IRB Forms

The forms can be found in IRBNet under the Forms and Templates tab.For registration, tutorials, and submission guides, please visit the IRB home page.

Amendment Application
Authorization Agreement
Adverse Event Report Form
Closure Application
Consent Form/Consent Waiver
Continuing Review Application
FMRI
HIPAA
Human Subjects Research Determination Form
ORA Account Approval before IRB Approval
Participant Incentives Reimbursement Form
Research Participant Support Payments
Initial Application
Photo Consent Form

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Amendment Applications

Submitting an Amendment Request

The UMCP IRB will no longer accept an email request for an Amendment Application.

Important Points Regarding Amendment:
(1) Federal Regulations require that all revisions be approved by the IRB prior to their implementation

(2) Amendment 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

Definitions

Amendment:
This is a modification to a currently IRB Approved protocol. Also known as an amendment. 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.

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. For example, if the protocol expires 6/14/09 and the Amendment Request is approved on 2/10/09, the Amendment Approval Letter will reflect the following approval period: 2/10/09 – 6/14/09.

Please Note: Amendment Requests do not change the duration of IRB Approval.

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 to the Research Team

If additional members will be added to the research team, IRB Approval is required prior to these members engaging in any research activities. All research team members must complete appropriate human subjects research training. We currently require all Principal Investigators and research team members to complete the CITI Basic Human Subjects Training https://www.citiprogram.org/. We will be offering additional human subjects training in the near future.

If there will be a change to the Principal Investigator, a signed letter from both he current PI and new PI must be submitted with the Amendment Request. The letter should clearly state that both PIs agree to the change. A signed letter from each PI may be submitted with the Amendment request if signatures cannot be obtained on a single letter.

Download Amendment Application Form

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Authorization Agreement

Download Authorization Agreement Form

When is IRB Authorization Agreement required?

This form is used when University of Maryland College Park (UMCP) engages in research with:

(1) An organization/institution with whom UMCP currently does not have a cooperative review arrangement, and

(2) Either UMCP or the collaborating organization/institution provides IRB (human subject) review to avoid dual review

Submission Instructions

If an IRB Authorization Agreement (AA) is appropriate for your research study, please contact the IRB office to determine which institution will be the IRB of record (Institution A).

IRB Authorization Agreement designation:

(1) Institution A: In most cases, Institution A (the institution conducting the IRB review) is the site where participant accrual takes place.

(2) Institution B: The institution who relies on Institution A's IRB review

IRB Registration #s: IRB00000474

Federalwide Assurance (FWA) #, if any: FWA00005856.

Checklist of Required Documents

(1) A copy of the approval letter for the project.

(2) A list of the names, briefly explaining the roles and responsibilities of each investigator from University of Maryland, College Park.

(3) The authorization agreement signed by the other institution's signatory official first, if they are listed as Institution A. Please contact both the IRBs for assistance with obtaining the correct signatory official signatures.

Please note: In order for the IRB AA to be processed and approved, the offsite institution must have an approved Federal Wide Assurance (FWA) on file with the office for Human Research Protections (OHRP). If the offsite institution does not have a FWA, the institution must first apply for a FWA. In addition to the offsite institution having an approved FWA on file with OHRP, the offsite institution's IRB registration must be current with OHRP.

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Closure Applications

Download Closure Application Form

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:

(a) data collection is complete

(b) there is no more participant contact (including follow-up interviews, calls, surveys)

(c) 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 Forms

A consent form is used to provide information to prospective subjects to enable persons to voluntarily decide whether or not to participate as research subjects. A consent form usually contains the basic elements of informed consent as identified in and required by the Federal regulations for the protection of human subjects (45 CFR 46).

Consent Form: Template

Consent Form: Completion Instructions

Consent Form Examples
Parental Consent
Assent – 13 to 17 years old
Assent – 12 years old and under

Consent Waiver

To request a waiver or alteration of the required elements of informed consent, address the following criteria in Section 7 of Initial Application Part 2:

(1) The research involves no more than minimal risk to the subjects

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects

(3) The research could not practicably be carried out without the waiver or alteration

(4) Whenever appropriate, the subjects 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 the above listed waiver criteria.

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Continuing Review Applications

When to Submit a Continuing Review Application

Human subject research projects are approved for no more than one year. The IRB recommends that Continuing Review Applications be submitted to the IRB Office forty-five (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.

