Compliance

Research in K-12 Educational Setting

Research in educational settings require special conditions be put in place to ensure the safety and welfare of student participants. Issues particular to students in grades K-12 include gaining access to school sites and obtaining parental consent and child assent for students under the age of majority at the study location (in most instances this will be 18 years of age but this can differ based on local and state regulations and interpretation).

Gaining Access to the Setting

All research conducted in, or in cooperation with schools or school districts requires approval from the district or school prior to the initiation of the study. Typically, district or school approval comes in the form of a site letter (on institutional letterhead) signed by the administrator in charge of making such decisions at the school site, or via an email approval from an institutional email address. A copy of this letter or email should be included in the attachments section of Kuali.

Parental Permission / Child Assent

For research conducted with participants who are under the age of majority, parental permission is required in addition to the child’s assent. Parental permission should be done in a manner that actively engages parents in the consent agreement. Passive consent is when an individual does not actively consent but also does not object to participation. Passive consent is not acceptable for research with children. 

Both parental permission forms and child assent forms (or waivers if applicable) should be included in the IRB submission. For more information on research with children, parental permission, and child assent please see our Assent Guidance and Assent Template, and our Parental Permission Template.

Things to Consider When Formulating Your IRB Submission

When submitting a protocol for research in an educational setting, the following information should be considered and addressed in the submission:

  • Undue influence is difficult to avoid in a classroom setting, where activities are determined and implemented by adults. Research designs should include strategies to reduce this risk. For instance, clear procedures should be in place for handling students who are not participating in the study in order to minimize interruption to the typical school day. Although students are generally obligated to participate in activity designed for the whole class, activities specifically implemented for the 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?);
  • The risks and inconveniences should be assessed and clearly described in the protocol and consent. For instance, in studies involving examination of classroom management techniques, will individual students be singled out for use of specific techniques? If so, what risks does that present to that child and to the other students (e.g., possibility of increasing in disruptive behaviors)?
  • Describe how privacy and confidentiality of all participants (i.e., student, teacher) will be maintained. For example, will study results be shared back with the school on an individual level or in aggregate? Will information about teacher performance be shared with school administration? What risks to participants are presented 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.  
  • 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.
  • Describe the plan for handling a student who wants to withdraw from the study after consent/assent has been obtained;
  • Benefits or compensation for participation should extend to the entire class, regardless of how many children agreed to participate. This prevents scrutiny or peer pressure on the students who decline to participate.
  • When research activities involve the use of video and audio recording it is incumbent on the researchers to ensure that only those participants who have consented to participate in the study and agreed to be video/audio recorded are included in the recording.  If a parent/participant has not agreed to be video recorded, then the researchers must make sure that these participants are out of the video shot range and/or that these persons are deleted from any video recordings collected during the research process.  Subsequent use of video recordings must exclude participants who did not agree to be video or audio recorded.  
  • Some school systems may require that researchers obtain criminal background checks prior to conducting research (e.g. CORI, SORI); researchers must follow the requirements of the school system.
  • 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. 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 see FERPA (Family Educational Rights and Privacy Act), and PPRA (Protection of Pupil Rights Amendment).

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In the course of designing a research project researchers may deem a survey or questionnaire as the best way to gather data from many participants in a short amount of time. When conducting survey research please remember to inform participants of the topics to be discussed, the risks and benefits of participation, and the manner and form in which data will be collected and confidentiality will be maintained. Below you will find more specific guidance on conducting survey research with an eye toward human subjects research compliance. For examples of a paper survey consent paragraph or an online survey consent document please refer to our consent form template page.

Signed Consent or Consent Paragraph

Some surveys may not require signed consent. For surveys where there is minimal risk to participants, where the signature on consent is the only piece of identifying information being collected, and/or for surveys conducted online, it would be best to utilize a simple consent paragraph as opposed to the much longer signed consent form. Please note that even though participants may not be required to sign the consent form, consent is still being obtained and participants should still be given the same type of information (voluntary nature of study, risks, benefits, procedures to maintain confidentiality, etc) as participants who will be physically signing a consent form. The shortened paper survey consent paragraph  or online survey consent acts as a consent document for participants and the process of participants proceeding to the survey and completing it constitutes consent.

