Podcast
Questions and Answers
What is a potential consequence of scientists conducting for-profit business activities?
What is a potential consequence of scientists conducting for-profit business activities?
- Conflict of effort impacting scheduled duties (correct)
- Increased funding for research projects
- Enhanced objectivity in research outcomes
- Improved collaboration with corporate entities
Which of the following best describes a conflict of interest?
Which of the following best describes a conflict of interest?
- When ethical considerations affect research direction
- When research demands exceed available time
- When a scientist has personal financial ties influencing their research (correct)
- When there is a disagreement among research collaborators
What is a primary concern regarding scientists receiving travel expenses from pharmaceutical companies?
What is a primary concern regarding scientists receiving travel expenses from pharmaceutical companies?
- It may enhance their professional network
- It provides opportunities for knowledge sharing
- It could lead to bias in their research findings (correct)
- It generally increases scientific credibility
How do mutual funds generally differ from common stock in terms of ownership?
How do mutual funds generally differ from common stock in terms of ownership?
What is a common conflict of conscience that scientists might encounter?
What is a common conflict of conscience that scientists might encounter?
Why might a journal choose to eliminate editorial board members from corporate entities?
Why might a journal choose to eliminate editorial board members from corporate entities?
What responsibility do scientist-consultants generally have regarding their consulting services?
What responsibility do scientist-consultants generally have regarding their consulting services?
What might be a sign of a conflict of effort for a predoctoral student?
What might be a sign of a conflict of effort for a predoctoral student?
What role should scientist-consultants avoid in relation to proposals submitted by their consulting companies?
What role should scientist-consultants avoid in relation to proposals submitted by their consulting companies?
What is a key concern regarding editor board members in the context of peer review?
What is a key concern regarding editor board members in the context of peer review?
Which statement describes a rule that most state and federal agencies have regarding employment relationships?
Which statement describes a rule that most state and federal agencies have regarding employment relationships?
What is one of the financial conflict of interest considerations when evaluating grant proposals?
What is one of the financial conflict of interest considerations when evaluating grant proposals?
What potential conflict might a postdoctoral trainee experience?
What potential conflict might a postdoctoral trainee experience?
How do mutual funds differ from common stock concerning financial investment?
How do mutual funds differ from common stock concerning financial investment?
What might be a rationale for a journal to exclude corporate reviewers from its peer review process?
What might be a rationale for a journal to exclude corporate reviewers from its peer review process?
Which guideline helps in avoiding conflicts of interest for grant reviewers?
Which guideline helps in avoiding conflicts of interest for grant reviewers?
What is the threshold for a significant financial interest that must be disclosed?
What is the threshold for a significant financial interest that must be disclosed?
Who is obligated to develop policies for the disclosure of potential conflicts of interest?
Who is obligated to develop policies for the disclosure of potential conflicts of interest?
Which individuals are covered under the regulations concerning conflicts of interest?
Which individuals are covered under the regulations concerning conflicts of interest?
What type of travel expenses do not need to be disclosed?
What type of travel expenses do not need to be disclosed?
What information must be disclosed regarding travel paid by an entity?
What information must be disclosed regarding travel paid by an entity?
Which party is responsible for managing conflicts of interest according to institutional policies?
Which party is responsible for managing conflicts of interest according to institutional policies?
Which situation would not require disclosure under institutional policies?
Which situation would not require disclosure under institutional policies?
For which type of grant program might PHS regulations apply?
For which type of grant program might PHS regulations apply?
What potential conflict might Andre face by accepting a position at Leaper Enterprises?
What potential conflict might Andre face by accepting a position at Leaper Enterprises?
Which of the following statements describes a conflict of interest in scientific research?
Which of the following statements describes a conflict of interest in scientific research?
Why might a journal choose to eliminate editorial board members from corporate entities?
Why might a journal choose to eliminate editorial board members from corporate entities?
What is one characteristic that differentiates a mutual fund from common stock ownership?
What is one characteristic that differentiates a mutual fund from common stock ownership?
Which of the following is NOT typically required to be disclosed by PHS-funded researchers?
Which of the following is NOT typically required to be disclosed by PHS-funded researchers?
What would be a possible benefit for a research institution accepting an equity position in a start-up?
What would be a possible benefit for a research institution accepting an equity position in a start-up?
