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Frequently Asked Questions (FAQ)



Frequently Asked Questions (Index)

A. General Information

B. Federal Regulations and Institutional Policy

  • When is IRB review required?
  • How is research defined?
  • How is a human subject defined?
  • What is OHRP?
  • What is 45 CFR 46?
  • What is a Form 310?
  • What is the FDA?
  • To what do Parts 50, 56, 312, 812, and 600 of Title 21 of the Code of Federal Regulations refer?
  • How is minimal risk defined?
  • What qualifies for expedited review?
  • What changes require approval by the IRB after the protocol is approved?
  • Do I have to use copies of the stamped consent documents (e.g., consent forms, assent forms, etc.) to recruit/enroll subjects?
  • What is an IND?
  • What is an IDE?
  • What is a HUD?

C. Types of Research

  • I'm just reviewing medical records; do I need IRB approval?
  • I'm just administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?
  • Is IRB review or exemption required for analysis of a data set that contains no identifiers and no means (anywhere) to link specific data with an individual respondent?
  • If I am using data compiled by someone else such as a governmental agency or another researcher, do I need IRB approval?
  • My project is not federally funded; do I need IRB approval?
  • I'm not doing a drug study; do I need IRB approval?
  • My study doesn't involve any risk of any kind. Do I still need to submit an application?
  • I'm working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to file?
  • I've already started a research project and didn't realize that I needed to receive IRB approval first. What should I do?
  • What happens if I conduct human research without IRB approval?
  • I intend to run a pilot study before my large research project begins. Do I need IRB approval before starting the pilot study?
  • I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?
  • Do I need IRB approval if my work will be conducted off campus?
  • My research will be done in another country. Do I have to obtain IRB review and approval?
  • Are there special requirements for protocols that involve gene therapy?

D. IRB Review Procedures

  • What criteria will the IRB use for reviewing my protocol?
  • How can I find out the status of my study?
  • What is the turnaround time for IRB review and approval?
  • When is the deadline for submission?
  • Who reviews my application?
  • What is: a) exempt determination; b) full board review; and c) expedited review?
  • The status of my eProst protocol is "Assigned to Meeting". Which meeting will it be assigned to?
  • How do I make changes, requested by the IRB, to the protocol and/or consent form during the initial review process, i.e., before the study receives initial approval?
  • Do advertisements need to be approved by the IRB?
  • What adverse events need to be reported to the IRB?
  • How do I submit for renewal of IRB approval (i.e., continuing review)?
  • How do I submit a modification or amendment to my IRB-approved research study?

E. Researcher Role and Responsibilties

  • How do I obtain the University of Miami's required educational training (i.e. Protection of Human Subjects and HIPAA)?
  • Does everyone listed on my protocol have to have training?
  • Does the training requirement apply to students conducting interviews?
  • Am I required to list all of the research faculty that might participate on my protocol - or only ones giving significant time?
  • What should I do if I receive a complaint from a participant about the project or if a participant is injured in some way during the course of the project?
  • What are the researcher's responsibilities if a serious or unexpected adverse event occurs?
  • When is a Certificate of Confidentiality required?
  • How do I submit a request for emergency use of an investigational agent?
  • Do I need to let the IRB know when I have completed the study?

F. Informed Consent

  • What is "informed consent"?
  • What's the difference between an Assent Form and a Consent Form?
  • Do I always have to obtain consent of everyone participating in the study?
  • Are sample consent forms available for review? Assent forms?
  • Under what conditions may the requirement for written documentation of informed consent be waived?
  • Under what conditions may some or all of the elements of informed consent be waived?
  • My eProst protocol is approved; how will the consent documents be stamped/watermarked?
  • If I'm changing the study, when do I need to tell my participants about the changes?
  • How can I manage consent forms if the survey is conducted on a web page?
  • How can I get signed consent forms for the surveys that will be mailed to research participants and still maintain confidentiality?
  • I'm doing research with a group of children, is it possible not to have parental consent?
  • Does a witness to the consent interview have to be there the entire time or only to witness the signature of the participant?
  • Can I obtain consent from a representative if the subject lacks capacity to provide their own consent (e.g. surrogate consent)?

G. Special Classes of Subjects

  • What additional requirements apply to research with pregnant women and fetuses?
  • What additional requirements apply to research with prisoners?
  • What additional requirements apply to research with children?

H. HIPAA

  • What is HIPAA?
  • Who reviews issues related to HIPAA?
  • Where do I send my HIPAA: a) authorization form; b) waiver request; c) preparatory to research certification; etc?

