Promoting Integrity in theNext Generation of Researchers A Curriculum for Responsible Conduct of Research in Occupational Therapy (2005) Funded by the Office of Research Integrity through the American Association of Medical Colleges
Abbreviated Cases – Part 1 Human Subjects Data Management Conflicts of Interest Peer Review Collaborative Science
PROTECTION OF HUMAN SUBJECTS Subject Recruitment 1 - Kissima Martin • Study is nearly complete. Has a homogeneous sample. • Potential subject who is diverse contacts interested in entering study. • Participation of this subject will complicate study treatment and data analysis.
Questions for Protection of Human Subjects –Subject Recruitment 1 - Kissima Martin 1. Describe Kissima’s dilemma in terms of beneficence, autonomy, and justice? 2. What should Kissima do regarding the interested person? 3. Could Kissima allow the person to attend sessions, but not include his data or report his participation in the study? 4. Is there anything that could have controlled or prevented this dilemma?
PROTECTION OF HUMAN SUBJECTS Subject Recruitment 2 - Rodney Manoweh • Trouble recruiting parents into a pediatric study leaves Rodney feeling that his job and his thesis plans are at risk. • Rodney asks help from a clinician friend at a local research hospital. • The friend gives Rodney a list of interested potential participants. • Rodney calls and recruits these potential participants into the study.
Questions for Protection of Human Subjects- Subject Recruitment 2- Rodney Manoweh • Rodney has his participants and his friend has helped a friend. Are there any procedural or ethical problems with the recruitment? If so, what? 2. What conflicts of interest are possible in Rodney being both a student and employee of his advisor?
PROTECTION OF HUMAN SUBJECTSData Collection - Anita Manosaen • The PI forgot to gather the height and weight data needed for her study, and now must get this data two months after the fact. • A colleague outlines the options. She can get the data by: 1) Reviewing participants’ current medical charts to which she has access, as a clinical therapist. 2) Calling participants’ parents and asking them. 3) Mailing participants’ parents a request for the height and weight, with return-address and pre-stamped envelope. Or…that Anita can toss current data and recollect.
Questions for Protection of Human SubjectsData Collection - Anita Manosaen 1. What other options are there? Which options are/aren’t ethically sound? Why? 2. Does Anita need to contact anyone before she enacts her decision? 3. Is gathering the needed data more or less ethical than starting the project anew? Consider what a researcher owes his or her participants. 4. In future articles or presentations, does Anita need to inform her audience that the weight and height data were collected after the fact?
PROTECTION OF HUMAN SUBJECTS Unexpected Event - Julie White • During an interview about a job placement program, a participant (Amy) discloses unrelated physical abuse to Julie White, a relatively inexperienced researcher and asks for her help. • Julie asks Amy for permission to call her back after checking with a supervisor. • Amy gets angry and hangs up without giving this permission.
Questions for Protection of Human Subjects Unexpected Event - Julie White 1. What could Julie have done differently? 2. What are the potential positive and negative consequences for each of Julie’s option? 3. How would Julie’s options differ if Amy’s disclosure had occurred in occupational therapy treatment instead of during a research interview? Why? 4. How could a principal investigator reduce the likelihood that another interviewer would face a similar situation?
DATA MANAGEMENTData Collection- Laura Schmidt • Laura is gathering qualitative interview data on job experiences of persons with disabilities. Participants are paid $30 per interview for 5 interviews in 1 year. • Laura and Jay (a study participant) begin dating. • Laura continues to interview Jay and to pay him for the interviews. • Toward the end of Jay’s participation in the study, Laura informs her advisor about the relationship, by announcing that she and Jay are engaged to be married.
Questions for Data ManagementData Collection - Laura Schmidt • Is there anything wrong with Jay and Laura’s relationship? • Now that the advisor knows about the relationship, what are her obligations? • What should become of Jay’s data? Can it be retained in the study? • Are there any agencies that need to be informed about Jay and Laura’s actions? • What could have prevented or stopped the issues that you see in this case?
DATA MANAGEMENTData Storage - Elena Jevehirjian • Elena is conducting an itinerant study. • When she finishes work on Friday, she stores study materials from 3 participants in her car’s locked trunk. • Returning after the weekend, she finds that her car was burglarized and the briefcases in which she kept her data (e.g., taped interviews, transcriptions), participant demographic, screening forms, and addresses with MapQuest™ instructions are missing or damaged.
