Following the publication of your recent paper, researchers from Swell University have expressed interest in collaborating with you on your promising new drug for Parkinson’s disease, which has been developed with the support of an NIH training grant They are looking to establish a multi-site clinical trial to further investigate its efficacy.
What do you need to consider prior to agreeing to collaboration with the researchers from Swell?
How will you determine issues such as ownership, and use of data and authorship on publications?
Variations
The following variations of this case can be used to discuss the issues further.
What if you were approached by a for-profit company rather than a University?
What if the folks from Swell just want use of some of the compounds you’ve developed?
The researchers from Swell attended a conference where preliminary data from your ongoing research was presented Given that the research is still in its early stages and not yet published, it raises important questions about the potential collaboration and the considerations that may arise from this early phase of research.
Continuation of a Previous Student’s Work
A graduate student in Professor Jones' laboratory has successfully conducted ten experiments aimed at testing a model that the Professor initially proposed This model was created to clarify an unpublished experimental result obtained by a previous graduate student.
A graduate student has submitted her manuscript for publication, co-authored by her professor While the reviewers support its publication, they require the inclusion of original experimental data This data can be retrieved from the former graduate student's old notebooks, which are available in the laboratory.
After a year of conflict with the Professor, the former student has now enrolled in medical school Both authors suspect that he would object to the use of his data in their paper, as he seems intent on complicating their work Consequently, they opt to include his data without seeking his permission.
Was this the appropriate action on the part of the co- authors? Why or why not?
Variations
Continuation of a Previous Student’s Work
The following variations of this case can be used to discuss the issues further.
What if the departed student refused on the grounds that he feels that his work is somehow misrepresented, perhaps selective results were omitted?
In a scenario where two graduate students, one lacking formal affiliation with the lab but possessing essential expertise, collaborate on documenting experimental results, a conflict may arise if the supervising Professor denies the unaffiliated student authorship This situation raises important ethical questions about credit and recognition in academic research, highlighting the need for clear guidelines on authorship contributions and collaboration in scientific work.
What if the departing student had taken his notebooks with him?
Collaboration is a crucial aspect of the scientific process, yet it often presents challenges due to the diverse personalities and agendas involved To facilitate effective collaborative research, it's essential to address key questions: What are the collaboration's goals, who are the participants, and what responsibilities does each individual hold? Additionally, determining the intended pace and duration of the collaboration, plans for authorship and credit, obligations to funding agencies, potential conflicts of interest, and strategies for sharing and ownership of outcomes are vital Lastly, establishing clear guidelines for how and under what circumstances participants can withdraw from the collaboration is important for ensuring a smooth and productive partnership.
The “data” that can be owned is broadly defined by most scientific agencies For example, the NIH Grants
The policy statement defines 'data' as any recorded information in various forms or media, encompassing writings, films, sound recordings, images, drawings, procedural manuals, forms, diagrams, workflow charts, equipment descriptions, data files, software programs, statistical records, and other research data.
2 http://ethics.ucsd.edu/courses/integrity/assignments/collaboration.html
"Ownership" of data usually refers to a particular way in which information might be controlled, such as control over access, disclosure, use, or distribution.
Federal regulations stipulate that institutions own data generated with federal funding, granting the government non-exclusive, royalty-free rights to this data Institutions are required to retain this data for at least three years to safeguard intellectual property rights Additionally, the evaluation of research findings and investigations into scientific misconduct reinforce the institution's ownership and control over the data Ensuring the privacy of human subjects also necessitates institutional ownership Furthermore, institutions may need to mediate disputes over data access and authorship among researchers, particularly in cases where trust issues arise between collaborators.
The PI is the “steward” of the data and is responsible for every aspect of the study, including decisions about access to data, even while the Institution has
“ownership” For this reason, Institutions are often highly cautious about signing any agreements with commercial or other entities that give control over data to an external party
Students should be aware that they can address concerns regarding authorship and the use of data, animals, genes, and reagents at the outset of their research It is advisable for learners to draft a letter or email that outlines their agreements on these matters and provide a copy to their advisor or principal investigator (PI).
