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Questions and Answers

What is one of the risks related to posting online?

Individuals may post private identifiable information about themselves online without intending it to be public.

Who must researchers report potential unanticipated problems that involve risks to others directly to?

Institutional Review Board (IRB)

What criteria must be met for a problem to be considered 'unanticipated' according to OHRP?

  • Expected and unrelated to the research
  • Unexpected, related or possibly related to the research (correct)
  • Related but anticipated
  • None of the above

    • Should a researcher report a participant's heart attack two weeks after a focus group for hygiene and disease prevention?

    <p>False</p> Signup and view all the answers

    Is a subject's automobile accident after participating in a drug study an unanticipated problem that requires reporting to the IRB?

    <p>False</p> Signup and view all the answers

    When must an unanticipated problem related to data theft be reported to the IRB?

    <p>Promptly</p> Signup and view all the answers

    What does medical vulnerability refer to in research contexts?

    <p>Individuals with serious illnesses may be at risk for exploitation.</p> Signup and view all the answers

    What is cognitive or communicative vulnerability?

    <p>Inability to comprehend information or make decisions about participation.</p> Signup and view all the answers

    What is economic vulnerability in a research context?

    <p>Participants may join studies due to financial incentives or costs related to treatment.</p> Signup and view all the answers

    Which of the following are four common abuses that lead to vulnerability?

    <p>Physical control</p> Signup and view all the answers

    Under what conditions might an individual be considered situationally cognitively vulnerable?

    <p>When they are otherwise competent but acutely ill.</p> Signup and view all the answers

    Who is required to disclose significant financial conflicts of interest?

    <p>Researcher</p> Signup and view all the answers

    What is an example of an individual financial conflict of interest?

    <p>A researcher's spouse holds equity in a pharmaceutical company sponsoring the study.</p> Signup and view all the answers

    Why can a researcher's membership on an advisory board create a conflict of interest?

    <p>It may compromise the researcher's perceived neutrality.</p> Signup and view all the answers

    What do FDA regulations require concerning financial conflicts of interest?

    <p>Applicants must disclose financial COIs of researchers who conducted clinical studies.</p> Signup and view all the answers

    What must an IRB member do if they have a potential conflict of interest?

    <p>Disclose their potential conflict of interest and recuse themselves from voting.</p> Signup and view all the answers

    Which vulnerable populations does the Common Rule not have specific requirements for?

    <p>Workers</p> Signup and view all the answers

    What vulnerabilities may workers face when participating in research?

    <p>Pressure from management, influence from employers, and potential job implications.</p> Signup and view all the answers

    What should include the proper management of study data and records?

    <p>Access permissions, usage in personnel records, data collection methods, and retention of personal identifiers.</p> Signup and view all the answers

    Must all planned future uses of biological samples be explained to research subjects?

    <p>True</p> Signup and view all the answers

    What is a typical concern for non-English speaking subjects?

    <p>All of the above</p> Signup and view all the answers

    What is the best strategy for a researcher working with an interpreter in a study?

    <p>Meet with the interpreter prior to the subject meeting.</p> Signup and view all the answers

    What is one of the best methods to enhance understanding of research for participants?

    <p>Asking a fluent staff member to explain concepts.</p> Signup and view all the answers

    What enhances understanding during the consent discussion for non-English speakers?

    <p>Allowing discussion with advocates</p> Signup and view all the answers

    Is using a family member as an interpreter in the consent process always appropriate?

    <p>False</p> Signup and view all the answers

    What defines an 'eligible student'?

    <p>Students when they turn 18 or enter a postsecondary institution.</p> Signup and view all the answers

    What did the U.S. Supreme Court rule in Gonzaga v. Doe?

    <p>The law does not permit lawsuits against non-compliant educational institutions.</p> Signup and view all the answers

    Which federal agency oversees the enforcement of FERPA?

    <p>Family Policy Compliance Office (FPCO)</p> Signup and view all the answers

    Who was originally opposed to FERPA?

