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SBCVL Research guidelines 1

Research guidelines

Written by: Arnau Benet

Reviewed by: Jordina Rincon-Torroella, Michael T. Lawton, Ivan El-Sayed, Mitchel S. Berger

Adapted from: The BTRC's Guidelines on Research Data & Reports, UCSF, 2001

UCSF skull base and Cerebrovascular laboratory

Departments of Neurological Surgery & Otolaryngology HNS

University of California, San Francisco

505 Parnassus Avenue HSW 780

San Francisco, CA 94143-0112

July, 2012

SKULL BASE & CEREBROVASCULAR

LABORATORY


EXECUTIVE SUMMARY

Objective

The UCSF skull base and Cerebrovascular laboratory is a space for creative research in neurosurgical and OHNS techniques, indications and strategies to optimize treatment of complex cranial base and Cerebrovascular lesions.

As a UCSF laboratory, we are committed to advancing healthcare worldwide through the highest research standards. Thus, our work in the laboratory is performed according to the scientific code and our results are shared with the medical community through publications in peer-reviewed journals, congress communications and educational courses.

The main aim of the present document is to provide researchers of the UCSF Skull Base & Cerebrovascular laboratory (SBCVL) with methodology guidelines and laboratory regulations.

Goals

• Foster good practice and equity in Authorship recognition.

• Standardize protocols for research project development.

• Health and Biohazard security protocol in the laboratory facility.

• Laboratory general organization and algorithm of responsibilities.

Disclosure The information detailed in the present document must be provided to any researcher/collaborator of the UCSF Skull Base and Cerebrovascular laboratory. Knowledge of all regulations, instructions and proceedings included in this guideline is essential for a safe and efficient use of the laboratory and is presumed to all researchers of the UCSFSBCV laboratory. Any violation of the following regulations must be informed to laboratory director or project PI immediately.


1 Research positions & Eligibility Laboratory access and use is restricted to all surgeons, faculty, residents, national or international fellows and experts that both have official recognition from the UCSF departments of neurosurgery/ OHNS and a research project accepted by the SBCVL. If any help or assistance is required from an expert outside the institution, his/her activities in the lab will be closely monitored by the project PI, lab director or a senior researcher with official UCSF enrolment.

Space and infrastructure are the main limitations to laboratory efficient use. Hence, a limited group of full-time research positions and ongoing research projects is available at the UCSF SBCV laboratory.

1.1.1 Research fellowship program.

The UCSF SBCVL offers the possibility of joining the skull base and cerebrovascular research team to any talented and creative person committed to neurosurgical/OHNS applied research. Candidates are required to devote full-time to laboratory research for a period not less than 3 months. However, we recommend a period of at least 6 months to take full advantage of the programmed educational courses and laboratory work. This also includes attending lectures and grand rounds, and assisting to OR cases of the departments of neurosurgery/OHNS. During this period, the research fellow must develop at least one research project, which is of peer-review caliber and which will be written in a final form before the fellowship concludes (see 4). Fellows in the SBCVL are also responsible to help with various neuroanatomy and neuroscience courses that are conducted during the time of their fellowship. The UCSF SBCVL will not cover living expenses for this position. Indeed, no salary is offered to research fellows. However, all laboratory expenses related to research development - cadaveric specimen, equipment maintenance, etc.- will be covered entirely by the SBCVL.

1.1.2 Research fellowship eligibility. The following information should be sent by the applicant:

A. Curriculum vitae (CV) updated to the application time.

B. Personal letter of interest. Should not extend from two pages in 12pt serif typeface.

C. Two letters of recommendation. One of them must be signed by a senior OHNS or neurosurgeon. Letters must be sent by their authors directly to the UCSF SBCVL director office or e-mail.

D. Project submission pack (see 4.1).

1.2 Medical student research clerkship. The UCSF SBCVL is committed to foster knowledge and expertise in treatment of neurosurgical and OHNS diseases and promote excellence in applied research to the medical community. Therefore, special attention will be directed to students with interest and commitment to any activity or project developed by the laboratory. Students will participate in a research project under the direction of a


member of the faculty. Extensive background reading will be required and discussion of important topics will be held at weekly laboratory and program project research conferences. UCSF SBCVL researchers are encouraged to mentoring and teaching medical students in research techniques and surgical knowledge.