Encouraging collaborative authorship is essential, as it establishes clear rights and responsibilities for both mentors and students When a principal investigator (PI) intends to utilize research results from a former student, it is crucial to inform them and extend an invitation for co-authorship prior to publication The former student has the right to decline co-authorship only if they believe that their data is being misrepresented in the resulting paper.
3 Primary Discussion Topic: Conflict of Interest
Additional Discussion Topics: Publication/Authorship, Data
Cases & Notes for Faculty Facilitators
1 Understand institutional rules governing financial conflict of interest
2 Understand the complexities involved in working with commercial sponsors of research and identify steps that can be taken to avoid problems these complexities can generate
3 Understand that financial conflict of interest is one of many types of conflict of interest.
4 Become familiar with local and international statements on requirements for authorship of scientific publications.
Grants Information Memorandum 10 of the University of Washington’s Significant Financial Interest Disclosure Policy http://www.washington.edu/research/gcs/gim/gim10.html
The International Committee of Medical Journal Editors “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” http://www.icmje.org/
The Fred Hutchinson Cancer Research Center emphasizes the importance of maintaining integrity in research through its Conflict of Interest Policy, which outlines guidelines to prevent any potential biases that may affect scientific outcomes Additionally, the center has established clear Requirements for Authorship, ensuring that all contributors to research are properly recognized and that their roles are transparently defined These policies collectively uphold the center's commitment to ethical research practices and accountability in scientific contributions.
Teaching Supplements
Conflict of Interest and Disclosure
Dr M, a dedicated cancer researcher, is applying for a grant to conduct a randomized clinical trial that will assess the safety and efficacy of Newblockbusteron, a novel drug produced by Newbigpharma Inc This trial aims to compare Newblockbusteron with Oldblockbusteron, the current standard of care manufactured by another company, to determine which treatment offers better outcomes for patients.
When evaluating the financial interest for your primary institution, respond with "yes" or "no" to indicate if disclosure and review are necessary Additionally, assess whether the investigator should be barred from conducting research in any given scenario.
1 Dr M gives after-dinner talks on cancer research for
Newbigpharma that are completely unrelated to either Newblockbusteron or Oldblockbusteron, for which he receives $15,000 annually.
2 Same as question 1, except that the annual income is
3 Same as question 1, except that the talks are for
4 Dr M is also engaged in outside consulting for
Anotherbigpharma, Inc which pays him over $10,000 per year to provide strategic advice on promising directions in the field of arthritis therapy, which are unrelated to the Newblockbusteron clinical trial.
5 Dr M’s wife owns $1,000 worth of stock in Oldbigpharma.
6 Dr M’s brother-in-law is an employee of Newbigpharma.
7 Dr M is a co-inventor of Newblockbusteron and receives annual distributions of royalty payments for the inventions through the university.
Dr M's department chair has stated that upon the successful award of the grant application and subsequent publication of the study results, Dr M will be promoted to full professor, receive a 20% salary increase, and gain access to a portion of the study's indirect costs, which will be allocated to a discretionary account.
Dr M can use for professional and other university business purposes.
9 Part of the grant funds will be used to pay for Dr M to travel to Newbigpharma headquarters located in the Great
Caymans to review certain aspects of the clinical trial.
10 Same question as 9, except Newbigpharma agrees to reimburse the University for Dr M’s travel costs.
Conflict of Interest and Disclosure
Disclosure requirements for policies in effect at University of Washington, Seattle WA (UW) and Fred Hutchinson Cancer Research Center (FHCRC)
Institution Yes No Not Covered By Institutional Conflict of Interest
FHCRC researchers, along with their spouses, domestic partners, and dependent children, are required to disclose any interests, payments, or relationships with for-profit companies that may be related to their research activities at FHCRC.
Teaching Supplements
Dr G., a newly appointed assistant professor, is conducting research on genotypes linked to adverse drug reactions in congestive heart failure treatment A pharmaceutical company has shown interest in funding her study after a productive discussion with their representative, Dr Y The proposed contract includes 40% salary support for three years and funding for additional research costs, including a full-time technician Data will be shared with the company biannually, and Dr Y will act as a consultant and co-author for any resulting publications, with the stipulation that no work can be published without his approval.
