Q.1 Which regulation primarily governs the protection of personal health information in the United States?
General Data Protection Regulation (GDPR)
Health Insurance Portability and Accountability Act (HIPAA)
California Consumer Privacy Act (CCPA)
Freedom of Information Act (FOIA)
Explanation - HIPAA sets standards for the privacy and security of protected health information (PHI) in the U.S., directly affecting bioinformatics data handling.
Correct answer is: Health Insurance Portability and Accountability Act (HIPAA)
Q.2 In bioinformatics hardware design, which ethical principle demands that a device must not be used to discriminate against individuals based on genetic information?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - The principle of justice requires fair treatment and non‑discrimination, ensuring that technologies do not create genetic bias.
Correct answer is: Justice
Q.3 The European Union’s GDPR defines 'personal data' to include which of the following?
Only name and address
Any information relating to an identified or identifiable natural person
Only financial information
Only biometric data
Explanation - GDPR’s definition is broad and covers any data that can directly or indirectly identify a person, including genetic data used in bioinformatics.
Correct answer is: Any information relating to an identified or identifiable natural person
Q.4 Which of the following best describes 'dual‑use' concerns in bioinformatics hardware development?
Using the same chip for both DNA sequencing and RNA sequencing
Technology that can be used for both beneficial research and harmful biological weapons
A device that works with both wired and wireless connections
A software that can be run on Windows and Linux
Explanation - Dual‑use refers to technologies that have legitimate scientific uses but could also be misapplied for malicious purposes, raising ethical and legal issues.
Correct answer is: Technology that can be used for both beneficial research and harmful biological weapons
Q.5 When publishing a new algorithm for genome assembly, which licensing model best ensures that the software remains open and reusable while protecting the developer’s rights?
Proprietary license
GNU General Public License (GPL)
Creative Commons Zero (CC0)
End‑User License Agreement (EULA)
Explanation - GPL is a copyleft license that keeps software free and requires derivatives to be released under the same terms, balancing openness and protection.
Correct answer is: GNU General Public License (GPL)
Q.6 Which ethical concern arises when bioinformatics pipelines use data from populations that were not adequately consented for secondary analysis?
Algorithmic speed
Data provenance
Informed consent violation
Signal‑to‑noise ratio
Explanation - Using data beyond the scope of the original consent breaches participants' rights and violates ethical standards.
Correct answer is: Informed consent violation
Q.7 In the context of electrical engineering for portable DNA sequencers, which standard addresses electromagnetic compatibility (EMC) to avoid interference with medical devices?
ISO 9001
IEC 60601-1-2
IEEE 802.11
ISO/IEC 27001
Explanation - IEC 60601‑1‑2 specifies EMC requirements for medical electrical equipment, relevant for bio‑instrumentation devices.
Correct answer is: IEC 60601-1-2
Q.8 What is the primary purpose of an Institutional Review Board (IRB) in bioinformatics research?
To fund research projects
To review and monitor ethical aspects of human subjects research
To design hardware circuits
To publish scientific papers
Explanation - IRBs ensure that research involving humans complies with ethical standards, including data privacy and consent.
Correct answer is: To review and monitor ethical aspects of human subjects research
Q.9 Which of the following best exemplifies a conflict of interest in the development of a commercial bioinformatics platform?
Using open‑source libraries
Hiring engineers from a competitor
An employee holds equity in a company that supplies the platform’s core algorithm
Publishing the source code on GitHub
Explanation - Financial stakes in a supplier can bias decision‑making, creating a conflict of interest.
Correct answer is: An employee holds equity in a company that supplies the platform’s core algorithm
Q.10 Which principle of the Belmont Report emphasizes giving participants control over how their genetic data is used?
Respect for persons
Beneficence
Justice
Non‑maleficence
Explanation - Respect for persons includes respecting autonomy and informed consent, crucial for handling genetic data.
Correct answer is: Respect for persons
Q.11 A researcher wants to share raw sequencing reads publicly. Which statement aligns with best ethical practice?
Publish all reads without any restriction
Remove all metadata, then share the reads
Share only after obtaining explicit consent for public release
Do not share any data to protect privacy
Explanation - Explicit consent ensures participants are aware of and agree to the level of data exposure.
Correct answer is: Share only after obtaining explicit consent for public release
Q.12 In hardware‑accelerated sequence alignment, which legal issue can arise if patented algorithms are implemented without a license?
Trademark infringement
Patent infringement
Copyright violation
Trade secret theft
Explanation - Implementing a patented algorithm without permission infringes the patent holder’s rights.
Correct answer is: Patent infringement
Q.13 Which of the following is NOT a typical component of a data‑governance policy for a bioinformatics lab?