1.2.1 Medical student eligibility. Medical students eligible for a SBCVL research clerkship position must send the following information to the SBCVL director office/e-mail:

A. Curriculum vitae (CV) updated to the application time.

B. Personal letter of interest. Should not extend from two pages in 12pt serif typeface.

C. Two letters of recommendation. One of them must be signed by a senior OHNS or neurosurgeon. Letters must be sent by their authors directly to the UCSF SBCVL director office or e-mail.

D. Letter of mentoring acceptation by a SBCVL permanent researcher.

[Note: Medical students submitting a valid research pack (see 4.1) will have preference. Last year medical students that both have large exposition to neurosurgery and submit a high quality research project may be accepted to lead their own project under direct supervision of a faculty member.]

1.3 Visitors, observers and short-term fellows. People visiting the UCSF Department of neurosurgery or OHNS for a period less than 3 months are welcome to attend all activities and lectures organized by the SBCVL. However, regular access to the laboratory will be restricted and any visits will always be supervised by a member of the SBCVL. We estimate the period required to develop a peer reviewed caliber research article to be not less than 3-6 months. However, people with advanced projects that send a submission research pack including a manuscript draft will be also admitted to validation process. In such cases, the candidate must declare a full time devotion to the laboratory work in the personal letter of interest before starting at UCSF.


2 Responsibilities and Organization

Principal Investigators (PIs) have final responsibility for:

The validity and quality of the data and reports generated from their laboratory or clinical program.

Fulfilling the research, reporting, and publication standards, policies, and procedures of the Department of Neurological Surgery, the University of California, San Francisco, and the USPHS, National Institutes of Health, National Science Foundation, and Office of Research Integrity.

Formally orienting junior faculty, fellows, residents, and staff to those standards, policies, and procedures and, to the maximum extent possible, seeing to it that they are upheld.

Overseeing the work done by fellows, residents, and staff to assure that each has the knowledge, information, and skills necessary to meet the standards of the institution and scientific convention.

2. Research Data

2.1 Data Management and Review

In general, two primary forms of data records are maintained in skull base and cerebrovascular research: the illustrative folder (photo & video) and the morphometric database. A "submission pack" file containing data selected for publication and documents related to journal submission is kept for each paper resulting from a study. Standards for accurate collection and recording of data and for storing data are detailed in 3 of these guidelines.

2.1.1 The PI has final responsibility for:

The validity of the data.

Maintaining and preserving the project's cloud pack, especially the illustrative and morphometric folders (see 3.1.2) and laboratory master logs relevant to the PI's laboratory and seeing to it that those project folders, including all data selection files,


related data and records are kept and stored according to the standards set out in these guidelines.

Ensuring that data (a) are collected and recorded in the pertinent folder according to the standards described in these guidelines, and (b) are stored in a comprehensible way for others to have access to them.

2.1.2 In some laboratories, a staff research associate designated by and responsible to the PI may maintain project folders, oversee morphometric notebooks, have laboratory management responsibilities, and/or instruct new fellows and residents in laboratory techniques and protocols. In those laboratories, the PI meets with the staff research associate to review research progress and data at least once each month (see 2.1.4).

2.1.3 The PI holds scientific meetings with junior investigators, fellows, and residents at least once each month, at which time the PI reviews the illustrative work, morphometric database, and related data and records. For educational purposes, however, PIs are encouraged to meet with them one-to-one more frequently, at least once a week (see 2.1.4).

2.1.4 PIs are encouraged to comment and track changes on each draft or illustrative work reviewed in the event that documentation of these reviews is needed at a later date.

2.2 Statistical Design and Analysis

Investigators are encouraged to consult a statistician during the earliest stage when designing a study, and then again when interpreting statistical data.

2.3 Use of Pooled Data

An investigator wishing to base a study on pooled computerized data that was generated by anyone other than himself or herself alone must discuss the project with the Director of the SBCVL and the PI who derived the data before work begins to assure proper authorship, acknowledgment, and attribution of ideas and data.

2.4 Ownership of Data

Illustrative and morphometric data and project records are the property of the SBCVL and the University of California. They may not be removed from the SBCVL, although


investigators may take a printed copy -with previous permission and signature of the PI- of all or part of them from the SBCVL. Illustrative data produced in the laboratory is a shared property between the researcher and the UCSF. Therefore, a copy of all photographs and videos must be kept in the illustrative folder (see 3.1.2) in the highest definition and in a no compressed file (e.g. TIFF extension) [Note: When a PI resigns from the University, arrangements can generally be made to transfer ownership appropriately.]

