Frequently Asked Questions (FAQs) - Human Subjects

    

Who are the members of IRB?

When does the IRB meet?

 Are 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?

If my research qualifies as "exempt" under the federal regulations, must I submit an application for approval?

Do course projects involving human subjects require IRB approval?

Do student thesis/dissertation require IRB approval ?

If I am just talking to people and there are no experiments or clinical trials, do I need human subjects 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 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?

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?

Who is responsible for reporting any problems that may occur during the conduct of approved research?

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?

What is an “assurance"?

What is HIPAA?

Who do I contact for information?

How are collaborations with Baystate Medical Center handled?

If I am collaborating with a researcher at another institution, do I need to file for IRB approval at both UMass Amherst and the other institution?

FAQs for Training in the Protection of Human Subjects/CITI


Who are the members of the IRB?

The UMass Amherst IRB currently consists of a community member, some non-scientific members, two physicians and eight faculty members from a range of academic departments.

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When does the IRB meet?

The IRB meets monthly. 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.

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Are there monthly due dates for protocol submission to the IRB for review? 

Protocols requiring full IRB review must be submitted 10 working days in advance of the meeting dates. All other protocols may be submitted at any time. Contact the Human Research Protection Office (HRPO) at 545-3428 for assistance in determining the level of review, if necessary.
   

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Can students and postdoctoral researchers submit protocols?

Studies undertaken by students must be sponsored by a faculty advisor. Postdoctoral scholars may submit independently if they have written approval from the Department and Dean. Otherwise they should submit listing the faculty mentor as Co-Investigator.

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How can I determine whether my research needs review by the IRB?

You can contact the Human Protections Administrator's office at 545-3428.  They will help you decide whether your project 1) fits the definition of research, and 2) fits the definition of ‘human subjects' research. If it fits both definitions it will need oversight by the IRB or, by a local review board as appropriate.

Additional information can be found at Activities Involving Human Subjects Research or in the OHRP decision charts.

 

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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.

 

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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.

 

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Do student thesis/dissertation require IRB approval ?

Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project. Please refer to the Information for Students and their Advisors.

 

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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, 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".

 

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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:

·        That the participation of all the subjects is voluntary.

·        That the rights and welfare of all the subjects will be adequately protected.

·        That the consent process will be conducted in accordance with federal regulations.

·        That the potential harms (risks) to the subjects are outweighed by the potential benefits to science and society. This determination can only be made if the protocol contains a robust description of the study procedures. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification. 

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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.

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 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.

 

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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.

 

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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 interacting and/or intervening with human subjects or handle the personally identifiable data of a human subject.

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What forms do I need to complete to get my protocol approved?

The Human Research Protection Office (HRPO) has converted to a new on-line human subject approval system called e-Protocol.

In order to access e-Protocol, you will need to contact the HRPO and provide the following information: Name, Department, Title (graduate student, postdoc, associate professor, etc) , e-mail and NETID . (Note your NETID is the login that you would use when checking your e-mail through UMAIL). Please note: The CITI human subjects on-line training must be complete before a login can be provided for e-Protocol.

Human subject review done by local boards will not be submitted through e-Protocol at this time.

Consent Forms will need to be attached in e-Protocol. See below for consent form templates:

 

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How many copies of my protocol should I submit to the Human Research Protection Office?

None. All protocols are now submitted through e-Protocol, an on-line human subject approval system.

 

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How soon before a grant deadline should I submit a protocol?

Once you have submitted your proposal to OGCA with “human subjects” checked, 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. 

 

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Where do I submit my protocol?

The Human Research Protection Office (HRPO) has converted to a new on-line human subject approval system called e-Protocol.

In order to access e-Protocol, you will need to contact the HRPO and provide the following information: Name, Department, Title (graduate student, postdoc, associate professor, etc) , e-mail and NETID . (Note your NETID is the login that you would use when checking your e-mail through UMAIL). Please note: The CITI human subjects on-line training must be complete before a login can be provided for e-Protocol.

Once your submission 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 them for more information. Departments without Local Review Boards should submit materials to the IRB.

 

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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:

  • That the participation of all the subjects is voluntary.
  • That the rights and welfare of all the subjects will be adequately protected.    
  • That the consent process will be conducted in accordance with federal regulations and UMass human subjects policies.
  • That the potential harms (risks) to the subjects are outweighed by the study's potential benefits to science and society. This determination can only be made if the protocol contains a robust description of the study procedures. Note that the IRB can review only the information submitted in the protocol. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification.

 

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How long will it take to review my protocol?

Approval date is dependent on the level of risk and the backlog of protocols to be reviewed. Generally your protocol will be reviewed within four-six weeks.

 

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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!

 

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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.

 

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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.

 

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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: Amendments/Modifications to a Protocol.


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 follow the instructions located at: Adverse Events.

 

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How long is a protocol approval good for?

If your protocol was reviewed and found to be exempt you will only need to update your protocol once every 3 years or if you wish to change the scope of work.  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.  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.

 

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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.

For e-Protocol continuations, please see instructions at: Renewal/Continuation of an Approved Protocol for e-Protocol Submissions.

 

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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.

 

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What is an “assurance”?

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.

 

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What is HIPAA?

HIPAA is shorthand for The Health Insurance Portability and Accountability Act which contains privacy regulations affecting researchers collecting data from a covered entity, such as Baystate Medical Center. (UMass is not a covered entity) These regulations provide significant new privacy protections for the health information of patients and research subjects. HIPAA:

  • Gives patients more control over their health information.
  • Sets boundaries on the use and release of health records.
  • Establishes appropriate safeguards that health care providers and others must achieve to protect the privacy of health information.
  • Holds violators accountable, with civil and criminal penalties that can be imposed if they violate patients' privacy rights.
  • Strikes a balance when public responsibility requires disclosure of some forms of data - for example, to protect public health. For patients - it means being able to make informed choices when seeking care and reimbursement for care based on how personal health information may be used.
  • Enables patients to find out how their information may be used and what disclosures of their information have been made.
  • Generally limits release of information to the minimum reasonably needed for the purpose of the disclosure.
  • Gives patients the right to examine and obtain a copy of their own health records and request corrections.

HIPAA Frequently Asked Questions

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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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How are collaborations with Baystate Medical Center handled?

UMASS researchers working with collaborators at Baystate may now be eligible to seek IRB review at Baystate only, thereby avoiding the requirement for both UMASS and Baystate IRB review. Please see IRB Guidance for more information.

 

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If I am collaborating with a researcher an another institution, do I need to file for IRB approval at both UMass Amherst and the other institution?

Investigators should contact the Human Research Protection Office (HRPO) whenever collaborative research is planned. Separate IRB applications may be necessary, or an IRB collaboration agreement may be reached with the other institution depending on the nature of the study.

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