Are these arrangements appropriate? Why or why not?
Same case as Case 2 but rather than the requiring that all publications include Dr Y, the pharmaceutical company wants all references to its company and employees omitted from publication.
Dr G has experienced two unsuccessful research projects, making it crucial for her career advancement to secure this grant Her department chair has indicated that obtaining this funding would enhance her tenure prospects and allow her to retain indirect costs in a discretionary account.
Participants should act as the institution's conflict of interest review board, potentially forming smaller groups of 4-5 if the overall group is large They will evaluate 10 scenarios, making decisions on whether each represents a conflict of interest It is important for the groups to justify their rulings, considering the nuances of the regulations, which allow for interpretation on various aspects.
Note: Faculty may wish to include a review of their own institutional policies a part of this case.
Why do institutions have conflict of interest policies?
Are they effective at limiting conflicts of interest?
Why does $10,000 seem to be the cut point for many policies? Is a moral distinction being drawn?
What other potential conflicts of interest exist, other than financial considerations?
The potential for conflicts of interest is a reality in the field of biomedical research
Conflicts of interest take a variety of forms Current regulatory practice focuses on financial conflict of interest, but other conflicts may affect research integrity as well
Understanding what constitutes a conflict of interest is essential for learners According to the University of Washington, a conflict of interest arises when an individual's private interests diverge from their professional obligations to the University, leading an independent observer to reasonably question whether personal gain is influencing their professional actions or decisions.
3 http://www.washington.edu/research/gcs/gim/gim10.html#definitions
Many institutions have established policies that outline the review and reporting requirements for financial conflicts of interest The main goal of these institutional reviews is to determine the appropriate response to identified conflicts Strategies to address these conflicts may include managing the conflict by limiting an investigator's involvement in a project, prohibiting certain activities when significant financial conflicts exist, and ensuring transparency through the disclosure of relevant financial relationships at the time of publication.
Non-financial conflicts of interest, such as authorship, career advancement, and primacy of discovery, are often harder to identify and are less frequently addressed by policy guidelines Institutional policies regarding conflicts of interest can vary based on the specific circumstances of the research, for instance, between clinical trials and non-clinical studies.
Concern for conflicts of interest stem from the ethical responsibility of researchers to preserve the integrity of the research process and protect research subjects.
Even if someone feels they are not compromised by specific situations, it is essential to consider that a reasonable person might view a conflict of interest This perception plays a crucial role in deciding the right course of action.
If a situation suggests conflict of interest, public trust in the institution and the research enterprise may be at stake.
Learners must understand that educational institutions have established policies regarding contracts with external companies Typically, individual researchers are not permitted to sign contracts with outside entities without the primary institution's review These policies are designed to safeguard researchers from unfavorable or restrictive agreements, ensuring their interests are protected.
Learners must recognize that conflicts of interest arise from specific situations rather than individual actions Ensuring transparency regarding these situations for research participants, reviewers, and institutional monitors is essential to safeguard the integrity of the research, its outcomes, and the reception of the data.
According to the International Committee of Medical Journal Editors (ICMJE) Uniform Guidelines for Manuscript Submission, all individuals designated as authors must meet specific criteria for authorship.
Likewise everyone who meets the qualifications ought to be listed as an author The qualifications for authorship credit are based solely on meeting all three of the following criteria:
Substantial contributions to conception and design, or acquisition of data or analysis and interpretation of data;
Drafting the article or revising it critically for important intellectual content; and
Final approval of the version to be published. o Authorship is not justified solely due to the acquisition of funding, collection of data or general supervision.
According to the Fred Hutchinson Cancer Research Center, authorship on papers or abstracts is contingent upon an investigator's genuine involvement in the research process Accepting authorship implies a formal acknowledgment of this active participation in the study.
4 http://www.icmje.org/ responsibility for the quality of the work being reported in the publication All individuals who qualify as authors shall be included as such 5 ”
Restrictions on freedom to publish results represent a threat to scientific integrity.
