Compliance

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Human subject research sometimes involves having potential participants engage in some type of screening activity to determine their eligibility for participation in a study.  Collecting data directly from subjects or prospective subjects such as through written screening tools or oral responses to questionnaires, or accessing private information, i.e., grades, medical test results, legal records, or any other non-public information linked to a potential subject, for purposes of eligibility screening constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review.

Although screening activities do not necessarily result in data that are used to evaluate study outcomes, such procedures occur because of the research and are, therefore, reviewed by the IRB during consideration of proposed protocols. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy and confidentiality of those who are screened.

Screening procedures may include:

  • Any interaction or intervention with the subjects to determine eligibility that would not otherwise have been performed if not for the study, or
  • Accessing the results of interventions that were performed for purposes other than the study.

IMPORTANT NOTE: In order to protect the privacy of potential participants, only the minimal information necessary for screening is to be collected.

The Kuali application should include the following information with respect to screening procedures:

  • The screening materials to be used
  • Data, if any, that will be acquired from the screening activities
  • A separate screening consent
  • When and how the screening data will be destroyed

In those instances where the screening activities involve no more than minimal risk or involve procedures for which written consent is not normally required outside the research context, the investigator may request, and the IRB may find, that it is appropriate to waive documentation of consent for screening activities (i.e. prospective subjects need not sign the screening consent) and the scope of the screening consent can be limited to:

  • A description of the screening tests (see for e.g. PAR-Q Screening Consent)
  • The reasons for performing the tests
  • A brief summary of the description of the study in which the individual may be asked to participate

Additional considerations:

  • Participants determined eligible to participate: If the screening indicates that the prospective subject is eligible for participation, the informed consent procedures for the study, as approved by the IRB, would then be followed.
  • Keeping information confidential: Often the greatest risk with obtaining information during a screening process is the loss of confidentiality.  The investigator must consider and describe how the confidentiality of this data will be maintained. Whenever possible, information obtained during this process should not be connected with subject identifiers.  As noted above, the amount of data collected should be limited. Once collected it should be kept secure or destroyed as appropriate.
  • A screening script for research may be needed in lieu of the normal documented informed consent process.
    • If such screening activities will take place prior to the prospective participant providing informed consent for participation in the research, the investigator may request a waiver of documentation of informed consent (i.e. signed consent) for screening activities.
    • If screening activities will take place only after the subject has provided informed consent for participation in the research, then the waivers described above are unnecessary.
  • HIPAA regulations apply to the screening process if it involves review of medical records. Investigators must obtain prospective HIPAA authorization or apply for a waiver of HIPAA authorization and informed consent.
  • Telephone Scripts: In telephone surveys, the initial recruitment call sometimes leads directly into the consent process. In such studies, the script should include, at least, a statement that the study involves research, the names of the persons responsible for the research, reference to UMass Amherst, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator's telephone number and email address in case the prospective subjects have questions about the study that the interviewer cannot answer, and the IRB phone number if there are questions about a research subject’s rights.

 

 

 

 

 

 

 

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Conflict of Interest Disclosure Statement - Intellectual Property and Commercial Ventures

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Final reports must be submitted upon completion of the study. Studies would be considered eligible for closure once the following is complete:

  • enrollment of subjects is closed, and subjects have completed all research-related interventions, and
  • data collection is complete, and
  • data are de-identified*, for example data are being maintained in such a way that identifiers are separated from the coding system, or data is in a secure location, and
  • there is no additional research beyond the original intent planned for these data.

*For the purposes of submitting the IRB final report, the study will be considered complete if only data analysis using de-identified data remains. If identifiers remain on the data, researchers must request continuing review.

Note that it is the continued responsibility of the research team to maintain the confidentiality of the data. Please complete a final report form and submit it to the HRPO so the study file may be closed.

Submitting a Final Report in e-Protocol

  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number for which you wish to submit the final report.
  • A window will open with several options.
  • Click the circle beside File a Final Report .
  • The protocol will open with a final report form. Fill out all of the information on the form.
  • When you are ready to submit your form, click on Submit Form located in the top right corner of the page.

 

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Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems in involving risk to subjects or others."

A. Definitions

1. Adverse Event: Any untoward physical or psychological occurrence or undesirable and unintended effect for a participant that may present itself during interventions and interactions used in the research or the collection of identifiable private information under the research, regardless of whether there may or may not be a relationship with the research intervention.