Anonymity and Confidentiality

Few surveys are truly considered anonymous. Even though a participant is not being asked for their name in the survey, other pieces of information (IP address, email address, zipcode, etc) and/or demographic questions (sex and race especially in a small sample with low diversity) can potentially be used to glean the identity of individual participants. Also, in a face-to-face survey even if a name is not being recorded the mere fact of the researcher meeting the participant face-to-face negates the concept of anonymity. A more accurate description of survey data would be that it will be confidential meaning that researchers will utilize certain procedures to maintain the confidentiality of participants’ data.

Confidentiality in an Online Survey

For online surveys special attention must be paid to how participants data will be secured. This entails having a familiarity with: the survey software being used, the types of information being collected (IP address, email address), the options the survey software provides regarding what information to collect, the ways in which information will be stored, and how any identifying information will be de-linked from survey data, etc. It is important to note that third party survey software companies (i.e. Survey Monkey, Zoomerang, etc.) differ from software licenses made available through UMass (i.e. – Qualtrics, etc) so the researcher will need to be aware of these differences and the affect this will have on how and where survey data is stored and maintained. Aside from the ways in which any survey software will collect and maintain survey data, the researcher will also need to provide information about how the data, once retrieved from the survey software provider, will be maintained (i.e. – on password protected computers, on password protected cloud storage [What are the Terms Of Service for cloud storage company], etc). This information is necessary for the IRB to assess the level of security and subsequent risk to participants data being divulged. Information regarding data security would need to be included in the protocol submission and in the consent form.

For specific language to use in the consent form regarding confidentiality and data security please see our consent form templates.

Debriefing Process for Online Surveys

Some research requires a debriefing after participants have completed an online survey. Online debriefing forms should be similar to the debriefing process done during in-lab experiments. The debriefing page should come immediately after the last question on the survey. Participants should be thanked for participation and more information as to the purpose of the study should be provided. Also, researchers contact information and information about other resources (IRB info, Health Services, Local Resources) should be provided and participants should be reminded to print a copy of the debriefing form for their records. Participants should also be given the option to withdraw their data at this point (now that they have been fully informed as to the intent and purpose of the study). If they agree to have their data used for the study then they should have an “I Agree” button to click and submit their data online. If they do not agree to have their data used in the study they should have an “I Do Not Agree” button to click so that their data is not submitted and collected online. Please check with the online survey program you are using to ensure that these capabilities are allowed.

For specific language to use in the debriefing form please see our debriefing form template (general or deception).

Recruitment

For recruitment of online surveys please be sure to detail how participants will be made aware of the survey. If emails will be sent out please be sure to follow the appropriate IT, UMass guidelines and policies regarding mass emails or emails to listservs. Approval of mass emails will need to be documented with the appropriate channels before a protocol submission is approved. For more information on recruitment please see our website.

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The International Affective Picture System (IAPS) image set contains images meant to elicit an emotional response from the research participant. Images are categorized as pleasant, neutral or unpleasant. As some of the images are categorized as unpleasant and meant to conjure disturbing or negative emotions in study participants, research using unpleasant IAPs poses a special concern to the IRB. Therefore, to best protect research participants and research staff involved with unpleasant IAPs protocols, specific measures must be taken to ensure that the risk of negative psychological consequences is minimized for all parties involved. Research protocols using pleasant or neutral IAPs do not automatically need full board review. If you are using pleasant or neutral IAPs and are unsure of the type of review you need, please consult our review guidance.

The following guidance will provide information for (1) all IAPS protocols as well as for (2) protocols using only unpleasant images:

  1. For ALL research using IAPS, the following must be included in Kuali Protocol submissions
  • Add the following information to the IAPS consent form:
    • [If your study includes the use of IAPS, the following suggested statement should be included: “If you decide to take part in this study, you will be asked to view a variety of pictures that have been categorized to be pleasant, neutral, or unpleasant. If any of the media presented should make you feel too uncomfortable to continue with the study, you are free to immediately withdraw your participation and leave without giving up credit or payment. The content of the pictures may include (insert description of image here. Suggested wording for unpleasant IAPs is as follows: images considered objectionable, such as sexually explicit and violent pictures that may be difficult to look at). To be clear: you may immediately end your participation if any aspect of the research procedure makes you too uncomfortable to continue. Lastly, if you have any discomfort or concerns after viewing the images, you are encouraged to call the principal investigator at (insert contact information for researcher(s)) or contact (list Psychological services with contact information).”]
  • Additionally, the following information should be clearly stated in the protocol:
    • Please include the percentage of pleasant, neutral and unpleasant photographs what will be shown. For example: Subjects will be shown 25% pleasant, 50% neutral, and 25% unpleasant photographs.