Which scenario describes a restriction placed on scientists regarding corporate funding?
Which scenario describes a restriction placed on scientists regarding corporate funding?
Which of the following best explains how monetary interests in common stocks and mutual funds differ?
Which of the following best explains how monetary interests in common stocks and mutual funds differ?
What main ethical concern arises from Dr. Jonas's role on the editorial board when reviewing the manuscript?
What main ethical concern arises from Dr. Jonas's role on the editorial board when reviewing the manuscript?
Which action taken by Dr. Jonas could be considered an ethical conflict of interest?
Which action taken by Dr. Jonas could be considered an ethical conflict of interest?
What potential issue does Dr. Prasad face due to his investments in biomedical companies?
What potential issue does Dr. Prasad face due to his investments in biomedical companies?
What serious findings did Dr. Prasad discover during his review of the candidate drug?
What serious findings did Dr. Prasad discover during his review of the candidate drug?
What would have been a more ethical course of action for Dr. Jonas upon receiving the competing manuscript?
What would have been a more ethical course of action for Dr. Jonas upon receiving the competing manuscript?
Which of the following best describes Dr. Prasad's situation as it relates to the ethical obligations of a consultant?
Which of the following best describes Dr. Prasad's situation as it relates to the ethical obligations of a consultant?
What kind of recommendations did Dr. Jonas make regarding the manuscript after her review?
What kind of recommendations did Dr. Jonas make regarding the manuscript after her review?
What is a potential consequence of Dr. Prasad's discovery about the drug?
What is a potential consequence of Dr. Prasad's discovery about the drug?
What immediate action did Dr. Prasad take in response to the serious findings about the candidate drug?
What immediate action did Dr. Prasad take in response to the serious findings about the candidate drug?
What ethical obligation is most crucial for Dr. Prasad regarding his consulting role?
What ethical obligation is most crucial for Dr. Prasad regarding his consulting role?
Which of the following reflects a potential harm to third parties related to Dr. Prasad's actions?
Which of the following reflects a potential harm to third parties related to Dr. Prasad's actions?
What could be considered a perceived conflict of interest for Dr. Prasad?
What could be considered a perceived conflict of interest for Dr. Prasad?
What key factor likely influenced Dr. Prasad's decision to act against the company's interests?
What key factor likely influenced Dr. Prasad's decision to act against the company's interests?
What is the primary reason for entering data directly into the data book as soon as it becomes available?
What is the primary reason for entering data directly into the data book as soon as it becomes available?
Which guideline is crucial for presenting calculations in the data book?
Which guideline is crucial for presenting calculations in the data book?
How should tables and graphs be represented in the data book?
How should tables and graphs be represented in the data book?
What should be avoided when writing discussions of experimental results?
What should be avoided when writing discussions of experimental results?
What is the ideal placement for conclusions in an experimental write-up?
What is the ideal placement for conclusions in an experimental write-up?
What common misstep should researchers avoid regarding materials not included in the data book?
What common misstep should researchers avoid regarding materials not included in the data book?
Which aspect of photographic materials should be adhered to when affixing them to the data book?
Which aspect of photographic materials should be adhered to when affixing them to the data book?
What key consideration should be made regarding comments in experimental discussions?
What key consideration should be made regarding comments in experimental discussions?
Who is considered the owner of the data generated under an NIH-funded research grant?
Who is considered the owner of the data generated under an NIH-funded research grant?
What is the required retention period for data obtained under an NIH grant?
What is the required retention period for data obtained under an NIH grant?
Which of the following is NOT a characteristic of a good data book?
Which of the following is NOT a characteristic of a good data book?
What role do scientific records play in investigations of research misconduct?
What role do scientific records play in investigations of research misconduct?
How do state laws regarding data retention generally affect NIH requirements?
How do state laws regarding data retention generally affect NIH requirements?
What is a potential consequence of sloppy and incomplete record-keeping in scientific research?
What is a potential consequence of sloppy and incomplete record-keeping in scientific research?
Which feature distinguishes a properly backed-up data book?
Which feature distinguishes a properly backed-up data book?
Which of the following is a component that good data books should include?
Which of the following is a component that good data books should include?
What is the primary benefit of documenting all laboratory activities, both successful and unsuccessful?
What is the primary benefit of documenting all laboratory activities, both successful and unsuccessful?