2. Expected adverse event: An adverse event that is not an unexpected adverse event.

3. Unexpected adverse event: Any adverse event, the specificity, frequency or severity of which is not consistent with either:

a. the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, the current IRB-approved informed consent document, and other relevant sources of information, such as product labeling and package inserts; or

b. the expected natural progression of any underlying disease or condition of the participant(s) experiencing the adverse event.

4. Related to the research: An event is related to the research if, in the opinion of the University of Massachusetts (UMASS) investigator, it was more likely than not to be the result of the interventions and interactions used in the research or the collection of identifiable private information in the research (i.e., there is a reasonable possibility that the event may have been caused by participation in the research).

5. Unrelated to the research: An adverse event is unrelated to the research if, in the opinion of the UMASS investigator, the adverse event is not related to the research.

6. Internal events: Adverse events experienced by participants enrolled at the site(s) under the IRB's jurisdiction for either multicenter or single-center research projects.

7. External events: Adverse events experienced by participants enrolled in multicenter clinical trials at sites other than the site(s) over which the IRB has jurisdiction.

8. Unanticipated problems involving risks to participants or others (unanticipated problems): Problems that are (1) unexpected (in terms of nature, severity or frequency) given the research procedures and the participant population being studied; and (2) suggest that the research places participants or others at a greater risk of harm or discomfort related to the research than was previously known or recognized including physical, psychological, economic or social harm.

B. IRB Reporting Requirements

1. Investigators are required to promptly report the following problems to the IRB:

a. Adverse events that are (1) unexpected and (2) related or likely related to the research as determined by the UMASS principal investigator;

b. Information that indicates a change to the risks or potential benefits of the research. For example:

•  An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB

•  A paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB;

c. Breach of confidentiality;

d. Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol;

e. Incarceration of a participant in a protocol not approved to enroll prisoners;

f. Specific protocol-defined events that requires prompt reporting to the sponsor;

g. Sponsor imposed suspension for risk;

h. Accidental or unintentional deviations to the IRB-approved protocol that involved risks;

i. Emergency protocol deviations taken without prior IRB review to eliminate apparent immediate hazard to research participants;

j. Complaints of participants that indicate unanticipated risk or which cannot be resolved by the research staff.

2. Investigators must report problems to the IRB in accordance with the following timelines:

a. Internal problems that require prompt reporting and are fatal or life-threatening must be reported to the IRB within one weekday of the principal investigator becoming aware of the problem.

b. All other internal problems that require prompt reporting must be reported within 5 weekdays of the principal investigator becoming aware of the event or problem.

c. External problems that require prompt reporting are to be reported within 30 days of their receipt by the UMASS principal investigator.

3. Reports must include the following:

a. An Unanticipated Problem Report Form, which includes identifying information (title of the research, name of principal investigator, and name of the sponsor), and a description of the event;

b. Any associated materials, if any, such as medical record notations, forms sent to a sponsor or the sponsor's safety report forms.

4. Records for problems and adverse events that do not require prompt reporting:

a. For internal adverse events that are expected and related and are consistent with the frequency and severity listed in the informed consent document, the principal investigator keeps a summary of the events that have occurred within the last approval period and submits the summary at the time of continuing review using the Event Tracking Log.

b. Accidental or unintentional deviations to the IRB-approved protocol that do not involve risks to participants may be submitted to the IRB using the Protocol Deviation/Violation Report Form if required by the sponsor.

c. External adverse event reports that do not require prompt reporting to the IRB, are reviewed, initialed and dated by the principal investigator and filed with the research regulatory documents. This record is to be made available to the IRB upon request.

C. IRB Process for Handling Reported Problems

1. All reports are provided to an IRB Administrator for review within five working days of their receipt.

2. The IRB Administrator reviews the materials to determine if the report includes the necessary information and for an initial evaluation.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

•  The UMASS principal investigator's assessment of external events must be provided or the report will be considered incomplete and will be returned to the investigator.

b. If in the judgment of the reviewer, the report is definitely not an unanticipated problem involving risks to participants or others, the following procedures are followed:

•  If the report is for an external adverse event, the report is returned to the investigator with an explanation for why it is being returned.

•  If the report is for an internal event, the report is accepted, signed by the reviewer and filed in the IRB study file. A correction to the log will be requested.

