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Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM - 4:30 PM

Amendment Applications

Amendment Application Form

Amendment: This is a modification to a currently IRB Approved protocol. Any changes to an IRB Approved protocol (Exempt/Expedited/Full Board) must be submitted to and approved by the IRB prior to implementation.

Amendment during Continuing Review: The IRB does not recommend submitting amendment requests during the Continuing Review process as this will increase the turnaround time for these applications. However, if the requested modifications are minor (for example: editorial or research staff changes) please make the changes to the appropriate section of the protocol and clearly identify the changes in the Continuing Review application. In certain cases the IRB will make an exception to this policy, please contact the IRB with questions.

Important Points Regarding Amendment(s):

  1. All revisions be approved by the IRB prior to their implementation.
  2. Amendments that increase the risk of research participation must be approved by the fully convened IRB committee.
  3. If the proposed revisions heavily modify the protocol, the IRB may request that a new protocol application be submitted. Contact the IRB Office if you have questions.

Risk Classification: The protocol application presents minimal risk or greater than minimal risk:

  1. Minimal Risk is defined as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of a routine physical or psychological examinations or tests” [45 CFR 46.102(i)].
  2. Greater than Minimal Risk is defined as research that does not meet the above definition.

Approval Dates:

The approval of an Amendment Request will not change the expiration date of the protocol. The expiration of IRB Approval will remain the same as determined at the previous Initial IRB Approval or Continuing Review. 

Revised Documents:

If revised versions of documents (consent documents, flyers, etc) previously approved by the IRB are submitted with changes, please note this in the footer of the document. For example: Revised-3/10/09. This helps maintain a proper protocol review history.

Adding Investigators:

If additional investigators/researchers will be added to the protocol and will be engaged in human subject research (HSR) activities (interaction with participants or identifiable data from participants), IRB Approval is required prior to these members engaging in any HSR activities. All HSR-engaged investigators/researchers must complete appropriate human subjects research training - CITI Basic Human Subjects Training. 

If there will be a change to the Principal Investigator, both the current PI and new PI must sign the IRBNet Amendment package.  

Closure Applications:

Closure Application Form (.docx)

Determining if Continuing Review is Required:

Please consider the following questions when determining if a Continuing Review Application or Closure Report must be submitted. If you have any questions, please contact the IRB Office.

  1. Will future research activities involve obtaining data through intervention or interaction with human subjects?
  2. Will future research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to the subjects. This includes any lists of participants that have not yet been destroyed.
  3. Will future research activities include analyzing identifiable private information about living individuals?

PLEASE NOTE: If you answered yes to any of these 3 questions, a Continuing Review Application must be submitted for your research project.

If you answered no to all of the above questions, a Continuing Review Application is not required and a Closure Report must be submitted. A protocol is eligible for closure if:

  1. Data collection is complete.
  2. There is no more participant contact (including follow-up interviews, calls, surveys).
  3. The only research activity remaining is data analysis of de-identified data.

Closure Report Guidance:

A Closure Report must be filed within 30 days of IRB Approved protocol completion. The IRB does not recommend allowing IRB Approved protocols expire or to be administratively closed by the IRB Office as this does not bring proper completion to the protocol history.

Harm to Participants:

If it is in the best interest of individual subjects to continue participating in interventions or interactions for research which has recently expired and a Continuing Review Application is pending, the Principal Investigator should submit a request to the IRB Office for those research subjects to continue participating. The request should include a description of the potential harm if the subjects do not continue participating in the research.

Consent Form Examples:

Waiver of Consent Documentation:

A waiver of consent documentation is when a participant will consent to participate without providing a signature (either a physical signature via pen and paper or a typed signature). Examples of consent methods that require a waiver of consent documentation include: verbal consent, clicking a button or checking a box to indicate consent, or in the case of research studies with children, when there will be an opt-out process for the parents. To qualify for a waiver of consent documentation investigators must address in Part 2 Section 7 how the project meets ANY of the following criteria:

  • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context;
  • That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  • If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

You may request a waiver of consent documentation by including response(s), in your IRB application, to ANY of the above listed waiver criteria. 

