/*! This file is auto-generated */ .wp-block-button__link{color:#fff;background-color:#32373c;border-radius:9999px;box-shadow:none;text-decoration:none;padding:calc(.667em + 2px) calc(1.333em + 2px);font-size:1.125em}.wp-block-file__button{background:#32373c;color:#fff;text-decoration:none} Problem 2 Does This Really Need to Be Revi... [FREE SOLUTION] | 91Ó°ÊÓ

91Ó°ÊÓ

Does This Really Need to Be Reviewed? A college professor would like to conduct a taste test of a new breakfast bar that contains only wholesome ingredients, such as whole grains, dried fruit, and honey without additives. He plans to ask students in his class if any would like to volunteer to serve as taste testers. Should he seek institutional review board approval before proceeding? Discuss.

Short Answer

Expert verified
Consulting the IRB is advisable to ensure ethical standards, even if the activity is low-risk and might be exempt.

Step by step solution

01

Understand Institutional Review Board (IRB) Role

An Institutional Review Board (IRB) is responsible for reviewing research involving human subjects to ensure their rights and welfare are protected. This includes evaluating the need for informed consent and assessing risk to participants.
02

Determine the Type and Purpose of the Research

Identify that the professor's test aims to evaluate the taste preferences of a new breakfast bar. This test is likely low-risk and does not intend to contribute to generalizable knowledge but rather to gather informal feedback.
03

Assess the Involvement of Human Subjects

Recognize that the students, as volunteers, are considered human subjects. Any research involving human subjects typically requires IRB oversight to ensure proper ethical standards are followed.
04

Identify Potential Risks and Benefits

Determine that the test poses minimal risk to participants, as it involves tasting a standard food product with wholesome ingredients. However, considerations like allergies and voluntary participation must be addressed.
05

Evaluate the Need for IRB Review Based on Criteria

Examine whether the activity classifies as research needing IRB review. Often, taste tests are exempt if they involve safe food constituents and non-sensitive data collection. If in doubt, consulting the IRB is advisable.

Unlock Step-by-Step Solutions & Ace Your Exams!

  • Full Textbook Solutions

    Get detailed explanations and key concepts

  • Unlimited Al creation

    Al flashcards, explanations, exams and more...

  • Ads-free access

    To over 500 millions flashcards

  • Money-back guarantee

    We refund you if you fail your exam.

Over 30 million students worldwide already upgrade their learning with 91Ó°ÊÓ!

Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Human Subjects Research
Human subjects research refers to any scientific study or investigation that involves humans as participants. In the context of the breakfast bar taste test, the students who volunteer are considered human subjects. These individuals provide data or responses that contribute to the research process.
The purpose of human subjects research is to allow investigators to gain insights, knowledge, and understanding in various fields, such as medicine, psychology, or nutrition.
However, it's crucial to approach these studies with caution to protect the participants' rights and welfare.
Some key aspects of human subjects research include:
  • Recruitment methods - Ensuring voluntary and non-coercive participation.
  • Confidentiality - Safeguarding personal information and data privacy.
  • Protection from harm - Avoiding any physical or psychological risk to participants.
Conducting research with human subjects requires careful ethical considerations and often demands oversight by an Institutional Review Board (IRB) to ensure that ethical standards are maintained.
Informed Consent
Informed consent is a foundational concept in human subjects research. It involves obtaining permission from participants after fully informing them about the study's purpose, methods, potential risks, and benefits.
In the case of the breakfast bar taste test, informed consent would require the professor to explain the following to the students:
  • The purpose of the taste test and what it involves.
  • Any potential risks, such as allergic reactions to ingredients.
  • Their right to withdraw from the study at any time without consequence.
Getting informed consent ensures that participants voluntarily agree to take part, equipped with all pertinent information. This process is crucial for building trust and respecting the autonomy of participants, allowing them to make informed decisions about their involvement.
Research Ethics
Research ethics refers to the principles and standards that guide responsible and ethical conduct of research. This framework helps protect human subjects and ensure the integrity of the research.
For the breakfast bar study, key ethical considerations include:
  • Respect for Persons - Honoring the autonomy of participants and obtaining informed consent.
  • Beneficence - Minimizing risks and maximizing potential benefits of the research.
  • Justice - Ensuring fair and equitable selection of participants.
The goal of research ethics is to prevent harm and misuse of data while promoting fair and beneficial outcomes. Researchers are expected to adhere to these principles to maintain public trust and the validity of the research results.
Risk Assessment
Risk assessment in human subjects research involves identifying and evaluating potential risks to participants before the study begins. This includes both physical and psychological risks.
In the breakfast bar taste test, the primary risk could be allergic reactions to ingredients.
To conduct an effective risk assessment, researchers should:
  • Identify all potential risks related to the study.
  • Assess the likelihood and severity of these risks.
  • Implement measures to minimize or eliminate risks.
It's important to note that even low-risk studies like taste tests need a thorough evaluation. By conducting a risk assessment, researchers can ensure they take all necessary precautions to protect the participants' safety and well-being. This process may also determine whether the study requires IRB review and oversight.