Questions for Data ManagementData Storage - Elena Jevehirjian 1. What went wrong? Is there a policy of behavior that would have protected against this? 2. Under what conditions is it acceptable to keep data outside of a research clinic or office? 3. Do Elena and the principal investigator need to inform any persons or agencies of this theft? If so – whom? 4. Can Elena ‘re-interview’ these 3 participants or ‘re-constitute’ the data from her recollection, so that the information is not lost ?
DATA MANAGEMENTData Cleaning - Michael Marshall • Michael is analyzing a database on assistive technology (AT) choices, costs, and satisfaction. • He finds and alters several discrepancies in the data: • Cases where cost is atypically high and the data collector has a history of not including notation. He alters entries of $25000 to read as $250.00 • Cases where data on satisfaction is missing, and data forms are illegible. He inserts a neutral (middle) option. • Cases where there are illogical responses, e.g., people state that they were very unsatisfied with AT but would definitely refer others to the agency. He alters data to indicate very satisfied.
Questions for Data ManagementData Cleaning - Michael Marshall 1. What do you think of Michael’s approach to data cleaning? Are any of Michael’s choices more or less responsible? 2. What other options could have been used to address the questionable items (i.e., costs and satisfaction ratings)? 3. Michael later discovers that his actions were not reasonable or responsible and inappropriately altered the study findings: a. Is there any action that Michael should take now? b. Who else is responsible for the situation? What actions should they take? c. What actions could have helped avoid the problems?
DATA MANAGEMENTData Reporting - A Collaborative Group • A collaborative study used two methods of sampling. • The group argues how they should describe their sampling process in the article they are writing: • Dr. Grove thinks they should say they used a convenience sample (claiming nothing but the weakest form, without noting that some subjects were otherwise sampled). • Dr. Lou thinks that the change in sampling is a fatal problem, and that the work should not be published • Jan suggests reporting the estimated numbers of each sample based on the approximate dates for each sampling. • Bridget suggests that they avoid mentioning their sampling technique unless a reviewer requires it.
Questions for Data ManagementData Reporting – A Collaborative Group 1. Are any of the options more or less responsible? Why? 2. Are there better alternatives for describing the study’s data sampling? 3. How should a researcher determine which research weaknesses or problems to disclose when disseminating? 4. How could the current problems have been avoided by better data management and project planning?
DATA MANAGEMENTDissemination - Connie Friedland • Connie studied the effects of services received by women living in a shelter. Each participant is at risk of violence from her former partner. • Connie submits her serial case study to an AMA journal, disguising the shelter’s location and participants’ names and other data. • The editor discovers Connie’s use of false descriptors, and characterizes it as falsification of data.
Questions for Data ManagementDissemination - Connie Friedland 1. Is it ethical for Connie to seek participants’ permission to publish data, if she fears it increases the risk to these women? 2. Is it responsible for Connie to eliminate the fabricated data if it deadens the potency of her findings? 3. Are there any changes needed for the article if Connie decides to withdraw her manuscript from the first journal and submit it to a non-AMA journal? 4. Is it responsible for Connie to withdraw the work, as described in #3, if this reduces the influence that her study is likely to have on policy?
DATA MANAGEMENTData Retention - Nick Ramcharan • Nick completed his degree 2 years ago and co-published his master’s thesis with his advisor 13 months ago. • Before moving, he gave his advisor the study consent documents and data collection forms. • Nick and his advisor have been accused of plagiarizing their model. • Nick has thrown out the draft diagrams and notes that show their process of model development. • The advisor is angry at Nick’s data storage and retention. Nick is confused and defensive.
Questions for Data ManagementData Retention - Nick Ramcharan 1. What constitutes “data” in research? 2. Nick and Dr. Johns published over a year ago. For how long should research materials be kept? 3. What responsibility do Nick and his advisor each have for the materials that are missing? 4. What can Nick and Dr. Johns do, now that the needed materials are not available? 5. What strategies could help avoid this type of problem and still avoid drowning in paper (as Nick phrases it)?