Data retention schedule
Encryption standards
Circuit board layout guidelines
Access control procedures
Explanation - Circuit board layout is an engineering detail, not a data‑governance element.
Correct answer is: Circuit board layout guidelines
Q.14 What does the term 'algorithmic bias' refer to in bioinformatics?
The speed at which an algorithm runs
Preferential treatment of certain data due to biased training sets
The power consumption of a computing device
The number of lines of code in a program
Explanation - Algorithmic bias occurs when models produce systematic errors favoring certain groups, often because of biased training data.
Correct answer is: Preferential treatment of certain data due to biased training sets
Q.15 Which of the following best describes 'data minimization' under GDPR?
Storing as much data as possible for future use
Collecting only the data necessary for a specific purpose
Encrypting all data regardless of size
Sharing data with as many partners as possible
Explanation - Data minimization requires that only data needed for a defined purpose be collected and processed.
Correct answer is: Collecting only the data necessary for a specific purpose
Q.16 When designing a wearable biosensor that records electrophysiological signals, which ethical guideline should guide the handling of the collected data?
Maximize data collection for future research
Store data indefinitely on the device
Obtain informed consent and ensure data security
Share raw data publicly without restrictions
Explanation - Ethical handling of personal physiological data requires consent and protection against unauthorized access.
Correct answer is: Obtain informed consent and ensure data security
Q.17 A bioinformatics startup wants to protect its novel DNA compression algorithm. Which form of intellectual property protection is most appropriate?
Trademark
Patent
Trade secret
Design right
Explanation - Patents protect new, useful, and non‑obvious inventions, including algorithms that meet statutory criteria.
Correct answer is: Patent
Q.18 Which of the following is a key requirement of the NIH Genomic Data Sharing Policy?
All data must be kept on local servers only
Data must be shared in a controlled-access repository
Researchers must publish in open‑access journals only
Sequencing must be performed with Illumina platforms
Explanation - The NIH policy mandates that genomic data be deposited in controlled‑access repositories to balance sharing with participant privacy.
Correct answer is: Data must be shared in a controlled-access repository
Q.19 In the context of electrical engineering, which term describes a device’s ability to prevent unauthorized reading of genetic data it processes?
Throughput
Latency
Tamper‑evidence
Encryption
Explanation - Encryption secures data in transit or at rest, preventing unauthorized access to sensitive genetic information.
Correct answer is: Encryption
Q.20 What is the main ethical concern with using crowd‑sourced DNA databases for forensic investigations?
High computational cost
Potential violation of participants' privacy and consent
Insufficient storage capacity
Lack of standardized file formats
Explanation - Using publicly contributed DNA without explicit forensic consent can breach privacy expectations and consent agreements.
Correct answer is: Potential violation of participants' privacy and consent
Q.21 Which of the following best defines the concept of 'beneficence' in bioinformatics research?
Maximizing profit for the research institution
Ensuring that research outcomes do good and minimize harm
Keeping data confidential at all costs
Sharing all data openly regardless of consent
Explanation - Beneficence requires actions that promote well‑being and avoid causing harm to participants.
Correct answer is: Ensuring that research outcomes do good and minimize harm
Q.22 A bioinformatics platform aggregates genomic data from multiple countries. Which legal challenge is most likely to arise?
Incompatible voltage standards
Cross‑border data transfer restrictions
Insufficient RAM for processing
Lack of internet connectivity
Explanation - Different jurisdictions have varying data‑protection laws, making international data sharing legally complex.
Correct answer is: Cross‑border data transfer restrictions
Q.23 Which of the following best describes 'informed consent' for the use of a patient’s genomic data in AI model training?
A brief verbal agreement during a clinic visit
A detailed written document outlining purpose, risks, and data use
A checkbox on a website with no explanation
An implied consent by virtue of receiving medical care
Explanation - Informed consent must be explicit, documented, and include clear information about how data will be used.
Correct answer is: A detailed written document outlining purpose, risks, and data use
Q.24 When a researcher discovers a security vulnerability in a publicly released bioinformatics tool, what is the ethically appropriate first step?
Publicly disclose the flaw immediately
Ignore it and continue using the tool
Contact the tool’s developers privately to report the issue
Sell the information to a competitor
Explanation - Responsible disclosure allows developers to patch the vulnerability before it is exploited.
Correct answer is: Contact the tool’s developers privately to report the issue
Q.25 Which of the following is an example of a 'controlled‑access' data repository?
GitHub
Figshare (public dataset)
dbGaP (Database of Genotypes and Phenotypes)
Wikipedia
Explanation - dbGaP requires approved researcher access, providing controlled data sharing for sensitive genomic data.
Correct answer is: dbGaP (Database of Genotypes and Phenotypes)
Q.26 In the design of a high‑throughput sequencer, which ethical standard relates to ensuring the device does not cause undue physical harm to users?