2. For any research using UNPLEASANT IAPS images:

  • Please submit all IAPS research protocols that use unpleasant images for FULL BOARD REVIEW.
  • Please clearly justify why the use of unpleasant IAPS images is essential for your research and what insight you hope to gain from this method.
  • Detail all the risks associated with the research protocol clearly, and specifically state what measures will be taken to minimize all risks to research participants.
  • In section 11 of the protocol, attach an information sheet developed specifically to inform any personnel who will be involved with this study and who might be exposed to the images. This sheet should explain to lab personnel the nature of the images that will be shown along with representative samples of the images.
  • Explicitly state in the protocol how research personnel will be informed about the study and how their understanding of the nature of the images will be verified.
  • Due to the nature of the IAPs images, all research participants must be debriefed. For more information regarding debriefing, please visit the debriefing guidance section of the IRB website. A debriefing template can be downloaded here for your convenience.

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UMass Amherst, like all institutions, must be in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule by April 14, 2003. Regulations that have come from HIPAA affect the use of protected health information (PHI, i.e. person-identifiable information produced as a result of health-care services) by researchers. UMass Amherst under HIPAA is a “hybrid entity” meaning that only part of the organization is regulated by HIPAA.

If you are not conducting research that requires access to protected health information (PHI), HIPAA and the Privacy rule will not impact your research. UMass Amherst researchers who need access to their subject's PHI for research must request it from a covered entity. This includes requests for review of medical records, except where a waiver has been obtained. Once a covered entity discloses PHI to a researcher outside the covered entity, HIPAA and the Privacy rule no longer cover those records. However, a researcher outside the covered entity should expect to follow the spirit of the Privacy rule, as well as the Common Rule, and protect a subject's PHI by providing assurance to the subject in the informed consent document that the PHI will only be used for the purposes described in the informed consent document. The PHI should not be disclosed to any third parties not mentioned in the consent document without prior approval by the subject.

For additional information you can view the HIPAA rule text and get the big HIPAA picture from the Office for Civil Rights web site.

Baystate Medical Center

The Privacy Rule and HIPAA regulations will impact some of the collaborative research projects between the University of Massachusetts and Baystate Medical Center (BMC).  If you are working with a BMC collaborator and need access to your subjects' protected health information (PHI) stored at BMC you will need to obtain Authorization from the subject to disclose their PHI.  Your Authorization form will need to be reviewed by the Privacy Office at BMC and they request that you use the BMC HIPAA Authorization forms for collaborative projects with BMC.  Please contact the BMC IRB for further information about how to obtain BMC's Authorization template.

Check HIPAA Frequently Asked Questions for more information. 

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In the course of designing a research project researchers may deem a focus group as the best way to gather data from several participants in a short amount of time. When conducting focus groups please remember to inform participants of the topics to be discussed, the risks and benefits of participation, and the manner and form in which data will be collected and confidentiality will be maintained. Below you will find more specific guidance on conducting focus groups with an eye toward human subjects research compliance. For examples of consent forms please refer to our consent form template page.

Informing Participants: Participants should be informed about the topics that will be discussed and who will participate in the focus group so that they may make an informed decision to participate beforehand. This is especially important for research that will engage sensitive topics and are considered more than minimal risk. Please refer to the to the types of review to determine level of risk for your particular research project.

Audio and Video Recordings: Participants should be informed before the focus group if the session will be audio or video recorded. Participants should also be informed about what will be done with these recordings. If audio or video from the focus groups will be used for something other than data analysis for the approved protocol (i.e. – future research studies, educational purposes, conference presentations, etc.) then participants must explicitly agree to this in the form of a checked box agreeing to or not agreeing to have their video/audio used for the above purposes in the consent form. For an example of wording to be used in the consent form please refer to our consent form template page. For further information on audio, video, and digital recordings of data please refer to our guidelines.