I. Terminology

  • What is the difference between "confidential" and "anonymous"?
  • What is a medical device?

J. eProst Functions

  • How do I submit a new protocol?
  • How do I create a consent form?

 

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Frequently Asked Questions (A)

A. General Information

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. Once approved, the IRB must monitor the progress of the ongoing research, prospectively approve modifications, and, if necessary to protect subjects, suspend a research project.

What is the Human Subject Research Office (HSRO)?

The Human Subject Research Office (HSRO) provides administrative support for the University of Miami Institutional Review Boards. The HSRO supports the University IRB process by:

  • Maintaining files on all human subject research at the University of Miami and Jackson Health System
  • Maintaining a database for tracking all research proposals submitted to the IRB
  • Serving as a resource for investigators on general regulatory information
  • Developing, updating and providing guidance with forms, informed consent templates and submission procedures
  • Conducting educational workshops to instruct investigators and their staff on the IRB review process
  • Publishing the University of Miami's Policies and Procedures for the Protection of Human Subjects in Research
  • Keeping the University research community abreast of any new developments affecting human subject research

What are the HSRO's office hours?

The HSRO is open on weekdays from 8:30AM to 5:00PM, except on university holidays or pre-announced staff training days.

Where is the HSRO?

The HSRO is located on the 10th floor, room #1002, of Jackson Medical Towers (East), which is located at 1500 NW 12th Avenue, Miami, FL 33136.

How often does the IRB meet?

Each of the IRBs meet twice per month. The IRB Meeting Schedule is posted on the Institutional Review Boards page of the HSRO web site.

Who serves on the IRB?

IRB members are appointed by the University of Miami's Institutional Official. In accordance with applicable federal regulations, each Board must have a minimum of five members, including at least one scientist, once individual who is considered a non-scientist and one who is a non-institutional member. Members are selected from faculty, staff, and community members. Considerable effort is expended to recruit individuals who have expertise in different areas. This diversity helps to ensure that protocols are evaluated fairly by knowledgeable individuals. If necessary, non-voting consultants may be included to review specific protocols for which the IRB lacks the scientific or clinical expertise to conduct a substantive review.

What is an FWA?

Under the Department of Health and Human Services (DHHS) human subjects protection regulations at 45 C.F.R. 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). Most academic research institutions have a Federalwide Assurance (FWA), which allows them to conduct many different types of research projects. The Assurance formalizes the institution's commitment to protect human subjects. The University of Miami, like most universities extends the protections of the federal regulations to all research conducted under the auspices of the institution, regardless of source of funding, or lack thereof.

What is our FWA #?

The FWA number for the University of Miami is FWA00002247, and the FWA number for Jackson Health System is FWA00001733. The Univesity of Miami IRBs review protocols that involve research conducted at the University of Miami or by UM students and/or staff, and research conducted at Jackson Health System or by JHS employees.

Who is the IRB Administrator for Medical IRB-A? Medical IRB-B? Medical IRB-C? Social and Behavioral Sciences (SBS) IRB?

Each IRB has a team of staff that administers the IRB and each "pod" is overseen by a Senior IRB Regulatory Analyst. A list of the members of each "pod" is available on the About Us page of the HSRO website.

Who is the Chair of Medical IRB-A? Medical IRB-B? Medical IRB-C? Social and Behavioral Sciences (SBS) IRB?

The rosters for all of the UM IRBs are available on the Institutional Review Boards page of the HSRO website. 

 

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Frequently Asked Questions (B)

B. Federal Regulations and Institutional Policy

When is IRB review required?

IRB review is required whenever an investigator (whether professional or student) who is affiliated with the institution conducts research with human subjects, or when such activities utilize the facilities of either the University of Miami or Jackson Health System.

How is research defined?

Research is defined in the federal regulations (c.f. 45 CFR 46) as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge".

When an FDA-regulated drug, device or biologic is involved, the FDA definition of “clinical investigation”, which is considered to be synonymous  with “research” (c.f. 21 CFR 56) must also be considered: "any experiment that involves a test article and one or more human subjects".  

How is a human subject defined?

A human subject is defined in the federal regulations (c.f. 45 CFR 46) as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information".

When an FDA-regulated drug, device or biologic is involved, the FDA definition of “human subject” must also be considered (c.f. 21 CFR 56):  "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient".

What is OHRP?