ISO 13485
IEC 60601‑1
IEEE 802.3
ISO 9001
Explanation - IEC 60601‑1 sets safety requirements for medical electrical equipment, protecting users from harm.
Correct answer is: IEC 60601‑1
Q.27 What is the primary ethical issue with using synthetic DNA generated by an electrical‑engineered gene synthesizer without proper oversight?
Increased power consumption
Potential creation of harmful biological agents
Longer processing time
Higher manufacturing cost
Explanation - Unregulated synthesis can lead to dual‑use risks, enabling the production of dangerous pathogens.
Correct answer is: Potential creation of harmful biological agents
Q.28 Which of the following best illustrates the principle of 'data sovereignty'?
Storing data on any cloud provider worldwide
Ensuring data remains within the geographic borders of the originating country
Encrypting data with a 256‑bit key
Using open‑source software for analysis
Explanation - Data sovereignty dictates that data is subject to the laws of the country where it is collected or stored.
Correct answer is: Ensuring data remains within the geographic borders of the originating country
Q.29 A bioinformatics researcher wants to publish a dataset that includes rare disease variants. Which approach best respects participant privacy?
Publish the raw data without modification
Aggregate the data and remove individual identifiers
Share only summary statistics
Delete the data completely
Explanation - Summary statistics reduce re‑identification risk while still providing useful scientific information.
Correct answer is: Share only summary statistics
Q.30 Which legislation would most directly affect a U.S. company exporting a portable DNA sequencer to the European market?
HIPAA
EU Clinical Trials Regulation
EU GDPR
US Patriot Act
Explanation - GDPR governs personal data handling for EU residents, impacting any device that collects such data, even if manufactured in the U.S.
Correct answer is: EU GDPR
Q.31 When applying machine learning to predict disease risk from genomic data, which fairness metric helps evaluate bias across ethnic groups?
Accuracy
Precision
Equalized odds
Throughput
Explanation - Equalized odds measures whether false positive and false negative rates are similar across groups, addressing fairness.
Correct answer is: Equalized odds
Q.32 Which of the following best captures the concept of 'privacy by design' in bioinformatics software development?
Adding privacy settings after the software is released
Embedding privacy safeguards throughout the development lifecycle
Only storing data temporarily
Using open‑source licensing
Explanation - Privacy by design requires proactive integration of privacy measures from the earliest design stages.
Correct answer is: Embedding privacy safeguards throughout the development lifecycle
Q.33 A laboratory uses a cloud service to process genomic data. Which contractual clause is essential to ensure compliance with data‑protection laws?
Force majeure clause
Data processing agreement (DPA)
Non‑compete clause
Intellectual property assignment
Explanation - A DPA outlines responsibilities for data handling, security, and compliance between controller and processor.
Correct answer is: Data processing agreement (DPA)
Q.34 Which of the following is considered a 'protected class' under many anti‑discrimination laws, relevant to genomic data use?
Eye color
Blood type
Genetic information
Height
Explanation - Genetic information is protected in many jurisdictions (e.g., GINA in the U.S.) to prevent discrimination.
Correct answer is: Genetic information
Q.35 In the context of bioinformatics, what does the term 're‑identification risk' refer to?
The chance that a sequence will be misaligned
The probability that anonymized data can be linked back to an individual
The risk of hardware failure during sequencing
The likelihood of software bugs causing crashes
Explanation - Re‑identification risk assesses how easily de‑identified data can be traced back to its source.
Correct answer is: The probability that anonymized data can be linked back to an individual
Q.36 Which standard is specifically aimed at securing medical device communications, such as those from biosensors used in bioinformatics pipelines?
ISO/IEC 27001
IEEE 11073
ISO 9001
IEEE 802.11ac
Explanation - IEEE 11073 defines standards for interoperable and secure communication of medical devices.
Correct answer is: IEEE 11073
Q.37 A researcher discovers that a public genomic dataset contains errors that could mislead clinical decisions. Ethically, what should they do?
Ignore the errors; they are insignificant
Publish a paper criticizing the dataset without contacting its owners
Notify the dataset curators and suggest a correction
Delete the dataset from the internet
Explanation - Responsible conduct requires alerting curators so the data can be corrected, preserving scientific integrity.
Correct answer is: Notify the dataset curators and suggest a correction
Q.38 Which of the following is a common legal requirement when transferring human genomic data across international borders?
Obtaining a patent for the data
Ensuring compliance with both source and destination jurisdictions' data‑protection laws
Using a specific brand of encryption hardware
Storing the data on a hard drive
Explanation - Cross‑border data transfers must meet legal standards of both the exporting and importing countries.
