Northwestern Alzheimer S Disease Center (Nadc)

Northwestern Cognitive Neurology and Alzheimer’s Disease Center (CNADC)

320 E. Superior St., Searle 11-467, Chicago Illinois 60611

Phone: (312) 926-1851Fax: (312) 908-8789

Collaborative Research Request – NADC Clinical Core

All requests will be reviewed by the full Executive Committee of the NADC (which meets monthly) and the investigator will be notified as soon as possible of the decision. The committee may approve, reject or make recommendations for changes in the proposal and re-submission.

Please note that we must receive your request at least 2 months prior to the date by which you require a response to assure timely processing.

Included in this packet:

1)Northwestern ADC policy for authorship and acknowledgements. All requirements must be met so please make sure that you can be in full compliance with our policy prior to submitting your request.

2)PI (Faculty Member) to complete this on line Form. Students and postdocs can be the study lead but the study will be listed for our records under the supervising faculty person

3)Statement of agreement (attached) to be signed by the PI and returned to us.

4)Sample Tracking Form collaborators are asked to complete annually so that we can track which subject participated and what research developed from the use of our participants. This is a requirement for our NIA progress reports!

5)Script to use in contacting subjects that we provide in order to minimize subject confusion and clarify that the study is in addition to their annual participation in the Northwestern Memory Research clinical core and entirely separate from it although approved by us and collaborative.

Please send documentation of the following in addition to completing the online form:

Copy of IRB approval (or exemption) form

Copy of HIPAA approval (or exception) form

Northwestern Cognitive Neurology and Alzheimer’s Disease Center (CNADC)

Clinical Core

POLICY FOR AUTHORSHIP, ACKNOWLEDGEMENT, AND DATA SHARING ON COLLABORATIVE PROJECTS

The work that goes into establishing a research-quality diagnosis, and maintaining a resource such as ours, is considerable and we provide the highest level quality control to support investigators. The following is our policy regarding collaboration and access to our resources:

1. A copy of any manuscripts and publishable abstracts must be submitted for review by our center Executive Committee prior to submission so that we may determine what Center authorship and attribution is appropriate. We will respond within a week of receipt of the manuscript.

2. We require that you acknowledge the Clinical Core in all publications, abstracts and presentations as follows (NIH requires that the grant number be listed):

This study was supported in part by an Alzheimer’s Disease Core Center grant (P30 AG013854) from the National Institute on Aging to Northwestern University, Chicago Illinois. We gratefully acknowledge the assistance of the Clinical Core and its participants.

3. We require that you complete an annual progress report on your project that we will send you (sample attached), including a list of all abstracts and publications that have emanated from the use of Clinical Core subjects or data.

4. We request that you provide us with the data from your study on our participants so that we may supplement existing data with relevant information obtained on our cohort. For example, if you are studying hippocampal volume, we will ask for relevant parameters (data files, summary data) on those participants from our center.

We have been very successful in working with collaborators since our inception in 1996. We wish to continue providing valuable resources in a way that strengthens collaboration and also allows us to benefit from the combination of resources. Please do not hesitate to call me (312-908-9013) if you have any questions. I and the Northwestern CNADC look forward to working with you.

Sincerely,

Sandra Weintraub, PhD

Northwestern CNADC Clinical Core Leader
Professor of Psychiatry and Neurology

Northwestern University Feinberg School of Medicine
320 E. Superior, Searle 11-467
Chicago, IL 60611
phone:312-908-9013: fax:312-908-8789
email:

PLEASE READ AND SIGN THE FORM ON THE NEXT PAGE
Please read and sign to indicate your agreement with the following statements:

I will submit manuscripts (and abstracts, when appropriate) to the Northwestern CNADC Executive Committee prior to publication so that the committee can determine what Center authorship is appropriate and I anticipate a response within a week of submission.

I will acknowledge the Clinical Core in all publications, abstracts and presentations as follows:

I will complete an annual progress report on my project, including a list of all abstracts and publications that have emanated from the use of Clinical Core subjects or data.

I will not transfer clinical data or subjects provided to me through the NADC to other investigators without the express permission of the NADC after completion of an additional Collaborative Request Form.

______

Principal InvestigatorDate

Project Title

Northwestern Alzheimer’s Disease Center (NADC)

Phone: (312) 926-1851 320 E. Superior St., Searle 11-467 Fax:312-908-8789

Chicago Illinois

Subject and Clinical Data Distribution

Annual Tracking Report

SAMPLE ONLY

We are enthusiastic about collaborating with you on your clinical research. To meet the needs of our collaborators and align then our resources, we request each January that investigators utilizing subjects from the NADC Clinical Core complete the attached spreadsheet to update us on subject recruitment, publications from studies using these subjects, and other outcomes of your project(s). (You will also receive a separate e-mail from the CNADC requesting information about your presentations and publications for our progress reports but that is not a substitute for this tracking form.)

Please update the attached spreadsheet and return by February 15to: Laura Martindale, . If we are supporting any of your studies that are not listed on this sheet, please add them. We appreciate your cooperation.

