Human Subjects/IRB

Education Research Settings

Research in educational settings is an important area of study as it has the potential to improve learning for students and advance pedagogical knowledge.  Federal Regulations pertaining to research in educational settings and research with children, outline specific guidelines and policies that must be in place in order to protect participants.  What follows below is information to determine whether a study is exempt. If you have any questions about whether a study is exempt, please contact the HRPO at 413-545-3428.

There is guidance specific to Research in K-12 Settings and Research in Higher Education Settings as well.

1. Is Education Research eligible for Exempt Review?

Federal regulations allow specific categories of human subjects research to be exempt from continuing IRB review (45 CFR 46.101(b)). Category 1 applies to research conducted in schools and other education settings:

Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

i. research on regular and special education instructional strategies, or

ii. research on the effectiveness of or the comparison among instructional techniques, , or classroom management methods.

Please note that survey research involving children is not exempt, nor is observation of a minor’s public behavior unless the investigator does not participate in the activities being observed.

Research exempted as normal educational practice is often conducted in public school settings which may demand that specific steps be followed in order to comply with additional state and federal laws. Although the definition in the regulations is fairly straightforward, it can create a conflict with other regulations that the IRB is obligated to follow, such as Subpart D of 45 CFR 46 (link is external), FERPA (link is external) (Family Educational Rights and Privacy Act), and PPRA (link is external) (Protection of Pupil Rights Amendment). Subpart D specifically deals with children as a vulnerable population and most protocols that qualify for normal educational practice deal with children. If the IRB determines that a research study does not qualify for exempt status, then the extra protections for minors under Subpart D apply. Additionally, FERPA restricts researchers’ access to student records without written permission from parents. However, within FERPA [20 U.S.C. 1232g(b)(1)(F)], there are conditions under which student records can be disclosed without parental consent: “Organizations conducting certain studies for or on behalf of the school”. Investigators must contact each institution and follow that institution’s FERPA policy, in addition to the requirements of UMass IRB. Finally, PPRA outlines 8 categories of protected information for survey responses (for more information on FERPA and PPRA, see related links).

Topics: 

Research in Higher Education Settings

Research in college and university classrooms is a common occurrence. However, particular care should be taken with regards to issues of undue influence, recruitment, and confidentiality. Some of the issues outlined below will be similar to research in K-12 educational settings. Additionally, as with K-12 students, FERPA restricts researchers’ access to college students’ individual records without written permission from students. However, if you are analyzing grades in aggregate, without individual identifiers, you do not need written permission from students.

Things to Consider When Formulating Your IRB Submission

When submitting a protocol for research in a college or university setting, the following information should be considered and addressed:

  • Convenience is not enough of a reason to justify using college or university students as research subjects. There should be a compelling reason why this is the most appropriate population for your study.
  • Researchers should avoid asking students in their own classes to participate in their research studies because of the potential for undue influence.
  • When possible, somebody other than the instructor of the class should introduce the research study, and it should be clear to students that choosing to participate will have no impact on their performance in the class.
  • Undue influence is difficult to avoid in a college or university classroom setting because of the power differentials between students and faculty. Clear procedures should be in place for handling students who are not participating in the study. Although students are generally obligated to participate in activity designed for the whole class, activities specifically implemented for research need to be clearly explained and alternatives be provided for those choosing not to participate. Appropriate alternatives should be provided for those who opt out, and must be described in the protocol as well as the consent form.
  • Clearly describe the difference(s) between what would typically occur in class and what will occur related to the research (i.e., will all students be involved in the same activities or will there be individual students singled out within a classroom?);
  • Describe how privacy and confidentiality will be maintained.  Will course instructors know who has participated in the study (what risks might this pose for students)?   What are the potential risks to participants given how data will be both managed and shared?
  • When research activities are not part of the required class activities, the instructor should arrange to have the data collected by an independent third party, so that the instructor does not know who participated and does not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered.  
  • To alleviate any sense of repercussion from participating in research, researchers should include a statement on the informed consent indicating that participation or non-participation will in no way effect a students’ standing in the course.
  • Most college and university students are of the age of majority in their state, but some are not. If you will be including students who are considered minors in the state in which they reside, describe how you will obtain parental permission for these students.
  • Researchers should not mandate that an entire class of students participate, unless implementation of the intervention is a part of the course curriculum and researchers are only seeking to collect de-identified data of previously outlined course activities.
  • When course credit or extra credit is used as compensation, it is important to provide alternate means of earning course credit or extra credit for those students who choose not to participate in research.
  • As research volunteers, it is important to ensure student participants be allowed to withdraw from the study at any time. Describe the way compensation will be allocated in the event of early withdrawal.  For compensation in the form of extra credit, it may be necessary to provide full credit in a situation of early withdrawal.