The Office for Human Research Protections (OHRP) is an office of the federal Department of Health and Human Services (DHHS). OHRP governs the federal regulations for the protection of human subjects in research that involves human subjects that are either conducted or supported by DHHS, under the terms of Title 45 of the Code of Federal Regulations, Part 46 (c.f. 45 CFR 46). OHRP also conducts compliance oversight of such research and provides guidance and educational training.

What is 45 CFR 46?

45 CFR 46 (Title 45 of the Code of Federal Regulations, Part 46) are the regulations for the protection of human subjects in research which include the composition of review boards, criteria for protocol review, regulations for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and reporting requirements for non-compliance. The regulations are based on the ethical principles identified in the Belmont Report.

What is a Form 310?

Form 310 is the former name for Assurance Identification/IRB Certification/Declaration of Exemption form required for human subject research activities that are conducted or supported by the Departments and Agencies adopting the Common Rule; the revised form is now referred to by the title of the form or by OMB#0990-0263. 

What is the FDA?

FDA is the U.S. Food and Drug Administration. If a protocol includes the use of FDA-regulated drugs, devices, or biologics, then Title 21 of the Code of Federal Regulations (21 CFR) is applicable. The terms described in 21 CFR and 45 CFR 46 are similar in many ways, but there are important differences that investigators should be aware of (Comparison of Regulations).

To what do Parts 50, 56, 312, 600, 812 of the Code of Federal Regulations Title 21 refer?

These parts pertain to FDA-regulated agents and describe requirements for informed consent (50), IRB (56), investigational drugs (312), biologics (600), and investigational devices (812).

How is minimal risk defined?

A risk is minimal when "the probability and magnitude of harm or discomfort anticipated in the proposed 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" [Federal Policy 45 CFR 46.102(i)] and [21CFR50.3(k)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Per 45 CFR 46.303, when prisoners are subjects in research, "minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

What qualifies for expedited review?

Protocols that present no more than minimal risk to subjects and include only procedures described in a List of 9 Specific Categories of Research may qualify for expedited review. Expedited review requires all of the same considerations by the IRB as protocols that require full committee review. However, expedited review can be done by one or more designated reviewers.

What changes require approval by the IRB after the protocol is approved?

Any proposed change to the protocol procedures (including subject selection, and consent process), consent personnel, documents (including recruitment ads, investigator brochure and/or study instruments) must be submitted to the IRB for review and approval prior to implementation. Any other changes that may affect a participant's willingness to participate in the study must also be submitted for prospective IRB review.

The only time that a change may be implemented without IRB review and approval is when it is necessary to eliminate an immediate hazard to a subject or subjects.  In such cases, a modification describing the change and situation which required it must be submitted to the IRB as soon as possible.

Do I have to use copies of the stamped/watermarked consent documents (e.g., consent forms, assent forms, etc.) to recruit/enroll subjects?

Yes, all consent and assent documents need to include the IRB approval stamp. In some cases involving minimal risk research, the IRB may waive the consent requirements. Requests for waiver of consent must be made in writing and include a justification. Decisions are made on a case-by-case basis.

What is an IND?

An Investigational New Drug (IND) application is filed with the FDA when a pharmacological agent is being tested for safety and effectiveness in humans or when an FDA approved drug is being used in a different dosage, for a different purpose, or in a different population than previously approved by the FDA. When an application to test the drug is filed with the FDA, an IND number is issued for the drug. Additional information is available on the FDA web site:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
.

What is an IDE?

An Investigational Device Exemption (IDE) is the mechanism by which new medical devices that could impose "significant risk" to patients/subjects are tested in the U.S. An IDE allows an investigational device to be utilized in a study in order to gather information on the safety and efficacy (effectiveness) of the device. An IDE is also required for an approved device which is being used off-label in a research study. Additional information is available on the FDA web site: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/
InvestigationalDeviceExemptionIDE/default.htm
.

What is a HUD?

A Humanitarian Use Device (HUD) is a designation given to devices that may benefit patients being treated for a disease that affects less than 4,000 individuals in the U.S. per year. Because device manufacturers may be less inclined to put research and development costs towards devices for diseases in so few individuals, HUD provisions were created to provide greater access for the use of such devices. A sponsor or an investigator can apply for a humanitarian device exemption which authorizes marketing of the HUD. Additional information is available on the FDA web site: http://www.fda.gov/cdrh/ode/guidance/1381.html.

 

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Frequently Asked Questions (C)

C. Types of Research

I'm just reviewing medical records; do I need IRB approval?