2.5 Storage of Data

PIs store all project's folders, including illustrative and experimental data and records, in their laboratory for 5 years after the date when funding for a study ends. They may then continue to store them in their laboratory principal computer or may make backup copies in external devices (DVD, hard disc) for locked storage; both the PI and the SBCVL research administrator keep a record of the information necessary to retrieve the materials from the facility. Data notebooks and computer folders, and other related data and records for any study may not be destroyed.

3. Standards for data storage

3.1 Computerized data: cloud computing

3.1.1 Cloud computing account access. Each researcher responsible for a specific project will be granted with a cloud computing account free of charge. Upon account registration and before laboratory activity starts, the PI or SBCVL director will share a project folder to the researcher's cloud account. This folder contains a standard subfolder pipeline (see 3.1.2) where all data related to the project must be located until journal acceptance and paper publication. The researcher will have unlimited access to his/her cloud-shared project folder until journal acceptance or research finalization.


3.1.2 Project Folder Organization. All digital information related to one project must be stored in the same folder pipeline. The PI/SBCVL director and the researcher will determine the project's key name of the reference folder that contains the subfolder pipeline. The standard projects' pack is composed of three subfolders: "Illustrative", containing photos and videos related to the project; "Morphometry", where stereotactic coordinates and all types of measures and variable parameters must be kept; and "Manuscript", containing drafting, updated to-do's list, PIs review comments and brainstorming.

It is the responsibility of the PI and the researcher to preserve all data stored in the cloud folders throughout the research process. By accepting to share the research folder pack, the researcher takes the compromise to keep and store all data in order as explained in the present guidelines. Destroying or deleting any kind of files stored in the cloud-shared research folders is NOT permitted except for explicit permission of the PI/SBCVL director.

At the completion of a research project, all cloud-shared folders for each paper developed from the project are archived in the PI's laboratory together with paper notebook(s) for the project and photocopies of relevant material from loose-binders notebook(s). The submission pack is later added to the archive.

3.2 Data Notebooks

3.2.1 Bound Notebooks with consecutively numbered pages. These databooks, with a permanent (sewn) binding, are the hard copy of choice for data recording. One bound notebook will be available for any researcher with an approved project upon request. Duplicate pages in the notebook are used only to generate a carbon copy or to paste in auxiliary material-not to record data. Databooks are kept only in ink and must contain no erasures or 'whited out' changes.

An entry made by mistake is deleted only by drawing a single line through it, preferably in ink of a different color. The deleted material should remain legible beneath the overstrike. Large blocks or a page to be disregarded are crossed over with an 'X' or diagonal line and marked e.g. 'OMIT'. The page should remain legible.

The corrected data are written beneath or beside the original entry. The explanation for the alteration is clearly written in close proximity to the alteration-preferably on the same page or on the facing page.

3.2.1.1 If any changes are ever made in the experimental notebook-including a change in values, correction of a mistake, or like alterations-it is absolutely required that those changes be dated and initialed by the person making the alteration, and a clear explanation noted as to why the alteration was made.

In permanently bound databooks containing duplicate (often perforated) numbered pages, only the original bound-in page is used to record data. The duplicate page is


used only to make a carbon copy or to paste in auxiliary material, e.g. photographs; it is otherwise simply left blank.

Whether permanently bound or loose-leaf, only databooks with consecutively numbered pages should be used. Pages must never be torn from or replaced in a databook.

3.2.2 Loose-Leaf Binders. These are used instead of bound data notebooks, at the PI's discretion, to log all or portions of experimental records or generated data. All pages of the loose-leaf binder should be numbered consecutively before the binder is used. Each page should be identifiable as consecutive and belonging to a specific experiment according to a system created and followed in the laboratory (e.g. an experiment-identification number followed by the sequential page number and the investigator's or technician's handwritten initials: 1.23.MT ). The experiment-identification system used is clearly described on the first page of every binder in order to permit proper archiving and retrieval of data. When an experiment is completed, the consecutive pages of data and notes may be inserted into a plastic sleeve(s) for permanent storage in a binder for the one experiment, or in one binder including all experiments for the study.