Conflicts of interest, along with potential conflicts, must be disclosed and effectively managed to maintain the integrity of scientific research By transparently addressing these issues, we can help safeguard public trust in the scientific community.
5 http://www.fhcrc.org/admin/hr/pppm/p0912.htm#Principles
4 Primary Discussion Topic: Mentor/Trainee
Additional Discussion Topics: Collaborative Science,
1 Develop an awareness of the importance of working to develop good collaborative mentor/trainee relationship
2 Understand the roles and responsibilities that are a part of mentor-trainee relationships as well as the other relationships that are a part of collaborative science.
3 Become familiar with structures, policies and other resources that can help trainees negotiate difficult mentor-trainee situations.
4 Develop an appreciation for changing roles – current trainees will become mentors and should think about what kind of mentors they want to be.
A Guide to Training and Mentoring in the Intramural Research Program at NIH http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm
National Academy of Sciences Advisor, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering http://www.nap.edu/readingroom/books/mentor/
Office of Research Integrity Silence is not Golden: Making Collaborations Work http://ori.dhhs.gov/html/programs/science_is_not_golden.asp
Answers
Conflict of Interest and Disclosure
Disclosure requirements for policies in effect at University of Washington, Seattle WA (UW) and Fred Hutchinson Cancer Research Center (FHCRC)
Institution Yes No Not Covered By Institutional Conflict of Interest
FHCRC researchers, along with their spouses, domestic partners, and dependent children, are required to disclose any interests, payments, or relationships with for-profit companies that could be connected to their research activities at FHCRC.
Dr G., a newly appointed assistant professor, is conducting research on genotypes linked to adverse drug reactions in congestive heart failure management She has engaged with a pharmaceutical company, represented by Dr Y, which is interested in funding her research Following a productive discussion, they agreed on a research plan and a contract that offers 40% salary support for three years, along with funding for additional research costs, including a full-time technician Data from the research will be shared with the company every six months, and Dr Y will serve as a consultant and co-author for any resulting publications, with no work published without his approval.
Are these arrangements appropriate? Why or why not?
Same case as Case 2 but rather than the requiring that all publications include Dr Y, the pharmaceutical company wants all references to its company and employees omitted from publication.
Dr G faces the challenge of two failed research projects and is determined to advance her career by securing a crucial grant Her department chair has indicated that obtaining this grant would enhance her chances for tenure and allow her to retain indirect costs in a discretionary account, providing her with greater financial flexibility for future research endeavors.
Participants should act as the conflict of interest review board for the institution, working in smaller groups of 4-5 if necessary They are tasked with evaluating 10 scenarios, discussing their decisions on whether each situation constitutes a conflict of interest It's important for the group to delve into the reasoning behind their rulings, considering interpretations of regulations rather than just citing them.
Note: Faculty may wish to include a review of their own institutional policies a part of this case.
Why do institutions have conflict of interest policies?
Are they effective at limiting conflicts of interest?
Why does $10,000 seem to be the cut point for many policies? Is a moral distinction being drawn?
What other potential conflicts of interest exist, other than financial considerations?
The potential for conflicts of interest is a reality in the field of biomedical research
Conflicts of interest take a variety of forms Current regulatory practice focuses on financial conflict of interest, but other conflicts may affect research integrity as well
Learners must grasp the concept of a conflict of interest, which the University of Washington defines as a situation where an individual's private interests clash with their professional responsibilities to the institution This divergence can lead to a scenario where an independent observer may reasonably doubt whether the individual's professional decisions are influenced by personal gain Understanding this distinction is crucial for maintaining integrity in professional settings.
3 http://www.washington.edu/research/gcs/gim/gim10.html#definitions
Many institutions have established policies that outline the review and reporting requirements for financial conflicts of interest, aiming to determine the appropriate actions needed to address such conflicts Strategies for managing these conflicts may include limiting an investigator's role in a project, prohibiting specific research activities when significant financial conflicts exist, and ensuring that relevant financial relationships are disclosed at the time of publication.