Yes, if the project meets the criteria for research with human subjects. If the review is limited to existing data, and identifiers will not be recorded, the project may qualify for exemption under category 4. If prospective data collection is involved, and/or identifiers will be recorded, the protocol may be eligible for expedited review under category 5. In either case, the determination must be made by qualified IRB personnel.  Depending on the nature of the data collection, HIPAA forms may also have to be submitted for review.

I'm just administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?

Yes. Any activity conducted by an individual who is affiliated with the University of Miami or Jackson Health System that involves research on human subjects must be prospectively reviewed by the IRB, including those studies involving only a few subjects.

Depending upon the types of data collected, the project may be eligible for exemption or expedited review. In addition, the IRB may require additional safeguards for vulnerable populations involved in this type of research.

Is IRB review or exemption required for analysis of a data set that contains no identifiers and no means (anywhere) to link specific data with an individual respondent?

IRB review is required for research that involves human subjects.  If study procedures involve only the analysis of deidentified data, and it is not possible to readily identify the individuals about whom the data were collected, the project may not involve “human subjects” and therefore not require IRB review.  In these cases, submission of a Non-Human/Non-Research Determination Application is recommended (available on the HSRO Forms page within HSRO Forms and Documents on the HSRO home page). 

If a researcher will access identifiable data about living individuals, but will not record identifiers, the definition of human subjects is met, and IRB review is required.  If the investigator provides the IRB with details of the method by which data will be recorded without identifiers, and all of the data are already in existence, exemption under category 4 (45 CFR 46.101(b)(4)) may be appropriate. Alternatively, if the data are publicly available, and analysis is limited to existing data, the project may also be eligible for exemption under category 4.

If I am using data compiled by someone else such as a governmental agency or another researcher, do I need IRB approval?

The proposed analysis must be submitted via eProst to the IRB if the criteria for “research” and “human subject” are met.  In situations where it is not clear whether the criteria are met, submission of a Non-Human/Non-Research Determination Application is recommended (available on the HSRO Forms page within HSRO Forms and Documents on the HSRO home page).

For projects that are determined to be research with human subjects, the research may be exempt from the requirements of the federal regulations for the protection of human subjects if the research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by an investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The determination of qualifying for exemption must be made by qualified IRB personnel.

I'm not doing a drug study; do I need IRB approval?

All research that involves human subjects must be submitted to the IRB for review and approval (or exemption, as applicable) prior to commencement of study procedures, including recruitment of subjects. This policy applies to biomedical and social/behavioral research, whether or not investigational agents are being used.

My study doesn't involve any risk of any kind. Do I still need to submit an application?

All protocols involving research with human subjects that involve or are conducted by anyone affiliated with the University of Miami or Jackson Health System must be submitted to the IRB for review and approval/exemption. This requirement applies regardless of the risk level of procedures.

I'm working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to file?

For a University researcher to participate in a research project at another site, the project needs to be reviewed by the University of Miami IRB, as well as by the other institution's IRB. Changes in the protocol or consent forms required by the other IRB should be brought to the attention of the University of Miami IRB.

An exception to this requirement is that some institutions have an agreement with the University of Miami that removes the need for dual IRB review. You should consult with the IRB office for these situations.

I've already started a research project and didn't realize that I needed to receive IRB approval first. What should I do?

The research activities must be reported to the IRB as soon as possible. The IRB may not approve research retroactively. If approval was not obtained prospectively, a researcher should cease study procedures and contact the IRB. The researcher will be asked to submit an application to the IRB for review and include an explanation for why he/she thought that IRB approval was not required. Based on the information provided, the IRB will conduct an inquiry. The IRB will review the research activity and determine the extent of noncompliance, whether the research was conducted ethically, and whether the data may be utilized.

What happens if I conduct human research without IRB approval?

Federal regulations require that research on human subjects must include a prior review of the project by an IRB. Instances of non-compliance may be reported to the appropriate governing agencies. The University's policy states that non-compliance may result in, among other things, suspension or termination of the study.

I intend to run a pilot study before my large research project begins. Do I need IRB approval before starting the pilot study?

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB.

I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?

If students are conducting human subjects research as part of a class assignment, or to satisfy a degree requirement, the IRB must review the proposed research. However, class assignments to teach or practice research methodology generally do not require IRB approval unless the effort is intended to produce generalizable knowledge. When students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of subjects, even if the student is the primary researcher and actually directs the project. Consultation with IRB staff is recommended for situations in which it is not clear whether a submission is required

Do I need IRB approval if my work will be conducted off campus?

