Compliance

Research involving human subjects conducted by students (including honors theses) at the University of Massachusetts Amherst (UMass) is subject to the same policies and procedures as those for faculty members. If you will be carrying out systematic research leading to a thesis, field study reports, or a dissertation, and plan to interact with human subjects, or you will be utilizing private information about individuals, you will likely require IRB approval BEFORE the research begins.  For more information on whether your project needs IRB approval please see our Determination Form.

Generally speaking, review by a review board should take place if you answer yes to both the questions below:

1. Is your study a systematic investigation designed to develop or contribute to the body of generalizable knowledge? If yes, then your study is defined as research.

2. Will you obtain data through investigation or interaction with one or more living individuals, or will you obtain any identifiable private information about a living individual? If yes, then you are using human subjects.

If you answered yes to these questions, IRB review must be initiated before any research or recruitment of subjects is initiated. Submissions to the IRB are processed through an electronic submission system (Kuali). 

When your protocol is ready, you can submit it to our office through Kuali.  Upon submission you will receive an email indicating that the IRB review process has been initiated. IRB review consists of an administrative review by IRB staff members and a systematic review by some or all Board members as appropriate to the nature of the research. You will be notified regarding the status of your protocol via email and upon approval you will be able to access an official letter of approval by the IRB Chair attached to your protocol during the approval process.  Once approval has been granted you may begin your study. IRB review can take 4-6 weeks. Please plan accordingly.

For assistance with navigating the IRB submission process, please visit the HRPO Consultation page to set up an appointment to come in and talk with an IRB Analyst. 

Please Note: Internal presentations (including the undergraduate research conference), or internal publications (including archiving a thesis on scholarworks), that are not intended to contribute to generalizable knowledge but to demonstrate the skill and ability of the students research, do not require IRB review. Also, classroom assignments are not intended to contribute to generalizable knowledge and do not meet the federal definition of "research" and therefore are not under the purview of the IRB. It is very important to note, however, all classroom assignments must be conducted in accordance with the UMass honor code and all applicable UMass guidance, policies, and procedures. Classroom instructors are ultimately responsible for ensuring the ethical treatment of classroom participants, such as ensuring participant privacy, voluntary consent, and that all participants are treated with respect and dignity. Instructors who have questions about whether classroom projects might violate ethical guidelines should contact the HRPO for advice.

See Frequently Asked Questions (FAQs) for more information or call the Human Research Protection Office (HRPO) at 545-3428.

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Research projects often involve recruiting potential participants using a variety of methods. Some of the more commonly used recruitment methods include flyers, posters, brochures, media advertisements, recruitment letters and word-of-mouth recruiting.

Recruiting is part of the informed consent process; therefore the recruitment and advertising methods must be reviewed by the IRB prior to their use by an investigator. The review is done to ensure that the information is not misleading to subjects. The IRB is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

It is also the responsibility of the IRB to determine that the procedure for recruitment is not coercive and that it accurately describes the likely risks and benefits of study participation. In addition, Federal Regulation states that selection of subjects must be equitable (45 CFR 46.111).

The following guidelines are intended to offer guidance to researchers in advertising and recruiting participants for their studies. These guidelines are consistent with requirements published by the U.S. Department of Health and Human Services.

Recruitment

  1. Advertising and recruiting procedures must protect potential participants' confidentiality.
  2. When obtaining the names of potential participants from third parties, the investigator must consider whether any breach of confidentiality or privacy laws has occurred. For example, doctors must contact their patients for written permission before releasing their names to a third party.
  3. Investigators are responsible for ensuring that approved procedures are followed by any third parties (e.g., therapists, teachers, or social-service providers) who may be aiding in the recruitment and/or advertising process.
  4. There are acceptable means of recruiting UMass students or personnel via email (e.g., requesting permission from listserv masters to post a message to a group, obtaining permission from student organizations to send a message to their membership, obtaining permission from a department head or other authority to send a message to a select group of faculty or staff). The IRB does not generally support the use of wide-spread mass mailings to the campus community.  All proposed methods of recruitment must be described in every protocol and approved by the IRB.
  5. Researchers may not share names of previous research participants with other researchers without permission from the participants.
     