Risks and Confidentiality: The nature of a focus group is such that confidentiality cannot be guaranteed. The researchers must provide participants with the procedures in place to maintain confidentiality of the research data and they must inform participants not to repeat what is said in the focus group to others. For research that is minimal risk adding a paragraph to the informed consent detailing issues of confidentiality for focus groups will suffice.

Paragraph to be included in Focus Group Informed Consent:

Please be advised that although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.

For research that is above minimal risk it may be necessary to include a statement of non-disclosure that participants would agree to in the informed consent.

Non-Disclosure Statement:

____I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group session.
If you cannot agree to the above stipulation please see the researcher(s) as you may be ineligible to participate in this study.

Again please refer to the types of review to determine level of risk for your particular research project. For examples of consent forms please refer to our consent form template page

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In the course of designing a research project, researchers may find it useful to include a debriefing of the study for participants at the close of the project.  The debriefing process is a requirement for studies that employ deception (#1 below), however it could also be used as an educational tool (#2 below).  What follows are: a) guidelines for preparing a Kuali Protocol submission that incorporates deception and/or requires a debriefing process, and b) specific issues that should be addressed in the debriefing form.

1. Use of Debriefing for Deception Studies

Researchers may find that the use of deception, or incomplete disclosure, is a necessary tool for their study.  However, the use of such techniques raises special issues that the IRB will review closely.  Deception occurs when participants are deliberately given false information about some aspect of the research.  Incomplete disclosure occurs when participants are not given information about the real purpose or the nature of the research.

Preparing Your Kuali Protocol Submission for Deception Studies.

A. Justifying the Use of Deception

An investigator proposing to use deception or incomplete disclosure should justify its use in their IRB protocol submission.  Studies utilizing deception should not be submitted for Exempt Review, rather, depending on the nature of the deception the study will be reviewed under either Expedited or Full Board Review processes.  Please address the following when preparing your IRB protocol submission:

  • In the Study Procedures Section, justify the use of deception and explain why deception is necessary to achieve the goals of the study.  Researchers may also provide prior evidence and data that such research methods and use of deception on the proposed subject population does not negatively affect subjects’ attitudes about the research.
  • In the Procedures Section, explain the process to debrief participants.  Explain when participants will be debriefed, who will debrief them, and how they will be debriefed (online studies may require a different debriefing process than in-lab studies – for more information read the Debriefing Requirements below and/or see our website for guidance of online research).
  • In the Risk Section, explain if use of deception is likely to cause the participant psychological discomfort (i.e., stress, loss of self-esteem, embarrassment) while the deception is taking place.  Explain how this risk will be minimized during the experiment and after the experiment is complete (i.e. full debriefing).
  • When participants are not given complete information about the study in the informed consent document, it is no longer considered an “informed” consent.  In this instance the “informed” consent should merely be labeled a consent document.  The IRB must waive certain required elements of the informed consent process (i.e. an explanation of the purpose of the research, a description of the procedures involved, etc.) in such instances.  See below for additional information.
  • Provide a copy of the debriefing statement(s) that will be given to participants and if applicable, the script that will be used by the researchers to orally explain the study (see below for guidance regarding the debriefing).

B. Debriefing Requirements and Process

The debriefing is an essential part of the consent process and is mandatory when the research study involves deception.  The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them.  It should also include other relevant background information pertaining to the study.

After participants have been debriefed immediately following completion of the study the IRB expects that participants will be given a debriefing statement to take with them.  For online studies the debriefing process should occur as soon as a participant has completed the research activity.  As an added measure, it may be necessary to send an email out to all participants after the study is completed to ensure that all participants (those that completed and those that may have stopped mid-way) receive a debriefing form.  The debriefing statement must be reviewed and approved by the IRB.

The process to debrief participants must be explained in your IRB submission. Your submission must indicate who will debrief participants.  The IRB expects that this person is a member of the research team who has knowledge about the research and the deception.

