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SMART IRB Online Reliance System

Terms of Use and Privacy Policy

Section 1 Terms of Use

The SMART IRB Online Reliance System (accessible at https://beta.reliance.smartirb.org/) is a web-based software tool developed and operated by a collaboration of Harvard Catalyst, Dartmouth Synergy, and University of Wisconsin ICTR, and funded by the NIH Clinical and Translational Science Award (CTSA) through grant number UL1TR001102-04S1 (hereinafter "SMART IRB"). The SMART IRB Online Reliance System (the "System") is designed to facilitate single Institutional Review Board (IRB) review for multi-site research by enabling IRBs and researchers to select, upload, view and exchange information necessary for IRB reliance determinations. All use of the System is limited to authorized and authenticated users.

The System is offered under the terms and conditions described in this Terms of Use.

When you registered to use the System, you agreed to be bound by these Terms of Use. SMART IRB reserves the right to take such legal actions as may be necessary to enforce these Terms of Use.

Section 2 Use of Services
IRB Reliance Purposes Only

The SMART IRB Online Reliance System is available to researchers, staff, institutional representatives, IRBs associated with Participating Institutions (https://smartirb.org/participating-institutions/) signatory to the SMART IRB Joinder Agreement (https://joinder.smartirb.org/download_mra), authorized third parties and SMART IRB staff.

Research information uploaded and shared through the System is solely for purposes of enabling IRB reliance evaluations and determinations by the institutions participating in that research project. Any use of the System not reasonably related to the IRB reliance function is prohibited.

Operational, Reporting and Quality Control

Information from the System may be used by authorized users for institutional internal reporting and research grant administration. Such information may also be used by SMART IRB for technical enhancements and operational services supporting SMART IRB functionality.

No Identifiable Patient Or Research Subject Information

Do not upload any Protected Health Information (PHI) as that term is defined by HIPAA (45 CFR 160 and 164 as amended), nor any other individually identifiable data about patients or research subjects.

Information Sharing

The SMART IRB Online Reliance System has protections in place to ensure that access to research information you provide is limited to the institutions named in your SMART IRB application. SMART IRB staff may also have access to such information.

Nevertheless, information uploaded to this System will be available and accessible to one or more independent research sites within a research study that are external to your institution. Therefore, you should upload only the research information necessary for SMART IRB reliance determinations (e.g., the research protocol). Research information that does not serve IRB reliance determinations should NOT be uploaded and you are advised not to do so.

Your Account

Upon registration, you will develop a username and password. You are solely responsible for maintaining the confidentiality of your password and for all activities that occur under your username and password. You agree to prohibit anyone else from using your username and password and will immediately notify SMART IRB (contact information below) and the appropriate person at your institution of any unauthorized use of your username and password or other security concerns of which you become aware.

You agree that SMART IRB or its authorized agents may access, preserve and disclose your account information if required to do so by law, or if it is necessary or advisable to do so to enforce these Terms of Use, or to respond to your requests for customer service.

Third Party Sites

Although SMART IRB may include links providing direct access to third party internet sites as a convenience, the inclusion of a link does not imply endorsement of the linked site. SMART IRB takes no responsibility for the content or information contained in those sites.

Third Party Vendors (including software cloud service providers)

SMART IRB may share information with third party vendors, including cloud service providers such as Amazon Web Services, as may be necessary to provide technical or administrative services that the SMART IRB considers at its sole discretion necessary to effectuate the System.

Operation And Record Retention

SMART IRB reserves complete and sole discretion with respect to the operation of the System and its role as the system of record. SMART IRB or its designee shall have the right to conduct audits of members’ compliance hereunder. SMART IRB may, among other things, suspend, withdraw, or discontinue any functionality or feature of the System. SMART IRB is not responsible for transmission errors, or corruption of data carried over local or interchange telecommunication carriers. SMART IRB is not responsible for loss of data arising from use of the SMART IRB services and SMART IRB may delete information uploaded into the System as it deems necessary.

Limitations on Use

You agree not to access or use the System in an unlawful way or for any unlawful purpose. You agree not to post or transmit a message under a false name or any information which (i) is libelous, defamatory, offensive, fraudulent, false or contrary to the ownership or intellectual property rights of any other person, or (ii) contains any virus, worm, Trojan horse or other code which is contaminating or destructive to the files or programs of SMART IRB or any of its users. SMART IRB reserves the right to delete any information that it deems in its sole discretion violates these Terms of Use.

Section 3 Privacy
Information We Gather: Your Communication To Us

We may ask you to upload information including, but not limited to, the following:

Overall Principal Investigator Information

  • Name
  • Home institution
  • Degrees

Site Investigator Information

  • Name
  • Home institution
  • Degrees

Study information

  • Brief description of study
  • Funding source
  • Copy of protocol
  • Informed Consent Templates

Other data

  • Institutional reasons for requesting a particular reviewing institution
  • Institutional reasons for declining to serve as reviewing institution
  • Other information as the tool is updated or as new versions are released

If you request information or other resources or register on the SMART IRB Online Reliance System, we may ask for contact information such as your name, email address, mailing address, phone number, position, institutional affiliation, title, or other information. We may also ask you to upload other documents relevant to the IRB reliance decisions. We use this information to allow multi-site research stakeholders to efficiently deliver and share data over a network to improve the SMART IRB reliance decision-making process.