    <p>School counselors</p> Signup and view all the answers

    What is the time frame for an educational institution to respond to requests to review records?

    <p>45 days</p> Signup and view all the answers

    When is an eligible student's educational record generally not disclosed?

    <p>When the student's professor is collecting data for personal research.</p> Signup and view all the answers

    Can individual educational institutions determine their own directory information?

    <p>True</p> Signup and view all the answers

    What would be the least risky option for reporting outcomes of a study involving graduate students?

    <p>Provide a summation of survey results without the grades.</p> Signup and view all the answers

    What does student administrative data refer to?

    <p>Student educational records in paper and electronic form.</p> Signup and view all the answers

    What prevents schools from providing identifiable student performance data?

    <p>FERPA without prior consent</p> Signup and view all the answers

    What is a risk of small cell sizes in educational data reporting?

    <p>Risk of disclosure of students' information.</p> Signup and view all the answers

    What content is not protected under FERPA?

    <p>Any metadata that is not tied to identifying information.</p> Signup and view all the answers

    Where can student researchers find additional resources regarding the IRB approval process?

    <p>Both A and B</p> Signup and view all the answers

    What type of review would a student's dissertation study of 15 principals require?

    <p>Full Board Review</p> Signup and view all the answers

    What type of review would a student's non-identifiable survey research fall under?

    <p>Exempt Review</p> Signup and view all the answers

    What is the charge of the Institutional Review Board (IRB)?

    <p>All of the above</p> Signup and view all the answers

    What must be included in an informed consent document according to federal regulations?

    <p>All foreseeable risks and discomforts.</p> Signup and view all the answers

    Which of the following is a principle included in the Belmont Report?

    <p>All of the above</p> Signup and view all the answers

    What does the Belmont Report's principle of respect for persons incorporate?

    <p>Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.</p> Signup and view all the answers

    How can the Principle of Beneficence be applied to a study employing human subjects?

    <p>Determining that the study has a maximization of benefits and a minimization of risks.</p> Signup and view all the answers

    According to the Belmont Report, what does the principle of justice express?

    <p>Fair outcomes in the selection of research subjects.</p> Signup and view all the answers

    What is the primary ethical violation in the 'Tastes, Ties, and Time (T3)' study?

    <p>Failure to protect research subjects from deductive disclosure.</p> Signup and view all the answers

    What should the IRB do regarding a research proposal for a biography about Bill Gates?

    <p>The IRB will not review this study because it is not research as defined by the federal regulations.</p> Signup and view all the answers

    According to federal regulations, how are human subjects defined?

    <p>Living individuals about whom an investigator conducts research.</p> Signup and view all the answers

    Which study meets the definition of research with human subjects according to federal regulations?

    <p>A study of twenty 4th grade classrooms collecting assessments.</p> Signup and view all the answers

    What may qualify research under federal regulations for exemption?

    <p>Research that falls into one of eight categories of research activity described in the regulations.</p> Signup and view all the answers

    Officials of the institution can overrule an IRB approval.

    <p>True</p> Signup and view all the answers

    What defines minimal risk in the expedited review process?

    <p>Study procedures that pose no more than minimal risk and fall within identified eligible categories.</p> Signup and view all the answers

    Who else, in addition to pregnant women, fetuses, and neonates, is provided additional protections under HHS regulations?

    <p>Prisoners</p> Signup and view all the answers

    What must occur within 12 months for continuing review of an approved study posing more than minimal risk?

    <p>Review must occur.</p> Signup and view all the answers

    What is the primary purpose of a Certificate of Confidentiality?

    <p>To protect identifiable research information from compelled disclosure.</p> Signup and view all the answers

    If a subject's involvement in a research study could be harmful, what is advisable?

    <p>Obtain a waiver of documentation of informed consent.</p> Signup and view all the answers

    When evaluating risk of harm in a web-based survey, what factors should be considered?

    <p>Both the magnitude and the probability of harm.</p> Signup and view all the answers

    What are the three categories of risk of harm in social and behavioral sciences?