Correct answer is: Ensuring compliance with both source and destination jurisdictions' data‑protection laws
Q.39 Which ethical principle is most directly challenged when a bioinformatics company sells anonymized genetic data to third‑party marketers without user consent?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - Selling data without consent violates individuals’ control over their own information, infringing autonomy.
Correct answer is: Autonomy
Q.40 In a research project, data is stored on an FPGA‑based accelerator. Which security measure is most effective for protecting the data at rest?
Using a higher clock frequency
Implementing hardware‑based encryption modules
Increasing the number of logic cells
Optimizing power consumption
Explanation - Hardware encryption secures data stored on the device, preventing unauthorized access.
Correct answer is: Implementing hardware‑based encryption modules
Q.41 Which U.S. law specifically prohibits discrimination based on genetic information in health insurance and employment?
Americans with Disabilities Act (ADA)
Genetic Information Nondiscrimination Act (GINA)
Fair Credit Reporting Act (FCRA)
Family Educational Rights and Privacy Act (FERPA)
Explanation - GINA protects individuals from genetic discrimination in health insurance and employment contexts.
Correct answer is: Genetic Information Nondiscrimination Act (GINA)
Q.42 When publishing a new bioinformatics pipeline, which statement about reproducibility best reflects ethical scientific practice?
Only share the final results, not the code
Provide the source code, data, and detailed methods to enable replication
Obfuscate the algorithm to protect intellectual property
Release the software under a commercial license only
Explanation - Transparency and sharing enable other researchers to reproduce and validate findings, a core ethical norm.
Correct answer is: Provide the source code, data, and detailed methods to enable replication
Q.43 Which of the following best describes the ethical concern of 'function creep' in bioinformatics systems?
Gradual increase in computational speed
Using data for purposes beyond the original consented intent
Hardware overheating over time
Increasing the size of datasets without justification
Explanation - Function creep occurs when data collected for one purpose is later repurposed without new consent, raising privacy issues.
Correct answer is: Using data for purposes beyond the original consented intent
Q.44 A developer wants to incorporate a patented sequence alignment algorithm into an open‑source bioinformatics tool. Which action is legally required?
Release the source code under any license
Obtain a license from the patent holder or ensure the algorithm is not patented
Publish the code without mentioning the patent
Ignore the patent because the tool is free
Explanation - Patented algorithms cannot be used in software without permission, regardless of open‑source status.
Correct answer is: Obtain a license from the patent holder or ensure the algorithm is not patented
Q.45 Which ethical guideline would most likely require a researcher to destroy genomic data after a predetermined retention period?
Data minimization
Open science
Algorithmic transparency
Intellectual property protection
Explanation - Data minimization includes limiting storage duration to what is necessary for the research purpose.
Correct answer is: Data minimization
Q.46 In an EEG‑based brain‑computer interface used for neuro‑genomics research, which safety standard is most relevant?
IEC 62304 (medical device software)
ISO 14001 (environmental management)
IEEE 802.3 (Ethernet)
ISO 26000 (social responsibility)
Explanation - IEC 62304 governs the life‑cycle processes for medical device software, ensuring safety and reliability.
Correct answer is: IEC 62304 (medical device software)
Q.47 What is the primary purpose of the 'right to be forgotten' in data protection regulations?
To allow deletion of outdated hardware components
To enable individuals to request erasure of their personal data
To force companies to delete all data after one year
To mandate open‑source licensing
Explanation - The right to be forgotten lets individuals have their personal data removed under certain conditions.
Correct answer is: To enable individuals to request erasure of their personal data
Q.48 When a bioinformatics service uses cloud computing, which of the following is a key ethical consideration?
Choosing the fastest server region
Ensuring that the cloud provider complies with relevant data‑protection standards
Maximizing the number of virtual machines
Using proprietary file formats
Explanation - Compliance ensures that data stored in the cloud is protected according to legal and ethical requirements.
Correct answer is: Ensuring that the cloud provider complies with relevant data‑protection standards
Q.49 A consortium wants to combine genomic datasets from multiple institutions. Which governance model best ensures ethical data sharing?
Centralized ownership by one institution
A federated model with shared policies and joint oversight committees
Unrestricted public release of all raw data
Selling the data to the highest bidder
Explanation - Federated governance balances data accessibility with ethical oversight and respect for each contributor’s policies.
Correct answer is: A federated model with shared policies and joint oversight committees
Q.50 Which of the following is a major ethical concern when using CRISPR‑Cas9 editing data in a bioinformatics pipeline?
Power consumption of the sequencer
Potential off‑target effects leading to unintended genetic changes
The brand of the computer used for analysis
The color of the laboratory walls
Explanation - Off‑target edits raise safety and ethical issues, especially when data informs clinical decisions.