The Debriefing Form should include the following:

  • Study title
  • Researcher’s name and contact information, if applicable, for follow-up questions.
  • Thank participants for taking the time to participate in the study
  • Explain what was being studied (i.e., purpose, hypothesis, aim).  Use lay terms and avoid use of jargon.
  • Explain how participants were deceived
  • Explain why deception was necessary in order to carry out the research
  • Explain how the results of the deception will be evaluated
  • If the study involves use of audio or videotaping an individual participant, give the participant an opportunity to withdraw his/her consent for use of the tapes and, potentially, withdraw from the study all together, after the true purpose of the study is revealed.  The IRB suggests that participants be given at least 48 hours to make this decision and provide contact information for whom participants should contact regarding their withdrawal from the study.  This option must be given to participants even if they were video or audiotaped during a focus group or during an experiment involving other participants.  If a participant decides to withdraw, the PI must use video editing tools to make an individual who withdraws unidentifiable.  If tools are not available, the PI cannot use the video or audiotape.
  • Provide participants an opportunity to withdraw their consent to participate or to withdraw their data from the study.
  • If applicable explain anticipated or observed results so far
  • Offer to provide them with the study results
  • Provide references/website for further reading on the topic
  • Provide a list of resources participants can seek if they become distressed after the study.  For a referral list of counseling resources to cite, please see our guidance page.

The IRB has provided a deception research debriefing form template for researchers to use.  Please note that the UMass Psychology Department may have their own guidelines and specifications regarding debriefing forms used by researchers in the department.  For further information on psychology department specific guidelines please see their website.

2. Use of Debriefing as an Educational Tool

Finally, the IRB suggests that the debriefing also be used as an educational tool, even when the study does not involve the use of deception.  Participants should be given a simple, clear and informative explanation of the rationale for the design of the study and the methods used.  It should also ask for and answer participant’s questions. The IRB has provided a generic debriefing form template for researchers to use as an educational tool

Source material for this policy guidance was provided by the University of Connecticut IRB.  The UMass IRB gratefully acknowledges this support.

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A Data Use Agreement (DUA) is a contractual document used for the transfer of non-public or restricted use data. Examples include records from governmental agencies, institutions or corporations, student records information, and existing human research subjects’ data.

IRB Requirements for DUAs

  • If a data use agreement is a part of the project you are submitting to the IRB, it should be noted in the protocol application and a copy of the DUA should be included in the Attachments Section.
  • The IRB can provide conditional approval of your protocol if it is needed in order to get a data use agreement signed, but final approval will not be granted until a copy of the signed data use agreement is submitted to the IRB.
  • The University of Massachusetts Amherst’s Office of Research Compliance serves as the campus signatory for data use agreements. DUAs must be routed through the Human Research Protection Office (HRPO).  The HRPO reviews and institutionally endorses DUAs to ensure compliance with appropriate policies and regulations.  HRPO will communicate with the Office of Research Compliance for the final sign-off and approval.
  • For human subjects research purposes, only the Office of Research Compliance is authorized to enter into contractual agreements, including DUAs, on behalf of the University. Researchers cannot sign (including electronic signature) data use agreements on behalf of the institution. DUAs should not be signed by University faculty or staff members in the absence of institutional approval from HRPO and the Office of Research Compliance.
    • Researchers are not authorized to negotiate or sign agreements on behalf of the University. When a researcher signs such an agreement, they could be subjected to legal and financial risks.
    • It is important for researchers to read the terms of a DUA before forwarding it to HRPO for review. It is the researcher’s responsibility to understand and follow the terms of the agreement and to only use data for purposes specified. HRPO assumes that a researcher who transmits a DUA has read and agrees to conform to those terms, whether or not the researcher’s signature is required on the DUA itself.

Importance of DUAs

  • DUAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data and data security measures that must be met in order to ensure that the data is kept secure.
  • Assures that the recipients are using the data in accordance with applicable law.
    • Contractually obligates the recipient to use the data only for the purpose described in the DUA
  • Prevents the inappropriate use of protected or confidential information that could cause harm to research subjects, the investigator or the University.