For non-exempt research that was approved through expedited review, a continuing review application should be submitted no later than 45 days prior to the last day of that one-year approval period. (For example, an application approved on June 30, 2007 would expire on June 30, 2008; a continuing review application will be due at the IRB no later than May 15, 2008.) For non-exempt research that was approved through Full Board review, a continuing review application should be submitted by the application deadline for the IRB meeting scheduled for the month before the application expires. Please check the IRB Full Board Review meeting dates that are posted on the IRB website.

Human subject protocols that have been determined by the IRB to be Exempt projects do not require continuing review as they are exempt from the requirements set forth in the Code of Federal Regulations [45CFR46]. If you have any question about continuing review applications, please contact the IRB Office at 301-405-7326 or email irb@umd.edu.

The IRB will no longer accept Continuing Review Applications after a protocol expires. There will be no “grace period” for a Continuing Review Application received after the Expiration Date of the protocol. The UMCP IRB and Federal Regulations do not permit extensions of human subject research projects beyond the IRB Approval dates.

If you would like to continue obtaining data from human subjects or collecting or analyzing identifiable private information for a human subjects research project, a Continuing Review Application must be reviewed and approved by the Institutional Review Board (IRB) prior to the expiration date for the previous IRB approval.

However, 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. 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 Office 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.

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:

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

Download Continuing Review Application Form

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FMRI Forms

Please use the IRB Application Forms available on IRBNet, if your research involves the use of FMRI. Please email jsmith54@umd.edu with any questions. Back to Top


HIPAA

Download HIPAA Identifiers and PHI Form
Download HIPAA Authorization Application Form
HIPAA:University of Maryland Policy
Are You Subject to HIPAA?


*If a translated version of the HIPAA form is needed, please email irb@umd.edu


Summary of HIPAA's Impact on Research at UM

The federal Health Insurance Portability and Accountability Act (HIPAA) provides privacy protections for medical records and other individually identifiable health information (“protected health information” or “PHI”) created or maintained by a HIPAA “covered entity.” The HIPAA “Privacy Rule” is intended to enhance the rights of individuals by providing them with greater access to their PHI and more control over its uses and disclosure. This summary generally describes HIPAA requirements regarding covered research, is for informational purposes only, and does not constitute legal advice. Additional HIPAA information is posted on the University's HIPAA website at http://hipaa.umd.edu. HIPAA's privacy requirements are in addition to existing humans subjects research protection requirements.

HIPAA Research

Footnotes

(1) HIPAA also covers health plans and health clearinghouses

(2) The University's HIPAA designations are posted on its HIPAA website at http://hipaa.umd.edu/.

(3) The minimum necessary standard does not apply to uses/disclosures required by law or for HIPAA compliance, or to disclosures to the subject of the PHI

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Human Subjects Research Determination Form

When should you use the IRB Office Human Subject Research Determination Request Form?

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

If the IRB Office determines that your project 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, you will receive a PDF memo to this effect via email.

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. We will review and make a determination as to whether an IRB Application is required because your project is human subject research or if your project does not qualify as human subject research. If your project does not qualify, we will generate an official document in IRBNet confirming that the UMD IRB Office has reviewed and made this determination.

Download Human Subject Research Determination Form

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Participant Incentives Reimbursement Form

Guidelines for Reimbursement of Human Subject Participant Incentives Form

This form may be used to assist in documenting reimbursement of allowable human subject participant incentives. It is designed to be supporting documentation included with itemized receipts for incentives purchased to acknowledge human subjects who participated in a research study as a group. Examples are groups of student participants in K-12 school classrooms.

This form should be completed before the research study visit occurs, and must be acknowledged with an original signature by the school or organization. Please attach the completed form along with original itemized receipts for allowable items purchased to accounts payable. For meal purchases provided as incentives, a list of attendee names or class roster must also be attached.

Please remember that this form is to be used as supporting documentation to ORIGINAL itemized receipts as required by the State of Maryland.

Download Participant Incentives Reimbursement Form

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Research Participant Support Payments

1) Guidelines for Research Participant Payment MOU
2) Research Participant Payment MOU Form

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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 Add New Document and then selecting Initial Application Part 1 from the drop down box titled Online Document

Initial Application Part 2: Template

Initial Application Part 2: Completion Instructions

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