Correct answer is: Potential off‑target effects leading to unintended genetic changes
Q.51 Which term describes the practice of making raw genomic data openly available for any researcher to download without restrictions?
Open source
Open data
Open hardware
Open licensing
Explanation - Open data refers to unrestricted access to datasets, fostering transparency and collaboration.
Correct answer is: Open data
Q.52 In the context of bioinformatics, what does the term 'synthetic lethality' refer to?
A hardware failure mode
A situation where two non‑lethal gene perturbations cause cell death when combined
A method of compressing DNA sequences
A type of encryption algorithm
Explanation - Synthetic lethality is a concept used in precision medicine; ethically, its exploitation must consider patient safety and consent.
Correct answer is: A situation where two non‑lethal gene perturbations cause cell death when combined
Q.53 Which of the following best captures the ethical issue of 'data hoarding' in bioinformatics research?
Storing data on high‑capacity drives
Retaining data longer than necessary and limiting access without justification
Using cloud services for storage
Compressing data to save space
Explanation - Data hoarding can impede scientific progress and increase privacy risks, violating principles of fairness and stewardship.
Correct answer is: Retaining data longer than necessary and limiting access without justification
Q.54 A bioinformatics platform uses AI to predict disease susceptibility. Which legal framework may regulate the algorithm if it is used in clinical decision‑making in the EU?
EU Medical Device Regulation (MDR)
EU Competition Law
EU Renewable Energy Directive
EU Agricultural Policy
Explanation - MDR classifies certain AI‑driven diagnostic tools as medical devices, subjecting them to regulatory oversight.
Correct answer is: EU Medical Device Regulation (MDR)
Q.55 Which ethical principle is most directly linked to ensuring that benefits of bioinformatics research are shared with under‑represented communities?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - Justice focuses on equitable distribution of benefits and burdens across all groups.
Correct answer is: Justice
Q.56 When integrating third‑party APIs that process genomic data, which contractual clause should specifically address liability for data breaches?
Indemnification clause
Force majeure clause
Limitation of liability clause
Governing law clause
Explanation - Indemnification defines who is responsible for covering damages caused by breaches.
Correct answer is: Indemnification clause
Q.57 Which of the following is a recommended practice to reduce re‑identification risk when sharing genomic variant tables?
Include full participant names
Publish exact geographic coordinates of participants
Aggregate variants by gene and remove rare allele counts
Provide raw FASTQ files
Explanation - Aggregating data and suppressing rare variants lowers the chance of linking data back to individuals.
Correct answer is: Aggregate variants by gene and remove rare allele counts
Q.58 Which ethical guideline would most likely require a researcher to disclose a potential conflict of interest when a study is funded by a genomics company?
Data minimization
Transparency
Algorithmic efficiency
Hardware reliability
Explanation - Transparency demands clear disclosure of funding sources and conflicts to maintain trust.
Correct answer is: Transparency
Q.59 In the development of a bioinformatics FPGA accelerator, which of the following security features helps protect against side‑channel attacks?
Increasing clock speed
Implementing constant‑time algorithms
Using larger lookup tables
Adding more logic blocks
Explanation - Constant‑time designs prevent leakage of secret data through timing variations, mitigating side‑channel attacks.
Correct answer is: Implementing constant‑time algorithms
Q.60 Which of the following best defines 'informed consent' in the context of using patient DNA for training a machine‑learning model?
A brief email confirmation
A comprehensive document explaining purpose, risks, benefits, and data use
An oral agreement during a clinical visit
Implied consent by providing a DNA sample
Explanation - True informed consent must be detailed, documented, and understandable to participants.
Correct answer is: A comprehensive document explaining purpose, risks, benefits, and data use
Q.61 A bioinformatics researcher discovers that a public dataset contains a mislabelled phenotype. The correct ethical response is to:
Ignore it; the dataset is public
Publish a critique without contacting the data curators
Notify the dataset owners and provide corrected information
Delete the dataset from all analyses
Explanation - Correcting errors maintains scientific integrity and respects participants whose data may be affected.
Correct answer is: Notify the dataset owners and provide corrected information
Q.62 Which law specifically addresses the protection of genetic information in the context of employment in the United States?
Americans with Disabilities Act (ADA)
Genetic Information Nondiscrimination Act (GINA)
Health Care Quality Improvement Act (HCQIA)
Family and Medical Leave Act (FMLA)
Explanation - GINA prohibits genetic discrimination in employment and health insurance.
Correct answer is: Genetic Information Nondiscrimination Act (GINA)
Q.63 When a bioinformatics pipeline includes a step that can identify individuals from anonymized data, what is the most appropriate ethical action?
Continue as is; the data is anonymized
Remove or mask the step to prevent re‑identification
Publish the pipeline without mentioning the risk
Sell the re‑identifiable data
Explanation - Protecting privacy requires eliminating capabilities that could re‑identify participants.
