The College owns a large sub-zero (-80^o) freezer located in room 12C NB.  The sub-zero freezer is kept locked and is connected to an alarm system that notifies CON Faculty in the event of a power outage or machine malfunction.  The system automatically contacts a list of people in the CON who can then access appropriate assistance.

Access to this freezer is available to all faculty who collect bodily fluids as a part of their research and need to store the same for extended periods of time.  Faculty are responsible for providing the necessary storage trays/receptacles to hold their specimens.

Once a need for access to the room and freezer is identified, faculty should contact the ONR (Nancy Goldsmith) who will arrange for keys to the room and freezer.   All faculty who have access to the sub-zero freezer agree to have their name and contact information (cell phone and email) added to the contact tree in the event of a power outage or machine malfunction.

Instructions on programming and reprogramming the freezer.  The freezer is programmed to trigger an alert if the temperature increases to -40degrees F or if the electricity goes out. 

If the alert sounds but the freezer temperature remains within a few degrees of -80 then it is a false alarm and wait and watch.  This has happened.  It may be that the alarm code needs to be reset or the phone alarm needs to be reset.

Specs on the Temperature Monitor:  ACC Sense model number A2-05a. http://www.accsense.com/p_p_A2.html [1]

A copy of the manual:  http://www.accsense.com/files/A2-05%20User_Manual_A2-05.pdf [2]

Freezer data are transmitted via the Ethernet connection on the monitor. All of the data on the freezer can be viewed online.

What to do if a power outage is anticipated. 

1. Get about 50 pounds of dry ice from Med Labs or HyVee (1^st Avenue in Iowa City) and put it in Freezer prior to the programmed outage.
2. Keep freezer door shut during the outage
3. If outage will be more than 10 hours, should arrange with Physical plant to get a back-up generator

What to do during unanticipated power outage:

1. Try to find out when the electricity will go on again, as many outages are short.  If power will be out for less than 4 hours, keep the freezer door CLOSED the entire time and the blood should be fine.
2. If power is anticipated to be out for more than 4 hours than follow instructions above for planned power outage.

Breakage.  In the event that the freezer alarm call needs to be reset or if the temperature increases in the absence of a power outage, call RM Boggs for evaluation and repair:  (800) 272-5001 or  (319) 665-3500.

The University takes the position that it owns any research data collected by faculty, staff or students. Any work (e.g., analysis, manuscript preparation) using identifiable data needs to be done under IRB approval – whether at Iowa or another institution.

Identifiable Private Information.  This is defined as private information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). This information is considered individually identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

(If information includes Protected Health Information (as defined later under Protected Health Information), identifiable information includes any of the following information for the individual, relative, employer, or household member of the individual:

• Name, street address, city, county, precinct, zip code, geocodes smaller than state
• Date of birth, ages > 89 years of age; or other dates such as diagnosis dates, procedure dates, admission or discharge dates
• Telephone numbers, fax numbers, e-mail addresses, social security numbers, medical record number
• Health plan beneficiary numbers, account numbers, certificate/license numbers
• Vehicle identifiers and serial numbers or license numbers, device identifiers and serial numbers
• Web URLs, Internet Protocol (IP) address numbers, biometric identifiers including finger/voice prints
• Full face photographic images and any comparable images.

This means that if you leave the University and have closed out your HawkIRB project (which you must do upon termination of your connection to Iowa), you will:

1. Leave the hard copy data here (usually with your dissertation chair).  You can take a copy with you.
2. If your data will continue to be associated with identifiers, you must get IRB approval from your new institution (local IRB) to continuing working with the data.

• Often the new institution wants Iowa to give approval for use of this data.  To get that, the individual contacts the relevant department head – in the case of the CON, that would be the Associate Dean for Research – in writing outlining their request to use the data.
• The approval from Iowa will include the condition that IRB approval be in place at the new institution prior to working with the data.

If your data will be de-identified (i.e., if you are able to continue your work with a data set containing only aggregated data and/or data that have no identifiers), you may be able to work with the data at your new institution without formal IRB approval, although it would be wise to review this with the IRB at the new institution.

Deadline policy.  In order to be maximally effective, the Office for Nursing Research follows a table of deadlines that is used to guide the preparation of new grant applications.