Advertisement

  1. Advertisements must clearly state that volunteers are being recruited for research purposes.
  2. Advertisements must identify the study as a UMASS project and state the responsible contact person including phone number and/or email address. If research site has a web site address, include the web address.
  3. Advertisements must present the nature of the research and any potential benefits to the participants in ways that are not misleading or coercive.
  4. Advertisements recruiting children must explicitly state that parental consent is required for participation (unless the IRB has granted approval for a waiver of parental consent).
  5. Typically advertisements should include eligibility criteria.
  6. The IRB requires that a copy of the planned advertisement and the mode of its communication to ensure that advertisements do NOT:
    • State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the informed consent form and the application/protocol.
    • Make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.
    • Use catchy words like “free” or “exciting.”
    • Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.
    • Promise "free medical treatment" when the intent is only to say participants will not be charged for taking part in the investigation.
    • Advertisements may state that participants will be paid, but should not emphasize the payment or the amount to be paid by such means as larger or bold type.
  7. The IRB must review and approve the final copy of printed advertisements in order to evaluate the relative size of type used and other visual effects.

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Adverse event reporting to the IRB, and in some circumstances, Federal agencies and the Sponsor, is required by Federal regulation.  The UMASS IRB has established the following policies and procedures for the reporting of adverse events as a means of ensuring that the risks and benefits relationship to subjects participating in research studies remains acceptable, and the consent form contains information necessary for subjects to make an informed decision about their participation or continuation in a study. Adverse event reporting requirements differ depending on the nature of the study.

  • To report an adverse event, go to the Kuali website and login.

Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems in involving risk to subjects or others." All adverse events as defined below must be reported to the IRB. The type of event as defined below determines the reporting requirements:

1. Significant Adverse Events

Investigators must report the event as soon as possible, but no later than five (5) weekdays after first awareness of the problem. Significant adverse events include, but are not limited to:

a. any death, excluding death due to the progression of a disease process; OR

b. the combination of the following three conditions:

  • unexpected - any adverse experience that is not identified in nature, severity, or frequency in the consent form, and is not due to the progression of a disease process.
  • serious – includes, for example, any experience that is fatal or life threatening, is permanently or significantly disabling (physically or psychologically), requires inpatient hospitalization or prolongation of hospitalization, contributes to a congenital anomaly/birth defect or is any medical event that requires treatment to prevent one of the medical outcomes listed above.
  • related/possibly related – as determined by the research team.

The same type of events from another study site should also be reported to the IRB within ten (10) weekdays of receipt.

The IRB relies a great deal on the expertise of our investigators to assess SAEs. Therefore, the investigator must provide advice concerning:

  • the relationship of the SAE to the drug, device, intervention, or study protocol
  • whether or not a change in protocol is necessary to minimize risks, and
  • whether or not information about the SAE is relevant to consent and/or re-consent of participants already enrolled.

Reporting Requirement

Once the Principal Investigator (PI) determines that an adverse event meets the IRBs’ reporting requirements, he/she must report the SAE, and related safety information, to the IRB on the required Significant Adverse Event Report Form provided for this purpose. Supporting documents, including a copy of the Informed Consent (IC), should also be attached. For reasons of confidentiality, subjects names must not be included in the report. If the adverse event results in the need to revise the informed consent, or other study documents, the PI must submit a study amendment to the IRB.

2. Trends in One Type of Event

Any new trend toward one type of adverse event within a protocol, serious or not, should be reported to the IRB as soon as the trend is noted. This includes a trend in an expected side effect or noted risk that has created concern. Reporting Requirements: To report a trend, submit the Event Tracking Log with an explanatory cover letter.

3. Other Adverse Events

All events that do not meet the criteria of significant or trends as listed in numbers 1 and 2 above, should be recorded in summary form. Reporting Requirements  All non-significant adverse events occurring in the research and judged by the research team to be related/possibly related to the research protocol should be recorded in summary form and included with the yearly Continuing Progress Report and at the close of the study. To create the summary, use the Event Tracking Log.

4. IRB Actions

Significant Adverse Events reports are immediately forwarded to Human Subject Administrator and IRB Chair. Reports result in the following actions:

  • Accept the report – no further action required.
  • Request additional information pending final action.
  • Recommend review by the original IRB reviewer(s) or the full IRB for possible action.
  • Require information concerning the adverse event be provided to subjects or others when such information may relate to their willingness to continue to take part in the research. In some cases, this may require changes in the informed consent, protocol, or other study documents, which may require reconsenting currently enrolled subjects.
  • If reviewed at a full IRB meeting, the Board may reconsider approval of the study, including suspension and/or termination, if it is determined that the adverse event has resulted in an increased risk to the subjects. In some cases, this could mean modifying (shortening) the continuing review cycle.