Non-financial conflicts of interest, such as authorship, career progression, and priority of discovery, are often challenging to identify and are not consistently addressed by policy guidelines Furthermore, conflict of interest policies can vary within an institution based on the specific context of the research, such as the differences between clinical trials and non-clinical studies.
Concern for conflicts of interest stem from the ethical responsibility of researchers to preserve the integrity of the research process and protect research subjects.
It is essential to acknowledge that even if a person feels unaffected by specific situations, the potential perception of a conflict of interest by a reasonable observer must be taken into account when deciding on the best course of action.
If a situation suggests conflict of interest, public trust in the institution and the research enterprise may be at stake.
Learners must understand that institutions have established policies regarding contracts with external entities Typically, individual researchers are not permitted to sign contracts with outside companies without the primary institution's review These institutional policies are designed to safeguard researchers from unfavorable or restrictive contractual agreements.
Learners must recognize that conflicts of interest typically arise from specific situations rather than individual actions Ensuring transparency regarding these situations for research participants, reviewers, and institutional monitors is essential to maintain the integrity of the research process and the credibility of the results.
According to the International Committee of Medical Journal Editors (ICMJE) Uniform Guidelines for Manuscript Submission, all individuals designated as authors must meet specific criteria for authorship.
Likewise everyone who meets the qualifications ought to be listed as an author The qualifications for authorship credit are based solely on meeting all three of the following criteria:
Substantial contributions to conception and design, or acquisition of data or analysis and interpretation of data;
Drafting the article or revising it critically for important intellectual content; and
Final approval of the version to be published. o Authorship is not justified solely due to the acquisition of funding, collection of data or general supervision.
According to the Fred Hutchison Cancer Research Center, authorship on papers or abstracts is only granted to those who have genuinely participated in the research process By accepting authorship, an investigator acknowledges their significant involvement in the study.
4 http://www.icmje.org/ responsibility for the quality of the work being reported in the publication All individuals who qualify as authors shall be included as such 5 ”
Restrictions on freedom to publish results represent a threat to scientific integrity.
To maintain the integrity of scientific research, it is essential to disclose and effectively manage conflicts of interest and potential conflicts Transparency regarding these issues plays a crucial role in preserving public trust in the scientific community.
5 http://www.fhcrc.org/admin/hr/pppm/p0912.htm#Principles
4 Primary Discussion Topic: Mentor/Trainee
Additional Discussion Topics: Collaborative Science,
1 Develop an awareness of the importance of working to develop good collaborative mentor/trainee relationship
2 Understand the roles and responsibilities that are a part of mentor-trainee relationships as well as the other relationships that are a part of collaborative science.
3 Become familiar with structures, policies and other resources that can help trainees negotiate difficult mentor-trainee situations.
4 Develop an appreciation for changing roles – current trainees will become mentors and should think about what kind of mentors they want to be.
A Guide to Training and Mentoring in the Intramural Research Program at NIH http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm
National Academy of Sciences Advisor, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering http://www.nap.edu/readingroom/books/mentor/
Office of Research Integrity Silence is not Golden: Making Collaborations Work http://ori.dhhs.gov/html/programs/science_is_not_golden.asp
Inappropriate Use of a Trainee’s Work
As a graduate student crafting the protocol for your doctoral dissertation, you sought the guidance of your advisor, Dr Flanders, who also serves as your principal investigator (PI) Although he was only casually involved in the development of your research topic, you requested his review of your proposal before submission, and he provided valuable feedback However, you later discovered that Dr Flanders had written his own research proposal, incorporating sections from your work, despite your understanding that his research was pursuing a different direction.
Does it matter if Dr Flanders’ proposal is regarding research that is merely similar to your own, rather than being virtually the same?
Inappropriate Use of a Trainee’s Work
After the first version, you can offer the following variations to help the discussion participants appreciate the issues.
The research proposal Dr Flanders submitted was to the same funding agency you submitted it to.
You are drafting an abstract for an article based on research conducted by Dr Flanders, with the intention of publishing it However, during a convention presentation, Dr Flanders utilizes portions of your abstract without giving you credit for your contribution.