Topics: 

Document File: 

Topics: 

Human subject research sometimes involves having potential participants engage in some type of screening activity to determine their eligibility for participation in a study.  Collecting data directly from subjects or prospective subjects such as through written screening tools or oral responses to questionnaires, or accessing private information, i.e., grades, medical test results, legal records, or any other non-public information linked to a potential subject, for purposes of eligibility screening constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review.

Although screening activities do not necessarily result in data that are used to evaluate study outcomes, such procedures occur because of the research and are, therefore, reviewed by the IRB during consideration of proposed protocols. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy and confidentiality of those who are screened.

Screening procedures may include:

  • Any interaction or intervention with the subjects to determine eligibility that would not otherwise have been performed if not for the study, or
  • Accessing the results of interventions that were performed for purposes other than the study.

IMPORTANT NOTE: In order to protect the privacy of potential participants, only the minimal information necessary for screening is to be collected.

The Kuali application should include the following information with respect to screening procedures:

  • The screening materials to be used
  • Data, if any, that will be acquired from the screening activities
  • A separate screening consent
  • When and how the screening data will be destroyed

In those instances where the screening activities involve no more than minimal risk or involve procedures for which written consent is not normally required outside the research context, the investigator may request, and the IRB may find, that it is appropriate to waive documentation of consent for screening activities (i.e. prospective subjects need not sign the screening consent) and the scope of the screening consent can be limited to:

  • A description of the screening tests (see for e.g. PAR-Q Screening Consent)
  • The reasons for performing the tests
  • A brief summary of the description of the study in which the individual may be asked to participate

Additional considerations:

  • Participants determined eligible to participate: If the screening indicates that the prospective subject is eligible for participation, the informed consent procedures for the study, as approved by the IRB, would then be followed.
  • Keeping information confidential: Often the greatest risk with obtaining information during a screening process is the loss of confidentiality.  The investigator must consider and describe how the confidentiality of this data will be maintained. Whenever possible, information obtained during this process should not be connected with subject identifiers.  As noted above, the amount of data collected should be limited. Once collected it should be kept secure or destroyed as appropriate.
  • A screening script for research may be needed in lieu of the normal documented informed consent process.
    • If such screening activities will take place prior to the prospective participant providing informed consent for participation in the research, the investigator may request a waiver of documentation of informed consent (i.e. signed consent) for screening activities.
    • If screening activities will take place only after the subject has provided informed consent for participation in the research, then the waivers described above are unnecessary.
  • HIPAA regulations apply to the screening process if it involves review of medical records. Investigators must obtain prospective HIPAA authorization or apply for a waiver of HIPAA authorization and informed consent.
  • Telephone Scripts: In telephone surveys, the initial recruitment call sometimes leads directly into the consent process. In such studies, the script should include, at least, a statement that the study involves research, the names of the persons responsible for the research, reference to UMass Amherst, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator's telephone number and email address in case the prospective subjects have questions about the study that the interviewer cannot answer, and the IRB phone number if there are questions about a research subject’s rights.

 

 

 

 

 

 

 

Topics: 

Final reports must be submitted upon completion of the study. Studies would be considered eligible for closure once the following is complete:

  • enrollment of subjects is closed, and subjects have completed all research-related interventions, and
  • data collection is complete, and
  • data are de-identified*, for example data are being maintained in such a way that identifiers are separated from the coding system, or data is in a secure location, and
  • there is no additional research beyond the original intent planned for these data.

*For the purposes of submitting the IRB final report, the study will be considered complete if only data analysis using de-identified data remains. If identifiers remain on the data, researchers must request continuing review.

Note that it is the continued responsibility of the research team to maintain the confidentiality of the data. Please complete a final report form and submit it to the HRPO so the study file may be closed.

Submitting a Final Report in e-Protocol

  • From the main screen, click on the double arrow to the right of Protocols (Approved).
  • Click on the protocol number for which you wish to submit the final report.
  • A window will open with several options.
  • Click the circle beside File a Final Report .
  • The protocol will open with a final report form. Fill out all of the information on the form.
  • When you are ready to submit your form, click on Submit Form located in the top right corner of the page.

 

Topics: 

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."

A. Definitions

1. Adverse Event: Any untoward physical or psychological occurrence or undesirable and unintended effect for a participant that may present itself during interventions and interactions used in the research or the collection of identifiable private information under the research, regardless of whether there may or may not be a relationship with the research intervention.

2. Expected adverse event: An adverse event that is not an unexpected adverse event.

3. Unexpected adverse event: Any adverse event, the specificity, frequency or severity of which is not consistent with either:

a. the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, the current IRB-approved informed consent document, and other relevant sources of information, such as product labeling and package inserts; or

b. the expected natural progression of any underlying disease or condition of the participant(s) experiencing the adverse event.

