Human Subjects/IRB

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. The following guidance is intended to help researchers determine whether their research is eligible for such review. Eligible research includes collaborative human research studies where the source of the subjects, data, or specimens is Baystate. The research itself may occur at either or both campuses.

Studies NOT eligible for review at Baystate include:

  1. Research using human tissue or body fluids where labs have not been cleared through EH&S Biosafety procedures. Please contact Judy LaDuc for more information (577-7293).
  2. Collaborative research involving more than UMASS Amherst and Baystate researchers.
  3. Where there is a potential conflict of interest (COI) that has not been cleared through the UMass COI Committee. Please use the following grid to determine this:

If you have answered YES to any of the following questions, please submit your COI disclosure materials to the Human Research Protection Office (HRPO) prior to your application to Baystate. 

  1. Do any of the involved investigators or their immediate family (as described below) have consulting arrangements, management responsibilities or equity holdings in the Sponsoring company, vendor(s), provider(s) of goods, or subcontractor(s)?
  2. Do any investigators or their immediate family have any financial relationship with the Sponsoring company, including the receipt of honoraria, income, or stock/stock options as payment?
  3. Is any Investigator(s) a member of an advisory board with the Sponsoring company?
  4. Do any investigators receive gift funds from the Sponsoring company?
  5. Do any investigators or their immediate family have an ownership or royalty interest in any intellectual property utilized in this protocol?  ("Immediate family" means a spouse, dependent children as defined by the IRS, or a domestic partner.)

Registration: The research must be registered with the UMass Human Research Protection Office (HRPO) prior to application to the Baystate IRB using this registration form.  The initial IRBNet application to the Baystate IRB will require an electronic signature from the UMass HRPO. This will serve as the verification to Baystate that the project has been registered with the UMass HRPO.

Principal Investigator:  A Baystate Principal Investigator must be named on the Baystate IRB application, while the grant or study-wide Principal Investigator may be from either UMass or Baystate. UMass researchers registering must hold faculty level position.*

Ethics Training and Research Personnel:  Individuals who directly interact with subjects or their identifiable data must be listed on the application to the Baystate IRB and have current (within the past 3 years) Baystate training in the protection of human subjects (CITI or approved substitute).  UMass personnel can identify Baystate as a secondary affiliation on the CITI website to gain access to the Baystate-required modules.  There is overlap between the institutions requirements, the secondary affiliation feature “credits” the researcher for the modules already completed for UMass.

Access to Baystate Facilities and Records:  Research personnel from UMass who will be assisting in the conduct of research at a Baystate facility can gain the necessary clearance and access to Baystate systems through the “Associates in Research” process.  Associates in Research are processed through the Academic Affairs Allied Health Office.  See below for contact information.

Grant Application:  When a project is funded, the grant application must be included in the submission to the Baystate IRB so that the IRB can fulfill it's duty to verify that the research proposed to the IRB is consistent with the research as described to the grantor.

ClinicalTrials.Gov:  When registration on ClinicalTrials.Gov is required, the study-wide Principal Investigator holds responsibility for ensuring that registration, interim updates, and reporting of results takes place.  The Baystate IRB Application Part 1 contains information on the ICJME and FDA guidelines to help investigators determine whether or not their study must be registered.

Event Reporting:  When UMass is the recipient of grant or other funds to support the project, both the Baystate IRB and the UMass HRPO must be informed of any unanticipated problems, noncompliance, or suspension or termination of the research.  Baystate and UMass will collaborate on any required reporting to the grantor and applicable federal and state agencies.

Repositories:When data or specimens will be retained for future research projects at UMass the repository must be approved by the UMass IRB and documentation of the repository approval included in the Baystate application.  Subjects should be consented separately for the banking of their specimens or data for future research; this should not be a condition of participation in the primary research project.

Policies:  The policies and guidance documents of the Baystate HRPP must be adhered to including allowing access at reasonable times and with reasonable notice for routine and for-cause quality assurance monitoring.  The policies of the Baystate HRPP can be accessed internally on eWorkplace or externally on BaystateHealth.org.

*(Students' projects must be submitted by faculty sponsor).

Contact Information

Baystate University of Massachusetts
Jennifer Pacheco, BS, CIM, CIP
Director: Human Research Protection Program
Phone: (413) 794-3458
Email: Jennifer.Pacheco@baystatehealth.org
Human Research Protection Office (HRPO)
Phone: (413) 545-3428
Email: humansubjects@ora.umass.edu
Glenn Markenson, MD
Medical Director HRPP
Phone: (413) 794-3470
Email: Glenn.Markenson@baystatehealth.org
Vice Chancellor Michael F. Malone, PhD
Institutional Official, VC for Research and Engagement
Phone: (413) 545-5270
Email: vcre@umass.edu
Matthew Richardson, MD
Chair: IRB #1
Phone: (413) 794-9338
Email: Matthew.Richardson@baystatehealth.org
Lynnette Leidy Sievert, PhD
Chair: UMass Amherst IRB
Phone: (413) 545-1379
Email:  leidy@anthro.umass.edu
Robert Baevsky, MD
Chair: IRB #2
Phone: (413) 794-4159
Email: Robert.Baevsky@baystatehealth.org
Judy LaDuc
Manager: Biological Safety Services, EHS
Phone: (413) 545-7293
Email: jladuc@ehs.umass.edu
HRPP/IRB Main Office: (413) 794-4356 HRPO/IRB Main Office: (413) 545-3428