All grants are due to the Division of Sponsored Programs (DSP) 5 business days before the final, sponsor’s deadline. This rule is university‐wide and nonnegotiable: https://research.uiowa.edu/dsp/late-routing-policy [3]

The deadline for submitting proposals to the ONR occurs in two phases:

1. Fifteen business days before the sponsor’s deadline:  All supporting materials (e.g., budget and justification, resources, letters of support, biosketches, and appendices). Submitting these pieces early will allow a significant amount of the document uploading to take place ahead of time and minimize the likelihood that a last-minute technology failure or electronic bottleneck due to high internet traffic will prevent a grant from being submitted.

2. Ten business days before the sponsor’s deadline:  The research narrative of the grant (i.e., Research Plan: Specific Aims, Research Strategy, and other pieces detailed below).

Priority for Submission.  Given the reduced lead time that results from changing the deadlines, there is less leeway for late submissions. Priority for submission will be given to those who meet the deadlines. If a proposal comes in late, it will be sent to the back of the queue and it may not be submitted.

Holidays.  When a deadline falls on a Saturday (e.g., June 5), most sponsors automatically extend the deadline to the next business day.

Quality Control.  Grants that are submitted prematurely reflect poorly on the CON as a whole. If the ONR feels a proposal is not sufficiently complete to be a viable submission, the Associate Dean for Research may ask a PI to delay submission to the next cycle of applications.

Beginning April 20, 2012, applications receiving an impact score of 40 or less will receive a standard notice and request from NIH for submitting JIT information. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-101.html [4]

When an NIH grant application on which a CON faculty member is a Senior/Key Person (not Consultant or Other Significant Contributor) receives a JIT request, the ONR may assist in collecting Other Support information for their active and pending research by:

• Providing an Other Support template and examples to be completed and sent to the study PI for submission to NIH.

• Helping identify annual direct costs received/pending from  funding source(s), whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards.

• Noting effort devoted to each project measured in person months, i.e. calendar, academic, and/or summer months.

All supporting materials in final format are to be in the ONR office no later than fifteen (15) business days before the sponsor’s deadline.  Prior to this deadline, the ONR staff will assist as outlined below.

Biographical Sketches:

• Collection and review of biosketches for each key person and consultant in the Principal Investigator’s (PI) grant application after PI has made initial contact with them.
• Conversion of CV or resume to acceptable NIH biosketch (2010 short format).
• Upload biosketches into the grant application.
• Maintain electronic copy of each biosketch submitted with a grant application.
• Maintain electronic copy of master NIH formatted biosketch with all prior Personal Statements, Positions & Honors, Publications and Research Support (ongoing projects and those completed in the past three years).  This master biosketch will be returned for updating purposes with each new grant application.

Letters of Support:

• Collection and review of letters of support for consultants and other significant person/entities in the PI’s grant application after PI has made initial contact with them.  Word files rather than pdf files are preferred.
• Obtain permission from author of letter to change the letter date when grant submission has been delayed.
• Upload letters into the grant application
• Maintain electronic copy of each letter of support submitted with a grant application.

Letters of Reference:

• Collection and review of letters of reference for referees after the applicant for an F or K series award has made initial contact with them.
• Upload each letter of reference directly to the eRA commons for the candidate.

Maintain electronic copy of each letter of reference submitted with a grant application.

Eligibility.  Only grant applications seeking $150,000 or more in direct costs to sponsors that also provide F&A costs will be eligible. PI’s must be CON faculty members or postdocs. Note:  External reviewers cannot be a current member of the panel that will review the proposal.

Honoraria.  $250 will be paid to external reviewers who provide a written critique of a draft proposal prior to its submission. $350 will be paid to external reviewers who provide a written critique and are present for the peer review session by phone.

Limits.  Only one external reviewer is permitted for each proposal.

Format.  Peer reviews will be scheduled no later than 5 weeks before the sponsor’s deadline. A peer review session takes 2 hours and is attended by the PI, 2-3 reviewers, and the ONR Director. The PI may also wish to have collaborators attend. The session is recorded using SmartPen technology so that both written comments and an audio recording of the entire session can be made available to the PI.