3.2.3 Raw Data. Whenever possible, raw data are stored together with the experimental notebook; e.g. they may be stapled on the duplicate page following the related databook entry or placed in a plastic sleeve(s) and inserted in the binder. Data too unwieldy to include are listed in the experimental notebook as they are collected, are described sufficiently for recognition, and are annotated with the name of investigator and explicitly where the data can be found (e.g. location of the tape or disc and its identification number).

3.3 Laboratory Master Log

For studies involving several investigators, or for laboratories with several individual research projects, the PI(s)/SBCVL director keep a master log that serves to catalog the experiments of the whole study or laboratory. This central log, a digital file encrypted and password protected should contain:

A. the titles of the studies done by everyone in the laboratory,

B. the investigators' names,

C. the inclusive dates of the experiments/ laboratory activities, and

D. the location of the experimental notebook and any raw data, computer files, or other relevant materials stored separately for each logged experiment.


3.4 Illustrative folder

3.4.1 A large amount of different approaches and techniques to access the cranial base and explore de brain are available in the neurosurgical and OHNS armamentarium. One or a combination of several approaches could be included in a specific research project. To maintain order and ease identification, the illustrative data is classified into four subfolders:

• MTA (microscopic transcranial approach);

• EEA (endoscopic endonasal approach);

• NEA (neuroendoscopic -intraventricular- approaches) and

• Neuroanatomy (gross anatomy dissection).

An additional subfolder named "edited" will also be present in all cases. This must be used to keep intermediate steps in the edition process of selected pictures for publication.

The correct classification of photographs and videos into these folders is responsibility of the researcher.

A 'table of contents' is kept at the "illustrative" folder in a text file (.doc, .pages, .rtf).

3.4.2 Post-research media storage and further use policies. All media produced throughout the research process and stored into the "Illustrative" folder will be stored in the SBCVL and a backup may be kept in an external device under strict security protocols by the PI/SBCVL director. The UCSF has the right to use the stored media in further institutional activities and will show explicit recognition to the researcher who generated the photographs and videos. The SBCVL will contact the original author of any illustrative data to be included in further publications to agree his/her recognition status.

3.5 Morphometry folder

3.5.1 The Morphometry folder must keep ALL measurements acquired during research. Separate files containing raw data exported from devices (stereotactic coordinates, ICP mmHg lectures...); edited data such as spreadsheets (excel, numbers...); and statistical analysis must be stored in this folder.

3.5.2 The Morphometry folder is the final and absolute arbitrating reference when questions of data validity and morphometric adequacy are raised in the context of the educational and training responsibilities of the SBCVL. A brief conclusion of the experiment, including a 'value judgment' about the validity of the experiment, whether the study needs to be repeated to validate it, what can and cannot be definitively concluded from the data, and other observations may be added in this folder. Simple concluding descriptions such as 'bad study,' or 'data suspect,' are not acceptable. It is essential to document why the study or data were considered suspect. Justifications for positive judgments similarly should be recorded.


3.5.3 Entries should be organized in such a way that someone not familiar with the specific experiment recorded can retrieve all the pertinent details of the study, from the hypothesis to the published article. Notes entered at the time of the experiment summarizing the goals, details, or problems can be invaluable during subsequent analysis or defense of the results and are therefore encouraged.

3.6 Manuscript folder

Manuscript drafting, brainstorming notebooks, To-Do's lists and comments of the PI/SBCVL director are stored in this folder. Also, any idea or improvements resulting from the laboratory experience are very welcomed to be shared in a text file named "feedback". All comments are logged in the text file in chronological sequence. Date and initials of the comment should be introduced right before the comment. [e.g. AB 06-19-2012 We experienced substantial benefits...]

In each laboratory, certain techniques or protocols are used in common on a daily basis, such as navigation set up, stereotactic co-registration and 3D coordinate acquisition, endoscopic equipment set up, specimen preparation, neurologic examinations, animal anesthesia, and others. Specific details about each of these commonly used methodologies (including the statistical) are documented and numbered or assigned reference notations that facilitate citation in paper notebooks or shared files into the research pack in the cloud. Such documentation serves to standardize all experiments that generate data of the same form and is also instrumental in training new laboratory personnel.

