial (RCT) concludes.

Keywords:
adverse eventsdisclosurehuman research ethicshuman subjects researchinformed consentrandomized controlled trialresearch designtrial unblinding

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Area of Science:

  • Clinical Trials
  • Research Ethics
  • Medical Ethics

Background:

  • Randomized controlled trials (RCTs) are crucial for evaluating new treatments.
  • Participant blinding is standard in RCTs to prevent bias.
  • Ethical considerations surrounding post-trial participant unblinding require examination.

Observation:

  • A pregnant participant in a double-blind RCT requested to know her assigned treatment post-trial.
  • The request stemmed from a desire to inform future pregnancy healthcare decisions.
  • This highlights a gap in standard RCT procedures regarding participant unblinding.

Findings:

  • Unblinding participants may offer personal health benefits for future decision-making.
  • Potential harms of unblinding, such as psychological distress or altered future care, must be weighed.
  • Ethical principles of participant communication and harm reduction guide decisions on unblinding.

Implications:

  • Investigational drug unblinding protocols need careful ethical consideration.
  • Balancing scientific integrity with participant autonomy is essential.
  • Further guidelines may be needed for managing participant requests for treatment information post-RCT.