Introduction
This manual has been compiled for graduate students completing research in the Hearing and Speech Sciences Department at the University of Maryland. The contents of this manual will focus on the Institutional Review Board (IRB) process and the basic directions for using the Protocol Approval System (PAS).
What is the IRB?
An Institutional Review Board (IRB) is a committee designated by an institution to help assure the protection of the rights and welfare of human subjects. The IRB approves the initiation of and conducts periodic reviews of research involving human subjects. Investigators also share the responsibility of protecting human subjects. IRB review is required for research involving human subjects. Information can be found at http://www.umresearch.umd.edu/IRB/index.htm.
What is a Human subject?
A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46).
What is Research?
Research is defined by the U.S. Department of Health and Human Services as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46).
What is 45 CFR 46?
The Common Rule (Federal Policy for the Protection of Human Subjects) set forth the human subject protection requirements adopted by the following Federal agencies (Code of Federal Regulations). The University of Maryland, College Park Federal Wide Assurance assures that the University will apply "The Common Rule" to all human subject research regardless of the source of support. Title 45 (Public Welfare) Code of Federal Regulations Part 46 (Protection of Human Subjects) is what governs the IRB protocols followed by the University of Maryland.
45 CFR 46 can be found at the following website: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
What does all of this mean for the HESP graduate student?
Any time a student or faculty member plans to collect data from another person for purposes of reporting this data to others, the project is considered research and must first undergo IRB review. Some examples include: 1. bringing subjects to the lab for assessing listening behavior; 2. administering questionnaires to students in a class; 3. assessing the benefit of treatment for a group of patients in the clinical setting. Also, prior IRB approval is needed if a student or faculty member does not plan to interact or intervene with human subjects but plans to collect private identifiable information.
Students at the University of Maryland, College Park (UMCP) who are conducting research that involves human subjects must go through the same process as faculty members or other UMCP employees to secure IRB approval for their research. Master's theses projects and doctoral dissertation projects involving human subjects research require prior IRB approval.
The student cannot be the Principal Investigator. That role belongs to the student's faculty advisor or another faculty member. When filling out an IRB application form, the student investigator is listed on the student investigator line; and the student's advisor or other faculty member is listed on the principal investigator line.
When research projects involve no more than minimal risks, the student may, in some cases, be listed as a co-investigator if the project is wholly generated and carried out by the student with little input or oversight by a faculty advisor. If the student wants to be listed as a co-investigator, he/she should provide rationale for this role.
Important Message for Students Completing Dissertations or Theses
The Vice President for Research and Dean of the Graduate School issued a memo in 2000 that stated:
"Any research project using animals or humans must be approved by the appropriate Campus committees prior to the initiation of research. This applies not only to research conducted on campus but also to all research conducted under the auspices of the University of Maryland, that is by UM faculty, students, or staff at other sites anywhere in the world.
"During the past several years both the IRB and IACUC have encountered a growing number of graduate students who seek protocol reviews well after research has started, and sometimes after it has been completed. This is in direct violation of all regulations. I have therefore instructed both committees to not approve such after the fact protocols in the future. Please be aware that this policy change could prevent a student's graduation."
In essence, what this means is:
- All requests for permission to use human subjects in research must be obtained before beginning the research.
- Retroactive approval from the IRB will not be granted.
- The Graduate School will not clear a dissertation that involves human subjects without IRB approval.
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Outline of IRB Process
- Complete application form.
- Submit three hard copies. Place them in the IRB Faculty Liaison's mailbox (currently Dr. Gordon-Salant). Make sure each copy of the application has a cover sheet (mark the original cover sheet). The cover sheet is considered to be the first page of the application with all of your information on it. If possible, please include a note containing the PAS number for your investigation.
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B. Departmental Review of Application
- Members of the faculty review the research protocol for clarity, and for adherence to rules covering protection of human subjects. In most cases, they will request changes to the document.
- You will receive notification via PAS of the questions and comments from the Departmental Human Subjects Review Committee, usually within two weeks following submission.
C. Response to Department Review
- Make the appropriate modifications to your investigation via PAS.
- Submit the changes to PAS.
- Your faculty advisor must approve your changes prior to automatic routing to the Faculty Liaison.
D. Department Approval
- You will receive a notice in PAS when the IRB Faculty Liaison has approved the proposal. The proposal is automatically sent to the University IRB. You may not collect data until you receive approval from the University IRB.