All proposals that will involve research with human subjects and will be conducted by anyone affiliated with the University of Miami or Jackson Health System must be submitted to the IRB for review and approval/exemption. This requirement applies regardless of the site of research activity.

My research will be done in another country. Do I have to obtain IRB review and approval?

Human Research conducted by University of Miami or Jackson Health System investigators, whether in the U.S. or in foreign countries remains under University purview,applicable federal regulations, and institutional guidelines. Human subjects in foreign countries merit the same level of protection as subjects in the United States, and acceptable practices may vary from place to place. Different mores, traditions, and institutions may require different research procedures, particularly in informed consent, recruitment practices, and documentation.

The IRB must ensure that it has adequate knowledge of the local research context during its review of the proposed international research.  Such knowledge may be obtained from a foreign ethics review board, an agency of the federal government, other sources within the foreign country, consultants, or the study team.  The route by which knowledge of the local context will be obtained is dependent, in part, on the level of risk presented by study procedures, and the characteristics of the foreign site.

In general, clinical research projects that include an intervention should be approved by the local equivalent of an IRB in addition to review by a University of Miami IRB. Investigators may be asked to also obtain review approval or permission from local experts or community leaders, especially if a local IRB is not available. The University of Miami IRB generally requires documentation of this "local approval" before it will give its own approval. Researchers should describe what, if any, knowledge or experience they possess regarding the language and culture of the country in question;for very low risk protocol,this may be in terms of local knowledge. Researchers proposing international research should allow additional time for this review process.

Are there special requirements for protocols that involve gene transfer?

Appendix M of the NIH Guidelines describes additional considerations for gene transfer trials. Investigators are advised to review Appendix M early in the protocol development process to ensure that all requirements are met. In addition to IRB approval, approval will need to be obtained from the University of Miami Institutional Biosafety Committee (IBC) and the Recombinant DNA Advisory Committee at the National Institutes of Health (NIH).

 

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Frequently Asked Questions (D)

D. IRB Review Procedures

What criteria will the IRB use for reviewing my protocol?

An IRB may approve non-exempt research only after it has determined that the following requirements, as described by federal regulations, have been satisfied:

  1. Risks to subjects are minimized;
  2. Risks to subjects are reasonable in relation to the anticipated benefits and the importance of the knowledge that may be gained;
  3. Selection of subjects is reasonable in view of the purpose of the research and the setting in which it will be conducted;
  4. Legally effective informed consent will be obtained from each prospective subject, or the subject's legally authorized representative, unless waived by the IRB. The informed consent process and the consent form must provide the appropriate information and be understandable to a lay person;
  5. Informed consent will be appropriately documented in a written consent form unless this requirement is waived by the IRB;
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
  7. When appropriate, adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of data; and
  8. Additional safeguards have been included in the study to protect the rights and welfare of vulnerable populations, such as children; prisoners; pregnant women; mentally disabled persons; or, economically or educationally disadvantaged individuals.

If any of these requirements are not met, the IRB will either recommend modifications that will ensure the study satisfies these requirements or disapprove the study.

How can I find out the status of my study?

The status appears a number of places in eProst. It appears on the study workspace for a given study in the upper-left-hand corner in the box labeled "Current Status." There is also status information available for an event by reviewing the last activity on the "History" tab of the Study Workspace. If you are unable to find the status in eProst, call the HSRO, provide the eProst protocol number and our staff will search the database to determine the status.

What is the turnaround time for IRB review and approval?

We request 4-6 weeks to process all submissions. However, turnaround time depends on a number of factors, including, but not limited to: completeness of submission, IRB meeting dates, type of review required and the investigator's responsiveness to an IRB request for information or changes.

When is the deadline for submission?

Please refer to the current list of IRB Meeting Dates on the Institutional Review Boards page of the HSRO website for submission deadlines for submissions requiring review by the convened IRB. A submitted research proposal will be placed on the next available agenda. At least one IRB is scheduled to meet each week, except during certain holiday periods.

Who reviews my application?

The IRB reviewer depends on the type of review required. An IRB Chair and/or an experienced member of the IRB review protocols that are eligible for exemption or expedited review.

A majority of the full Board (that is, a quorum) must be present at a convened meeting of the Board in order to vote to approve, disapprove or require modifications to a research study that is not exempt or eligible for expedited review.

What is: a) exempt determination; b) full Board review; and c) expedited review?

Exemption means that the project is not subject to the requirements of the federal regulations for the protection of human subjects.  A protocol may be determined to be exempt from IRB review if all procedures fall into one or more of 6 specific categories of research, described in 45 CFR 46.101(b). A designated IRB reviewer makes this determination; the protocol is not reviewed further by the IRB.