One App. One Place for Learning.

All the tools & learning materials you need for study success - in one app.

Get started for free

Most popular questions from this chapter

Undue Influence? Undue influence in obtaining informed consent often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. Which of the following circumstances do you believe constitutes undue influence? Discuss. a. The students in a professor's class are told they will be given extra credit if they participate in a research study she is conducting. An alternative means of obtaining extra credit is available for students not wishing to participate. b. The students in a professor's class are told they will be given extra credit if they participate in a research study she is conducting. Extra credit is only available for students who choose to participate but will be awarded even if a student drops out of the study before it is completed. c. The students in a professor's class are told they will be given extra credit if they participate in a research study she is conducting. The extra credit will only be awarded to those students who continue in the study until it is finished.

Undue Influence? An investigator wants to conduct a funded study of the safety of a vaccine to prevent hepatitis \(C\) involving prisoners as subjects. Prisoners will receive either vaccine or placebo and then be asked to complete surveys and undergo physical exams to assess for adverse effects. In order to ensure that subjects will report side effects and cooperate with exams, prisoners who are judged by the guards to be most compliant and well behaved are nonrandomly assigned to the experimental arm; others are assigned to the control (placebo) arm. To encourage participation, prisoners are offered better meals and the opportunity for better-paying jobs in the prison. Are there any aspects of this study that you object to? Why?

Anonymous or Confidential? The website for STDcheck.com contains the following information about HIV testing: "We offer \(100 \%\) private testing. You are not required to show your ID at the lab, you're given a unique code which allows the lab to perform testing wit hout your ID, and your results are uploaded to your private online account .....We encrypt our data with industry standard 128-bit encryption. All communication and transactions between you and our website are secure." Does this practice offer anonymity or confidentiality or both? Explain your answer.

Informed Consent. Facebook claims that its data privacy policy covered this experiment because it included this line: "For example, in addition to helping people see and find things that you do and share, we may use the information we receive about you ... for internal operations, including troubleshooting, data analysis, testing, research and service improvement." Do you agree that this policy does enough to count as informed consent? Discuss your reasoning.

Who Reviews? Government regulations require that an institutional review board consist of at least five people, including at least one scientist, one nonscientist, and one person from outside the institution. Most boards are larger, but many contain just one outsider. a. Why should review boards contain people who are not scientists? b. Do you think that one outside member is enough? How would you choose that member? (For example, would you prefer a medical doctor? A member of the clergy? An activist for patients' rights?)

See all solutions

Recommended explanations on Math Textbooks

View all explanations

What do you think about this solution?

We value your feedback to improve our textbook solutions.

Study anywhere. Anytime. Across all devices.