E. University IRB Approval
- You will be notified via an automatic email from PAS or a letter from the IRB.
- After you receive written approval and a stamped consent form (for research requiring informed consent), you may begin collecting data.
F. Modification Requests If Necessary (i.e., adding another investigator, etc.)
- If any aspect of your research project changes, you must submit an addendum or modification request to the IRB. Modification requests include: Changes to recruitment procedures, changes to subject selection or criteria, changes to investigators, and/or changes to procedures in any way.
- If your investigation has been previously approved in PAS, you may make a modification request via PAS.
- You may not implement modifications prior to IRB approval except when a change is necessary to eliminate apparent immediate hazards to the subjects.
G. Renewal of an Investigation
- Approximately 1-2 months before your investigation is due to expire, fill out a renewal application. You should be able to do so via PAS.
- If your investigation was not previously approved via PAS, and PAS will not let you choose the renewal option, submit a hard copy application for renewal . You will then send the application for renewal to the University IRB. Once you receive a signed letter of approval to continue your investigation, please place a copy of that letter in the IRB Faculty Liaison's mailbox.
- PAS is working on the capability of renewing applications online, even for applications that were previously approved in paper format. Check the PAS system to see if you can renew online, prior to preparing a renewal on paper.
** You may make modifications to your investigation at any time. Whenever you do so, be sure to follow modification protocol**
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IRB/PAS Application Review Process
- Abstract - Up to 200 words describing the purpose of the research, summarizing strategies used to protect human subjects, and explaining why the benefits of the project are greater than the risk to the subjects.
- Subject Selection - A description of the subjects and how they will be recruited.
- Procedures - A detailed explanation of exactly what will be done to the subjects, methods and procedures to be used, and copies of the questionnaires or handouts used in the experiments and recruitment materials.
- Risks and Benefits - An explanation of the risks and benefits that participating in the project would involve.
- Confidentiality - A description of what will be done to protect the privacy of subjects and to maintain confidentiality of identifiable information. Information should be provided concerning data storage (including location and duration), the persons who will have access to the data, when or if the data will be destroyed, and how the data will be destroyed at the conclusion of the project.
- Information and Consent Forms - Statement of what information will be provided to the subjects about the investigation and copies of all consent forms to be used, including parental permission forms and assent forms for minors (<18 years old).
- Conflict of Interest - A description of any potential conflicts of interest.
- HIPAA Compliance - Statement of whether HIPAA-protected health information will be used.
- Research Outside of the United States - Responses to questions regarding research that will be conducted outside of the United States.
- Research Involving Prisoners - A statement of whether research involves prisoners. For research involving prisoners, responses to additional IRB criteria.
What do the possible outcomes of IRB application review process mean?
Exempt
If the application is declared exempt and approved by the IRB Manager or IRB Co-Chair, no further IRB reviews are needed. The approval forms will be mailed to the address on the application. Exemption is granted for three years. Exemption categories can be found here.
Expedited Review
Certain types of research are eligible for an expedited review. The IRB may use an expedited review procedure when the research involves no more than minimal risk to the subjects and where the only involvement of human subjects will be in one or more of the Expedited Review Categories. In an Expedited Review, the application is forwarded to one or two IRB members for review. The IRB is kept informed of all protocols approved by expedited review at its monthly meetings.
Full Board Review
An application which involves more than minimal risk to human subjects and/or does not qualify for expedited review is reviewed by the members of the IRB at a convened monthly meeting. The IRB meeting dates for Full Board Review and deadlines for submitting applications are listed under IRB Full Board Review Meeting Dates. After the Full Board Review, the Principal Investigator may need to revise the application to address concerns raised by the IRB. If the research is approved pending specific changes and clarification, the Principal Investigator's responses will be reviewed through Expedited Review. If the changes requested by the IRB are not minor, the Principal Investigator's responses will be reviewed by the full board at one of its monthly meetings.
What is "Minimal Risk?"
The Federal regulation for the protection of human subjects defines minimal risk 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 routine physical or psychological examination or tests." For research involving prisoners, minimal risk is defined as: "The probability and magnitude of physical or psychological harm that is normally encountered in daily lives, or in the routine medical, dental, or psychological examination of healthy persons."
