Exam prep

Research Ethics (CITI) study guides

IRB, consent, and integrity — explained with decision trees and plain-language examples.

34 explained questions, each with the answer, a worked explanation, and something interactive to help it stick.

Which of the following is true about the management of conflicts of interest?True: a conflict of interest can usually be managed rather than always eliminated. Institutions create a written management plan — using tools such as disclosure, independent oversight, or recusal — to reduce the COI's impact on research integrity while the work continues.Read the guide
Which author is normally responsible for sharing reprints of a publication with readers?The corresponding author is normally responsible for sharing reprints. This author manages manuscript submission, editorial and peer-review correspondence, and post-publication requests, including sending reprints or PDFs to readers who ask for a copy of the article.Read the guide
As specified by FERPA, noncustodial parents:Under FERPA, noncustodial parents have the same right to access their child's education records as custodial parents. A school must grant access unless a court order, state law, or legally binding document specifically revokes that parent's rights to the records.Read the guide
Additional safeguards that may be included in a social and behavioral study may include:Additional safeguards may include removing direct identifiers from data as soon as possible, collecting data anonymously, and actively monitoring the data being collected to protect subjects' safety and confidentiality — the main risks in social and behavioral research.Read the guide
Amendments involving changes to IRB-approved protocols do not need prior IRB approval if:An amendment does not need prior IRB approval only if the change must be implemented immediately to eliminate an apparent hazard to a subject's health or well-being. The change is made to protect the subject and must then be reported promptly to the IRB.Read the guide
Which of the following brought increased public attention to the problems with the IRB system?The deaths of two research participants: Jesse Gelsinger, who died in a 1999 gene-therapy trial at the University of Pennsylvania, and Ellen Roche, a healthy volunteer who died in a 2001 asthma study at Johns Hopkins. Both cases exposed serious flaws in IRB oversight and prompted reform.Read the guide
Which of the Following Was the Result of the Beecher Article?Henry Beecher's 1966 article exposed widespread unethical human-subjects research in respected institutions and journals. Its result was heightened awareness that helped drive federal regulations requiring informed consent and independent ethics review (IRB oversight), making it a landmark in modern research-ethics reform.Read the guide
Does HIPAA exclude information considered education records under FERPA law?True. The HIPAA Privacy Rule expressly excludes FERPA-covered education records (and FERPA-defined treatment records at postsecondary institutions) from its definition of Protected Health Information, so those records are governed by FERPA rather than HIPAA.Read the guide
Which of the following is true regarding industry-sponsored research?True: industry sponsors may place restrictions on how and when investigators publish or disclose results. Sponsorship agreements often include publication-delay or confidentiality clauses to protect proprietary data, which can limit an investigator's freedom to publish findings.Read the guide
As Part of the Consent Process, What Do Federal Regulations Require Researchers To Do?Federal regulations (45 CFR 46.116) require researchers to provide potential subjects with information in language understandable to them, at an appropriate reading level. Consent must be plain and comprehensible, not legalese, and must genuinely inform the person's voluntary decision.Read the guide
Which of the following most accurately describes an institutional conflict of interest?An institutional conflict of interest exists when the financial interests of the institution itself — or of a senior official acting on its behalf — could inappropriately affect, or appear to affect, the institution's research, education, or clinical activities.Read the guide
Issued in 1974, 45 CFR 46 raised to regulatory status what?Issued in 1974, 45 CFR 46 raised to regulatory status the U.S. Public Health Service policy of 1966 titled "Clinical Research and Investigation Involving Human Beings." What had been an internal PHS policy became binding federal regulation for HHS-funded human-subjects research.Read the guide
To Minimize Potential Risks of Harm, a Researcher Conducting an Online Survey Can:Design the survey so that no direct or indirect identifiers are collected, keeping responses anonymous. This protects participants' privacy and confidentiality and greatly reduces the harm that could result from a data breach or subpoena of the records.Read the guide
Which of the Following Is an Important Component of Drug Accountability?Drug shipping and disposition records. Under Good Clinical Practice (GCP), drug accountability requires documenting an investigational product's entire lifecycle, receipt, storage, dispensing to subjects, return, and final disposal or destruction, so every unit can be traced.Read the guide
Which of the Following Are the Three Principles Discussed in the Belmont Report?The three core ethical principles of the Belmont Report are Respect for Persons, Beneficence, and Justice. Published in 1979, these principles guide the ethical conduct of research involving human subjects and map to informed consent, risk/benefit assessment, and fair subject selection.Read the guide
Which of the Following Is True Regarding Research Misconduct?Research misconduct is defined as fabrication, falsification, or plagiarism (FFP) in proposing, performing, reviewing, or reporting research. It explicitly excludes honest error and honest differences of opinion, and federal agencies normally rely on the researcher's institution to make the initial response to an allegation.Read the guide
According to federal regulations, how are "children" defined?Under federal regulations (45 CFR 46.402(a)), "children" are persons who have not attained the legal age for consent to the treatments or procedures involved in the research, under the applicable law of the jurisdiction where the research is conducted. It is jurisdiction-dependent, not a fixed age.Read the guide