Waiver/Alteration of Consent:

A full waiver of consent is when an individual will not be approached for consent or it is not possible to approach an individual for consent such as in a secondary data analysis. An alteration of consent refers to altering some or all of the elements in the informed consent process, such as use of deception. To qualify for a full waiver/alteration of consent, investigators must address in Part 2 Section 7 how the project meets EACH of the following waiver criteria:

  • The research involves no more than minimal risk to the subjects;
  • The research could not practicably be carried out without the requested waiver or alteration;
  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
  • Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

You may request a waiver of informed consent by including responses, in your IRB application, to EACH of the above listed waiver criteria.

Continuing Review Application:

Exempt Review: IRB protocols that have received an Exempt Determination do not require Continuing Review.

Expedited Review: Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review. However, if it is deemed necessary, the IRB member reviewer may require a Continuing Review for a protocol undergoing Expedited review (up to one year approval).

Full IRB: Protocols reviewed by the fully convened IRB will be approved for up to one year. If you plan to continue obtaining data from human subjects or collecting or analyzing identifiable private information for your research project, a Continuing Review application must be reviewed and approved by the IRB prior to the Expiration Date.

The IRB recommends that Continuing Review Applications be submitted to the IRB Office 30-45 days in advance of the Expiration Date of the protocol. This will allow appropriate time for review, administrative modifications, and approval prior to protocol expiration.  Please check the IRB Full Board Review meeting dates that are posted on the IRB website to ensure the Continuing Review is submitted by the application deadline.

Please Note: If the Continuing Review Application is submitted prior to the Expiration Date this does not guarantee the application will receive IRB Approval before the protocol expires (i.e. if the Continuing Review has been submitted shortly before expiration).  If the protocol does expire after a Continuing Review Application has been submitted, all research activities involving human subjects must cease until approval is granted.  If a Continuing Review Application is not received by the IRB prior to the Expiration Date, the protocol will expire and a new Initial Protocol Application must be submitted and approved in order to continue human subject research activities.

FMRI:

Please use the IRB Application Forms available on IRBNet, if your research involves the use of FMRI. Please email the IRB Office with any questions.

HIPAA:

HIPAA at UMD:

The University of Maryland is a Hybrid Entity under the HIPAA Privacy Rule. This means we are allowed to have covered and non-covered functions. The University Health Center is a covered entity under HIPAA. The Health Center must work with other units on campus where it might be necessary to disclose PHI to these units in order to carry out its health care function. These units are defined as business associates under HIPAA and must comply with requirements to ensure the safeguarding of protected health information. General Counsel, Chief Information Security Officer, and the HIPAA Privacy Officer are considered business associates. For more information, click here. 

Human Subjects Determination Form:

The Human Subject Research Determination (HSRD) Form may be used by faculty, staff and students who are not sure if their activity requires IRB review. The HSRD Form will isolate elements of your project so the IRB Office can make a quick and accurate determination.

Log into IRBNet and download the Human Subject Research Determination Form under Forms and Templates. Complete this form and submit to the UMD IRB Committee in IRBNet. The IRB Office staff will review and make a determination as to whether an IRB Application is required due to the protocol meeting the definition of human subject research or if the protocol does not meet the definition of human subject research. 

If the IRB Office determines that your protocol meets the definition of human subject research and requires IRB review, you will be notified via email to submit an Initial Application. If your project is determined to not require further IRB review, a determination letter will be published in IRBNet.

Initial Application:

Initial Application Part 1: This is a Smart Form and is completed online. Part 1 can be found by clicking Designer, then clicking Start a Wizard and then selecting Initial Application Part 1 from the drop down box.

To request a text-only version of any file on this page, please contact the IRB.

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