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Introduction to the Protocol Approval System (PAS)
The Protocol Approval System (PAS) has been set up by the University of Maryland as an efficient way of handling IRB applications and the review process. PAS is set up through a website and can be accessed through the University's internet or at your home computer. The website is: http://pas.umd.edu/PAS/default.aspx. When you are ready for your research to be reviewed, you must submit an application through PAS which will then be routed between you, your faculty advisor, and the department liaison to the IRB. At the end of that process, PAS will send the application directly on to the IRB for review. Notification of approval, renewal notifications, or requests for information are automatic via email.
At this moment, the Hearing and Speech Sciences Department is involved in the pilot phase of PAS; therefore, please be patient if you experience problems with the PAS system, as there are still bugs to be worked out. If you experience any problems, please do not contact the IRB Manager, Roslyn Edson, directly since she may already be aware of the problem you are experiencing. Instead, you should contact the IRB graduate assistant and Dr. Gordon-Salant (see contact information below). Due to the problems that may occur with PAS, the Hearing and Speech Department asks that you still submit three hard copies of the application to the department via Dr. Gordon-Salant, the IRB Liaison for the HESP Department.
Specific instructions for accessing and using PAS are presented below.
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Basic Guide to Using the Protocol Approval System (PAS)
The website for PAS is found at http://pas.umd.edu/PAS/default.aspx . The very first step in accessing the system is to sign in with your University directory ID and your directory password (this is the same information you use to login to Testudo or WebCT). Once you are logged in your PAS homepage will appear.
A. Starting a New Application
- Expand the Sliding Menu, located on the left side of the screen, by placing the mouse over the blue Menu bar.
- Click the "Getting Started" link. You will be taken to the Getting Started page.
- Click "New" under Submission Type column.
B. Filling Out the Request for Protocol Approval Form (RPAF)
This includes the description of the investigation. You will also need to upload consent forms and other documents as needed (see Step C).
- When you first open a RPAF, your name should automatically be filled in as the Student Investigator. You must select a Principal Investigator (your Faculty Advisor) by using the search button.
- Specify Co-Investigators, if this applies to you, by clicking the search button under the Co-Investigator section.
- Cut and paste your abstract, procedures, risks/benefits, etc. from Word in to the RPAF.
- Once you have filled in the other information on the form, click the save button at the bottom to save your work. You do not have to fill in all of the fields the first time you open the form. You only have to select a Principal Investigator and conflict of interest the first time you open the form. The form can later be opened from the Protocol Information Page to be finished.
C. Uploading a Supporting Document (signed consent form, advertisement, etc.)
You will need to upload consent forms, recruitment flyers, test forms, etc. You should have all of these documents scanned into and/or saved onto your computer before you start this process.
- Click the "Upload New Document" link on the Protocol Information Page. You can upload any .txt, .rft, .doc, .pdf or .xls file.
- To upload a document, click the "Browse" button and select your file, then click on the "Upload File" button.
- All files you upload are automatically converted to PDF format unless the file already is in that format. Since you are the Student Investigator, you will have access to the original file.
D. Deleting Documents
Documents can be deleted provided that they have not been submitted.
- Go to your Protocol Information page.
- Under the Documents section, click on the trashcan icon to delete the document
*Documents that have been added to a protocol after it has been submitted can be deleted before they are released. Use the trashcan icon in the Unreleased Documents section*
E. Submitting Your Protocol
- After completing the RPAF, and uploading all supporting documents, you will be ready to submit your application.
- At the bottom of your Protocol Information Page you will see a box asking if you are ready to submit the protocol for approval.
- Click on the "Please Submit this Application" button, and your application will be routed to your advisor for approval prior to being submitted to the Department IRB Faculty Liaison for Department level review.
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Returning to PAS After Initial Submission
The Protocol Information Page
This is the page where you will find all information related to a specific protocol. It can be accessed via the homepage on your PAS account by clicking on the investigation you want to edit or submit listed under "Unsubmitted Protocols." It is generated in PAS the first time you save a RPAF with an associated PAS number.
- Sign into PAS. You will then see your homepage listing unsubmitted, pending, and active protocols.
- You can open the RPAF for viewing or editing by clicking on the PAS number under the Unsubmitted or Pending Protocols section. You may also view already approved protocols under the Active Protocols section.
- Once viewing the specific Protocol Information Page you can also open supporting documents for viewing by clicking on the name in the Document Title column of the Documents section. Note: Only the RPAF can be directly edited. You may upload new versions of documents with the same name. This will cause the new version to appear below the original and the version number will be increased by one.
