Compliance

Post Approval Monitoring (PAM) at UMass Amherst

The University of Massachusetts, Amherst is a Public Health Service (PHS) Assured Institution. Compliance Monitoring is sometimes referred to as Post Approval Monitoring (PAM), wherein approved animal work is continuously monitored during the approval period. The goal of continuous monitoring is to provide federally required assurance that animal work at UMASS Amherst is conducted according to federal regulations (as approved in animal use protocols).

PAM is accomplished in several ways at UMASS Amherst:

1. The Institutional Animal Care and Use Committee (IACUC) performs semi-annual inspections of all areas that house animals or where animals are used for experimental purposes. This includes, but is not limited to: support areas such as transportation vehicles, feed and bedding storage areas, wash rooms, surgical rooms, drugs and medications, and autoclaves. During these inspections, members of the IACUC are able to observe animals in their current housing locations and periodically may observe animals in active procedures. These inspections are typically announced, but may not be.

2. Each protocol is reviewed and approved for a 3 year period; however, the IACUC requires annual renewal of all protocols, thereby allowing for additional monitoring during the one year anniversary of a protocol.

3. The IACUC Office works closely with the Animal Care Services (ACS). Animal Care Technicians monitor health and well-being of animals daily. Animal Care Technicians often are the first to notice a problem, whether it is a facility issue, an animal health issue, or concerns regarding a procedure they may observe as they work in the facilities. Animal Care Technicians communicate concerns to ACS Managers who then communicate to the IACUC Office.

4. The Research Compliance Specialist may perform interim inspections and laboratory visits between the formal semi-annuals as one component of the PAM program. These visits are modeled on the semi-annual inspections where all facilities and labs in the program may be inspected for, but not limited to: animal well-being, cleanliness, expiration dates, labels, SOPs, up-to-date personnel lists, condition of equipment and surgical records. These visits are typically unannounced.

5. The IACUC Office may perform follow up checks to areas that were cited and reported as corrected in order to confirm correction is; complete, thorough and appropriate.

6. The Research Compliance Specialist may perform additional full protocol reviews. These focus on individual lab operations and research protocols and may include: meeting with PI or other lab personnel, performing facility and animal inspections, and observing procedures. These PAM visits will be announced scheduled visits. Compliance and the PI will work together to ensure all work is being performed in accordance with the approved protocol(s).

 

Updated August 12, 2015

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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.

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To assure the protection of human subjects and to comply with Federal law, the University of Massachusetts Amherst requires researchers to obtain approval for proposed human subjects research prior to recruiting subjects or collecting data from subjects. This applies to preliminary and pilot studies which are developing or testing instruments and procedures, as well as the full study.

Researchers shall explain to subjects, prior to their decision about whether or not to participate, the objectives of the research, the procedures to be followed and the potential risks and benefits.

Once a study is approved, researchers responsibilities include the following:

  • Modifications – Changes in any aspect of the study (for example, project design, procedures, consent forms, advertising materials, additional key personnel or subject population) are submitted to the IRB for approval before instituting the changes.
  • Consent Forms – All subjects are given a copy of the signed consent form. Investigators are required to retain signed consent documents for six (6) years after close of the grant or three (3) years if unfunded.
  • Training – Human subject training certificates, including those for any newly added personnel, are provided for all key personnel.
  • Adverse Events – All adverse events occurring in the course of the protocol are reported to the IRB as soon as possible, but not later than ten (10) working days.
  • Continuing Review – IRB Protocol Report Forms are submitted annually at least two weeks prior to expiration, six weeks for protocols that required full review.
  • Completion Report – The IRB is notified when your study is complete. To do this, complete the IRB Final Report Form.

OHRP Investigator Responsibility Frequently Asked Questions

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Who is considered study personnel on a protocol involving human subjects?

The following information is intended to help researchers determine who is to be included on a protocol involving human subjects. This information is also related to the mandatory training requirement that the University of Massachusetts Amherst has for involvement in human subjects protection.

A person listed as study personnel in the IRB application is an individual who is interacting and/or intervening with human subjects or handles the personally identifiable data of a human subject.

Study personnel that are involved in the informed consent process should also be included on the IRB study personnel list.

All study personnel listed in the IRB application must complete the CITI human subjects protection training. This training is required for all researchers. Every 5 years a refresher course will be required in order to be considered in good standing and have research protocols processed through Kuali. Investigators must take either:

Group 1 -Biomedical Research (Researchers collaborating with Baystate should complete all modules to be certified for Baystate Collaborative Studies.);

Group 2 - Social and Behavioral and Educational Research;

or the

Refresher Course for either Group 1 or Group 2.

Addition of new study personnel to an IRB approved protocol will only be approved if the proposed study personnel have completed the required CITI training. Please note that funding agencies may have their own definition of study personnel as it applies to grant or other funding applications.

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The following is based on guidance received from the Office of Human Research Protections (OHRP). (From Standard Operating Procedures, UMASS Amherst )

An Oral History decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to the policies and regulations outlined in an institution's FWA and HHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of "research" under HHS regulations at 45 CFR 46.102(d): "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Specifically, for the purposes of this policy, the evaluation of such activities hinges upon whether:

The activity is involves a prospective research plan which incorporates data collection, including qualitative data, and data analysis to answer a research question; and

The activity is designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

In order to be subject to the University's human research protections policies, the activity must meet both of the above standards. This determination will be made according to the procedures described in Section 7.1 above.

General principles for evaluating Oral History type activities:

1. Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would NOT constitute "research" as defined by HHS regulations 45 CFR part 46.

Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum . The creation of the video tape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.

2. Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute "research" as defined by HHS regulations at 45 CFR part 46.

Example: An open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.

3. Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR part 46, the creation of such an archive WOULD constitute research under 45 CFR part 46.

Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research.

Investigators are advised to consult with the IRB Office regarding whether their oral history project requires IRB review.

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According to Massachusetts law any physician, medical intern, hospital personnel engaged in the examination, care or treatment of persons, medical examiner, psychologist, nurse, public or private school teacher, educational administrator, guidance or family counselor, drug and alcoholism counselor, psychiatrist, and clinical social worker, etc., is considered a mandatory reporter. What this means is that these individuals are required by law to report the abuse of children.

This information is important to disclose to potential participants as a part of the consent process. Subjects must be informed that there are instances where breach of confidentiality is required by law. Thus, all projects that involve minors and in which the researchers involved are mandatory reporters, should include a statement in the consent and assent forms that indicates this to the subject. A statement, such as the following, should be incorporated in the "Confidentiality" section of the consent form:

There is one exception to confidentiality we need to make you aware of. In certain research studies, it is our ethical responsibility to report situations of child abuse, child neglect, or any life-threatening situation to appropriate authorities. However, we are not seeking this type of information in our study nor will you be asked questions about these issues.

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When a research project involves children, (in Massachusetts, those under 18 years), permission must be obtained from a parent/legal guardian. Children above age seven should be given the opportunity to assent. Assent means the child’s affirmative agreement to participate in research; mere failure to object should not be construed as assent. The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child’s age, experience and maturity. The assent document should also discuss the study purpose, any discomforts or inconveniences the child may experience if he/she agrees to participate, and that participation is voluntary.

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