Raw data, or explicit instructions for locating the raw data or retrieving them from storage must be clearly included in this folder. Of particular importance are notations about excluded data, specimens or animals, with detailed information about why those data, specimens or animals were excluded.

3.6.1 Manuscript drafting. All versions of the manuscript resulting from co-Author draft revision must be preserved. A new manuscript version is saved adding the initials and date of revision to the paper original file title. [e.g. The revision of the manuscript paper.doc by the senior author named AB on june 2012 is named paperAB062012.doc].

3.6.2 Submission pack. A subfolder named "submission pack" is included to gather all data related to journal submission process. It must include:

• the manuscript,

• the edited and labeled figures and tables,

• the cover letter to the journal editor

• A document naming the coauthors and detailing their specific contribution(s) to the study.

• A document naming the persons cited in the acknowledgments as contributing to the paper and detailing their specific contribution(s) to the study.


• Any other material considered pertinent to selection of data, to authorship, or to any substantial related matter arising during the development of the paper.

This folder should be the primary location for paper submission follow-up, including changes and corrections to the manuscript required by the journal reviewers.

4. Research Project Submission

Only accepted research projects can be developed in the SBCVL. The UCSF SBCVL uses a strategic dissection planning for specimen efficient use and space optimization. Accordingly, a dissection schedule based on approach and dissection landmark identification is defined for each project and specimen. Therefore, the methodology and objectives of new project applications must be known in advance and will be determinant in the SBCVL project evaluation. Research project submission pack (see 4.1) must be sent to the SBCVL director office or e-mail. After a reasonable evaluation time, the SBCVL will contact the applicant and explain the viability of the project. In case of approval, a meeting with the PI/SBCVL director will be scheduled to introduce the researcher to the team, provide him/her with a cloud account and negotiate a laboratory use schedule.

4.1 Project submission pack. All project applications must include the following information:

Tit le

Type of investigation: surgical anatomy, comparative analysis, technical report, clinical report, other.

Researcher name and academic status

Background: Short text explaining the most relevant research that has been previously published about the topic and the reasons why the proposed research is necessary or innovative.

Objective(s): Very short text about the main aim of the study. Hypothesis identification.

Methodology: study design, number of specimen, a timeline illustrating the sequence of the dissection procedures, approaches/techniques used and special equipment necessary to assess the objective.

Starting date: The earliest day that the researcher is willing to start laboratory activities.

Dedication: Full time/ part time. Time preferences for dissection work & schedule limitations are also described in this section.

Personal experience that the applicant already has on the topic.

Disclosure: The researcher must declare that the research project is original, never done before and it is a product of his/her creativity alone. An explicit statement must be included if the main objective or primary idea of the project is shared with another person/institution.


[Important note: The SBCVL will set first preference to applicants submitting a preliminary draft of the entire manuscript. This include Abstract, Introduction, Materials&methods, expected Results, preliminary Discussion and figures description.]

5. Authorship

5.1 The first author of a paper is named, coauthors are selected, and order of authorship is assigned and agreed on by all coauthors before a study begins. Although changes may take place, such an initial plan provides a context for the relative responsibilities and expectations of each investigator.

5.2 Authors should meet the standards described in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals 1 [http://www.icmje.org/:

All persons designated as authors should qualify for authorship, and all those who qualify should be listed.

Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

One or more authors should take responsibility for the integrity of the work as a whole, from inception to published article.


Authorship credit should be based only on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Conditions 1, 2, and 3 must all be met.

Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship.

Authors should provide a description of what each contributed and should expect that the journal may publish that information.

All others who contributed to the work who are not authors should be named in the Acknowledgments, and what they did should be described.

When a group is named as authors of a multicenter trial, all members should fully meet the above criteria for authorship. Group members who do not meet these criteria should be listed, with their permission, in the Acknowledgments or in an appendix.

The order of authorship on the byline should be a joint decision of the coauthors. Authors should be prepared to explain to the journal editor the rationale for] the order in which authors are listed.

5.2.1 The senior author is the PI responsible for the validity of the data reported and may or may not be the first author of the paper. If the senior author is not the first author, his or her name appears last in order of authorship. The senior author is the 'corresponding author', i.e. is cited as the author to whom correspondence should be addressed.

5.2.2 The first author is the person who generates the data, collects and/or collates the data for review by coauthors, and writes the first draft of the paper. If these responsibilities are shared equally, those coauthors sharing decide the order of authorship; on the title page of the paper, their names are asterisked with a footnote stating that equal credit is due.