4. Related to the research: An event is related to the research if, in the opinion of the University of Massachusetts (UMASS) investigator, it was more likely than not to be the result of the interventions and interactions used in the research or the collection of identifiable private information in the research (i.e., there is a reasonable possibility that the event may have been caused by participation in the research).

5. Unrelated to the research: An adverse event is unrelated to the research if, in the opinion of the UMASS investigator, the adverse event is not related to the research.

6. Internal events: Adverse events experienced by participants enrolled at the site(s) under the IRB's jurisdiction for either multicenter or single-center research projects.

7. External events: Adverse events experienced by participants enrolled in multicenter clinical trials at sites other than the site(s) over which the IRB has jurisdiction.

8. Unanticipated problems involving risks to participants or others (unanticipated problems): Problems that are (1) unexpected (in terms of nature, severity or frequency) given the research procedures and the participant population being studied; and (2) suggest that the research places participants or others at a greater risk of harm or discomfort related to the research than was previously known or recognized including physical, psychological, economic or social harm.

B. IRB Reporting Requirements

1. Investigators are required to promptly report the following problems to the IRB:

a. Adverse events that are (1) unexpected and (2) related or likely related to the research as determined by the UMASS principal investigator;

b. Information that indicates a change to the risks or potential benefits of the research. For example:

•  An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB

•  A paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB;

c. Breach of confidentiality;

d. Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol;

e. Incarceration of a participant in a protocol not approved to enroll prisoners;

f. Specific protocol-defined events that requires prompt reporting to the sponsor;

g. Sponsor imposed suspension for risk;

h. Accidental or unintentional deviations to the IRB-approved protocol that involved risks;

i. Emergency protocol deviations taken without prior IRB review to eliminate apparent immediate hazard to research participants;

j. Complaints of participants that indicate unanticipated risk or which cannot be resolved by the research staff.

2. Investigators must report problems to the IRB in accordance with the following timelines:

a. Internal problems that require prompt reporting and are fatal or life-threatening must be reported to the IRB within one weekday of the principal investigator becoming aware of the problem.

b. All other internal problems that require prompt reporting must be reported within 5 weekdays of the principal investigator becoming aware of the event or problem.

c. External problems that require prompt reporting are to be reported within 30 days of their receipt by the UMASS principal investigator.

3. Reports must include the following:

a. An Unanticipated Problem Report Form, which includes identifying information (title of the research, name of principal investigator, and name of the sponsor), and a description of the event;

b. Any associated materials, if any, such as medical record notations, forms sent to a sponsor or the sponsor's safety report forms.

4. Records for problems and adverse events that do not require prompt reporting:

a. For internal adverse events that are expected and related and are consistent with the frequency and severity listed in the informed consent document, the principal investigator keeps a summary of the events that have occurred within the last approval period and submits the summary at the time of continuing review using the Event Tracking Log.

b. Accidental or unintentional deviations to the IRB-approved protocol that do not involve risks to participants may be submitted to the IRB using the Protocol Deviation/Violation Report Form if required by the sponsor.

c. External adverse event reports that do not require prompt reporting to the IRB, are reviewed, initialed and dated by the principal investigator and filed with the research regulatory documents. This record is to be made available to the IRB upon request.

C. IRB Process for Handling Reported Problems

1. All reports are provided to an IRB Administrator for review within five working days of their receipt.

2. The IRB Administrator reviews the materials to determine if the report includes the necessary information and for an initial evaluation.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

•  The UMASS principal investigator's assessment of external events must be provided or the report will be considered incomplete and will be returned to the investigator.

b. If in the judgment of the reviewer, the report is definitely not an unanticipated problem involving risks to participants or others, the following procedures are followed:

•  If the report is for an external adverse event, the report is returned to the investigator with an explanation for why it is being returned.

•  If the report is for an internal event, the report is accepted, signed by the reviewer and filed in the IRB study file. A correction to the log will be requested.

•  If the report is for a publication, safety monitoring report, interim results, or other findings, the report is accepted, signed by the reviewer and filed in the IRB study file.

c. All other reports are referred to the full IRB for further action with the following exceptions.

d. If, in the judgment of the reviewer, participants may be at immediate risk of harm and there is insufficient time to wait for review by the convened IRB, an IRB Chair, or the Director of the Human Research Protection Office is consulted. If the Chair or a Director determines that participants are at immediate risk of harm, the principal investigator will be required to suspend the study according to IRB policy for suspension or termination of research.

