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Clinical Trials Guidance

NIH Clinical Trial Definition – Updated January 7, 2019

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 (PDF)

More information about the clinical trial requirements for grants and contracts can be found here:

The revised Common Rule also requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. More information about these requirements can be found here:

In addition, informed consent documents for clinical trials are required  to include a specific statement relating to the posting of clinical trial information at ClinicalTrials.gov. For more information please visit: NIH's Policy on the Dissemination of NIH-Funded Clinical Trial Information.


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 eight (8) 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:

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.

Unanticipated Problems (UPs)

are defined as any incident, experience or outcome that meets all of the following criteria:

  • Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;
  • Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

The Office of Human Protections' (OHRP) has created an educational video describing the differences between Unanticipated Problems and Adverse Events.

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.


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".


Full Board Meeting Deadlines & Dates

Meeting Date Application Submission Deadline
December 9, 2021 November 21, 2021
January 13, 2022 December 26, 2021
February 10, 2022 January 23, 2022
March 10, 2022 February 20, 2022
April 14, 2022 March 27, 2022
May 12, 2022 April 24, 2022
June 16, 2022 May 29, 2022
July 14, 2022 June 26, 2022
August 11, 2022 July 24, 2022
September 15, 2022 August 28, 2022
October 13, 2022 September 25, 2022
November 10, 2022 October 23, 2022
December 8, 2022 November 20, 2022

 


IRB Investigator Handbook

IRB Investigator Handbook (PDF)


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

Belmont Report:

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

Levels of Review

Review Path Flowchart (PDF)

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.

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 available in the table above.


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