 

 

 

 

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Because audio, video or digital recordings include images or voices of research participants, they pose a greater concern to the IRB than do data that do not have readily available identifying information. Therefore, to best protect research participants, the IRB requires that any such recordings be destroyed within a definitive timeframe (e.g., five years following the making of the recordings, five years after data are collected).

Although recordings are not specifically addressed in 45 CFR 46, the consent process is clearly defined and holding recordings indefinitely and/or for an unspecified purpose challenges the spirit of informed consent and has the potential to increase risk to participants (e.g., breach of confidentiality, damage to reputation, legal ramifications). To be in line with informed consent and to minimize risk, participants must be informed (in the informed consent form) about the destruction timeframe, as well as informed about who will have access to the recordings and where they will be stored.

PLEASE NOTE: Exceptional circumstances will be considered on a case-by-case basis to determine whether these guidelines should or should not apply.

Archiving Recordings for Future Research

Because the IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

  1. Included in the application must be sound justification for archiving recordings indefinitely.
  2. The informed consent form must include the following:
  • A statement indicating where and how recordings will be stored, secured.
  • A statement indicating who will have access to recordings.
  • Space for participants to indicate whether they
    • Want recordings to be destroyed by the timeframe specified, or
    • Permit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes).

PLEASE NOTE: The application may need to be reviewed at the Full Board Review level, allowing the IRB to decide collectively whether or not archiving the recordings increases risk to participants. The time required for full reviews is tied to IRB meeting dates. Please see meeting dates and submission deadlines and plan accordingly.

Using Archived Recordings for Secondary Data Analysis

Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the IRB. A copy of the informed consent form from the original study must be submitted with the protocol application.

If the IRB finds that the purpose of the secondary data analysis is related to the purpose of the original study and the material in the recordings does not put the participant at risk, the application for secondary data analysis is likely to undergo an Expedited Review.

If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study or the material in the recordings could put the participants at risk, the application for secondary data analysis is likely to undergo a Full Board Review. The Full Board IRB will determine whether or not secondary analysis of the recordings increases risk to participants and whether or not participants were adequately informed during the original study about the use, confidentiality, and destruction of their recordings. Based on these findings, the IRB may require that informed consent for secondary analysis is obtained from participants.

Use of Research Recordings for Educational Purposes or Presentation Purposes

The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. For example:

______I agree that segments of the recordings made of my participation in this research may be used for conference presentations.
______I do not want segments of the recordings made of my participation in this research to be used for conference presentations.
______I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners.
______I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners.

Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). Segments cannot be used for purposes beyond those detailed and consented to in the informed consent form.

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The federal regulations (Subpart D of 45 CFR 46, 46.401) provide additional protection for children involved as subjects in research.  They require that adequate provisions be made for the assent of the child when the child is capable of providing assent, taking into consideration the age, maturity and psychological state of the child involved. Although there are very formal requirements for the elements that must be present in a consent form, no such requirements exist for assent forms.  This means that the investigator can propose assent content that he/she believes will best inform children about the study.  The following are general guidelines for creating an assent form for your study.

  • For research projects involving children, the IRB requires consent from the parent/legal guardian and, if the children are aged 7 years or older, assent from the children.
  • Assent is defined as a child’s affirmative agreement to participate in research. Failure to object is not considered assent.
  • The assent document should discuss the study purpose, any discomforts or inconveniences the child may experience if he/she agrees to participate, and that participation is voluntary.
  • The length of the assent form should be proportional to the complexity of the study and the age of the participants.
  • The use of topic headings may improve readability.

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All revisions/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 revisions/changes may be submitted at any time by an investigator.

"Major" revision requests for protocols that were approved by full IRB review must be reviewed through the full committee review process. Major revisions to protocols initially reviewed by the expedited review process may receive expedited review. However, depending on the nature of the revisions the reviewer may recommend review by the full committee. Examples of revisions considered to be major include, but are not limited to, the introduction of additional risk; the addition of a new invasive procedure change in population group. Major revisions may impact on the risk/benefit ratio in the study. It is the investigator's responsibility to assess the degree of change in the risk/benefit ratio.

"Minor" revision requests are reviewed administratively. If during this review it is determined that the revision is not minor the investigator will be contacted with instructions on how to proceed. A revision is approved only to the expiration date that was received at the protocol's most recent review.

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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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