Institutional Review Board Basics

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Video: UMD IRB Overview

 


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Clinical Trials Guidance

NIH Clinical Trial Definition – Updated January 17, 2018

Clinical trials must be registered at clinicaltrials.gov prior to collecting data from human subjects if the researcher wants to submit a manuscript of their study to the journal.  In addition, this is required by many peer-reviewed journals if an investigator is planning to submit a manuscript to that journal.

Clinicaltrials.gov Registration Guidance

Definitions

Human Subject Research
45CFR46.102(f)-Human Subject means a living individual about whom an investigator conducting research obtains:

(1) data through interaction or intervention with the individual, or
(2) identifiable private information

45CFR46.102(d)-Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Informed Consent
Written informed consent must be obtained from all participants when possible. If not possible, a waiver or alteration of informed consent may be requested with proper justification. Consent is not just a form, it is a process. Participation is always voluntary. Participants may ask questions before signing, during the study and after the study has been completed.

Minimal Risk
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 routine physical or psychological examinations or tests.

Exempt Review
Although this category is called "exempt," this type of research does require IRB review. The exempt review process is less rigorous than an Expedited or Full Board review. To qualify, research must fall into one or more of six (6) federally-defined exempt categories. These categories present the lowest amount of risk to potential participants because, generally speaking, they involve either collection of anonymous or publicly-available data. Some examples of Exempt research are: anonymous surveys/interviews, passive observation of public behavior without collection of identifiable information, retrospective chart/record/data reviews, analysis of discarded pathological specimens without identifiers, etc.

Vulnerable Populations
A group of individuals with diminished autonomy who require additional protections. For example, minors must have parental consent to participate. Examples of vulnerable populations: children, pregnant women, prisoners, cognitively impaired, illiterate, etc.

For information regarding prisoner research, please visit the Office of Human Research Protections' (OHRP) webinars listed below:

Prisoner Research 1:  45 CRF 46 Subpart C-Basics

Prisoner Research 2: Considerations When a Subject Becomes a Prisoner

Adverse Event
An event that occurs during the course of a research protocol that either causes physical, social, economic, or psychological harm, or increases the risk of physical, social, economic, or psychological harm, or results in loss of privacy and/or confidentiality to a research participant or others (i.e. family members). Adverse events include expected and unexpected harmful effects and unexpected harms of an interaction or an intervention. 

Protocol Deviation
Any difference in study conduct from the criteria or activities prescribed in the IRB approved protocol, which may or may not affect the participants' rights, safety, welfare, and/or the integrity of the study. 

 


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Federalwide Assurance 

FWA: 00005856
IRB Registration: IRB00000474
IRB Organization: 0000281

To check the expiration dates for these Assurances, please refer to the Department of Health and Human Services website for the Office for Human Research Protections(OHRP) database.

The UMCP Federal Wide Assurance and the IRB registration are listed under "U of Maryland Coll Park Campus".

 


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Full Board Meeting Deadlines & Dates

Meeting Dates Application Submission Deadline
January 17, 2019 December 30, 2018
February 14, 2019 January 27, 2019
March 14, 2019 February 24, 2019
April 11, 2019 March 24, 2019
May 9, 2019 April 21, 2019
June 13, 2019 May 26, 2019
July 11, 2019 June 23, 2019
August 15, 2019 July 28, 2019
September 12, 2019 August 25, 2019
October 10, 2019 September 22, 2019
November 14, 2019 October 27, 2019
December 12, 2019 November 24, 2019

 


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IRB Investigator Handbook

Click below to Download/View IRB Investigator Handbook
IRB Investigator Handbook

 


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IRB Composition & Background

It is a review committee consisting of faculty, students, staff, and outside members that has been established to help protect the rights and welfare of human participants participating in research. It is established to evaluate the ethical implications and conduct a risk-benefit analysis of research involving human participants through the application of 45CFR46 (Code of Federal Regulations governing human subject research).

For additional information regarding the review committee, the Office for Human Research Protections' (OHRP) provides the webinars listed below:

History Lesson:

  1. Nuremburg Code
  2. Tuskegee Syphilis Study
  3. STD Inoculation Study

Belmont Report:

  1. Respect for Persons/Autonomy
  2. Beneficence
  3. Justice

 


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Levels of Review

Review Path Flowchart
Review Path Flowchart

Human Subject Research Determination
If you are unsure if your project requires IRB review and approval, please download and complete the HSRD Form through IRBNet. You will receive an official determination confirming no IRB Approval is needed or additional information will be requested.

Expedited Review
To qualify for an Expedited Review, research should fall into one or more of nine (9) federally-defined Expedited categories. These categories involve collection of samples/data in a matter that is not anonymous and involves no more than minimal risk to participants. Some examples of expedited research include: collection of blood samples, analysis of existing, identifiable pathological specimens, behavioral interventions, surveys/interviews/focus groups, etc.
Expedited Review Guidance and Categories
Expedited Review Flowchart

Full Board Review
Proposed human participant research which does not fall into either Exempt or Expedited review categories will be added to the next available agenda for Full Board Review. Projects presenting greater than minimal risk or transactions increasing the potential risk, will always be reviewed at the Full Board.
Submission Deadline and Meeting Dates

 


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UMD Policy

IRB Office - Standard Operating Procedures
IV-2.10- UNIVERSITY OF MARYLAND SYSTEM POLICY ON HUMAN SUBJECTS OF RESEARCH: Please read the official policy here.

 

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Division of Research
University of Maryland
College Park, MD 20742-1541
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Did You Know

Sergey Brin, co-founder of Google, is an alumnus of UMD's College of Computer, Mathematical, and Natural Sciences.