    <p>Invasion of privacy, breach of confidentiality, and study procedures.</p> Signup and view all the answers

    Identify a situation where timing is key to assessing risk of harm in research.

    <p>Asking women if they have had an abortion.</p> Signup and view all the answers

    Why might parents feel pressure regarding permission to use their children's data in research?

    <p>Parents might feel pressured to give permission for continued services.</p> Signup and view all the answers

    What constitutes exculpatory language in informed consent?

    <p>Language waiving any of the subject's legal rights.</p> Signup and view all the answers

    In which scenario would it not be appropriate to provide information about missing elements of consent?

    <p>Assigning subjects to study activities based on undesirable physical characteristics.</p> Signup and view all the answers

    When may a waiver of informed consent be granted?

    <p>When the principal risk is a breach of confidentiality.</p> Signup and view all the answers

    What is required during the consent process according to federal regulations?

    <p>Researchers must provide information at an appropriate reading comprehension level.</p> Signup and view all the answers

    How can data be made anonymous?

    <p>By destroying all identifiers connected to the data.</p> Signup and view all the answers

    What occurred when a research file was stolen from a researcher's car?

    <p>There was neither a violation of privacy nor a breach of confidentiality.</p> Signup and view all the answers

    What can a researcher not control regarding confidentiality in focus groups?

    <p>What participants repeat about others outside the group.</p> Signup and view all the answers

    What example constitutes both a breach of confidentiality and a privacy violation?

    <p>Making identifiable data about sexual behavior available to graduate students.</p> Signup and view all the answers

    What procedure helps protect against compelled disclosure of identifiable information in longitudinal studies?

    <p>Securing a Certificate of Confidentiality.</p> Signup and view all the answers

    Which research with prisoners is allowable under regulations?

    <p>Examining age at first arrest as a predictor of adult criminal history.</p> Signup and view all the answers

    Why should the student's IRB not approve her project involving prisoner demographics?

    <p>Prisoners are merely a population of convenience for the student.</p> Signup and view all the answers

    What is the correct decision regarding a prisoner's demographic dataset study's exemption?

    <p>It is wrong; research in prisons may not be exempt.</p> Signup and view all the answers

    What statement about prison research is true?

    <p>Researchers may study the effects of privilege upgrades awarded by the prison.</p> Signup and view all the answers

    Which protections apply to all research funded by HHS?

    <p>Subpart D of HHS regulations regarding additional protections for children.</p> Signup and view all the answers

    Under what conditions can research with children be exempt under Category 2?

    <p>When it involves using educational tests.</p> Signup and view all the answers

    What are the specific regulations for research with children known as?

    <p>Subpart D: Additional Protections for Children Involved as Subjects in Research.</p> Signup and view all the answers

    What must happen before an IRB can waive parental permission for classroom research?

    <p>The research must pose no more than minimal risk.</p> Signup and view all the answers

    How are 'children' defined according to federal regulations?

    <p>Persons who have not yet attained the legal age of consent.</p> Signup and view all the answers

    Which research activity with children could qualify for exemption under Category 2?

    <p>Research about aptitude testing.</p> Signup and view all the answers

    When is parental notification allowed without active permission?

    <p>When an IRB waives the requirement for parental permission.</p> Signup and view all the answers

    What is the purpose of the Family Educational Rights and Privacy Act (FERPA)?

    <p>To provide parents certain rights over their children's educational records.</p> Signup and view all the answers

    What governs research in public schools, in addition to the Common Rule?

    <p>FERPA, PPRA, and Subpart D of the federal regulations.</p> Signup and view all the answers

    What control does PPRA give parents regarding their child's research participation?

    <p>Participation in third-party survey research or exposure to instructional materials.</p> Signup and view all the answers

    What must be described in an 'assurance of compliance' with a U.S. federal agency?

    <p>Procedures that ensure subjects will be protected according to the Common Rule.</p> Signup and view all the answers

    Which activity is the least important when protecting human subjects in international research?