What should be included in a laboratory notebook to ensure proper linkage with electronic records?
What should be included in a laboratory notebook to ensure proper linkage with electronic records?
Which measure can help ensure the quality of laboratory records?
Which measure can help ensure the quality of laboratory records?
What is a key consideration for the safekeeping of laboratory records?
What is a key consideration for the safekeeping of laboratory records?
How should electronic records be protected to ensure their authenticity?
How should electronic records be protected to ensure their authenticity?
In what language did Ming Shu initially record her observations, complicating their review?
In what language did Ming Shu initially record her observations, complicating their review?
What should a written laboratory notebook ultimately include regarding electronic files?
What should a written laboratory notebook ultimately include regarding electronic files?
What is a potential downside of relying solely on electronic record-keeping?
What is a potential downside of relying solely on electronic record-keeping?
What must be included in the laboratory data book for each experiment?
What must be included in the laboratory data book for each experiment?
How should methods that deviate from standard procedures be documented?
How should methods that deviate from standard procedures be documented?
What information about biological materials should be recorded in the data book?
What information about biological materials should be recorded in the data book?
When is it acceptable to reference previously documented materials and methods?
When is it acceptable to reference previously documented materials and methods?
In what scenario should extraordinary explanations be provided in the data book?
In what scenario should extraordinary explanations be provided in the data book?
What should be documented regarding the storage of data in a laboratory data book?
What should be documented regarding the storage of data in a laboratory data book?
What is an important detail to include about specialized chemicals in the data book?
What is an important detail to include about specialized chemicals in the data book?
Why is it necessary to provide a thorough description of any new methods used in experiments?
Why is it necessary to provide a thorough description of any new methods used in experiments?
What is the minimum overall class grade required to pass the course?
What is the minimum overall class grade required to pass the course?
Which learning outcome focuses on understanding the implications of the mentor-trainee relationship in research?
Which learning outcome focuses on understanding the implications of the mentor-trainee relationship in research?
What combination of instructional strategies is employed in this course?
What combination of instructional strategies is employed in this course?
Which of the following is NOT a topic covered in the responsible conduct of research?
Which of the following is NOT a topic covered in the responsible conduct of research?
What percentage of the overall grade is allocated for quizzes in the course?
What percentage of the overall grade is allocated for quizzes in the course?
Which aspect of research ethics involves managing the use and welfare of animals and humans?
Which aspect of research ethics involves managing the use and welfare of animals and humans?
Which course learning outcome addresses the ethical dilemmas encountered in research?
Which course learning outcome addresses the ethical dilemmas encountered in research?
Which of the following is a method students are expected to engage in as part of their learning strategies?
Which of the following is a method students are expected to engage in as part of their learning strategies?
What is the primary aim of familiarizing with relevant written guidelines in research ethics?
What is the primary aim of familiarizing with relevant written guidelines in research ethics?
Which of the following factors does NOT typically govern the ownership of intellectual property in scientific research?
Which of the following factors does NOT typically govern the ownership of intellectual property in scientific research?
What role does effective data management play in scientific research?
What role does effective data management play in scientific research?
In what way does understanding conventions and normative behavior benefit the mentor-trainee relationship?
In what way does understanding conventions and normative behavior benefit the mentor-trainee relationship?
Which aspect of responsible scientific conduct is most directly impacted by ethical dilemmas?
Which aspect of responsible scientific conduct is most directly impacted by ethical dilemmas?
Why is active learning emphasized in the instructional strategies of the course?
Why is active learning emphasized in the instructional strategies of the course?
What is the minimum overall class grade a student must achieve to pass the course?
What is the minimum overall class grade a student must achieve to pass the course?
In regards to scientific authorship, which statement is considered ethically correct?
In regards to scientific authorship, which statement is considered ethically correct?
Study Notes
Conflict of Conscience
- Scientists face ethical dilemmas that may clash with their personal beliefs.
Conflict of Effort
- Scientists may face challenges when their time commitments extend beyond their assigned duties.
- For example, a predoctoral or postdoctoral trainee might be offered a lucrative consulting position.
- This could lead to a conflict with their research responsibilities and academic duties.
- Management of this conflict can be achieved through open communication between the trainee and their supervisor, establishing clear expectations of time management and prioritizing academic responsibilities.