For Human Subject Data, a DUA is typically required when:

  • Disclosure of data is for research purposes, and
  • Individual authorization for disclosure to this recipient is not/has not been obtained (i.e. through use of a subject-signed informed consent authorization), and
  • When no other form of contract concerning the data transfer exists between the provider and the recipient (i.e. sub-award agreement or a contracted services agreement)

Examples of Data that might be exchanged under a DUA include:

  • Records from governmental agencies or corporations
  • Student record information
  • Existing human research subject data

For Human Subject Data, a DUA is NOT typically required:

  • When data is publically available in public domain
  • When data is exchanged that is not subject to a legal or other restriction on its use
  •  If a research subject signs a consent authorization form that authorizes data sharing with the recipient
  • When another agreement, such as a sub-award agreement or a contracted services agreement is in place
    • Data transfer as part of such a collaborative research project is often addressed in the study protocol or in the funding agreement terms and conditions (i.e. grant, contract, sub-award, contracted services agreement, etc.). In these cases, a separate DUA is generally not necessary.

Source material for this policy guidance was provided by the University of Wisconsin-Madison Education and Social/Behavioral Science IRB. The UMass IRB gratefully acknowledges this support.

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Federal regulations require the IRB to determine that research plans submitted provide adequate provisions for monitoring data collected in order to ensure the safety of subjects.  Monitoring should be commensurate with risks and with the size and complexity of the trials.  Phase III clinical trials generally require a data and safety monitoring board.  Investigators involved in Phase I and II clinical trials must submit a general description of the data and safety monitoring plan as part of the research application and as part of the protocol submission to the IRB.  The following template is provided for UMASS investigators as a guide to developing a data and safety monitoring plan.

I.  Protocol Title

II. Oversight of this Investigation will be provided by person’s name, department, title, contact information

III. Purpose of the Study may use protocol abstract

IV. Assessment of Level of Risk

  • Estimate risk level (minimal, moderate, high) and briefly discuss risk considerations relevant to your protocol.
  • Adapt the monitoring plan based on the risk. Use the following information as guidance only. Check with the IRB for final risk assessment.

a) Minimal Risk: All protocols presenting the potential of risk to subjects, even minimal risk, should address how the investigator will monitor risk and report adverse events. A minimal risk study is defined as one where the probability and magnitude of harm and/or discomfort in the proposed research are not more than ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Minimal risk studies may include non-therapeutic studies such as survey research, questionnaires, blood samples (venipuncture or intravenous catheter insertion), observational studies, DEXA scans, routine MRI scans, special diets, exercise testing, EKG’s, and anthropomorphic evaluations.

However: survey research and questionnaires may present more than minimal risk to subjects if they address highly sensitive information. inclusion of special populations (children, prisoners, pregnant women mentally disabled persons, or economically and/or educationally disadvantaged persons) who may be more sensitive or vulnerable to the risks posed by the research, regardless of the study, may increase the level of risk to moderate or high.

Monitoring Plan for Minimal Risk research does not require an independent Data and Safety Monitoring Board (DSMB). Monitoring is the responsibility of the investigator.

b) Moderate Risk: Moderate risk studies exceed the minimal risk, but constitute less risk to the subject than studies with the potential for serious risks to subjects. Moderate risk studies may include phase I, II or phase III multi-institutional trials, studies using drugs for their indicated use, studies that use invasive hemodynamic monitoring with arterial lines, and studies in which blood and tissue specimens are stored. Studies in which blood is drawn for genetic studies, either real time and/or stored for later use are also deemed to present risk to subjects.

Monitoring Plan for Moderate Risk will, in most cases, require independent safety monitoring. For some strictly genetic studies, in targeted populations, the investigator may serve as the monitor. For small, moderate risk studies, monitoring might be performed by an independent investigator who is an expert in the agent being studied and the patient population.

c) High Risk: Protocols presenting the potential for serious risks and adverse events may include clinical trials using investigational agents, gene transfer studies, studies using FDA-approved agents for non approved indications; Phase I clinical trials; studies requiring investigator-initiated IND’s (investigational new drug) or IDEs (investigational devices); and some Phase II clinical trials.

This category may include studies involving procedures in which there is a high risk for adverse events such as conscious sedation or interventional radiology. Studies in which some or all subjects are at risk of death or severe morbidity because of existing illness or disease are also considered high risk.