Procedure.  Beginning 10 weeks before the sponsor’s deadline, PI’s should email the ONR Director to request an external review.  In the email, the PI should provide relevant information about the proposal, including:

• PI’s name and area
• Working proposal title
• Prospective sponsor
• The PA or RFA number
• Sponsor’s due date
• Total amount of direct costs to be requested

9 weeks prior to Proposal Due Date.  The PI provides the ONR with the Name and Contact Information of the prospective reviewer (institution, department, mailing address, phone number and email). At this point, the PI will also forward the current draft of the 1-page Specific Aims to the ONR Director.

8 weeks prior to Proposal Due Date.  If the Specific Aims are judged to be in reviewable condition, the request for review will be approved and the ONR will begin the process of contacting the reviewer and soliciting a commitment to read the proposal. Please note that the expert cannot be a current member of the panel that will review the proposal.

The ONR will contact the prospective reviewer. If the External Reviewer agrees to review the full proposal, the ONR will then obtain needed information for honorarium payments.

                6 weeks prior to Proposal Due Date.  Faculty member provides a full draft proposal (electronic) to the ONR Director. If the proposal draft is judged to be reviewable condition, it will be sent to all reviewers (internal and external). Appropriate institutional paperwork for honorarium payment must be obtained by this date.

5 weeks prior to Proposal Due Date.  Peer review is held (with or without presence of External Reviewer). External reviewer must return critique to faculty member (and copy to the ONR).  Honorarium check is then mailed.

Assignment of reviewers.  The ONR Director helps to identify potential reviewers and coordinates scheduling of the review.

Lead time for review materials.  PI’s must send their proposal draft to the ONR Director at least 1 week before the scheduled date of the review. PI’s who do not provide their reviewers with sufficient lead time to review the materials, the review session may be canceled or rescheduled.

The National Science Foundation (NSF) has joined the National Institutes of Health (NIH) in a new requirement to ensure funded investigators are formally trained in the Responsible Conduct of Research. Under the NSF implementation, institutions must, at the time of proposal submission, certify that an RCR training plan is in place and must, as a condition of award, ensure that all undergraduate students, graduate students, and postdoctoral research scholars/fellows supported under NSF-funded projects receive appropriate training. The NSF implemented these RCR responsibilities as of January 2010 under Section 7009 of the America COMPETES Act, rendering compliance a statutory requirement, and has formally amended its policies, procedures, and conditions of award to incorporate this requirement. More background information is available through the NSF RCR website at http://www.nsf.gov/bfa/dias/policy/rcr.jsp [5].

To meet the institutional obligation for RCR training, The University of Iowa has developed a Responsible Conduct of Research Plan under the joint sponsorship and responsibility of the Graduate College and the Office of the Vice President for Research. The Plan delineates a training program that responds to the specific requirements set forth by the NSF and NIH and meets wide-ranging needs for RCR training, accommodating all disciplines engaged in research and other scholarly creativity.

The program includes various types of training, targeting position-specific groups of “trainees.” Trainees must complete the RCR program that aligns with their current positions and obtain additional RCR training as position levels change. The program serves four distinct groups of trainees:

1. Undergraduate and professional degree students receiving NSF or NIH support will meet the RCR requirement online, by completing the Collaborative Institutional Training Initiative (CITI), a web-based training course comprising 10 topic-specific modules; trainees are expected to complete the CITI course before or within the first month of research participation/compensation.
2. Predoctoral Students receiving NSF or NIH support must enroll in UI course 650:270, Principles of Scholarly Integrity, which comprises a four-hour orientation and a series of 90-minute, topic-specific workshops. Master’s degree students must complete the orientation and four topic-specific workshops, for a total of 10 contact hours; doctoral-degree students must complete the orientation and eight topic-specific workshops, for a total of 16 contact hours. All students, master’s and doctoral, are expected to complete the orientation within the first year and the workshops at the rate of two per semester, finishing within a one- or two-year period, respectively.
3. Postdoctoral Research Scholars (FP01) and Fellows (FP02) receiving NSF or NIH support must complete UI course 650:604, Principles of Scholarly Integrity, including a four-hour orientation and four 90-minute, topic-specific workshops, for a total of 10 contact hours. Trainees are expected to complete the workshops at the rate of two per semester, finishing the orientation and workshops within a one-year period.
4. Early-Career Faculty – currently limited to those holding NIH K Awards – must complete UI course 650:614, Principles of Scholarly Integrity. The course includes a four-hour orientation and four 90-minute, topic-specific workshops, for a total of 10 contact hours. Trainees are expected to complete the workshops at the rate of two per semester, finishing the orientation and workshops within a one-year period. Early-career trainees will also be expected to assume a role in the other RCR courses, as described in the following paragraph.