Conflict of Interest
- A conflict of interest occurs when a scientist's personal interests, such as financial gains or professional alliances, may compromise their objectivity in research or professional activities.
Equity Interests
- Public institutions have restrictions on scientists who are entrepreneurs and equity owners in companies that receive grants or contracts from their universities.
Disclosure Requirements for Publicly Funded Research
- All U.S. institutions receiving federal funds for research are required to develop policies and procedures for disclosing potential conflicts of interest.
- The regulations apply not only to the institution but also to sub-recipient organizations, and they encompass individuals defined as "investigators."
- These regulations may extend to collaborators, consultants, postdoctoral fellows, graduate students, and other individuals involved in the research.
- PHS regulations might apply to non-PHS grant programs, depending on the program's terms and conditions and the institution's policies.
- Essential disclosures include income related to intellectual property rights, travel expenses, and any other interests required by the institution's policies.
Case Studies
- Andre Cesar faces a potential conflict of interest when offered a position at Leaper Enterprises, a competitor to the company sponsoring his mentor's research.
- Dr. Cecilia Jonas potentially compromises her objectivity by reviewing a manuscript similar to her own, which conflicts with her role as an editorial board member.
- Dr. Rudee Prasad encounters a conflict of interest as a toxicological consultant for a company in which he has significant investments. He discovers potential safety concerns with a drug under development, creating a dilemma between his financial interest and his professional responsibility for patient safety.
Managing Conflicts of Interest
- Many journals require authors and reviewers to disclose their financial interests.
- Grant review panels and advisory boards have established conflict-of-interest guidelines, such as excluding individuals with financial interests in the product or company under review.
- Institutions receiving federal funds for research are required to develop policies addressing potential conflicts of interest.
Financial Conflicts
- Common stocks and mutual funds can both create financial conflicts of interest, requiring disclosure of any significant holdings.
- Scientists should consult their university's conflict of interest guidelines for specific details and requirements.
Data Ownership and Retention
- The grantee institution owns the data generated by NIH-funded research
- The principal investigator nor any member of the research team owns the data
- NIH requires data retention for 3 years beyond the final financial expenditure report
- Data retention requirements may vary for public and private funding agencies
- State laws regarding the retention of data may override federal laws
- The Commonwealth of Virginia has a 5-year data retention requirement
Good Data Books
- Legible and written in ballpoint pen ink
- Well organized and up-to-date
- Accurate and complete
- Include data output affixed to pages
- Allow repetition of experiments
- Compliant with relevant funding agency and institutional requirements
- Accessible to authorized persons, stored properly, and appropriately backed up
- Properly witnessed when necessary
- Properly recognized as the property of the institution
- The ultimate record of scientific contributions
Investigation of Allegations of Research Misconduct
- The record should describe all the researcher's activities, not just successful ones
- Written laboratory notebook should reference electronic records with enough detail to be able to locate them
- Regular (weekly or monthly) laboratory notebook review by a supervisor or faculty advisor should be documented
- All laboratory records should be maintained in a secure manner and backed up with copies stored in an alternate location
Electronic Record Keeping
- Computer-assisted record-keeping should involve printing all electronic files and affixing them to the pages of a traditional data book
- An official procedure for the lab's electronic record-keeping process should be developed and communicated to all users
- The storage location and organization of electronic records should be clearly defined
- Storage should ideally be on servers that are password-protected
- Electronic files should be write-protected, using read-only permission for anyone accessing research data files
- All electronic files should be time stamped
- A record of the name and location of the digital file should be described in the data book
Scientific Record Keeping: Data Book Format
- If an observation requires a complex explanation, it should be described in detail
- The same is true for interpretations and plans for additional work
- Presentation and detail must be complete and comprehensible
- Each experiment should begin with a brief statement of its purpose, whether routine or not
- Descriptions of any methods not found in the laboratory's central manual should be included
- The appropriate literature from which methods are derived should be cited
- Deviations from referenced procedures must be precisely indicated
- The grade, sources, and lot numbers of specialized chemicals, reagents, and enzymes should all be recorded
- The name, address, and phone number of the supplier should be included if there is any question about name recognition