3. For reports that are sent to the full IRB for review, the report is added to an IRB meeting agenda and is assigned to a primary reviewer by the IRB staff on the basis of the scientific expertise of the review. The primary reviewer and all other board members receive the following information:

a. A copy of the report;

b. A copy of all supplemental material attached to the report;

c. A copy of all tracking logs, if applicable;

d. A copy of the sponsor adverse event report form, if applicable;

e. A copy of the DSMB or safety report, if applicable;

f. A summary of the study;

g. Copies of the current, IRB-approved informed consent document(s) and revised informed consent document(s); and

h. Any other relevant materials.

4. The primary reviewer summarizes the report at the convened IRB meeting and the full IRB will determine if the report meets the definition of an unanticipated problem involving risks to participants or others by deciding if the event meets the following criteria:

a. Unexpected, i.e., not anticipated (in terms of nature, severity or frequency) given the research procedures and the participant population being studied; and

b. Places participants or others at a greater risk of harm or discomfort related to the research than was previously known or recognized including physical, psychological, economic or social harm.

5. The IRB may decide to postpone a decision while awaiting additional information. If, in the judgment of the IRB, participants may be at immediate risk of harm while waiting for this information, the principal investigator may be required to suspend the study according to IRB policy for suspension or termination of research.

6. If the IRB determines that the event meets both criteria, then the event will be considered an unanticipated problem involving risk to participants or others and will be processed as follows:

a. The IRB will consider the following actions:

•  No action necessary;

•  Modification to the protocol;

•  Modification to the informed consent document(s) for future participants;

•  Notification of current or past participants by phone, letter or addendum to the informed consent document;

•  Modification of the continuing review schedule;

•  Monitoring of the research or consent process;

•  Referral to legal counsel, risk management or the institutional official; or

•  Other appropriate action as determined by the IRB.

b. For a report of an accidental or unintentional deviation to the IRB-approved protocol that involved risks or has the potential to recur, the IRB will also consider if the event represents serious or continuing non-compliance.

c. For a report of an emergency protocol deviation taken without prior IRB review, the IRB will consider if the changes were consistent with the rights and welfare of participants.

d. The IRB decision and required actions are documented using the appropriate template and this documentation is sent to the principal investigator.

e. The IRB submits a report of the unanticipated problem involving risk to participants or others to appropriate institutional officials and entities.

7. If the IRB determines that the reported event or information does not meet one of the two criteria, then the event or information will not be considered an unanticipated problem involving risk to participants or others; therefore, no further action is required. The IRB decision is documented using the appropriate template and this documentation is sent to the principal investigator.

8. Investigators may appeal the IRB determinations regarding the report of an unanticipated problem involving risks to participants or others. In order to appeal an IRB decision, the investigator must submit his/her rationale or that of the sponsor and any supporting information. An appeal must be reviewed by the IRB that made the original decision.

D. IRB Process for Handling Non-Reported Events

1. Internal events submitted on the Event Tracking Log will be reviewed at the time of continuing review.

2. Accidental or unintentional deviations to the IRB-approved protocol that do not involve risks are reviewed by an IRB Administrator.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

b. If the investigator indicates that the deviation involved risks, the IRB Administrator contacts the investigator to request that the investigator complete the Unanticipated Problem Report Form.

c. Otherwise, the IRB Administrator stamps the form acknowledging receipt by the IRB office, signs, dates the form and returns a copy of the form to the investigator.

3. External events submitted to the IRB are reviewed by an IRB Administrator.

a. If the report is incomplete, it is returned to the investigator with a request for the additional information.

b. If the investigator indicates that any event meets the definition of a reportable problem, the IRB Administrator contacts the investigator to request that the investigator complete the Unanticipated Problem Report Form.

c. Otherwise, the IRB Administrator stamps the form acknowledging receipt by the IRB office, signs, dates the form and returns a copy of the form to the investigator.

Topics: 

Human Research Protection Office Student Consultation Registration Form

The UMass Amherst Human Research Protection Office (HRPO) offers assistance for students navigating the Institutional Review Board (IRB) review process.  Whether you are conducting human subjects research as part of an honors project, thesis or dissertation project, or an independent study, the HRPO staff is here to help! Sign up here.

For further information, please see: Students Conducting Human Subjects Research.

Topics: 

If a study deals with sensitive topics, such as alcohol/drug use, suicide or child abuse, or uses the Beck Depression Inventory (BDI), subjects should be forewarned in the informed consent form that they will be asked questions on these topics. Subjects should also be given contact information for counseling services should they experience any distress as a result of their participation. Recommended language is available in the informed consent template for sensitive topics.

Depending on the nature of the study, it may be appropriate to also give subjects a separate handout at the conclusion of the study with a list of counseling services in case they experience any distress after completing the study. See the template for list of counseling services. Counseling resources should be local to where subjects are located. If subjects are located in various places, national resources would be appropriate.

In some cases, it may also be appropriate for subjects to be given a debriefing form at the conclusion of the study to reiterate the purpose of the study and to answer any questions they may have.

Topics: 

Pages