In any collaboration, data ownership is typically determined by what?Data ownership in a collaboration is typically determined by the type and source of funds used to support the project. The funding agreement, sponsor terms, and applicable institutional or federal policies decide who owns the data, not the individual researchers.Read the guide
When required, what information must be provided to the data subject in a HIPAA disclosure accounting?A HIPAA accounting of disclosures must cover disclosures from the six years before the request and, for each one, list the date of disclosure, the recipient's name and address, a brief description of the PHI disclosed, and the purpose of the disclosure.Read the guide
Which of the following most accurately describes a conflict of commitment?A conflict of commitment exists when an individual's outside activities and time commitments interfere with or divert time and effort from their primary institutional obligations. It is about the allocation of time and effort, not necessarily financial gain.Read the guide
Which of the Following Most Accurately Describes the Practice of Ghost Authorship?Ghost authorship occurs when someone makes a substantial contribution to a manuscript but is deliberately left off the author list and acknowledgments. A classic example is a paid professional writer, often industry-funded, whose involvement is hidden from readers.Read the guide
Informed Consent Is Considered an Application of Which Belmont Principle?Informed consent is an application of Respect for Persons. This Belmont Report principle requires honoring participants' autonomy to make voluntary, informed decisions and providing extra protection for individuals with diminished autonomy, which is exactly what the consent process operationalizes.Read the guide
Which of the following is a key reason why international collaborations can be challenging?International collaborations are challenging mainly because partners bring different disciplinary, cultural, and regulatory backgrounds. Add language barriers, time-zone gaps, and differing laws on data, ethics, and intellectual property, and communication and shared expectations become much harder to align.Read the guide
Which is an example of a situation where deferential vulnerability might be a factor?A physician recruiting his or her own patients into a study. Deferential vulnerability arises when a participant tends to defer to the authority of someone in a trusted role — here, the doctor-patient relationship makes patients reluctant to refuse or withdraw.Read the guide
Which of the following statements is true regarding the regulations that govern research?The true statement is that research is governed by overlapping federal, state, and institutional regulations, and requirements vary by country and funding source. U.S.-funded human-subjects studies generally must follow U.S. rules (the Common Rule, 45 CFR 46) regardless of where the research is conducted.Read the guide
What is an example of an individual financial conflict of interest (COI)?An individual financial COI is a personal or family financial interest that could bias research — for example, a researcher (or their spouse/dependent) holding stock, receiving consulting fees, or earning royalties from a company that sponsors or benefits from the study.Read the guide
Which of the Following Statements Is True Regarding the Responsibilities of a Reviewer?The true statement is that a reviewer must keep the manuscript confidential, disclose any conflict of interest (and recuse if needed), evaluate the work objectively and promptly on its merits, and never use privileged information from the submission for personal or professional gain.Read the guide
What is an example of an institutional conflict of interest (COI)?An institutional COI exists when a university or its senior officials hold a financial interest — such as equity, royalties, or a large gift or grant — in a company whose product is being studied in research conducted at that institution. The institution's own interests could bias the research.Read the guide
PPRA Gives Parents Some Level of Control Over Their Child's What?PPRA gives parents control over their child's participation in surveys, especially third-party or federally funded surveys that ask about protected topics, and the right to inspect instructional materials. It does NOT cover a child's medical records.Read the guide
What Is the Primary Purpose of a Certificate of Confidentiality?A Certificate of Confidentiality's primary purpose is to protect identifiable, sensitive research data from compelled or forced disclosure. It lets researchers refuse to release identifying information in response to civil, criminal, administrative, or legislative subpoenas, safeguarding participants.Read the guide
Which Statement Is True Regarding the Responsibilities of Reviewers?The true statement is that reviewers must maintain confidentiality of the submission, disclose any conflict of interest, and provide an objective, professional, timely evaluation. A reviewer may not share, use, or exploit the unpublished ideas they review.Read the guide
OHRP is an oversight body primarily concerned with what?OHRP (the Office for Human Research Protections) is primarily concerned with protecting human research subjects. It oversees Institutional Review Boards (IRBs) and enforces the federal regulations, 45 CFR 46 (the Common Rule), that safeguard people who participate in HHS-funded research.Read the guide
What Is a Primary Purpose of the ICH?A primary purpose of the ICH is to harmonize and standardize technical guidelines and requirements for pharmaceutical product registration across regions. This reduces duplicate (redundant) clinical research, speeds drug development, and ensures data quality while protecting the rights and safety of human subjects.Read the guide
What Do the FDA Regulations Governing Disclosure of Individual COIs Require?They require applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of, or disclose, specified financial interests of clinical investigators. The FDA may refuse to file an application that lacks this certification or disclosure.Read the guide