Compliance

It is the policy of the University of Massachusetts Amherst to comply fully with U.S. export control and trade sanctions laws and regulations. U.S. laws and regulations that govern exports or access to certain information or technologies, or services by foreign persons inside the U.S., have received increased attention recently and have impacted programs at all major research universities. These laws and regulations are currently administered by various Federal agencies, chief among them the Departments of Commerce, State, and Treasury

For more details on Export controls and the University of Massachusetts Amherst please go to the Export Controls page.

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Changes to the Informed Consent

Summary of Changes

  •  [New] "Key information" to be presented at the beginning of the consent form
  • If you are collecting private information or identifiable biospecimens for future research you must include one of the following statements:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject.
    • The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
  • Additional Elements of Informed Consent 46.116(c) - Three New Requirements (when appropriate)
  1. Biospecimens: a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  2.  Clinically relevant results: a statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
  3.  Whole genome sequencing:  a statement about whether the research project might include whole genome sequencing.

UMass IRB/HRPO has updated the consent templates available on our webpages to reflect these changes.

Studies approved BEFORE January 21, 2019

  • Impact on Researchers: NONE
  • The new consent requirements will NOT be applicable.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • The new consent requirements WILL BE applicable to all studies.
  • UMass IRB/HRPO will provide guidance regarding new requirements for consent documents during the IRB protocol review process.
  • UMass IRB/HRPO has updated the consent templates available on our webpage to reflect these changes (https://www.umass.edu/research/compliance/human-subjects-irb/forms).

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Changes to the Exempt Categories

Summary of Changes

  • [Revised] Exempt Category 2(iii) has now been expanded to allow collection of potentially sensitive or harmful identifiable private information from adults if an IRB conducts a limited review* and determines that there are adequate provisions for protecting privacy and maintaining confidentiality

*The revised Common Rule allows for the exemption of research collecting identifiable information with the potential to cause harm if disclosed, provided that the IRB has determined that “there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data”. This new requirement is called a limited IRB review.

  • [New] Exempt Category 3 "Benign behavioral interventions*" such as solving puzzles or playing online games. Can also collect sensitive information with a limited IRB review

      *Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”.  Excludes physiological data collection methods (e.g., EEG, wearable devices such as FitBitTM, accelerometers, eye-tracking devices, blood pressure monitors, etc.)

  • [Revised] Exempt Category 4 (medical record review) can now be prospective as well
  • [New] Exempt categories 7 & 8 include limited reviews and Broad Consent.

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • UMass IRB/HRPO will continue to review all exempt protocols.
    A determination of "exempt" means the proposed research activity meets one of the exemption criteria and thus is exempt from the federal regulations that govern the conduct of human subjects research, Common Rule (45 CFR 46). However, a research activity determined as "Exempt", must still be reviewed by the IRB and conducted in accordance with the ethical principles outlined in the Belmont Report: respect fro persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: NONE
  • The UMass IRB/HRPO will evaluate each submission and manually assign the applicable Exempt categories per the revised Common Rule. Meanwhile, the researchers should continue to select from the pre-2019 Exempt categories as listed in Kuali.

NOTES:

Please do NOT submit revisions to protocols reviewed under the "Expedited" categories to change the review category to "Exempt".

UMass IRB/HRPO reviews all exempt protocols and thus a review category re-assignment will not make any difference to the IRB protocol review process.

At this time UMass Amherst will not implement new Exempt categories 7 & 8 due to a possible increase in researcher's burden to track and store broad consents. This may change after additional guidance is provided by OHRP.

 

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Changes to the Continuing Review Procedures

Summary of Changes

Continuing review is no longer required for some minimal risk research such as Exempt and Expedited studies that were approved on or after January 21, 2019 unless the IRB explicitly justifies for each study why continuing review would enhance protection of research subjects.

Continuing Review Procedure Changes – Impact on Researchers

FULL BOARD PROTOCOLS

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Important: Continuing Review requirements for Full Board Protocols remain unchanged.

EXEMPT AND EXPEDITED PROTOCOLS

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Studies will continue to require submission of a renewal form annually until the study is completed at which time a final report form must be filed.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • Continuing Review/Renewal - NOT REQUIRED (CHANGED)
  • Continuing review will no longer be required as a general practice unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human research subjects. Your IRB approval letter will indicate the designation as requiring or not requiring a continuing review/renewal.

NOTE: UMASS/HRPO may re-evaluate its decision of not requiring continuing review/renewal for a particular study that was approved ON or AFTER January 21, 2019 based on changes proposed in a revision that increase the risk(s) to subjects, or as an outcome of the IRB's review of unanticipated problems/adverse events/research-related complaints.

UMASS/IRB/HRPO will notify the research if there is any change in the designation.
 

The following research team responsibilities remain unchanged (for both Exempt and Expedited Protocols)

  1. Complete a final report form when all participants have completed all research-related interventions AND you are only doing data analysis of de-identified data.

  2. Submit a revision in the following instances prior to implementation (unless to eliminate an apparent immediate hazard to subjects):

    • Enrollment of additional participants beyond the number approved

    • Any changes to study design/methodology, questionnaires, etc.

    • Any changes to study personnel

    • Any changes to consent procedures/documents

    • Any changes to recruitment procedures/materials

  3. Report the following to the IRB:

    • Unanticipated problems

    • Adverse Events

    • Research-related complaints

    • Protocol deviations/violations

 

 

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New and Revised Definitions

Revised Human Subjects Definition

The definition of “human subject” has been changed to include “identifiable biospecimens” based upon how data and/or biospecimens have been collected or will be used.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e) of the revised Common Rule)

Removal of four categories of activities from the definition of human subject research

The following activities are NOT considered to be human subject research:

  1. Scholarly and journalistic activities that focus directly on the specific individuals about whom the info is collected: (e.g., oral history, journalism, biography, legal criticism, legal research, and historical scholarship)

  2. Public health surveillance activities limited to those conducted, supported, requested, ordered, required, or authorized by a public health authority for public health importance (includes “timely situational awareness”)

  3. Criminal justice or criminal investigational purposes

  4. Authorized activities in support of intelligence, homeland security, defense, or other national security missions.

Addition of the definition of clinical trial

“Clinical trial” means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102(e) of the revised Common Rule).
 

Impact on Researchers: MINIMAL
UMASS IRB/HRPO has updated the guidance and forms to include the revised definition.

 

 

 

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