DATA MANAGEMENTData Sharing - Virginia Mathers • Virginia got federal funding for her dissertation study of the effects of a wellness program on falls in community elderly. • The intervention used a commercial DVD on tai chi, donated by its creator at no cost. • Virginia has published her outcome data. Focus group data have not been published. • Two groups want access to Virginia’s raw data: • Researchers want to compare Virginia’s data to their own study of a more costly program. • A company that makes tai chi DVDs want to use the focus group transcriptions to improve and competitively market their product for home use by the elderly.
Questions for Data ManagementData Sharing - Virginia Mathers 1. What should Virginia do? 2. Is Virginia under any obligation to share her data with either or both of these requesting groups? 3. Is Virginia under any obligation not to share her data with the DVD company that competes with the one used in the study?
CONFLICTS OF INTERESTIndustry-based Research - Marlene Manella • Marlene works collaboratively with a school and a w/c company to study the effects of the company’s stair-climbing wheelchair (w/c) • The company analyzes the data and finds, unexpectedly, that the stairclimbing w/cs have limited effects. • Knowing that this could limit their w/c sales, Marlene selectively publishes only the positive finding. • With the company’s support, Marlene gathers additional data and presents their positive findings at a national conference
Questions for Conflicts of InterestIndustry-based Research - Marlene Manella 1. What actions are ethically questionable in this case? 2. How do the different missions and cultures of the manufacturer and researcher mesh? How do they conflict? 3. How would you handle the friendships that naturally develop when individuals with different responsibilities collaborate closely? 4. Would the case be different if the same parties were involved, but the study was funded by Marlene out of pocket, or by government or a non-profit research agency? 5. Could Marlene meet the need for disclosure by noting that there were other study data that were not being reported?
CONFLICTS OF INTEREST Article Review - Charlotte Guthrie • Dr. Guthrie is a rare expert on a topic, and has a publicly known bias against the other major theory. • When asked to review an article written from the other perspective, Dr. Guthrie assumes that the editor knows about her bias and therefore says nothing. • Dr. Guthrie writes a thorough and objective review, recommending that the researcher add opposing interpretations for his or her findings. • The author complains to the editor, arguing that the reviewer had a known bias against her theoretical model. • The editor chastises Dr. Guthrie for not disclosing her bias. • Dr. Guthrie is hurt and angry, and considers refusing further review requests.
Questions for Conflicts of Interest Article Review - Charlotte Guthrie 1. Where could a different action have resulted in a more reasonable outcome? 2. If Dr. Guthrie held the same view, but had never publicly disagreed on the theory, would conflict of interest still be an issue? 3. If Dr. Guthrie’s review was objective, is there any reason to worry about the conflict of interest? 4 . How could this journal’s review protocol be changed to protect against future conflicts of interest? 5. What do you think of Dr. Guthrie’s plan to avoid problems by not reviewing articles again?
CONFLICTS OF INTERESTClassroom Peer Review - Carla LeBeck • Carla is assigned as the peer reviewer for Dan Claven’s thesis. Dan is a friend with a history of not accepting constructive, but negative, input. • Afraid to anger or hurt Dan, Carla’s critiques have been inappropriately mild. • The instructor warns Carla that unless her critiques become more scholarly, her grade will be a “C”. • Carla doesn’t think that’s fair, and also worries that Dan will not accept a turnaround in her critical form.
Questions for Conflicts of InterestClassroom Peer Review - Carla LeBeck 1.What conflicts of interest do you see in this case? 2.What is the faculty role in Dan and Carla’s conflict? Was the instructor responsible to prevent or help resolve the conflict? 3. In what ways could Dan help resolve the issue? How would he know that there is a problem, and should he be more directly informed? 4. How could the conflicts described in #1 have been avoided by action by the participants or by a change in the protocol (i.e., the mechanisms of the assignment and the peer review)?
PEER REVIEWLearning by Doing - Kayla Thomas • Dr. Cefalu is asked to peer review a manuscript toward publication in professional journal. • Dr. Cefalu is mentoring Kayla Thomas, a doctoral OT student, and invites her to write her own review. • Kayal sends electronic copies of the article to her dissertation discussion/support group, who agree to critically analyze the work at their next meeting. • Kayla summarizes her input on the manuscript, including ideas from her discussion group. Dr. Cefalu incorporates many of these observations into her own review, and sends the work to the journal.