    <p>Assessing transportation conditions.</p> Signup and view all the answers

    Is review required at a foreign site if a study is determined to be exempt by institutional policy?

    <p>No, federal regulations do not require review at the foreign site.</p> Signup and view all the answers

    What determines the age of majority in international research?

    <p>Laws, customs, and norms in the area where the research is conducted.</p> Signup and view all the answers

    What key question should an IRB ask regarding research conducted in Chile?

    <p>Will the researcher have collaborators at the research site abroad?</p> Signup and view all the answers

    What is a way to minimize potential risks of harm in an on-line survey?

    <p>Design the survey so that no direct or indirect identifiers are collected.</p> Signup and view all the answers

    What online research strategy raises concerns about respecting the autonomy of subjects?

    <p>A researcher poses as a cancer survivor in a support group to gather data.</p> Signup and view all the answers

    How can a survey about a sensitive topic ensure participation remains voluntary?

    <p>Designing the survey so that subjects are not forced to answer one question before progressing.</p> Signup and view all the answers

    What is a best practice for informing respondents about data protection in an online survey?

    <p>Using informed consent to explain how data will be protected.</p> Signup and view all the answers

    Study Notes

    Belmont Report Principles

    • Respect for Persons: Individuals should be treated as autonomous agents; those with diminished autonomy require protection.
    • Beneficence: Emphasizes maximizing benefits and minimizing risks in research.
    • Justice: Ensures fair outcomes in the selection of research subjects.

    Ethical Violations in Research

    • The "Tastes, Ties, and Time (T3)" study exemplified failure to protect subjects from deductive disclosure.
    • Humphreys' Tearoom Trade study violated respect for persons by collecting data under false pretenses.

    Human Subjects Research Criteria

    • Human subjects are defined as living individuals from whom information is collected via interaction or identifiable private information.
    • Studies that involve systematic variation of teaching times or gender-related stereotypes in performance qualify as research with human subjects under federal regulations.

    Regulatory Exemptions and Reviews

    • Research qualifies for exemption if it falls under one of eight specified categories by federal regulations.
    • For studies posing minimal risk and in compliance with specific guidelines, an expedited review process may apply.

    Special Populations and Additional Protections

    • Additional protections apply to vulnerable groups such as prisoners, fetuses, and neonates under HHS regulations.
    • Research with children requires adherence to Subpart D, which offers further safeguards.
    • Informed consent cannot include exculpatory language that waives legal rights of subjects.
    • Waivers for documentation of consent can occur when the only record linking subjects to research is the consent document.

    Data Privacy and Confidentiality

    • Data anonymity is achieved by destroying all identifiers connected to the data.
    • Confidentiality breaches occur when identifiable data is disclosed contrary to agreements made with participants.

    International Research Considerations

    • In international settings, local laws determine the age of majority for research participants.
    • Studies qualifying for exemption from federal regulations do not require local institutional review if determined exempt by institutional policy.

    Online Research Ethics

    • Researchers should design online surveys to avoid collecting identifiable information and ensure participation remains voluntary.
    • Risks unique to online research must be acknowledged, such as potential inadvertent sharing of private information.

    Reporting Obligations

    • Unanticipated problems posing risks to research subjects must be reported directly to the IRB.
    • Problems are classified as unanticipated when they are unexpected or increase risk related to the research.

    Specific Case Scenarios

    • Researcher access to prisoners must avoid coercion or influence by prison staff to ensure voluntary participation.
    • Reports to the IRB are unnecessary for health events unrelated to research participation.

    Conclusion

    • Adhering to ethical principles and regulatory standards is vital for the protection of human subjects in research.
    • Continuous education and awareness of these principles support responsible research practices and the integrity of the research process.### Unanticipated Problems in Research
    • Unanticipated problems related to research must be reported due to factors including unexpected incidents and increased risks of harm.
    • According to OHRP, these reports must be submitted to the IRB promptly.

    Medical Vulnerability

    • Individuals with serious illnesses are at risk for exploitation, driven by desperation for cures.