Bill, a graduate student, approaches Professor John Smith for guidance regarding his challenging relationship with his thesis advisor Despite the unclear reasons behind their difficulties, it is evident that Bill's independent nature clashes with his advisor's notorious lack of tact in student interactions.
Nevertheless, the work done in the thesis advisor’s lab is exciting and innovative, and Bill’s project, in particular, has been highly successful
Bill is preparing a paper based on his thesis work, with significant assistance from his friend Kim, a graduate student in a related lab Kim has provided valuable critiques on the initial draft, suggested an important additional control experiment, and contributed to drafting the discussion section, all of which have greatly enhanced Bill's paper.
Bill initially offered Kim co-authorship due to her significant contributions, but this offer was revoked by his thesis advisor, who argues that Kim has no rightful claim to authorship and disapproves of her involvement without his consent Bill believes that denying Kim's authorship equates to an act of plagiarism.
He asks what he should do.
The following variations of this case can be used to explore the issues further.
Bill recalled a conversation with his advisor, where he mentioned that his friend Kim had suggested a helpful technique for conducting challenging experiments He expressed uncertainty about obtaining the necessary data without her input His advisor responded by emphasizing the importance of collaboration in science, stating, "That's what science is about We become better scientists through sharing ideas." This exchange reinforced Bill's understanding of the value of collaborative efforts in scientific research.
In a situation similar to the initial variation, Bill struggled to execute the technique recommended by Kim To assist him, Kim demonstrated the method, and together they successfully completed the series of experiments Bill acknowledges Kim's valuable contributions to the data collection and her insightful methodological advice.
Bill's advisor highlights the crucial support from Hank R., who provided essential materials for Bill's experiments, enabling him to complete his work Additionally, Hank possesses other materials that are needed for a different student's upcoming experiments in the lab.
He puts Hank’s name on the paper as an author despite Bill’s protests that Hank has not contributed intellectually to the paper
Bill, who speaks English as his second language, struggles with refining his writing skills After receiving criticism from his advisor regarding the unprofessional quality of his early drafts, he seeks assistance from Kim However, the support Bill requires extends beyond simple copy-editing, as Kim ends up composing most of the paper for him.
Institutions typically mandate the establishment of departmental policies that outline the procedures for reviewing student grievances It is essential for learners to become acquainted with these policies early in their academic journey, as they serve as a valuable reference throughout their training If any aspects are unclear or issues arise, students should seek assistance from the relevant departmental personnel.
Learners bear part of the responsibility for making sure expectations regarding their work are clear from the outset They also share in the responsibility for practicing good communication.
Learners should actively confront injustices they perceive, as this responsibility is crucial for their growth Gaining insight into a mentor's rationale for specific actions can enhance learners' understanding of the larger context surrounding those decisions.
Mentors have a responsibility to set clear guidelines regarding the work expected Other members of the thesis committee may also play a role in this process
All members of a research team have responsibilities to ensure effective teamwork, through personal integrity, good communication and a respectful attitude toward others.
Mentors have a special responsibility to foster the learning and professional growth of trainees
As part of their guarantee of research integrity, universities and research institutions have an obligation to promote productive interactions between trainees and mentors
Most labs operate within a hierarchical structure, which can leave trainees feeling powerless when conflicts arise with faculty members It's crucial for learners to be aware of the institutional resources available to help them navigate these issues Identifying these support structures at one's institution can provide essential assistance For instance, Bill may consider requesting a departmental review regarding authorship decisions, while also recognizing the legitimate interests of the principal investigator (PI) in the lab's work during this process.
Learners play a crucial role in fostering collaborative relationships, and it's essential for the Principal Investigator (PI) to be informed about the research activities of graduate students and their collaborations with peers In this context, Bill should have communicated with his mentor regarding Kim's potential involvement in the research prior to its commencement.
The Principal Investigator (PI) is responsible for the lab's productivity and has substantial authority over authorship decisions It is essential for learners to initiate discussions about authorship early in their research journey, even in the absence of apparent conflicts Ongoing conversations about authorship should be maintained throughout the research process to ensure clarity and understanding.