When you send email or other communications to us, we may retain the email address and the communications in order to process your inquiries and respond to your requests.

Logging and Metrics Collection for Troubleshooting and Audit

The System logs transactions tied to your username for audit and troubleshooting purposes. For example, we will log dates and times you access the System, when you’ve made changes or revisions and what those changes are. Such logging and auditing helps us to solve problems with the System. Logging and audits will also be used to report aggregate metrics on system usage such as decision wait times and other transactional information (see also "Use of Information" section herein).

When you access the System, our servers automatically record information that your browser provides. This may include, among other data, your Internet Protocol (IP) address, browser type, device identifiers and location, the date and time of your access, web pages visited, and files accessed.

The System will attempt to store a small piece of data known as a "cookie" on your computer, which will be read each time you visit the site. We may use cookies to establish continuity between related requests, to personalize the site to your preferences, to authenticate your log-in, and to analyze site traffic. Cookies do not themselves contain any personal information. You may choose to block cookies with your browser, but if you do, you may not be able to take advantage of all of this site’s features.

Use Of Information

We use the information collected for the following purposes, in addition to those described above: tailoring the SMART IRB Online Reliance System to user needs and improving our content and service; generating data and reports about usage of the website and its content, supporting the functioning and security of the System; protecting our rights and safety and the rights and safety of others; and research.

We may evaluate System usage, measure response times and generate usage metrics, by collecting statistics about the behavior of users and analyzing user information and demographics, but only to generate aggregate statistical reports and to facilitate institutional reporting and assure quality control. We may use third-party services such as Google Analytics to collect such information. We may display this statistical information publicly or provide it to others. Such reports will not disclose site usage by individual visitors or by IP addresses.

Any third parties who receive user information for these purposes are prohibited from using such information for any other purpose.

We also may provide your personally identifiable information to third parties when we believe that doing so is necessary or appropriate to: satisfy any applicable law, regulation, legal process or governmental request; detect, prevent or otherwise address fraud, or security or technical issues; or protect our rights and safety and the rights and safety of our users or others.

Other Websites And Cookies

This website may contain links to other websites. We are not responsible for the privacy practices or the content of such web sites.

Cookies may be set by parties other than us. These "third-party cookies" may, for example, originate from websites such as YouTube, Twitter, Facebook, Google Plus or other social media services for which we have implemented "plug-ins." Since the cookie policies of these sites change over time, you should determine their policies by visiting the privacy policy pages of these sites directly.

Section 4 Disclaimers

The SMART IRB Online Reliance System and all updates/enhancements and support work are provided "AS IS." SMART IRB hereby disclaims all representations or warranties of any kind (express, implied or otherwise) regarding the System, updates/enhancements, and support work, including but not limited to, any implied warranties of merchantability, fitness for particular purpose, ownership, and noninfringement. Without limiting the foregoing, SMART IRB does not warrant that the functions contained in the System will meet user requirements, or that the operation of the System will be uninterrupted or error-free, or that all defects in the System will be corrected. SMART IRB has no control over the conditions under which users use the System and does not warrant any results that can be obtained by such use. SMART IRB shall not be liable for any direct or indirect, consequential, punitive, incidental, exemplary or special damages, or lost profits, even if advised of the possibility of such damages.

Section 5 General Provisions
Use of Names

You may not use the SMART IRB name or logo without express written permission.

Notice

SMART IRB may provide notice by e-mail to the e-mail address you provided SMART IRB, by a general notice on the SMART IRB website, or by written communication delivered by first class U.S. mail or express courier to your address on record in the SMART IRB account information. You may give notice to SMART IRB by contacting Help@smartirb.org or via U.S. mail or express courier to SMART IRB, C/O Harvard Medical School, 10 Shattuck St, Boston, MA 02115.

Waiver

If SMART IRB does not exercise or enforce any particular right or provision in these Terms, SMART IRB does not waive that right or provision. Failure to exercise or delay in exercising any right hereunder, or failure to insist upon or enforce strict performance of any provision of this Terms of Use, shall not be considered waiver thereof, which can only be made by a signed writing. No single waiver shall be considered a continuing or permanent waiver.

Information Protection

This site has security measures in place to help protect against the loss, misuse and alteration of the posted information. However, no such measures are 100% secure.

Contact Information

If you have any questions about these Terms of Use, you can contact Help@smartirb.org.

Changes to Terms of Use

SMART IRB reserves the right to update or change these Terms of Use at any time and for any reason without notice to the user by posting the modified Terms of Use. Your continued use constitutes your agreement to be bound by any such revisions. The date of the last update to these Terms of Use is stated at the bottom of this document. All Terms are automatically effective as soon as they are posted.

Thank you for reading the SMART IRB Terms of Use
https://smartirb.org/

Last Updated: 4-15-2017