•  If the report is for a publication, safety monitoring report, interim results, or other findings, the report is accepted, signed by the reviewer and filed in the IRB study file.

c. All other reports are referred to the full IRB for further action with the following exceptions.

d. If, in the judgment of the reviewer, participants may be at immediate risk of harm and there is insufficient time to wait for review by the convened IRB, an IRB Chair, or the Director of the Human Research Protection Office is consulted. If the Chair or a Director determines that participants are at immediate risk of harm, the principal investigator will be required to suspend the study according to IRB policy for suspension or termination of research.

3. For reports that are sent to the full IRB for review, the report is added to an IRB meeting agenda and is assigned to a primary reviewer by the IRB staff on the basis of the scientific expertise of the review. The primary reviewer and all other board members receive the following information:

a. A copy of the report;

b. A copy of all supplemental material attached to the report;

c. A copy of all tracking logs, if applicable;

d. A copy of the sponsor adverse event report form, if applicable;

e. A copy of the DSMB or safety report, if applicable;

f. A summary of the study;

g. Copies of the current, IRB-approved informed consent document(s) and revised informed consent document(s); and

h. Any other relevant materials.

4. The primary reviewer summarizes the report at the convened IRB meeting and the full IRB will determine if the report meets the definition of an unanticipated problem involving risks to participants or others by deciding if the event meets the following criteria:

a. Unexpected, i.e., not anticipated (in terms of nature, severity or frequency) given the research procedures and the participant population being studied; and

b. Places participants or others at a greater risk of harm or discomfort related to the research than was previously known or recognized including physical, psychological, economic or social harm.

5. The IRB may decide to postpone a decision while awaiting additional information. If, in the judgment of the IRB, participants may be at immediate risk of harm while waiting for this information, the principal investigator may be required to suspend the study according to IRB policy for suspension or termination of research.

6. If the IRB determines that the event meets both criteria, then the event will be considered an unanticipated problem involving risk to participants or others and will be processed as follows:

a. The IRB will consider the following actions:

•  No action necessary;

•  Modification to the protocol;

•  Modification to the informed consent document(s) for future participants;

•  Notification of current or past participants by phone, letter or addendum to the informed consent document;

•  Modification of the continuing review schedule;

•  Monitoring of the research or consent process;

•  Referral to legal counsel, risk management or the institutional official; or

•  Other appropriate action as determined by the IRB.

b. For a report of an accidental or unintentional deviation to the IRB-approved protocol that involved risks or has the potential to recur, the IRB will also consider if the event represents serious or continuing non-compliance.

c. For a report of an emergency protocol deviation taken without prior IRB review, the IRB will consider if the changes were consistent with the rights and welfare of participants.

d. The IRB decision and required actions are documented using the appropriate template and this documentation is sent to the principal investigator.

e. The IRB submits a report of the unanticipated problem involving risk to participants or others to appropriate institutional officials and entities.

7. If the IRB determines that the reported event or information does not meet one of the two criteria, then the event or information will not be considered an unanticipated problem involving risk to participants or others; therefore, no further action is required. The IRB decision is documented using the appropriate template and this documentation is sent to the principal investigator.

8. Investigators may appeal the IRB determinations regarding the report of an unanticipated problem involving risks to participants or others. In order to appeal an IRB decision, the investigator must submit his/her rationale or that of the sponsor and any supporting information. An appeal must be reviewed by the IRB that made the original decision.

D. IRB Process for Handling Non-Reported Events

1. Internal events submitted on the Event Tracking Log will be reviewed at the time of continuing review.

2. Accidental or unintentional deviations to the IRB-approved protocol that do not involve risks are reviewed by an IRB Administrator.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

b. If the investigator indicates that the deviation involved risks, the IRB Administrator contacts the investigator to request that the investigator complete the Unanticipated Problem Report Form.

c. Otherwise, the IRB Administrator stamps the form acknowledging receipt by the IRB office, signs, dates the form and returns a copy of the form to the investigator.

3. External events submitted to the IRB are reviewed by an IRB Administrator.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

b. If the investigator indicates that any event meets the definition of a reportable problem, the IRB Administrator contacts the investigator to request that the investigator complete the Unanticipated Problem Report Form.

c. Otherwise, the IRB Administrator stamps the form acknowledging receipt by the IRB office, signs, dates the form and returns a copy of the form to the investigator.

