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ComplianceFrequently Asked Questions - Human SubjectsAre there monthly due dates for protocol submission to the IRB for review? Can students and postdoctoral researchers submit protocols? How can I determine whether my research needs review by the IRB? Do course projects involving human subjects require IRB approval? Do students' academic research projects require IRB approval? What information does the IRB look for in a human subjects protocol? What is the difference between “confidential” and “anonymous” data? Does my study need an informed consent form? Can I get a waiver of informed consent? What is an informed consent document? How does it differ from an information sheet? Do I need human subjects training before starting my work? What forms do I need to complete to get my protocol approved? How many copies of my protocol should I submit? How soon before a grant deadline should I submit a protocol? Where do I submit my protocol? What is the IRB looking for when it reviews a protocol? Where can I find the forms to put together my protocol? How long will it take to review my protocol? I am in a rush to do my research work, can my protocol be granted pre-approval status? How will I find out whether my protocol has received committee approval? I have received word that my protocol is approved. When can I start my project? How should I report changes or modifications to my protocol? How long is a protocol approval good for? Will I be notified when it is time for me to renew my protocol? What if I forget to renew my protocol after one year? Who do I contact for information? Who are the members of the IRB? The UMass Amherst IRB currently consists of a community member, a non-scientific member, two physicians and eight faculty members from a range of academic departments.
The IRB plans a monthly meeting during the academic year and as needed in the summer months. Protocols requiring review by the full IRB should be submitted 10 days in advance of the full board meeting. Meeting times and places are posted on the Compliance web site.
Are there monthly due dates for protocol submission to the IRB for review? Can students and postdoctoral researchers submit protocols? Studies undertaken by students must be sponsored by a faculty advisor. Postdoctoral scholars do not require a faculty sponsor.
How can I determine whether my research needs review by the IRB? Additional information can be found at http://www.umass.edu/research/comply/Guidelines/activities.htm or in the OHRP decision charts at: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm.
If my research qualifies as "exempt" under the federal regulations, must I submit an application for approval? Yes. The term "exempt" in terms of review process really means exempt from IRB oversight. It is UMass policy to review all research in order to ensure that the research is, in fact, exempt. The application for exempt research is less extensive, and under some circumstances, written, signed informed consent is not required. However, as a general matter, investigators are required to give their subjects a written statement containing information about the study and their part in it.
Do course projects involving human subjects require IRB approval? Not usually. Course-related research projects usually are limited in scope, do not lead to generalizable knowledge and are not undertaken with that goal in mind. These projects are considered classroom exercises and are not subject to review by the IRB.
Do students' academic research projects require IRB approval ? Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project. Please refer to the IRB Guidelines - Information for Students and their Advisors.
If I am just talking to people and there are no experiments or clinical trials, do I need human subjects approval? Yes. Federal regulations define human subjects research to broadly cover interactions as well as interventions with human subjects for research purposes. Surveys, interviews, questionnaires, oral history interviews etc. are all covered by the federal regulations. IRB approval must be obtained prior to commencing the research. Most of this research, however, qualifies as "exempt".
What information does the IRB look for in a human subjects protocol? A protocol will not be approved unless it contains adequate information for the IRB to determine the following:
What is the difference between “confidential” and “anonymous” data? Anonymous data are recorded so that the information can never be linked to the subject who supplied it. Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually “coded”- that is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data and the subject's identity is kept separate from the code and data. Coded data are not anonymous.
Does my study need an informed consent form? Can I get a waiver of informed consent? Under certain conditions the IRB can waive the requirement that the subject sign an informed consent document. These are : 1) where the informed consent document is the only record linking the subject and the research, and the principal risk would be potential harm resulting from breach of confidentiality, subjects may be asked whether or not they want documentation linking them to the research and their wishes should be respected. 2) where the research presents no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside the research context; 3) for projects of minimal risk involving the use of questionnaires, the elements of informed consent may be included in an introductory letter attached to the instrument which should also include a statement to the effect that return of the questionnaire will constitute consent to participate.
What is an informed consent document? How does it differ from an information sheet? An “informed consent document” is a document that records a subject's voluntary participation in a research study and which provides the subject with a description of the study, the risks and benefits of the study to the subject and society, and contact information. Usually subjects are asked to provide written consent to participate in the study by signing the informed consent document, but there are times when written consent is not needed (e.g., if the data collected are to be anonymous). In those cases, a subject can be “consented” through consent discussion and be provided with an “information sheet”. This should provide a description of the study and contact information. If verbal consent is to obtained the researcher should provide a script for the IRB to review.