Correct answer is: Remove or mask the step to prevent re‑identification
Q.64 Which ethical concept is most closely related to ensuring that bioinformatics tools are accessible to low‑resource settings?
Beneficence
Equity
Non‑maleficence
Autonomy
Explanation - Equity focuses on fair access to technologies regardless of socioeconomic status.
Correct answer is: Equity
Q.65 A university bioinformatics core facility wants to charge external users for data analysis. Which principle should guide the fee structure to avoid unethical practices?
Maximizing profit
Cost‑recovery with transparency
Providing services for free only
Charging the highest possible rate
Explanation - Transparent, reasonable fees prevent exploitation and ensure fairness.
Correct answer is: Cost‑recovery with transparency
Q.66 Which of the following best exemplifies the concept of 'data provenance' in bioinformatics?
The speed at which data is processed
The origin, history, and transformations applied to a dataset
The physical location of the storage server
The size of the dataset
Explanation - Data provenance tracks where data came from and how it has been processed, essential for reproducibility and accountability.
Correct answer is: The origin, history, and transformations applied to a dataset
Q.67 When a bioinformatics software includes a machine‑learning model trained on proprietary data, which licensing approach best respects both openness and IP protection?
Public domain
GNU GPL with source code
Dual licensing – open for academic, commercial under paid license
All rights reserved
Explanation - Dual licensing balances open scientific collaboration with protection of commercial interests.
Correct answer is: Dual licensing – open for academic, commercial under paid license
Q.68 Which ethical principle requires researchers to consider long‑term societal impacts of releasing powerful bioinformatics tools?
Autonomy
Beneficence
Non‑maleficence
Justice
Explanation - Beneficence obliges researchers to promote overall good and anticipate downstream consequences.
Correct answer is: Beneficence
Q.69 In a multi‑institutional genomics project, a participant requests that their data be removed after publication. Which regulation most directly supports this request in the EU?
EU GDPR – right to erasure
EU Clinical Trials Regulation
EU ePrivacy Directive
EU Digital Services Act
Explanation - The GDPR grants individuals the right to have personal data deleted under certain conditions.
Correct answer is: EU GDPR – right to erasure
Q.70 Which of the following is an example of a 'non‑technical' ethical challenge in bioinformatics?
Algorithm runtime optimization
Data storage capacity planning
Obtaining appropriate consent from participants
Signal‑to‑noise ratio improvement
Explanation - Consent is a social/ethical issue rather than a technical one.
Correct answer is: Obtaining appropriate consent from participants
Q.71 A bioinformatics company uses patient genomic data to develop a commercial product. Which of the following practices would be considered unethical?
Providing participants with a summary of findings
Selling the data to third parties without consent
Anonymizing the data before analysis
Obtaining ethics committee approval
Explanation - Distributing personal data without consent violates privacy and autonomy.
Correct answer is: Selling the data to third parties without consent
Q.72 Which standard specifically addresses the security of health‑related data transmitted over wireless medical devices?
IEEE 802.15.6 (Body Area Networks)
ISO 9001
IEEE 802.3 (Ethernet)
ISO/IEC 27001
Explanation - IEEE 802.15.6 defines security and communication protocols for body area networks, common in wearable biosensors.
Correct answer is: IEEE 802.15.6 (Body Area Networks)
Q.73 When a bioinformatics algorithm is found to have a bias that disproportionately misclassifies a minority group, the ethical response should be to:
Ignore it; the algorithm works for most users
Publish the results without addressing the bias
Investigate, correct the bias, and transparently report the changes
Discontinue the project entirely
Explanation - Addressing bias upholds fairness and responsibility in scientific research.
Correct answer is: Investigate, correct the bias, and transparently report the changes
Q.74 Which of the following best describes a 'data use agreement' (DUA)?
A contract that defines how shared data may be used, stored, and protected
A software license for open‑source code
A hardware warranty document
A privacy policy for a website
Explanation - A DUA outlines responsibilities and restrictions for data recipients, ensuring legal and ethical compliance.
Correct answer is: A contract that defines how shared data may be used, stored, and protected
Q.75 Which ethical principle is most relevant when a bioinformatics tool inadvertently reveals a participant's carrier status for a severe disease?
Autonomy
Beneficence
Justice
Non‑maleficence
Explanation - Non‑maleficence requires preventing harm; unintended disclosure of sensitive health information can cause psychological harm.
Correct answer is: Non‑maleficence
Q.76 A researcher wants to use publicly available RNA‑seq data to develop a commercial diagnostic test. Which step is ethically required before commercialization?
Obtain a patent on the algorithm
Verify that the original data usage permits commercial exploitation
Publish the test in a high‑impact journal
Share the source code on GitHub
Explanation - Data licences may restrict commercial use; respecting those terms is essential.