Expedited review means that the convened IRB need not review the proposed research.  Expedited review is appropriate for a protocol that presents not more than minimal risk to subjects, and all procedures fall into one or more of a list of 9 specific categories. The IRB chair or designated IRB reviewer makes this determination; the protocol is not reviewed at a convened meeting of the IRB.

Full Board review is required for all protocols that are not eligible for exemption or expedited review. The protocol is reviewed at a convened meeting of the IRB, at which a majority of members are present. Recommendation for action must be voted upon, and a majority must approve the recommendation.

The status of my eProst protocol is "Assigned to Meeting". Which meeting will it be assigned to?

The protocol should be added to the agenda of the next meeting of the given IRB to which the protocol was assigned. Once a protocol has been assigned to a meeting, the meeting date can be seen in eProst on the "History" tab of the study workspace.

How do I make changes, requested by the IRB, to the protocol and/or consent form during the initial review process, i.e., before the study receives initial approval?

If additional information or revision of submitted documents is required during the initial review process, the departmental or ancillary committee reviewers or the HSRO regulatory staff member preparing your submission for the IRB may request changes to the submission. When changes are requested, correspondence will be generated by the eProst system and sent to the researcher.

To ensure that all concerns or requests of the IRB are addressed, the researcher should make the necessary changes to the applicable documents (e.g. consent form, protocol, study instruments), ensure that all documents are attached (or reattached, as applicable), and submit the changes via eProst. Correspondence will be generated by the eProst system and sent to the person requesting changes that allows you to describe the changes/additions that were made, identify the location of the changes/additions, and provide any additional information that may be relevant to the concerns raised by the IRB.

Do advertisements need to be approved by the IRB?

Yes, all advertisements and other recruitment material are considered to be part of the consent process, and therefore, must be submitted to the IRB for review and approval, prior to use.

What adverse events need to be reported to the IRB?

Please review the University of Miami policies on Unanticipated Problems and Adverse Events for specific descriptions of the reporting requirements. 

How do I submit for renewal of IRB approval (i.e. continuing review)?

Every research study involving human subjects must be re-reviewed and approved by the IRB prior to the expiration of IRB approval. No human subject activity may continue once IRB approval has expired. Please refer to the Creating a Continuing Report section of the eProst User's Guide for specific instructions.

All information that is required for a new protocol submission must be entered into eProst  and submitted at least 45 days before a study expires 

How do I submit a modification or amendment to my IRB-approved research study?

Modifications to a study must be submitted via eProst. Detailed instructions may be found in the Submitting Amendments section of the eProst User's Guide.

The changes/additions may not be implemented until the researcher has received written notification from the IRB that the modification was approved.  The only exception to the requirement for prospective review and approval is when a change must be implemented immediately to avoid harm to one or more subjects.  In such situations, a modification must be submitted as soon as possible after the change was made, describing the circumstances as well as requesting review of the change.  

 

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Frequently Asked Questions (E)

E. Researcher Role and Responsibilities

How do I obtain the University of Miami's required educational training (i.e. Protection of Human Subjects and HIPAA)?

University of Miami policy requires that all research personnel complete of the Course in the Protection of Human Subjects in Research available via the CITI program.

Does everyone listed on my protocol have to have training?

Human Subjects Protection training is required for all personnel listed on the protocol. Individuals named on the protocol who are not affiliated with the University of Miami or Jackson Health System may provide evidence of equivalent training in lieu of CITI certification.

Does the training requirement apply to students conducting interviews?

Anyone who has contact with subjects or with confidential study data must satisfy the training requirements.

Am I required to list all of the research faculty that might participate on my protocol - or only ones giving significant time?

The Principal Investigator (PI) must be listed along with all other research staff that will be responsible for the design and conduct of the study and analysis of data.

What should I do if I receive a complaint from a participant about the project or if a participant is injured in some way during the course of the project?

If study procedures involve greater than minimal risk, your consent form should have a detailed account of compensation for injury, if any, as well as what a subject should do in the event of a complaint. Complaints and injuries should be dealt with and reported to the IRB promptly. If a participant has a question about their rights in the study, they should contact the HSRO.

What are the researcher's responsibilities if a serious or unexpected adverse event occurs?