    Cognitive or Communicative Vulnerability

    • Cognitive or communicative vulnerability affects prospective subjects unable to understand, deliberate, and decide on study participation due to limitations in comprehension or communication.

    Economic Vulnerability

    • Economic vulnerability occurs when subjects engage in studies because of treatment that is affordable only through research participation.

    Common Abuses Leading to Vulnerability

    • Common abuses that increase vulnerability include physical control, coercion, undue influence, and manipulation.

    Situational Cognitive Vulnerability

    • Situational cognitive vulnerability considers that seriously ill individuals may be at higher risk for psychological harm when making decisions about participation.

    Financial Conflict of Interest Regulations

    • PHS regulations mandate that researchers disclose significant financial conflicts of interest.

    Individual Financial Conflict of Interest Example

    • An example includes situations where a researcher's family member has stakes in a pharmaceutical company sponsoring the researcher’s study.

    Advisory Board Membership and COI

    • A researcher's role on an advisory board for a sponsoring organization can complicate perceptions of neutrality regarding research outcomes.

    FDA Regulations on COI Disclosure

    • FDA regulations require transparency about financial conflicts involving researchers in clinical studies during marketing application submissions.

    IRB Member Conflict of Interest

    • During IRB meetings, members aware of potential conflicts must disclose and recuse themselves from voting on related studies.

    Vulnerable Populations under Common Rule

    • Vulnerable populations are legally recognized as requiring additional protections except for workers, who do not have specific requirements under the Common Rule.
    • Workers may face pressures related to management expectations, implications for pay or benefits, and union influences when approached to participate in studies.

    Safeguards for Workers in Research

    • Research involving workers must employ safeguards, clarifying data access, confidentiality measures, and the handling of personal identifiers.

    Biological Samples in Research

    • Comprehensive explanations regarding the future use of biological samples and associated data are essential for informed consent.

    Considerations for Non-English Speaking Subjects

    • Cultural differences must be accounted for when researching subjects who do not speak English.

    Importance of Certified Interpreters

    • Using certified interpreters enhances communication; researchers should pre-meet with interpreters to ensure understanding of key concepts.
    • Providing interpreters and discussion time during the consent process significantly aids understanding for non-English speaking subjects.

    Risks of Using Family Members to Interpret

    • Family members may misinterpret due to various factors, making it risky to rely on them for the consent process.

    Definition of "Eligible Student"

    • An eligible student is defined as one who turns 18 or enrolls in a postsecondary institution.

    Gonzaga v. Doe Ruling

    • The U.S. Supreme Court ruled that no private cause of action exists against educational institutions for FERPA non-compliance.

    Oversight of FERPA

    • The Family Policy Compliance Office (FPCO) enforces compliance with FERPA regulations.

    Initial Opposition to FERPA

    • Initial opposition to FERPA came from school counselors and university administrators.

    Response Time for Educational Record Requests

    • Educational institutions must respond to requests for educational records from eligible students or parents within 45 days.

    Disclosure of Educational Records

    • A student's educational record cannot be disclosed when a professor is collecting data for personal research.

    Directory Information Definition

    • Schools can define what constitutes directory information within specific regulatory guidelines.

    Risk of Disclosure in Small Cell Data

    • Small cell size in data reporting poses a risk of inadvertently disclosing individual students' information.

    Non-FERPA Protected Online Tool Content

    • Metadata from online educational tools, not linked to identifiable information, is not subject to FERPA protections.

    Resources for IRB Approval Process

    • Additional resources for students regarding the IRB approval include Faculty Advisors and the IRB Office.

    Types of IRB Review

    • Studies involving identifiers and sensitive information typically require Full Board Review, while studies without identifiable information may qualify for Exempt Review.

    Institutional Review Board Responsibilities

    • The IRB is responsible for protecting human subjects' rights and welfare, ensuring compliance with regulations, and reviewing recruitment strategies and materials.
    • Informed consent documents must include descriptions of all foreseeable risks and discomforts associated with participation.

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