5. Reporting to the Sponsor

In accordance with the terms of the Federal Wide Assurance, the Office for Human Research Protections (OHRP) and the Federal Drug Administration (FDA) are notified in a timely manner of 1) serious or continuing noncompliance; 2) significant adverse events involving risk to participants or others; or 3) suspension or termination of IRB approval for a study. Unexpected problems involving risk, unless the event is serious and related to the research, are not routinely submitted to the sponsor.

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The University of Massachusetts Institutional Review Board (IRB) for the Protection of Human Subjects in Research is responsible for protecting the rights and welfare of people who are subjects in UMass research activities. Several types of activity, both research and non-research, involving human subjects commonly occur at UMass. In order to clarify whether or not an activity is research or if human subjects are involved, UMass employs the federal government's definition of research as:

 "A systematic investigation designed to develop or contribute to generalizable knowledge."

Human subjects are defined as:

"Living individual(s) 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."

To apply the definition of research to an activity, one must look at the intent of the investigation, the researcher's relationship with the subjects, and the dispensation of the data.

Activities at UMass involving human subjects commonly fall into the following categories:

Research - the purpose of the activity is to contribute to generalizable knowledge and data gathered may be shared with a research community or the public at large. (requires IRB approval)

Evaluation/Assessment/Service/Reporting - the purpose of these activities is to gather data to measure the current situation in regard to a specific phenomenon or set of factors. Data gathered may be shared only with the sponsor/client/requesting party and where appropriate, the faculty advisor, or used for internal decision making or informational purposes. (typically does not need IRB approval)

Classroom Assignments/Educational Inquiry/Practice - the purpose of these activities is the education of an individual student through an inquiry or experiential approach to discover known principles or phenomena. Data gathered may be shared only with the course instructor or faculty advisor, or in the case of an internship/practicum, the collaborating party. (typically does not need IRB approval)

IMPORTANT: Individuals gathering data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice abrogate their rights to publish data as research data; if they choose to share observations with others, their actions ought to be governed by the ethical standards of their discipline (e.g. American Psychological Association or American Anthropological Association). Individuals who wish to gather data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large, must obtain IRB approval PRIOR to conducting the activity.

The UMass IRB recognizes that human subjects may be harmed by unethical or careless activities resulting from evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice. As a board that values the protection of human subjects and the conduct of ethical behavior, the board strongly disapproves of such unethical behavior. However, the IRB recognizes the limits of its mandate and authority.

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The Attending Veterinarian (AV) at University of Massachusetts Amherst (the University) is responsible for all the duties listed in the Animal Welfare Act Regulations §2.331, the Guide for the Care and Use of Laboratory Animals 8th Edition2 (the Guide) and listed in tThe IACUC Handbook Second Edition3.

The Guide (p.14) states “…. the institution must provide the AV with sufficient authority, including access to all animals, and resources to manage the program of veterinary care.” In accordance with the Guide and AWAR §2.33(2)4 the University fully authorizes the Attending Veterinarian to provide medical care and, if necessary, euthanasia to all “research animals”.  The Attending Veterinarian is not required to obtain approval from the Principal Investigator or any other parties prior to providing treatment or euthanasia to research animals.

Definition 

“Research animals” are vertebrate animals used at the University of Massachusetts Amherst for research, research training, experimentation, biological testing, teaching and related activities, as well as to animals usually maintained on University premises being transported in the care of University personnel.

Policy Guidelines

  1. This policy pertains to the Attending Veterinarian (AV) or his/her designee(s) under the authority and/or direction of the AV.
  2. The AV has free access to all animals, but whenever reasonably possible, the AV or designee will solicit the input of the Principal Investigator (PI) or responsible research staff member(s) prior to implementing treatment or euthanasia of a research animal.
  3. If the responsible research staff member and the AV or designee disagree regarding the need for animal treatment or euthanasia, the AV or designee is authorized to implement any and all actions deemed necessary based on her/his medical judgment.
  4. In extreme and rare circumstances, it may be necessary for the AV or designee to implement animal treatment or euthanasia prior to contacting the PI or responsible research staff member.  The AV or designee will promptly notify the Principal Investigator or responsible research staff of the animal treatment or euthanasia. 

1.  Animal Welfare Act and Animal Welfare Regulations (2002)  pp. 36-37.  Published by United States Department of Agriculture Animal Plant Health Inspection Service.
2. The Guide for the Care and Use of Laboratory Animals 8th Edition (2011), National Academies Press, Washington DC
3. Silverman, J., Suckow, M.A., Murthy, S eds. (2007) The IACUC Handbook Second Edition  pp. 499 – 500.  Published by Taylor & Francis.
4. AWAR §2.33(2). Each research facility shall ensure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.

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