RCR training workshops will require faculty facilitators at the rate of approximately one faculty member per 10 trainees. Departments and programs with participating trainees must provide faculty facilitators in order for their predoctoral students and postdoctoral scholars/fellows to participate in course 650:270 or 650:604, respectively. Early-career faculty enrolled in course 650:614 will automatically be expected to serve as faculty facilitators.

The latest RCR program information is available through an umbrella website located on the OVPR website at http://research.uiowa.edu/content/responsible-conduct-research [6]. At this stage the UI RCR program is naturally evolving and subject to revision, so please revisit this site periodically.

When?  Beginning Fall 2010, the UI Office of the Vice President for Research required that all graduate students (and others) funded through resources from NIH and NSF must complete RCR training in their first year.

How do I determine if I need RCR training?  Use the following flowchart to determine if you need to take Principles of Scholarly Integrity to satisfy the RCR training requirement. Note: This flowchart was developed for the College of Nursing. Students/postdocs in other Colleges should contact their departments for information.

Eligibility.  CON Faculty and Postdocs may request editorial support from the CON Editor. The Editor is available  to work on manuscripts, book chapters, and grant proposals that are in reviewable condition.  It is expected that work that is being submitted jointly with other authors will have been reviewed by all of the other authors on the research team before it is sent to the CON Editor. Please note that graduate students are not eligible to use the editor’s services unless they make separate arrangements and pay for the services on their own.

Scope of work.  The CON Editor is a valuable, shared resource. To be maximally effective, her role will be limited to performing substantive, content editing (e.g., improving logic, organization, flow, and persuasiveness) but not proofreading.

Procedure.  Faculty or postdocs who wish to submit work to the Editor should contact the Secretary in the Office for Nursing Research and forward the work that is to be reviewed. The ONR Secretary will contact the Editor with the request and handle all workflow and billing issues.

Limits of use.  Each piece of work (i.e., manuscript, proposal, or chapter) can be sent to the Editor no more than one time. Therefore, authors should work to ensure that their work is in good shape before it is sent to the Editor.  Exceptions:  Resubmissions of a grant proposals and manuscripts are considered to be a separate piece of work from the original submission and are eligible for a second review by the Editor.

Acknowledgement of work.  The ICMJE is now encouraging journals to create a policy defining contributorship as well as authorship. Specifically, the policy states:

When using "ghost writers" or outside assistance for writing, those contributors should be listed in the acknowledgments section of the manuscript.

As such, the ONR policy is that faculty who enlist the editorial services of the CON Editor must include an acknowledgement to the Editor by name.

The Research Computer Lab (137 CNB) is located in the College of Nursing Building and is overseen by the Office for Nursing Research to facilitate research and scholarship at the college. The lab is equipped to support the development and peer review of manuscripts, conference abstracts and posters, and grant proposals as well as providing a base for a wide range of education and training activities.

Access.  Access to the Advanced Lab is only available via University ID for those who need to use the specialized software loaded on Lab computers.  To obtain access:

• An email request should be sent to the Office for Nursing Research (nursing-research@uiowa.edu [7]) indicating why access is required and including the individual’s HawkID.
• The request will be forwarded to the department that control keyswipe access (this process usually takes 24-48 hours).
• Once access has been granted, the requestor will be notified via email.

Usage.  The computers can be used for individual work or scheduled for group training classes or meetings. Those who wish to reserve the entire lab must reserve RES-NB137 using the Microsoft Outlook calendar. Individuals who plan to use the room should first verify that the room has not been reserved by checking the Outlook Calendar for RES-NB137.