Correct answer is: Verify that the original data usage permits commercial exploitation
Q.77 In the context of bioinformatics, what does the term 'open‑source' primarily refer to?
Hardware that is free of charge
Software whose source code is publicly available and can be modified
Data that is stored on public servers
A type of encryption algorithm
Explanation - Open‑source software promotes transparency, collaboration, and reproducibility.
Correct answer is: Software whose source code is publicly available and can be modified
Q.78 Which of the following best illustrates the concept of 'informed refusal' in bioinformatics research?
A participant declines to give a DNA sample after understanding the study’s purpose
A participant signs a consent form without reading it
A participant agrees to the study but later forgets
A participant provides a sample but asks for a copy of the data
Explanation - Informed refusal respects autonomy by allowing participants to opt out after full disclosure.
Correct answer is: A participant declines to give a DNA sample after understanding the study’s purpose
Q.79 Which regulatory framework requires that medical devices, including diagnostic bioinformatics software, undergo a conformity assessment before being marketed in the European Union?
EU GDPR
EU Medical Device Regulation (MDR)
EU Directive on Data Retention
EU Renewable Energy Directive
Explanation - MDR mandates conformity assessment to ensure safety and performance of medical devices.
Correct answer is: EU Medical Device Regulation (MDR)
Q.80 A bioinformatics lab plans to share a dataset containing rare disease genomes. To minimize re‑identification risk, they should:
Publish all raw reads with no restrictions
Aggregate data at the gene level and remove extremely rare variants
Share data only with industry partners
Encrypt the dataset but share the key publicly
Explanation - Aggregation and suppression of rare variants reduce the chance of linking data back to individuals.
Correct answer is: Aggregate data at the gene level and remove extremely rare variants
Q.81 Which principle of the UNESCO Universal Declaration on Bioethics and Human Rights emphasizes the need to respect privacy and confidentiality of genetic data?
Beneficence and non‑maleficence
Respect for human dignity and human rights
Justice
Social responsibility and solidarity
Explanation - This principle explicitly calls for protecting privacy and confidentiality in bioethics.
Correct answer is: Respect for human dignity and human rights
Q.82 When a bioinformatics pipeline includes a step that automatically flags potential pathogenic variants, which ethical safeguard should be in place before reporting to clinicians?
No safeguard needed; automation is sufficient
Human review by qualified personnel to confirm findings
Immediate public release of the flagged variants
Deletion of all flagged results after analysis
Explanation - Clinical decisions require validated, expert‑reviewed results to avoid false positives/negatives.
Correct answer is: Human review by qualified personnel to confirm findings
Q.83 Which of the following best describes the term 'dual‑use research of concern' (DURC) in the context of bioinformatics?
Research that can be used for both academic and commercial purposes
Research that has potential to be misapplied for harmful biological weapons
Research that utilizes both hardware and software components
Research that is funded by both public and private sectors
Explanation - DURC refers to legitimate research that could be repurposed to create threats, necessitating oversight.
Correct answer is: Research that has potential to be misapplied for harmful biological weapons
Q.84 Which ethical concern is most relevant when a bioinformatics algorithm is trained on data predominantly from one ethnic group?
Higher computational cost
Algorithmic bias leading to reduced accuracy for under‑represented groups
Increased storage requirements
Longer execution time
Explanation - Training on non‑representative data can cause systematic errors affecting fairness and clinical utility.
Correct answer is: Algorithmic bias leading to reduced accuracy for under‑represented groups
Q.85 A university wants to share a large genomic dataset with a private biotech company. Which governance document should be consulted to ensure ethical sharing?
The university’s financial audit report
The Institutional Review Board (IRB) protocol and data use agreement
The campus cafeteria menu
The IT department’s hardware inventory
Explanation - IRB protocols and DUAs define permissible uses and protections for human subject data.
Correct answer is: The Institutional Review Board (IRB) protocol and data use agreement
Q.86 Which of the following best captures the concept of 'ethical stewardship' in bioinformatics data management?
Maximizing data collection without regard to consent
Ensuring data is responsibly stored, shared, and disposed of according to ethical standards
Keeping data secret from all collaborators
Selling data to the highest bidder
Explanation - Stewardship involves responsible handling of data throughout its lifecycle.
Correct answer is: Ensuring data is responsibly stored, shared, and disposed of according to ethical standards
Q.87 Which of the following is a key requirement of the NIH Genomic Data Sharing (GDS) Policy for investigators receiving large-scale genomic data?
All data must be published within 6 months
Data must be deposited in a controlled‑access repository and shared with qualified researchers
Data must be stored on personal hard drives only
Data can be shared without any consent considerations
Explanation - The GDS policy promotes responsible sharing while protecting participant privacy.