Core elements of research integrity include collegiality in scientific interactions, adherence to mutual responsibilities among members of a research team, and accuracy in representing individual contributions to scientific reports
According to the International Committee of Medical Journal Editors (ICMJE) Uniform Guidelines for Manuscript Submission, all individuals designated as authors must meet specific criteria for authorship.
Likewise everyone who meets the qualifications ought to be listed as an author The qualifications for authorship credit are based solely on meeting all three of the following criteria:
Substantial contributions to conception and design, or acquisition of data or analysis and interpretation of data;
Drafting the article or revising it critically for important intellectual content; and
Final approval is essential before publishing a version of a paper Authorship should not be granted solely based on funding, data collection, or general supervision Authors must clearly describe the contributions of each collaborator Additionally, there are established guidelines for acknowledging significant contributions from individuals who do not meet authorship criteria, which can be found at http://www.icmje.org/Acknowledge2.
Fred Hutchison Cancer Research Center, Seattle, WA, states the requirements for authorship as follows: o “Authorship shall not be accepted on papers or abstracts unless the investigator has had a genuine
All investigators who accept authorship of a research publication take on the responsibility for the quality of the work presented It is essential that all individuals who meet the criteria for authorship are acknowledged as authors in the publication.
A clinical psychologist-investigator conducted a pilot study on psychiatric patients, revealing insights that inspired your own research You proposed collaborating with him as a co-investigator on a new study, where he would interview specific patient populations and assess them for key characteristics Meanwhile, you focused on analyzing biological samples collected from the research subjects It was agreed that you would be the first author on publications related to your field, while he would take the lead as first author on publications in clinical psychology.
Several years ago, you completed a project and published two articles as the first author, while your colleague, who has since taken on significant administrative duties, contributed to only one article As the Principal Investigator (PI) for the grant that funded the work, you are responsible for maintaining the confidentiality of patient data, which raises concerns about your collaborator's access to sensitive information Although he has anonymized the data by removing names, addresses, and record numbers, the interviews still reveal intricate details about the patients' physical and mental conditions, which he claims are essential for his own writing.
Your colleague says that he does intend to publish based on his pilot study and your joint work, but he does not know when.
As a graduate student nearing graduation, you prepare to transition from your lab position to a new role at another university You request your advisor to provide a recommendation and a summary of your contributions in the lab, which she fulfills Along with this, she includes a list of research materials that must remain in the lab and outlines specific research areas, some of which are still unexplored, in which you agree not to engage Your advisor then requests your signature on this document to formalize the agreement.
Does the advisor have the authority to require this statement from you?
If you disagree with what your advisor is doing, who do you talk to?
What materials, notes, etc do you have rights to when you leave?
How should you go about determining your relationship with the lab you are in and the research you have been a part of once you leave?
The following variations of this case can be used to explore the issues further.
While transitioning to a new position at another university, you will maintain your collaboration with your current lab, broadening your research into a multi-institutional project This raises the question of whether this change grants you enhanced access to the records and data from your current lab.
Rather than having a position in another university, you have a position at a commercial institution o Does this change anything?
In your new position, you aim to explore research that builds upon your previous work in your current lab, even though it falls outside your advisor's interests and is not included in the restricted topics list To ensure a smooth transition and facilitate your ongoing research, consider whether you should take your lab notebooks with you when you leave and if making copies of them is advisable.
There are regulations pertaining to the use and management of data A researcher in this position has at the very least the responsibility to ensure pertinent regulations are complied with.
Learners should understand the responsibilities involved in protecting sensitive data and the importance of eliminating the potential for identification of individuals when a study involves human subjects.
Learns should appreciate the need for frank conversations regarding the timely and appropriate use of data they helped to obtain and toward which they have a responsibility
Consulting with the Institutional Review Board (IRB) is essential to identify which data elements can be preserved in the colleague's dataset and to establish the allowable duration for data retention.
The NIH highlights critical topics related to data acquisition, management, sharing, and ownership, emphasizing accepted practices for obtaining and maintaining research data It underscores the importance of proper record keeping and electronic data collection methods in scientific research Additionally, the NIH stresses the need to define what constitutes data and the significance of maintaining data notebooks, along with the processes of data selection, retention, sharing, ownership, and analysis Furthermore, it is essential to understand the legal implications of intellectual property and copyright laws as they relate to data and records management.