5.2.2.1 The first author is responsible for maintaining and archiving the data related to the study (see 3).

5.2.2.2 If the first author leaves the SBCVL before the project is complete (and is not the senior author), responsibility for maintaining all project folders reverts to the senior author/PI.

5.2.3 The first and senior authors together decide whether or not another participant is to be a coauthor. Other coauthors of the paper are named on the byline in the order of the importance of their contribution to the research reported.


5.3 Order of authorship may be changed by agreement between the first author and the senior author; e.g. if any author recommends that changes of personnel over the course of a study call for revision of the initial authorship. All who have been named a coauthor should be notified of authorship changes before a paper is submitted for publication, and any changes should meet the authorship standards listed in 5.2.

5.4 Disputes about assignment or order of authorship that cannot be resolved among the authors should be referred to the Director of the SBCVL.

6. Coauthorship

6.1 All coauthors meet at least once to discuss the selected data and the results of the work and to reach agreement on their conclusions, the general direction of the paper, and the work of others, if any, to be referenced or acknowledged.

6.1.1 This meeting is usually conducted in person but, if necessary, it may be by conference call or computer communications.

6.1.2 If these alternatives are unworkable, the senior author e-mails or otherwise sends the absent coauthor(s) a written summary of the coauthors' meeting. In such cases, the resolution of any disagreements on the work among coauthors should be documented in letters that are archived in the manuscript file (see 3.6).

6.2 Coauthors should review the raw data on which their report is based.

7. Research Reports Submitted for Publication

7.1 Papers submitted for publication should meet the standards and requirements specified in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals ,1 except when those standards conflict with the instructions of the journal to which the paper is being submitted.

7.2 Papers should include a notation of all funding for the work reported and disclosure of any actual or potentially perceived conflict of interest. To assure that all relevant sources of funding (e.g. grants, donor gifts) are acknowledged, consult the SBCVL research administrator before submitting a paper.


7.3 All coauthors must read and approve the final draft of the paper before it is submitted for publication.

7.3.1 Before the initial submission and any substantially revised resubmission, the first or senior author sends a copy of the penultimate draft of the paper to each coauthor for final review. If differences still must be settled among coauthors the paper goes through another draft, which is also reviewed by all coauthors.

7.3.2 If a journal requires that all coauthor's signatures accompany the submitted paper, all coauthors must personally sign the letter or form (or a copy). Signatures in absentia are never legally acceptable. If an author becomes incompetent to sign or lost, note this in the signature space or a cover letter. One copy of the cover letter and form is included in the submission pack file (see 3.6.2)

7.3.3 When, after journal peer review, the revision of a paper involves additional or different data, a substantial revision of content or conclusions, a change in authorship, or a change in order of authorship, the renewed agreement of all coauthors is necessary and documentation of the renewed agreement should be kept in the manuscript folder (see 3.6). What constitutes "a substantial revision of conclusions" is at the PI's discretion.

8. Publication of Negative Results, Corrections, Errata, and Retractions

8.1 In addition to original reports of positive findings, the SBCVL supports investigators in submitting for publication (a) papers reporting results that disprove or fail to replicate earlier published conclusions, (b) errata in published reports, (c) a correction of published work that is scientifically flawed, and (d) a retraction of any report determined invalid or fraudulent (consult 1).

8.2 SBCVL investigators are responsible for informing all of their coauthors when a correction or retraction is warranted and for publishing it in the journal that published the paper originally. All coauthors of the original paper should coauthor a retraction together with any other investigator(s) later involved in the work. Conflicts and questions that cannot be resolved among authors are referred to the Director of the SBCVL.


9. Questions of Research or Publication Practices Other than Authorship

9.1 SBCVL personnel and trainees should refer questions or problems about research or publication practices to their immediate supervisor and/or PI.

9.2 SBCVL personnel and trainees should refer any allegation of improper practice or misconduct in the performance or publication of research to their immediate supervisor and/or PI. The person alleging the claim must be able to support it with documentation. All SBCL personnel involved with such an allegation must observe due process during all phases of inquiry.

9.3 SBCVL personnel and trainees should refer any question, problem, or allegation not resolved through the channels just described to the Director of the SBCVL and thereafter, if necessary, to an appropriately responsible University officer.