- Specific information on properties and source should be recorded for biological materials such as cell lines, bacterial strains, or animals
- Each repeat of an experiment should be written up separately
- It is acceptable to record materials and methods with appropriate detail and completeness the first time the experiment is performed, and to refer back to the first experiment if there is no methodology change in future runs
Scientific Record Keeping: Data Book Observations and Results
- Data should be recorded directly in the data book as soon as available
- Original data recorded in hand script should always be entered directly into the data book
- Data should never be written on loose sheets of paper and then transcribed later into the data book
- The data book should contain all renderings of the data, including calculations and organized presentations such as tables and graphs created using the data
- Calculations should be explained
- Tables and graphs should be clearly labeled
- Photographic materials should be affixed to the page using archival-quality glue or tape
- Any related materials not included in the data book should be catalogued, and their location identified
Scientific Record Keeping: Data Book Discussion and Conclusion
- Each experiment should be discussed following the recording of observations and calculations
- Discussion comments may be entered at various places in the experimental write-up
- It is appropriate to include comments that capture impressions and interpretations at various places in the written experiment
- Investigators are cautioned against using phrases like “the experiment failed” or describing a yield as “no good”
- The last entry in the completed write-up of the experiment should state the conclusions of the work
- This should be done even if it repeats comments previously written into the data book
- Conclusion logically belong at the end of the experiment
Course Overview
- PHS601: Ethics, Responsible Conduct of Research
- Taught by Keykavous Parang
- Room 203, 9501 Jeronimo Road
Course Learning Outcomes
- Familiarize students with written guidelines for responsible scientific conduct.
- Cover topics like authorship, use of humans and animals, academic honor standards, conflict of interest, and general standards of scientific conduct.
- Introduce statutes related to intellectual property ownership, protection, and use in scientific research.
- Help students understand conventions and norms in scientific mentorship and training relationships.
- Explain conventions of scientific record keeping.
- Teach students to evaluate and manage potential conflicts of interest.
- Enable students to identify and address ethical dilemmas in their research.
Course Content
- Responsible conduct of research
- Data management
- Authorship and peer review
- Collaborative work
- Scientific record keeping
- Responsible use and welfare of animals and humans in biomedical experimentation
- Conflict of Interest
Instructional and Learning Strategies
- Combines didactic lectures and case studies
- Requires active learning both inside and outside of the classroom
- Students are expected to complete assigned activities before attending class sessions.
Course Grade
- Class participation: 15%
- Quizzes: 30%
- Final Exam: 55%
Grade Assignment
- A: 95.0-100
- A-: 90.0-94.9
- B+: 87.0-89.9
- B: 84.0-86.9
- B-: 80.0-83.9
- C+: 77.0-79.9
- C: 74.0-76.9
- C-: 70.0-73.9
- F: Below 70.0
- A passing grade (≥ 77%) is required to pass the course.
Course Overview
- PHS601: Ethics, Responsible Conduct of Research
- Covers ethical considerations in scientific research including responsible conduct of research, data management, authorship, peer review, collaborative work, scientific record keeping, responsible use and welfare of animals and humans in biomedical experimentations, conflict of interest
Course Learning Outcomes
- Become familiar with written guidelines on conducting scientific research, including scientific authorship, use of animals and humans in research, academic honor standards, conflict of interest, and general standards of scientific conduct
- Understand statutes governing ownership, protection, and use of intellectual property in scientific research
- Describe conventions and normative behavior in the mentor-trainee relationship
- Describe conventions of scientific record keeping
- Evaluate the potential impact of conflicts of interest and how to manage them as a researcher
- Identify and appropriately address ethical dilemmas and integrate these concepts into their research
Instructional and Learning Strategies
- Combines didactic lectures and case studies
- Requires active learning in and outside the classroom
- Students are expected to have completed assigned activities (e.g., reading materials or cases, completing practices) before class sessions
Course Grade
- In class participation 15%
- Quizzes 30%
- Final Exam 55%
- A grade of ≥77% is required to pass the course
- Grading scale: A (95-100), A- (90-94.9), B+ (87-89.9), B (84-86.9), B- (80-83.9), C+ (77-79.9), C (74-76.9), C- (70-73.9), F (below 70)
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
Test your understanding of the ethical dilemmas scientists face, including conflicts of conscience, effort, and interest. This quiz examines how personal beliefs and external commitments can challenge the integrity of scientific work. Explore various scenarios where these conflicts may arise and learn about the importance of management and communication in addressing them.