Responding to Questions from the Faculty Liaison
Once your RPAF is reviewed, it is likely that your advisor, the Faculty IRB Liaison and/or fellow Department reviewers will have questions for you about your application, or suggested revisions. These will be listed as Questions for the Applicant (QA).
- You will receive a To DO item. Access to your To DO section is located in the sliding menu on the left side of the screen. A reminder email should be sent to you when you have a QA.
- You will find the link to open the QA under your Protocol Information Page. After clicking on the QA link you can fill in responses. Be sure to click "Save" after you type in your response. Then you can select the "Please Send This QA" button. QA'a that you have not completed say "Pending Response" in the Status Column.
- After you submit your answers to the QA, they will be routed to your advisor for approval prior to submission to the Faculty Liaison or the IRB. You may need to submit a revised RPAF at this time. Click on the original document in PAS, make your revisions, and save. This should automatically be saved with a new version number.
- The revised application will be reviewed by the Faculty Liaison to the IRB and occasionally by members of the Department Review Committee. A dialog will continue with the student and faculty investigator(s) until the Faculty Liaison to the IRB approves the document.
**Tip for using PAS: Do not rely on receiving emails from PAS to remind you to check the progress of your investigation. Check back to your PAS homepage often to see if there are any updates in your investigation approval.**
Investigation Approval
Turnaround Time for the Review of IRB Applications at the University Level
Exempt research is usually reviewed within one week upon receipt of the application. Expedited reviews are conducted within about two weeks upon receipt of the application. Please note that the amount of time for an expedited review may be longer if the reviewers request changes or clarification. Full Board Reviews are conducted monthly. However, the turnaround time for applications reviewed by the Full Board may be longer than one month if the application is not submitted by the application deadline, the meeting agenda is full when the application is submitted, or the application is not approved as submitted when first reviewed by the Full Board.
Notification of IRB Approval Not Via PAS
Approval letters are mailed to the Principal Investigator at the location cited on the IRB application cover page. For applications reviewed by the Full Board, Principal Investigators are notified of the IRB's decision within approximately one week of the meeting. If you would like to know the status of an application, you should send an email to Roxanne Freedman or irb@deans.umd.edu.
Notification of Approval Via PAS
Notification of approval, renewal notifications, or requests for information are automatic via email. Again, check back on your PAS homepage frequently for notifications on the progress of the review of your investigation.
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Submitting an Addendum (Protocol Modification) Request
- Once your investigation receives approval, it will be listed under "Active Protocols" on the PAS homepage for your account. Click on the protocol to open the Protocol Information Page.
- Click the "Create a Request for Addendum" button.
- The original protocol is then copied and pasted into a new "Request for Addendum" form.
- At this point, you have the option of making changes to the information on the "Request for Addendum" form.
- Click "Submit" once appropriate changes have been made.
Upon IRB approval of your modification request, you will receive a modification approval letter from the IRB. Please foward copies of any modification approval letters to the Faculty Liaison to IRB by placing it in her Department mailbox.
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Renewal of Investigation
You should submit an "Application for Renewal" approximately 1-2 months before the IRB approval for your investigation is due to expire.
Renewal of Investigation Via Hard Copy to the IRB
In order to renew your application by hard copy you must fill out a renewal form and send it directly to the IRB. You can find this form on the IRB website or at http://www.umresearch.umd.edu/ORAA/forms/umoraa.html#6. Once you submit your renewal application and receive a letter of approval to continue your investigation, pelase forward a copy of that letter to the Faculty Liaison the the IRB by placing it in her Department mailbox.
Renewing an Active Protocol That is About to Expire via PAS
- PAS will place a reminder on your To Do list 60 days prior to the expiration of your protocol. You should also receive email reminders at 60, 30, 14 and 7 days prior to the expiration date unless you renew or terminate your protocol.
- To create a renewal, click on the "Prepare Protocol for Renewal" link on your To Do list. This will take you to your current Protocol Information Page.
- Click the "Please Copy this Protocol to Initiate the Renewal Process" button. This will make a copy of all the most recent versions of your documents attached to the protocol, create a new protocol, and attach the copied documents to this new protocol.
- Complete the Renewal Application. The remainder of the renewal process mirrors the process for creating an initial application.
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IRB/PAS Staff Contact Information