Questions for Peer ReviewLearning by Doing - Kayla Thomas 1. It sounds like everyone benefited from the experience. Is there any issue here? 2. What do you think of Dr. Cefalu’s handling of the review? Why? 3. What do you think of Kayla’s handling of the review? Why? 4. Are there variations that would have made everyone’s actions more appropriate?
PEER REVIEWA Well-Timed Peer Review - Sherry White • As a class assignment, Sherry reviews a single-masked journal manuscript. • Sherry is so impressed by the manuscript that she adopts its theoretical model and one of the questions in its Future Research section for her own thesis. • Sherry’s committee approve the thesis proposal, not realizing that her ideas came from a manuscript in review. • When the thesis proposal is approved for funding, Sherry’s summary explaining the theory and her research are published, without references, on the funder’s website.
Questions for Peer ReviewA Well-Timed Peer Review - Sherry White 1. In what way did Sherry deviate from acceptable peer-review behavior? 2. Have Sherry’s actions caused any harm to the author of the original manuscript? To the journal to which that manuscript was sent for review? 3. Are there any corrective actions that need to be taken?
COLLABORATIVE SCIENCE A School Project - Chenoa Bo • Chenoa and a school district are collaborating to research rural teenagers’ risk-taking behaviors. The school district hopes that the data will help them design a risk management curriculum. • The research group includes members of the school board, the school superintendent, a high school principal, and two high school teachers who instruct on health and biology. • When Chenoa pilot’s one of her measures, its frank phrasing about sexual risk-taking shocks the students participants and their parents. The parents complain to the principal. • The principal ends the study before it begins and tells Chenoa she is no longer welcome at the high school.
Questions for Collaborative ScienceA School Project - Chenoa Bo 1. How would you describe the current problem facing this community-based participatory research project? 2. What actions should Chenoa take immediately? Who should these actions involve? 3. Community-based participatory research assumes community investment. Were there people or types of participation that were missing from this case that might have prevented the problem?
COLLABORATIVE SCIENCE Participatory Action Research (PAR)- Carmen Washington • Carmen, an OT with a disability, is collaborating with a consumer advisory board to conduct a study on community integration post-discharge from rehabilitation. • The board includes members with a variety of physical and cognitive impairments. • Many board members oppose taking the required training on protection of participants. They believe that it is unnecessary because they are themselves disabled. In addition, they point out that the training is not adapted to persons with cognitive impairments and will divide the group into those able and those unable to perform the research. • Board members who do not take the training cannot perform paid work in the study or access to the database. • This is tearing apart the group.
Questions for Collaborative Science Participatory Action Research (PAR)- Carmen Washington 1. How could training be made more accessible and more acceptable for the board? 2. Should all board members have equal right to access to the database? Why? 3. Could the board resolve the issue by withdrawing from the auspices of the hospital? Does this create new problems? 4. Issues of privacy and confidentiality often arise in PAR, especially if cognition is an issue. What protections could minimize these risks? How is this different for PAR research vs other forms of research?
COLLABORATIVE SCIENCEData Ownership - Camilo Montoya • Camilo is working to publish his dissertation work with his ex-advisor (Dr. Kim). Camilo will be first author and Dr. Kim second. • A new student working with Dr. Kim has increased Camilo’s original database and further developed the theoretical model. • Dr. Kim refuses to publish with Camilo, preferring to wait and publish the new student’s work, with Camilo as second author. • Camilo submits his manuscript as sole author and it is accepted. • Dr. Kim asks the journal to rescind its offer to publish. She argues that: • The work is jointly owned, so Camilo can’t publish as sole author. • The work is incomplete, so the journal should wait for the better version, and • Not publishing is the only way to protect herself from an unwanted association with the work.
Questions for Collaborative ScienceData Ownership - Camilo Montoya 1. What should the editor do? 2. Do either of the parties (Camilo or Dr. Kim) have a more ethical claim to their viewpoint and behavior? 3. Were there turning points where different decisions or behaviors could have potentially avoided problems?