Correct answer is: Data must be deposited in a controlled‑access repository and shared with qualified researchers
Q.88 When deploying a bioinformatics web service that processes patient genomes, which security practice is essential to comply with GDPR?
Using a default password for all accounts
Implementing strong encryption for data in transit and at rest
Storing data on a public GitHub repository
Allowing anonymous access to all data
Explanation - Encryption helps meet GDPR’s requirements for data protection and confidentiality.
Correct answer is: Implementing strong encryption for data in transit and at rest
Q.89 Which ethical principle mandates that researchers should not withhold beneficial findings from participants when those findings could impact their health?
Justice
Beneficence
Autonomy
Non‑maleficence
Explanation - Beneficence requires acting in the best interests of participants, including sharing actionable health information.
Correct answer is: Beneficence
Q.90 A bioinformatics company wants to incorporate a newly discovered gene‑editing dataset into its product. Which step ensures compliance with ethical standards?
Ignore the source of the dataset
Check that the dataset was obtained with proper consent and complies with relevant regulations
Publish the raw data immediately
Sell the dataset to a third party
Explanation - Verification of consent and regulatory compliance is essential before using sensitive data.
Correct answer is: Check that the dataset was obtained with proper consent and complies with relevant regulations
Q.91 Which of the following best defines the 'right to data portability' under GDPR?
The ability for an individual to obtain their personal data in a structured, commonly used format and transfer it to another controller
The right to delete all personal data permanently
The right to be forgotten
The right to access public datasets for free
Explanation - Data portability enables individuals to move their data between services, enhancing control and competition.
Correct answer is: The ability for an individual to obtain their personal data in a structured, commonly used format and transfer it to another controller
Q.92 When a bioinformatics algorithm is patented, which of the following is true regarding its public availability?
The algorithm must be freely distributed to all researchers
The patent holder can restrict usage, but may license it under specific terms
Patents have no effect on software distribution
Patented algorithms cannot be used in any research
Explanation - Patents grant exclusive rights, allowing the holder to control distribution and licensing.
Correct answer is: The patent holder can restrict usage, but may license it under specific terms
Q.93 Which ethical guideline requires that participants be allowed to withdraw their data from a study at any time?
Data minimization
Right to withdraw
Data retention policy
Algorithmic transparency
Explanation - The right to withdraw respects autonomy, allowing participants to end their involvement and request data removal.
Correct answer is: Right to withdraw
Q.94 A researcher uses a publicly available genomic dataset that includes participants from indigenous communities. Which additional ethical consideration is most appropriate?
Ignore cultural sensitivities; data is public
Seek community engagement and respect cultural protocols before analysis
Charge the community for data usage
Publish the findings without acknowledgement
Explanation - Indigenous data sovereignty emphasizes respect for community values and consent beyond generic consent forms.
Correct answer is: Seek community engagement and respect cultural protocols before analysis
Q.95 Which of the following is a typical component of a 'responsible disclosure' policy for software vulnerabilities in bioinformatics tools?
Immediate public announcement of the vulnerability
Contacting the software maintainers privately and allowing time for a fix before disclosure
Selling the vulnerability to the highest bidder
Ignoring the vulnerability
Explanation - Responsible disclosure balances user safety with giving developers a chance to remediate.
Correct answer is: Contacting the software maintainers privately and allowing time for a fix before disclosure
Q.96 Which ethical principle is most directly challenged when a bioinformatics study disproportionately recruits participants from vulnerable populations without clear benefit to them?
Autonomy
Justice
Beneficence
Non‑maleficence
Explanation - Justice concerns fair distribution of research burdens and benefits; exploiting vulnerable groups violates this principle.
Correct answer is: Justice
Q.97 In the context of bioinformatics data sharing, what does the term 'controlled‑access' imply?
Anyone can download the data without restrictions
Data is only available to approved researchers who meet specific criteria
Data is encrypted but publicly listed
Data is stored on a private server with no external access
Explanation - Controlled‑access repositories require vetting and agreements to protect sensitive data.
Correct answer is: Data is only available to approved researchers who meet specific criteria
Q.98 Which legal framework in the United States specifically protects the privacy of genetic information held by health insurers?
HIPAA
GINA
ADA
FERPA
Explanation - GINA prohibits health insurers from using genetic information to make coverage decisions.
Correct answer is: GINA
Q.99 When developing a bioinformatics pipeline that will be used in clinical diagnostics, which regulatory classification does it most likely fall under in the EU?
Class I medical device
Class IIa medical device
Class III medical device
Non‑medical software
Explanation - Diagnostic software that provides information for clinical decisions often falls under Class IIa under the EU MDR.
Correct answer is: Class IIa medical device