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Institutional Policy for Oversight of Animal Use in Research and Teaching

The University of Massachusetts Amherst recognizes that the privilege of using animals in research is subject to three Congressional Acts: the Health Research Extension Act  (Public Law 99-158) and Public Health Service (PHS) Policy, the Food Security Act (Public Law 99-198), and the Animal Welfare Act (AWA) [7 U.S.C. 2131-2156].  Animal use policy at the University of Massachusetts Amherst (the University) applies each set of regulations equally to all vertebrate animal used for research and teaching.

The University has an NIH Assurance of Compliance with PHS Policy on Humane Care and Use of Laboratory Animals on file with OLAW/NIH.  This Assurance commits the University to comply with PHS Policy and documents University procedures to ensure compliance.  In accordance with its Assurance the University has committed to:

  • Comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
  • Be guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.”
  • Acknowledge and accept responsibility for the care and use of animals involved in activities covered by the Assurance. 
  • Make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with the Assurance as well as all other applicable laws and regulations pertaining to animal care and use.
  • Establish and maintain a program for activities involving animals in accordance with the ILAR Guide for the Care and Use of Laboratory Animals  (the Guide)

The university’s Animal Care facilities are built and operated in compliance with the Guide and recommendations developed by the Federation of Animal Science Societies.

The IACUC also follows guidelines published by the appropriate societies for reviewing protocols which involve field research.

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Human Research Protection Office Student Consultation Registration Form

The UMass Amherst Human Research Protection Office (HRPO) offers assistance for students navigating the Institutional Review Board (IRB) review process.  Whether you are conducting human subjects research as part of an honors project, thesis or dissertation project, or an independent study, the HRPO staff is here to help! Sign up here.

For further information, please see: Students Conducting Human Subjects Research.

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Data Ownership, Retention, and Access at UMass Amherst

Sen. Doc. No. 06-047

SPECIAL REPORT

of the

RESEARCH COUNCIL

concerning

THE POLICY

ON

DATA OWNERSHIP, RETENTION, AND ACCESS

AT THE

UNIVERSITY OF MASSACHUSETTS AMHERST

Presented at the

654th Regular Meeting of the Faculty Senate

May 18, 2006

Jenny Adams

Krishna Melnattur

Iqbal Agha

John Mullin

D. Anthony Butterfield

David Ostendorf

Charles Clifton

William Patterson

Kourosh Danai

Stanley Scarpati

Andrea Foulkes

Jay Schafer

Dorothy Gilbert

Lynnette Leidy Sievert

Paul Kostecki

Carol Sprague

Mason Lowance

Jean Swinney

Michael Malone

Martha Taunton

Ernest May

Paul Utgoff, Chair

Juan Zamora

 

Sen. Doc. No. 06-047

 

Data Ownership, Retention, and Access at the University of Massachusetts Amherst

Approved by Research Council on May 5, 2006. Forwarded to Faculty Senate on May 5, 2006.

 

The University of Massachusetts Amherst supports a wide variety of research and scholarly activity. A fundamental component of many research investigations is the creation and use of data. It is in the interest of the research enterprise at large to make such data available to others, to the extent possible. This is important for furthering new research efforts and for enabling others to examine previous research in detail. It is in the University's interest to facilitate these processes, and to assist and protect those who conduct research and scholarly activities on behalf of the University.

 

External Policies and Guidelines

Various federal agencies have formulated policies regarding data ownership, retention, and access. For example, see Part C.53 of the Office of Management and Budget's (OMB) grants management circular A-110, the Council on Government Relations (COGR) document `Access to and Retention of Research Data: Rights and Responsibilities,' Chapter 6 of Steneck's  `Introduction to the Responsible Conduct of Research,'and the various requirements regarding research data stated by the National Science Foundation (NSF), the National Institute for Health (NIH), and other government funding agencies. Some publishers impose requirements on the access to data as a condition for publication.

The Amherst Campus policy (this document) applies to all campus research and researchers, regardless of funding source, if any. For sponsored research, any relevant policies of the sponsor shall apply in addition to those provided here. Any apparent conflicts of policies are to be resolved in writing and approved by the Vice Chancellor for Research and Engagement prior to accepting an award, contract, or other binding agreement.

 

Data Definition

Data shall be construed as all recorded information, regardless of medium, and all actual samples or examples, that were created or gathered and that could serve to influence or support a research finding or conclusion. Data does not include such items as research papers cited by the researcher, preliminary notes or paper drafts, reviews, or related communications, or items that are already the property of others. This definition is intended to characterize current research norms, not to modify them.