Equipment.  The Lab is equipped with five computers as well as a large screen monitor that is connected to all five computers. All five computers are running standard Microsoft programs (Word, Excel, Powerpoint, etc.) as well as SAS. Two computers have QSR NVIVO 9 (Computers 1 and 2), and one computer has Excel QI Macro (Computer 3). SPSS is available through Virtual Desktop [8]. Please note there is no printer in the Research Computer Lab.

Logging in.  Individuals can log on to the computers with Hawk ID and password, which will allow them to access documents on their H-drive.  When users are finished with their work, they are asked to log off, shut down the computer, and turn off the monitor.

Protection of Data. This is a public computer lab, so users should not leave any documents or data on the hard drives of the computers.  All personal documents must be removed at the end of a work session.

NOTE:   Identifiable subject data should not be accessible to non-research team members.  If users plan to listen to audio data files, they must use headphones or reserve the lab to maintain confidentiality of data.

Personnel in charge of scheduling room use.  These rooms may be scheduled by faculty or research support staff by making a room request through each room’s Outlook Calendar. Anyone booking any of these spaces should include the following information on the calendar: 

1. Name and contact information for person making reservation
2. Name of the grant or project that is using the space
3. Name of the College of Nursing PI or contact

Priority for room use.  Requests will be prioritized as follows:

1. Research teams of funded projects with a CON PI housed in the Montoya Research Suite.
2. Research teams of funded research projects with a CON PI physically housed outside the College of Nursing Building.
3. Unfunded CON-PI led research teams.
4. Other uses when not used for 1-3 above. 
5. Special requests will be considered; decisions will be made by the Office for Nursing Research in conjunction with the Assistant Dean for Operations and Finance.

Priority for room use.  Reservations may be made for priority levels as follows:

• Priority 1 & 2: anytime
• Priority 3: up to 1 month in advance
• Priority 4: up to 2 weeks in advance

Confirmation of room requests.  Requests that include all required information and that are made within an appropriate timeframe (based on priority level) will be confirmed via email to the person requesting the room.

One of the missions of the ONR is to assist faculty and postdoctoral scholars with the dissemination of their scholarly pursuits. When faculty or postdoctoral fellows are involved in a book publishing project, the ONR is available to provide assistance with the following:

• Formatting chapters according to the publisher guidelines (on the final version to be submitted)
• Checking references in the text and in the reference list (on the final version to be submitted)
• Contacting and communicating with the contributors to the book and with the publisher
• Handling correspondence:  Sending out letters and emails to contributors and to the publisher
• Coordinating work on the book project
• Meeting with the authors and/or publisher about issues pertaining to the book project
• Providing feedback on book proposals

Limits of responsibility.  The ONR is NOT available to assist with the following aspects of book publishing:

• Creating book proposals

Scope of support.  The Office for Nursing Research can provide assistance with poster creation. Specifically, the ONR Secretary will:

1. Provide assistance with resizing posters
2. Provide suggestions for improving poster appearance, including layout, tables and figures
3. Check to ensure that posters adhere to conference guidelines
4. Make appropriate arrangements to print the poster.

Procedure for requesting support.

1. Two months before your conference date, please forward a copy of your abstract to the ONR Secretary.  In this email, please provide the following:
   1. Name of the conference
   2. Website link containing the conference’s poster requirements
   3. Date they will pick up their poster at the CON (Poster Pickup Date)
   4. The MFK to which the printing cost for the poster will be charged
2. Once this information is received, the ONR Secretary will provide you with the following:
   1. A Deadline Table for ONR Poster Creation
   2. Poster templates
   3. ONR Poster Sample
   4. Statistical Reporting Reference Sheet
3. A complete draft of your poster is due to the ONR Secretary at least 2 weeks in advance of the Poster Pickup Date. The ONR Secretary will review the poster draft to determine how much work is left to complete.  The poster author should be available (either by email or in person) to address requests for additional information and to review poster edits.
4. Final electronic poster files that are ready for printing are due to the ONR Secretary a minimum of 5 full business days before the Poster Pickup Date.