Monitoring Plan for High Risk research may require a DSMB. For example, in large, blinded studies involving high risk or special populations a DSMB should be constituted. For some high risk studies, monitoring might be performed by a single, independent investigator who is an expert in the agent being studied and the patient population.

V. Plan for Monitoring Safety/Confidentiality

  • Specify the name and contact information of the individual responsible for monitoring the safety environment of the participants (PI, or additional monitoring personnel)
  • Specify any conditions that would necessitate early termination of the study (i.e. some clinical trails require documentation of stopping rules that might be used if the participants are found to be exposed to excessive risks in relation to anticipated benefits).
  • Specify what you will monitor, for example:
    • State that only subjects who meet the study eligibility criteria are enrolled.
    • The informed consent process will be conducted appropriately and that informed consent will be obtained prior to proceeding with any study procedures. Monitor any problems with informed consent.
    • Data will be collected and analyzed as specified in the protocol.
    • Adverse events will be reviewed promptly and reported as required (see Section VII below).
    • Discuss how privacy and confidentiality of subjects will be maintained. Indicate your plan to protect the private health information from improper use and disclosure (e.g. assign study numbers, de-identification process, locked storage, etc.).
    • Documentation of dropouts.
    • Evaluation of primary and secondary endpoints.

VI. Plan for Data Management

  • Indicate who is responsible for collection and storage of data.
  • Describe how data will be organized, managed, and stored. Security measures used to protect study data from loss or inappropriate use (password protection, restricted access to database, database backup etc.).
  • Include a description of how often interim data will be reviewed and by whom.
  • Indicate who will perform aggregate analysis of data and adverse events, if applicable.

VII. Adverse Event

  • Describe the anticipated adverse events listed in the Consent Form for this protocol.
  • Indicate that you will follow the Adverse Event guidelines  and the Significant Adverse Event Report Form, and, in so doing, will report to the UMASS IRB and to NIH as required.
  • Indicate how adverse events will be identified, for example, interviewing subjects, physical exams, laboratory results, safety test etc.
  • Include the scale that will be used to grade the severity attribution of adverse event. The Common Toxicity Criteria (CTC) scale below is typically used:

0 = No adverse event or within normal limits

1 = Mild AE, not requiring treatment

2= Moderate AE, resolved with treatment.

3= Severe AE, resulted in inability to carry on normal activities and required professional medical attention

4= Life threatening or disabling AE

5= Fatal AE

  • Attribution of Adverse Events Categories : Indicate a scale to be used to attribute the relatedness of the experience to the study procedures/interventions. The following is a common reference:

Definitely related
Probably related
Possibly related
Probably not related
Definitely not related

VIII. Protection of Human Research Participants-Computer Based Training

The University of Massachusetts Amherst Institutional Review Board will approve this plan, with the project protocol, prior to implementation of the study.

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The videos listed below discuss activities involving biological specimens and other private information.  Discussion include how to assess whether an activity constitutes non-exempt human subjects research and clarifies when regulations (45 CFR 46) do and do not apply to an activity. This is an advanced topic video and is best suited to viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects. See also:

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The Public Health Security and Bioterrorism Preparedness Act of 2002 and the USA Patriot Act of 2001 require that research institutions collect information regarding "select agents" and register their presence with the federal government. DHHS and USDA have issued separate but complementary regulations.

In order for the campus to comply with the New Select Agent Regulation (42 CFR 73) and Agricultural Bioterrorism Protection Act of 2002 (7CFR Pt 331 and 9CFR Pt 121) the use of any Select Biological Agents and Toxins, High Consequence Pathogens or Toxins, or Plant Pathogens, must be reported it at proposal submission and to Environmental Health & Safety (EHS).

The Patriot Act also prohibits "Restricted Persons" from possessing, shipping, transporting or receiving Select Agents and prohibits the possession of a "Biological Agent, Toxin or Delivery System" of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The CDC Select Agent Program web site has a set of FAQs where you can learn more.

If you are proposing to use an agent on the list of Select Biological Agents and Toxins in your research you must file a Select Agent Registration Form with EHS. For more information, contact the Biological Safety Officer at EHS, at 545-2682.

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