 

Data Ownership

The Amherst campus of the University of Massachusetts is the owner

or joint owner of all data that is created or collected by its employees or contractors, except when the creation or collection of such data is governed by a written agreement or contract to the contrary, approved in writing by the Vice Chancellor for Research and Engagement. Terms of the campus policy on intellectual property may apply as well.

When another research institution or entity has joint ownership rights to data, agreed in writing prior to creation of the data, the data shall be owned jointly as agreed. Each such institution shall have unfettered access rights to the original data. Such an institution not holding or serving as custodian for the original data may copy the data and own the copy.

When a creator of data ceases to be an employee or contractor of the University, the creator must leave the data in the physical possession of the owner(s), but will continue to have access rights to the data. The creator may take a copy of the data, at creator's expense.

 

Data Custody

The researcher(s) who created the data typically serve as the custodian of the University's data. Such researchers act on behalf of the University, without limiting the University's ownership rights. Data may not be removed from the University premises, except on a temporary basis when work occurs elsewhere, without written approval of the Vice Chancellor for Research and Engagement. The custodian of the data shall take all reasonable steps to protect the data from damage or loss, including

damage or loss due to catastrophic events. The owner of the data shall provide storage space and financial support as necessary to maintain the data. The University may elect to serve as custodian of the data, but may not limit the creator's access to those data.

Data Quality

Data shall be maintained in a manner that prevents alteration or that makes any and all alterations evident. For example, written data should be recorded in a bound notebook with numbered pages. If a datum is revised, the reason for revising it must be documented and dated. Electronic data should be kept on a read-only medium, or in a read-only mode. The creator of data should be able to document and defend any modification of the data.

 

Data Retention

Data shall be retained for at least three years after its creation. If the data were created as part of a sponsored research project, then the data shall be retained for at least three years after the final report to the sponsor has been submitted, or the ending date of the project, whichever is later. The data shall be retained for a longer period as dictated by any applicable policy or written agreement. If more than one minimum period of retention is deemed to apply, the data will be retained for the longest of these

periods. If the data led to the granting of a patent, then the data shall be retained for the life of the patent and its extensions. The data shall be retained while any litigation or legal action or investigation of allegations regarding it is pending. The data shall otherwise be retained for as long as anyone expresses, in writing, an interest in its retention. In no case will the data be discarded or destroyed when it is known to be in use.

 

Data Access

Researchers shall endeavor to make their data publicly available as soon as possible, and to the extent possible. Access may be delayed while the correctness of the data is being verified, until an initial publication based on the data appears, for the minimum period needed to file a patent application, or for any other reasonable need. Data should be released early if benefit to the public is likely.

No data may be published or made available in a form that would breach aconfidentiality. For example, the medical and financial records of an individual are private. The identity of human subjects is also typically held in confidence. The confidential aspects of confidential data are to be protected by both the custodian and the owner of the data. This may include physically securing the data. When a means of hiding the identity of a protected individual or entity is possible, say by the encoding or removal of names, such steps will taken so that the data may be made public to the greatest extent possible. If the data cannot be made satisfactorily anonymous, it shall not be made public, and the Vice Chancellor forResearch and Engagement will be informed of the existence of the data and the reasons that it cannot be made public. The creator of the data must make every reasonable effort to release the data in a useful form. If the veracity of confidential research data is challenged, the creator must cooperate with the Vice Chancellor for Research and Engagement to devise a means to satisfy the challenge. As owner, the University will defend any challenge, with the cooperation of the researcher. All applicable laws and legal protections regarding confidentiality will be obeyed.

Data that is deemed sensitive may require restricted access or other limitations. The owner and custodian of such data will comply with applicable laws.

Applicable non-disclosure agreements must be honored. However, the Vice Chancellor for Research and Engagement must approve any non-disclosure agreement ahead of time and be a co-signer. Such agreements shall generally be of limited duration, to give a sponsor sufficient time to file a patent application or for other protection.

When a collaboration comes to an end, and data was created during the collaboration, each member of the collaboration shall retain access to that data.

 

MOVED: That the Faculty Senate approve the Policy on Data Ownership Retention, and Access at the University of Massachusetts Amherst, as presented in Sen. Doc. No. 06-047.

52-06

 

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