Abbreviated Cases – Part 2 Authorship Publication Issues Mentorship Fiscal Responsibility Research Misconduct and Whistleblowing
AUTHORSHIPDetermining Authorship/Acknowledgment - Case 1- Latisha Doe • Latisha is studying the effects of a device that controls upper extremity tremors and dyskinesias during feeding. • The project has been helped by: • Cathy – the clinical OT who screened potential subjects, and helped gather consent and orient participants to device. • Dr. Lange – who heads the clinic and authorized space to store the devices. He is listed as institutional-PI on the IRB. • Mary who developed the first prototype. • Dr. Jones –Latisha’s research advisor who helped plan the study. • Alice – an engineering student who helped design and manufacture 3 prototypes of the study’s device • Darnell, the project’s paid statistician
Questions for AuthorshipDetermining Authorship/Acknowledgment - Case 1- Latisha Doe 1. Who should be an author and who should be acknowledged? Be ready to discuss your reasoning for each choice. 2. Did you award anyone authorship as a gift or out of fear of repercussions? Why not take the attitude of the more the merrier? 3. Is Latisha the only one who should decide about authorship? Who else should be consulted? Why 4. Latisha feels pressure to list persons as authors who do not, in her opinion, deserve it. Could this have been avoided? How?
AUTHORSHIPDetermining Authorship/Acknowledgment -Case 2 - Barbara Chan • As a paid student research assistant on Dr. Meyer’s study of a new handwriting assessment, Barbara assesses 300 sets of data. • When Dr. Meyer reports the study’s findings, she lists Barbara and another student data collector as 2nd and 3rd authors on the article. • Barbara doesn’t understand the statistics used by Dr. Meyer, but does understand what the findings indicate. • Barbara conducts her own thesis is on a totally different topic using a different method of data collection and analysis.
Questions for AuthorshipDetermining Authorship/Acknowledgment -Case 2 - Barbara Chan 1. Do you see any problems or issues in the case? What? • When interviewing for a staff position at a community clinic, Barbara learns that they are especially interested in her because they believe that her research experience with Dr. Meyer may help them evaluate outcome measures for their clinic. During the interview lunch, the therapist asks Barbara to explain why specific statistical analyses were chosen. 2. What should Barbara do? Who is responsible for this dilemma?
AUTHORSHIP So You Want to be Sole Author - Etta Thurn • As Etta finishes her thesis, she asks how she can publish it as sole author. • Her school’s policy encourages faculty to include students in publications, but does not address sole publication by a student. • Etta argues that her advisor’s input did not warrant authorship, and that Etta could have gotten much of the same information by independently reading the advisor’s published work. And, that she had worked more independently had she known that it would allow her to be sole author. • The advisor feels that she deserves authorship because she helped Etta design and analyze her study, and assisted in many other ways on the project.
Questions for AuthorshipSo You Want to be Sole Author - Etta Thurn 1. What do you think of Etta’s reasoning? Why? 2. Neither Etta nor Dr. D’Alessandro discussed authorship as an issue early in the process. Each made her own assumptions. Does this affect who should be author? 3. Can Etta change advisors to avoid this problem? 4. What, if anything, should be done about the school’s policy or about Dr. D’Alessandro’s approach to advising?
AUTHORSHIPAuthor Order - Valentine Quin & Aggie Bickford • Valentine Quin, designs, conducts, and analyzes a study on the effects of a fatigue management program for people with HIV, using a single group pre-post design. Her findings on 8 participants are promising. • Aggie Bickford, another OT student working with the same advisor, continues the project. She gathers and analyzes data on an additional 42 persons (total n=50). The findings for this larger group are exciting. • Valentine and Aggie are committed to publishing their work. Their advisor will be final author. Both new graduates reason that they deserve to be first author. • Aggie plans to start a PhD. • The targeted journal does not permit authors to explain their author order.
Questions for AuthorshipAuthor Order- Valentine Quin & Aggie Bickford 1. Who should be first author? What criteria did you use? 2. Who should be making this authorship decision? Why? 3. What, if anything, could have helped prevent this dilemma at this late point in the process?
PUBLICATION ISSUESA Quick Publication - Olivia Eggert • Olivia and her advisor planned to publish Olivia’s thesis in a peer reviewed journal. • Last week, the advisor was surprised to find an article listing herself and Olivia as co-authors in a non-refereed journal. She is upset because: • She never read the manuscript and did not know that it had been submitted. • The literature review is out of date and the Discussion and Conclusion sections make unreasonable assertions. • The journal is not peer reviewed. • Another faculty member was acknowledged by name without that faculty’s permission. • Olivia does not understand that there is a problem. She wanted to publish something quickly and didn’t want to bother her advisor. She still plans to work with her advisor to publish the research in a peer reviewed journal.