Do I need human subjects training before starting my work? The training will be required of all investigators, including faculty, staff and students, who are engaged in the planning, conduct or analysis of research that is sponsored by a funding agency and that includes the use of human subjects. What forms do I need to complete to get my protocol approved? You should assemble the materials listed below before submitting your protocol for review by the IRB. For “no risk” or “minimal risk” research like surveys you may request a waiver of need for a formal informed consent document. As an example, mailed survey materials with a cover letter that contains a clear explanation of the aims of the study and a statement as to how you will protect the confidentiality of the participants. For other no-risk studies it may be appropriate to make an oral presentation to the participants in which case you should include a script of what you will say to the participants. You should also include, if available, copies of your questionnaires, data collection sheets, or subject recruiting materials. If you think that your research presents minimal risk to your subjects you may formally request that your research be exempt from further review and oversight by the IRB by including a Request for Exemption Form with your package. However, if you do not include this form it will not preclude the IRB from giving your research exempt status. This what a completed protocol package should contain:
How many copies of my protocol should I submit? Only one copy of each protocol form is needed.
How soon before a grant deadline should I submit a protocol? Once you have submitted your proposal to OGCA with “human subjects” checked, a copy of your proposal will be sent to the Human Research Protection Office. You will then receive a memo requesting protocol information. However, the exact timing of the requirement for your protocol approval depends on the funding agency, many agencies require the approval before funding is released and not before.
Where do I submit my protocol? To submit a protocol for review by the IRB, complete the protocol materials and send to Nancy Swett, Human Research Protection Office, 108 Research Administration Building, 70 Butterfield Terrace. If part of the package is missing they will contact you for the extra materials. Once the package is complete it goes to the IRB chair who reviews your protocol and decides whether your research 1) is exempt from further IRB oversight, 2) will receive expedited review, or 3) requires review by the full IRB. Depending on the level of review required he/she will assign reviewer(s) from among the IRB members. If your research is unsponsored and you plan to submit it for review by your Local Review Board you will need to contact your department. Departments without Local Review Boards should submit material to the IRB.
What is the IRB looking for when it reviews a protocol? The IRB is looking for content in your protocol that will allow it to determine the following:
Where can I find the forms to put together my protocol? You can find instructions, Form 441 and informed consent templates at http://www.umass.edu/research/comply/IRBsubmission.htm.
How long will it take to review my protocol? At this institution, often the human subjects research is minimal risk and is either exempt from further IRB oversight (a decision made by the IRB chair) or may receive expedited review. If so, once the IRB chair has received your protocol submission materials your protocol will be reviewed within two-three weeks. If the IRB chair determines that your protocol needs review by the full IRB the review period is typically 4 weeks.
I am in a rush to start my project. Can my protocol be granted pre-approval status? No. There is no provision allowing you to be granted a pre-approval status to start your project. Your protocol must be submitted, reviewed and approved in writing before you can start your project so plan ahead!
How will I find out whether my protocol has received committee approval? You will receive a letter from the IRB chair when your protocol is approved.
I have received word that my protocol is approved. When can I start my project? You can start your project as soon as you receive written approval signed by the IRB Chair.
How should I report changes or modifications to my protocol? All modification/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (IRB) must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of modifications/changes may be submitted at any time by an investigator. Additional guidelines may be found at: http://www.umass.edu/research/comply/protocolchanges.html
Who is responsible for reporting any problems that may occur during the conduct of approved reseach? Investigators and laboratory or department heads are responsible for reporting promptly to the Committee any serious or continuing noncompliance with university policies or federal regulations. In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Committee. Please use the Significant Adverse Event Report Form on the UMass website.
How long is a protocol approval good for? If your protocol was reviewed and found to be exempt from further IRB oversight you will only need to update your protocol if you wish to change it. For all other protocols IRB approval is for a maximum period of 1 year. At the end of this period you need to return an annual update form to the IRB requesting a renewal. If you have made significant changes to your research you will need to submit a new protocol. At any time, if you make changes to your procedures and/or your Informed Consent document you must inform the Review Board. Sponsored research is subject to a federally-required continuation review every year. Sensitive research may need review by the IRB at more frequent intervals. The interval will be determined at the time the protocol is first reviewed.
Will I be notified when it is time for me to renew my protocol? Normally yes. Every effort is made to remind you when your annual update is due by sending you a Continuing/Final Report Form when your protocol is approaching the end of its approval period. However, it is ultimately your responsibility to keep track of the deadlines and keep your approvals current.
What if I forget to renew my protocol after one year? If you allow the approval of your protocol to expire you cannot continue your project until you file a new protocol and have it approved by the IRB.
An assurance is a contract that the university enters into with the federal government to allow federally-sponsored human research to take place at that institution. The Federal Wide Assurance (FWA) number for UMass is FWA00003909.
HIPAA is shorthand for The Health Insurance Portability and Accountability Act which contains privacy regulations affecting researchers that become effective on April 14, 2003. These regulations provide significant new privacy protections for the health information of patients and research subjects. More information about HIPAA can be obtained from the compliance coordinator and there are excellent slide shows on a site that Stanford University has developed which you can find at http://www.med.stanford.edu/HIPAA/. The Privacy Rule for the first time creates national standards to protect individuals' medical records and other personal health information. HIPAA:
Who do I contact for information? If you have any questions, please contact Margaret Burggren at 545-3428 or e-mail at humansubjects@ora.umass.edu. If your research is unsponsored and you have a Local Review Board you can also contact a member of this review board or your department chair for contact person information.
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