10 Health protection and Biohazard control.

Accident prevention and health protection are two of the most important concerns of the SBCVL. Maintaining a pleasant and Biohazard free environment in the laboratory requires knowledge of the basic security protocols and health regulations involving both postmortem specimen and embalming fluids manipulation. The SBCVL is continuously dedicating part of its time and resources to improve postmortem specimen preservation techniques, and special efforts are directed to reduce biohazard components on embalming fluids stored and used in the laboratory.

The federal government and the State of California have defined permissible exposure limits for chemical exposures in the workplace. These limits apply to airborne contaminants and, if not exceeded, ‘‘workers may be exposed daily during a 40-hr work-week for a working lifetime without adverse effect'' (Calif Code 8 CCR 5155).


Summary Checklist

...protocol on recording data and preparing for publication

___ Review relevant literature (ongoing)

___ Read original sources in their entirety

___ Photocopy references or log complete and accurate citations with inclusive pages

___ Plan experimental study design

___ Obtain statistical consultation

___ Ensure that all necessary research approvals have been obtained

___ Review and print relevant sections from the appropriate methodology file for reference

In the experimental notebook, initially record:

___ Ttitle of study

___ PI's name

___ Date the study starts (inclusive dates after study ends)

___ Associate investigator (e.g. postdoctoral fellow, resident, staff research associate)

___ Brief statement of hypothesis or study goals

___ Experimental design in detail (e.g. treatment groups, projected number of subjects/ specimens), correlated specifically with the methodology file.

Perform study, recording:

___ Specific notes about special procedures or steps that differ from specific techniques (including statistical) taken from the methodology file; record of any variance from usual SBCVL procedures in specific correlation with the methodology files.

___ Raw data, including handwritten notes on data collection, endpoints, daily observations, location of SDCARDS and memory sticks, and particularly notations about excluded data or specimens, with detailed information on why they were excluded.

___ A 'time line' illustrating the sequence of study events (e.g. start--surgical exposure completed--measures acquired--etc.)


___ Brief conclusion, including a 'value judgment' on the validity of the experiment, whether the study needs to be repeated to validate it, what can and cannot be definitively concluded from the data, and other observations.

___ Analyze data

___ Meet with all coauthors at least once to discuss the raw and selected data and the results of the work, to agree on conclusions, to decide the general direction of the paper, and to agree on the work to be referenced in the paper.

___ Create a submission pack file in consultation with coauthors as much as possible.

___ Select data from the Morphometry folder and their analysis, including graphic presentations and statistical manipulations, and archive them in the manuscript file, which is clearly cross-referenced to any experimental notebook.

___ Select pertinent references

___ Select journal most relevant to the work

___ Write the paper for the journal chosen

___ Send a working draft to coauthors

___ Revise paper until final revisions are complete

___ Complete and archive documentation in the submission pack file (e.g. statement and order of authorship, contributors acknowledged, permission to use 'personal communications')

___ Submit paper to the journal


Reference

1. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Ann.Intern Med 1997;126:36-47; JAMA 1997;277:927-34; <www.icmje.org>.

A brief guide to the particulars of manuscript preparation in a style that is acceptable (for review purposes) to nearly 500 biomedical journals. Does not supersede the Instructions to Contributors of individual journals.

Links to Research and Reporting Guidelines Developed by Professional Societies

Society for Neuroscience

American Chemical Society

American Statistical Association

American Physical Society

American Mathematical Society

Association for Computing Machinery

Guidelines for Reporting Clinical Trials, Systematic Reviews, and Meta-Analyses (the Consort Statement)

Web Resources for Bioethics and Research Guidelines

Web Resources for Bioethics and Research Guidelines

http://onlineethics.org/


http://www.publicationethics.org.uk/

http://www.aslme.org/

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Developed and written in 2012 by the UCSF SBCVL: Arnau Benet MD (SBCVL director), Mitchel S. Berger MD (chair of the department of neurosurgery), Ivan El-Sayed MD (OHNS senior researcher), Michael T. Lawton MD (Neurosurgery senior researcher), Jordina Rincon-Torroella MD (Johns Hopkins Dept. of Neurosurgery).

skull base & cerebrovascular laboratoryskullbaselab.ucsf.edu/wp-content/themes/ucsf/images/ucsf...

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