All adverse events that occur during the conduct of a research protocol involving human subjects must be addressed in accordance with sound professional judgment and institutional policy.  Adverse events that meet the criteria for prompt reporting must be reported to the IRB in eProst, via the Reportable Events form. Review the University of Miami policy for more details: Problems and Events that Require Prompt Reporting.

When is a Certificate of Confidentiality required?

A Certificate of Confidentiality is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the information posted by the US Department of Health & Human Services on the Office for Human Research Protections (OHRP) web site at: http://www.hhs.gov/ohrp/policy/certconf.html.

Investigators who are considering submitting an application for a Certificate of Confidentiality are advised to plan well in advance, as the process can be very lengthy. If participation in research is likely to place an individual at risk of criminal liability, the IRB may require that a Certificate be obtained.

How do I submit a request for emergency use of an investigational agent?

Emergency treatment of a patient with an investigational agent may not need prospective IRB review and approval if the patients condition is life threatening and there is no standard treatment available. However, many sponsors and our pharmacy may not release the agent without receipt of an authorization letter from the IRB. Review the University of Miami policies for details: Emergency Use.

Do I need to let the IRB know when I have completed a study?

Yes. An investigator needs to inform the IRB that a study is being terminated or closed and complete a Final Report in eProst. A study should not be terminated until all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis. 

 

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Frequently Asked Questions (F)

F. Informed Consent

What is "informed consent"?

Informed Consent is an ongoing process which starts well before any consent forms are signed and continues until the subject's participation is completed. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation, providing an opportunity for the individual to ask questions and receive answers, and allowing individuals to decide whether to participate. If consent is to be informed, the subjects must genuinely understand the study.

The informed consent process is different from the consent form. The Informed Consent Form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.

What's the difference between an Assent Form and an Informed Consent Form?

An Informed Consent Form is appropriate for autonomous individuals who are legally and cognitively able to agree to participate. An Assent Form is issued for study subjects with diminished capacity, i.e. those who cannot give consent, but are able to participate in the process to some degree can do so through the assent process. With older children, for example, the assent process can be similar to the consent process used with a competent adult. For a younger child, the process and form may be less detailed. Parental permission or permission from a legal appointed representative is appropriate when a subject lacks capacity to consent for themselves.

Do I always have to obtain informed consent from everyone participating in the study?

The regulations generally require that the investigator obtain informed consent from subjects or, when appropriate, from a legally authorized representative of the subject. There are circumstances where an IRB may waive the requirement for informed consent (c.f. 45 CFR 46.116).

Are sample consent forms available for review? Assent forms?

The HSRO has developed and provided consent form and assent form templates, which are located in the "Consent Templates" section under the "HSRO Forms and Documents" section on the "HSRO Home Page".  

Under what conditions may the requirement for written documentation of informed consent (i.e., a signature on a consent form ) be waived?

The IRB may waive the requirement for written documentation of informed consent, (c.f. 45 CFR 46.117), if it finds and documents either of the following:

  1. Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality; or
  2. The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained outside of the research context. In situations in which signed consent will not be obtained, it is often advisable to present subjects with an information sheet or letter that contains the elements of informed consent, for their future reference.

Under what conditions may some or all of the elements of informed consent be waived?

Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent when (c.f. 45 CFR 46.116):

  1. The project involves no more than minimal risk
  2. The waiver doesn't adversely affect subjects
  3. The research couldn't practicably carried out without the waiver; and
  4. Where appropriate, subjects are given information about the project afterwards.

My eProst protocol is approved; how will the consent documents be stamped/watermarked?

Informed Consent Form will be watermarked when the study is approved. The watermark can be found at the top of every page of the document and will list the approval and expiration dates for the document. You can then print as many copies as necessary.

If I'm changing the study, when do I need to tell my participants about the changes?

Changes to a study must be reviewed and approved by the IRB before they are implemented. Consent documents may also need to be revised to reflect changes to a study. Subjects already enrolled and actively participating in the study should be informed of the change if it might relate to their willingness to continue their participation in the study (c.f. FDA: 21 CFR 50.25(b)(5) and DHHS: 45 CFR 46.116(b)(5)).

How can I manage consent forms if the survey is conducted on a web page?

A survey on a web page should contain the elements of informed consent. A reply (i.e., submission of responses to the survey questions) is considered to be implied consent. If there are confidentiality concerns, the IRB may require that the survey be printed and mailed back to the investigator. Where subjects are to reply via e-mail, they should be told in the cover letter that the confidentiality of their responses can not be guaranteed.

How can I get signed consent forms for the surveys that will be mailed to research participants and still maintain confidentiality?