Please complete the attached spreadsheet for your studies.
Add to the spreadsheet in the space provided a list of all MDRC subjects that participated in your study, including their MDRC numbers, initial of last name, minority status, and month and year of participation.
If you are using subjects for any studies that do not appear on your list, please add the name of the study and other pertinent information.

Please read and sign the following statement:

I will not transfer clinical data or subjects provided to me through the NADC to other investigators or to other studies I will do in the future without the express permission of the NADC after completion of an additional Collaborative Request Form. I agree to complete annual requests for progress (sample attached). I agree to comply with authorship and publication requirements as specified in the request form documents.

______

Principal InvestigatorDate

Northwestern Alzheimer’s Disease Center-Memory Disorders Research Core

General Guidelines To Reduce Subject Burden and Script For Contacting Potential Subjects For Collaborative Studies

Dear Investigator:

You have been approved to get referrals of potential subjects from the Clinical Core of the NADC. We have some guidelines to facilitate your interactions with the participants and reduce subject confusion and burden.

1. We want to minimize confusion about who is contacting our subjects and for what purposes. Thus, when you first contact the subject we recommend the following script:

“Hello. My name is ______. I am a researcher working with the Northwestern Alzheimer’s Disease Research Center and the Memory Disorders Research Core. I was given permission by the staff at the center to contact you to see if you are interested in participating in a study that I am conducting. My study is not part of your regular participation in the center. It is a separate study related to Alzheimer’s disease (PPA, FTD, cognitive aging, etc.)”

The investigator should make sure that all participants understand that this is not part of their regular involvement with our program and that this is an additional commitment and does not substitute for their annual visits for the Clinical Core.

2. You will have one or more of the following types of subjects: caregivers, patients with a dementia diagnosis or with mild cognitive impairment, and cognitively healthy control subjects.

If you are conducting a caregiver study, say“I am studying (brief one sentence of the main topic of your study) and would like to invite you to participate”.

If you are calling to invite a patient to participate, ask to speak to the caregiver, whose name you will be given in addition to the patient’s name. Say: “I am studying (give a brief description of your project) and would like to invite your spouse (parent, other relationship) to participate. However, I wanted to also speak with you to make arrangements if the patient is willing to participate.” You should also speak with the patient to ascertain their willingness to participate.

Cognitively healthy older subjects are capable of making arrangements for themselves.

For all subjects please say:

“Do you think you might be interested in hearing more about this study and deciding if you (or the patient) would like to participate?”

Wait for answer:

If the participant is not willing you may ask if you might call them back at another time. If the participant still says “No”, then move on to the next subject in the list of referrals.

If the participant is willing, make sure to provide a brief description of the study including the following:

What is the compensation for the participant: parking, transportation, stipend? We require that you stipulate that all patients be accompanied by a caregiver and that transportation is facilitated- please do not ask patients and their caregivers to take buses. Please make sure that you provide convenient parking or taxi/limo service. Also, please make sure that the caregiver is comfortable while waiting for the patient. What provisions are there for the caregiver? Is there a comfortable waiting area? Will the caregiver be given coffee, money for refreshments? When the patient is participating, please make sure that s/he is not left alone and is always accompanied by a research assistant.
How many sessions will be required to complete the study? Is there more than one phase?
How long will each session take and over what period of time?
Will these procedures be repeated at regular intervals or is this a one-time involvement? If you are running a longitudinal study or one in which repeat visits are necessary, it is very important to again stress that this is in addition to their regular visits to our center.
Where will the study be carried out?
Who is the contact person in the event that any questions are asked? We request that investigators provide us with a cell phone number that can be reached at all times since participants may show up at the clinic or elsewhere and we need to be able to contact the study personnel.
You may also want to have a brief flyer about your study with all the above information that you can send to the participant, including the location of the study and a contact number for the investigator or research coordinator in the event that they are lost or have questions.

If subjects have questions about your calling them, please direct them to the research office number: 312-503-5103.

Clinical Tips for interacting with individuals with cognitive impairments:

Diagnosed individuals expect to be treated like everyone else. There is no need to raise your voice (unless hearing is poor). Speak clearly. Be friendly!
Even if the caregiver is present, speak directly to the patient and include them in the consent and study explanation process.
In most cases you should simplify your instructions as much as possible. Providing too much information at once can be overwhelming. Provide instructions one at a time and ask them if they’ve understood what you have said before moving on. An abstract of the study on a single sheet of paper can also provide cognitively impaired subjects with a simple explanation that they can refer to.
Give the participant time to respond to your questions. Aphasic patients may need time to think of their words. Sometimes you may feel as though there is awkward silence while they are thinking about what to say. In general, you should give them time to respond. Sometimes you may need to help them think of the words they are trying to say (if it is appropriate to your study).
Offer encouragement and feedback. Even if the participant is not performing perfectly, it is helpful to encourage them throughout your tasks so they stay motivated to do the best they can.
Do not leave the patients alone. Please make sure that they are accompanied at all times.

We want to make sure that our collaborators have easy access to the subjects they need and also that the participants feel well taken care of and experience as little burden as possible. We look forward to a productive

Collaborative Request Form 09-01-14