Scope of Policy.  The Policy Applies to Any Paper that is peer-reviewed and is accepted for publication in a journal on or after April 7, 2008; and arises from any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008, or;

• Any direct funding from an NIH contract signed on or after April 7 2008, or;
• Any direct funding from the NIH Intramural Program, or;
• An NIH Employee.

Compliance.  There are three actions grantees must take to comply with the policy:

1.  Address Copyright.  Authors of articles arising from NIH funds are responsible for ensuring that publishing agreements allow for full compliance with the NIH policy.

2.  Submit Article.  Authors must submit to PubMed Central an electronic version of every peer-reviewed article arising from NIH research funds, once an article is accepted for publication. NIH has worked with publishers to develop several ways to submit articles:

1. The author or someone in their organization may deposit a copy of the peer-reviewed manuscript in the NIH Manuscript Submission (NIHMS) system.  The link to this is http://www.nihms.nin.gov/ [9] Author verifies content.
2. The journal may offer to send the peer-reviewed manuscript files to the NIHMS. Author verifies content.
3. Publishing in a PubMed Central Journal. No additional effort required from the author. See: http://publicaccess.nih.gov/submit_process_journals.htm [10] for a list of these journals.

3.  Cite.  Authors must include PubMed Central ID numbers in NIH applications and reports when citing their articles covered by the policy.

Scope of use by UI College of Nursing.  The CON Statistician provides support to the CON faculty and postdoctoral fellows as they prepare grant proposals and conduct research.

Types of assistance.  For investigators in the research planning phase, the Statistician works directly with the researchers to formulate research questions and hypotheses, choose an appropriate study design, and, with the Data Manager’s participation, develop plans for analysis, data entry, and data management.  For investigators in the data analysis phase, the Statistician consults with the researcher and provides advice on the appropriate statistical methods or conducts statistical analyses, depending on the need. The Statistician also helps with report preparation and dissemination of results.

Procedure for requesting an appointment (UI CON).  CON faculty and postdoctoral fellows are asked to complete the CON Statistical and Data Management Services Request Form available here: https://uiowa.qualtrics.com/SE/?SID=SV_6yhweZvBpKk7P8M [11]

Scope of use by the UIHC Department of Nursing.  The Office for Nursing Research at the CON is jointly sponsored by the CON and the UIHC Department of Nursing. As such, the services of the Research Office that are available to CON faculty, including consultation with the CON Statistician, are also available to UIHC DON staff and faculty. UIHC DON faculty/staff are asked to follow the following procedure:

1. Email the Director of the Office for Nursing Research for approval.
2. Once the request is approved, complete the CON Statistical Services Appointment Request Form:

https://uiowa.qualtrics.com/SE/?SID=SV_6yhweZvBpKk7P8M [11]

Human Subjects Protection.  If the data that will be shared with the Statistician are identifiable, the PI is responsible for submitting a modification to add the Statistician to the IRB application as a research team member.

Access to Data.  The PI may need to provide the Statistician to the folder on the shared drive where the electronic files for the research project are stored.

Prioritization of Projects.  To ensure that the Statistician can be maximally effective, projects may be prioritized according to their time-sensitive nature and also their likelihood of being completed quickly. Typically, grant proposals receive the highest priority, followed by work related to funded grants and, finally, unfunded research (i.e., no funding or expired funding).

Expectations regarding authorship.  For projects on which the Statistician works collaboratively with a faculty member or postdoc, it is expected that the Statistician will be included as an author on publications that result from this collaboration. The work of a Statistician meets all of the authorship requirements outlined in the University of Iowa’s Authorship Policy:  http://www.uiowa.edu/~our/opmanual/ii/27.htm#2710 [13]

Specifically, a Statisticians have a legitimate claim to authorship due to their:

Please note that according to the UI Policy, “It is expected that each author has been given the opportunity to participate in the drafting of the manuscript (or substantive revision of its scholarly content) and approves the final version of the manuscript to be published.”

Including the Statistician as an author is important for three reasons.  First and foremost, inclusion as an author recognizes the Statistician’s intellectual contribution to the project.  Second, inclusion of a statistician strengthens manuscripts when they are reviewed and considered for publication. Finally, having co-published with a statistician provides evidence for a strong, existing collaboration, which is regarded favorably by reviewers of grant proposals on which the Statistician is included as personnel.