There should be a cover letter that accompanies the survey and which contains the elements of informed consent. Return of the survey implies agreement to participate.

I'm doing research with a group of children; is it possible not to have parental consent?

Researchers are generally required to obtain parental consent in order to conduct research with children. However, pursuant to 45 CFR 46.116 and 45 CFR 46.408(c), there are certain situations where parental consent can be waived. Waiving consent must be appropriate to the study and the protocol must provide details on what mechanisms (in lieu of parental consent) will be put in place for protecting the children who will be participating in the study. The waiver must also be consistent with federal, state, and local law.

Does a witness to the consent interview have to be there the entire time or only to witness the signature of the participant?

Yes, when a witness is required on the IRB-approved consent document, the witness must be present for the entire consent process or at least be present for sufficient time to determine that the subject understands all of the elements of consent and witness the signature of the participant.

Please note, under 45 CFR 46 and 21 CFR 50.27(b)(1) there is no requirement for a witness' signature to ensure that the subject can read and understand the consent process. A witness becomes necessary under 21 CFR 50.27(b)(2) when the elements of informed consent are presented orally to the subject or the subject's legally authorized representative. When this method is used, both a witness and the person actually obtaining the consent must sign to confirm the informed consent process. This method requires specific documentation using a short form in addition to the full consent form and requires prior approval by the IRB.

Can I obtain consent from a representative if the subject lacks capacity to provide their own consent (e.g. surrogate consent)?

If the potential subject lacks capacity to provide their own consent, permission may only be obtained from a legally-authorized representative (i.e., court appointed representative) or an individual who has such authority under a health care proxy if the research is determined by the IRB to provide potential therapeutic benefit and the health care proxy is not restrictive for research.

The IRB must review and approve all recruitment and consent procedures for studies that may potentially enroll subjects who lack the capacity to consent.

 

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Frequently Asked Questions (G)

G. Special Classes of Subjects

What additional requirements apply to research with pregnant women or fetuses?

Under the terms of 45 CFR 46, Subpart B, pregnant women and fetuses are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart B defines both the types of permissible research with pregnant women and fetuses, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartb

What additional requirements apply to research with prisoners?

Under the terms of 45 CFR 46, Subpart C, prisoners are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart C defines both the types of permissible research with prisoners, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartc

What additional requirements apply to research with children?

Under the terms of 45 CFR 46, Subpart D, children are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart D defines both the types of permissible research with children, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd

 

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Frequently Asked Questions (H)

H. HIPAA

What is HIPAA?

The Health Insurance Portability and Accountability Act, most commonly referred to as "HIPAA", is the Privacy Standard that many researchers need to address, and which may require submission of authorization, waiver of authorization, or preparatory to research documents to the Privacy Board.

Who reviews issues related to HIPAA?

The IRBs at the University of Miami are also the Privacy Boards for consideration of HIPAA matters that require Privacy Board review, i.e., partial or complete waivers of authorization. 

Where do I send my HIPAA: a) authorization form; b) waiver request; c) preparatory to research certification; etc?

All applicable HIPAA forms should be uploaded in the HIPAA section of the eProst new protocol form. 

 

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Frequently Asked Questions (I)

I. Terminology

What is the difference between "confidential" and "anonymous"?

Anonymous: Data does not contain any information that would permit identification of the individual(s) about whom the data were collected.  

De-identified: When collected, data contained identifiers or information that would permit identification of the individual(s) about whom the data were collected, but the identifiers or other links to identity have been removed.

Coded:  Data contains identifiers but the identifiers are stored separately from the data; a subject identifier or other code is used to link the two.

Confidential: Data contains information that would permit identification of the individual(s) about whom the data were collected, but is maintained in a manner that protects the information from release to unauthorized individuals.

What is a medical device?

A medical device is defined as "a diagnostic or therapeutic article that does not achieve any of its principal intended purposes through chemical action within or on the body". Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.

 

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Frequently Asked Questions (J)

J. eProst Functions

How do I submit a new protocol?

All new protocols must be submitted to the IRB via eProst, the University of Miami's Electronic Protocol Submission and Tracking system. For specific details, we recommend the eProst User's Guide, a comprehensive and user-friendly manual detailing all of the steps necessary to accurately complete a new study application.  You may also call the HSRO at 305-243-3195 if you have questions regarding IRB issues or if you require technical assistance with eProst.

How do I create a consent form?

You may use the consent form templates located in the "Consent Templates" section under the "HSRO Forms and Documents" section on the "HSRO Home Page".  

 

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