Researchers have an obligation to honor the privacy and contribution of the individuals who participated in their research A part of this obligation is ensuring that
Identifiable information is securely protected, ensuring that data collected is strictly utilized within the boundaries of the specific research for which it was gathered.
When addressing questions about the appropriate use and management of data, it is essential to consider relevant regulations and institutional policies Researchers can seek assistance from institutional resources, such as the Institutional Review Board (IRB), to navigate challenging situations that may arise.
Learners should familiarize themselves with the policies that regulate their work environment, as the rules regarding what a trainee can take upon leaving a lab differ by institution or principal investigator (PI) Proactively addressing these policies before departing can facilitate a smoother transition between labs and help maintain positive collaborative relationships.
Learners must understand that their lab work is typically part of a broader research process that starts before they arrive and continues after they leave Generally, the data generated belongs to the Principal Investigator (PI) or the funding institution Trainees should proactively discuss any concerns regarding recognition with the PI and clarify what they can take with them upon departure to avoid misunderstandings.
Students should be aware that they can address concerns regarding authorship and the use of data, animals, genes, reagents, and other resources at the onset of their research It is advisable for learners to draft a letter or email that outlines their agreements on these matters and provide a copy to their advisor or principal investigator (PI).
The issue of ownership of data is complex Providing or obtaining funding does not alone justify ownership of the data generated though it is a significant part
Therefore a PI is clearly the primary steward of data
When a study is funded by the NIH, the data itself belongs to the institution in which the research was performed 10
The Principal Investigator (PI) plays a crucial role in determining the future work opportunities for post-doctoral trainees upon their departure from the lab It is expected that these trainees will pursue careers within the same field, but the PI should refrain from imposing excessive limitations on their future endeavors.
Understanding the broader scope of a project, including the necessary circumstances and equipment, is crucial for trainees Recognizing this complexity not only enhances their training experience but also helps prevent potential challenges related to ownership and access to essential materials, data, and information.
10 http://www.life.uiuc.edu/micro/ethics/data-ownership.html
7 Primary Discussion Topic: Human Subjects in Research
Additional Discussion Topics: Conflict of Interest,
Collaborative Research Cases & Notes for Faculty Facilitators
9 Understand factors that influence participation in research (for researchers and subjects) and the potential for coercion.
10 Be aware of federal and institutional regulations governing federally funded human subjects research and the underlying ethical principles.
11 Understand the relationship between subject and investigators and the rights and duties of the relationship.
12 Be aware that there are circumstances in which a waiver of consent may be an appropriate substitution for actual consent by study participants
Belmont Report (1979) http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm
U.S Food and Drug Administration Guidance for Institutional Review
Boards and Clinical Investigators: A Guide to Informed Consent (1998): www.fda/gov/oc/ohrt/irbs/informedconsent.html.
The University of Washington emphasizes the importance of informed consent in research, ensuring that participants are fully aware of their rights and the nature of the study The policy also outlines conditions under which waivers of consent may be granted, providing flexibility in specific research scenarios Additionally, the Human Subjects Division has established a clear statement on conflict of interest for researchers, promoting integrity and transparency in research practices Furthermore, the university has guidelines regarding enrollment incentives, which were updated in March 2002, to ensure ethical recruitment of participants while maintaining compliance with institutional policies.
The University of Washington School of Medicine offers a dedicated Office of Research and Graduate Education that provides essential resources on Ethics in Science This includes comprehensive links to both University and Federal Policies, ensuring that students and researchers have access to important ethical guidelines For more information, visit their official page at [Ethics in Science Resources](http://www.washington.edu/medical/som/research/ethics.html).
Ethical Principles from the Belmont Report
In group discussions about research ethics involving human subjects, it is beneficial to utilize established principles as a foundation for justification While these principles may occasionally conflict, their interpretation should be tailored to the specific context of each case, ensuring that the dialogue remains anchored in a recognized ethical framework.