Research Compliance Services News

March Remote RCR Training 3/26

The Responsible Conduct of Research (RCR) Office within Research Integrity & Compliance in the OVPR hosts monthly remote RCR training sessions. For our March remote event, we will be discussing several case studies. This 1-hour event will count towards the 8-hour in person requirement for NIH, however all those who conduct research are strongly encouraged to attend!

For more details about RCR requirements, please visit our RCR Program website.

For questions, please contact Research Compliance Monitor, Ellen Ciesielski or Karen Moré, Director of Research Compliance.

What: March RCR remote training session featuring case study discussions

When: Tuesday, March 26th from 12:00 p.m. to 1:00 p.m.

Where: Remote WebEx Registration Link

March RCR Training

Calling All Human Subjects Research Staff! Please join the Responsible Conduct of Research (RCR) Office for our March in-person RCR training session with a focus on clinical and social researchers!

 

This month, we will be highlighting the importance of appropriately protecting research participants and avoiding research misconduct. We will meet in the library to view the Office of Research Integrity’s (ORI) interactive movie: “The Research Clinic.” Snacks will be provided!

 

The movie is designed as a “choose your own adventure”-type experience to allow participants to work through some common pitfalls and challenges in a low-risk environment. This 1.5-hour event will count towards the 8-hour in person requirement for NIH, but we highly encourage anyone conducting human subjects research to join us!

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski.

What: March RCR in-person training, “The Research Clinic”

When: Wednesday, March 13th from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

 

For questions, please contact Karen Moré, Director of Research Compliance. For more details about RCR requirements, please visit our RCR Office website.

 

2024 Responsible Conduct of Research Training Remote Sessions

This is the last week of the 2024 Responsible Conduct of Research (RCR) training sessions! Sessions will be presented live via WebEx in a series of hour-long sessions. This week’s sessions include “Managing Mentoring and Peer Relationships” on Monday 2/26, “Research Security/Export Control” on Tuesday 2/27, “Ethics in the Use of Human Subjects in Research” on Thursday 2/29.

 

Who should sign up? All trainees, fellows, participants, and scholars receiving support through any NIH training grant, career development award (individual or institutional), research education grant, or dissertation research grant (specifically, the following programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R) are required to complete RCR training per NIH policy. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

 

What kind of training is required? Unlike NSF or USDA NIFA RCR requirements which can be satisfied by online training through the CITI program, NIH requires training to be “face-to-face.” Specifically, 8 hours of unique face-to-face presentation material are required by NIH. The February remote RCR training sessions may be utilized to satisfy this requirement.

 

How do I sign up? Please visit the UConn Health RCR website for a list of the sessions offered along with registration links.

 

To learn more about the NIH RCR requirement or other options to satisfy NIH’s RCR training requirement, please visit the UConn Health RCR website.

 

Questions? Please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.

OCTOBER, NOVEMBER, DECEMBER, 2023 – HSPP NEWSLETTER

OCTOBER, NOVEMBER, DECEMBER, 2023 – HSPP NEWSLETTER

 

The HIPAA Privacy Rule & Human Subjects Research – Overview

 

The HIPAA Privacy Rule (the “Privacy Rule”) may impose additional requirements to the federal human subjects protection regulations applied to all human subjects research.

 The purpose of this overview is to clarify concepts and apply them to commonly seen human subjects research activities/studies. Specifically, the sections below highlight some of the main provisions of the Privacy Rule as they relate to human subjects research.

A series of questions and answers explain the scope of the Privacy Rule, the difference between an Authorization, a Waiver of HIPAA Authorization and an Alteration of HIPAA Authorization.  In addition, several sections explain how to address the Privacy Rule in recruitment activities, and when using specimens for research studies.  Examples of research activities and the appropriate HIPAA forms are included in some of those sections.

 

Section A- Questions related to the Privacy Rule and Human Subjects Research

 

The Privacy Rule regulates the way certain organizations called covered entities under the Rule handle protected health information (PHI). Since UConn Health is a covered entity, investigators conducting research with UConn Health PHI need to address HIPAA.

 

Question: How do I know if I need to address the Privacy Rule in my research study?

Answer: The Privacy Rule affects research and researchers when either:

Research creates or generates PHI, or research requires access to and/or use of PHI.

If your study involves the use of PHI you must address the Privacy Rule within your application for approval. PHI means individually identifiable health information transmitted or maintained in any form (electronic means, on paper, or through oral communication) that relates to the past, present or future physical or mental health or condition of an individual. Health information is not considered PHI if it has been de-identified in accordance with the Privacy Rule (i.e., by expert analysis or by removing all identifiers specified in the Privacy Rule of the individual or of relatives, employers, or household members of the individual).

Examples of research studies for which the HIPAA regulations apply are:

  • Studies using individually identifiable health information that is generated as part of a health care service.
  • Studies gathering individually identifiable health information that is entered into a medical record.
  • Studies gathering individually identifiable health information that is used to make treatment decisions.
  • Retrospective or Prospective research studies involving the review of medical records.
  • Research studies involving surveys, questionnaires or focus groups, which obtain PHI from patients receiving treatment.

 

 Question: When does the Privacy Rule not apply to research?

Answer: Research studies that do not use, disclose or create PHI are not subject to HIPAA regulations.

Examples of studies that are not subject to HIPAA:

  • Studies that use tests that do not go into the medical record because they are part of a basic research study and the results will not be disclosed to the subject.
  • Studies that review de-identified health information.
  • Studies that obtain data from records open to the public.
  • Interviews, focus groups, and surveys studies that collect information that is not considered health information (e.g., opinions, beliefs, wants/preferences, etc.)

 

 Question: What is the difference between HIPAA “Authorization” and Informed Consent?

Answer: An informed consent is the individual’s volunteer permission to participate in the research. The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46 ( AKA as the Common Rule).  The Common Rule’s focus is in protecting the safety of the individuals, their privacy, and confidentiality. To do so, the investigators need to include in the consent forms the applicable elements /information described in the Main Consent Form Checklist.doc .

The Privacy Rule, a different regulation, focuses on protecting the privacy and security of PHI. The Privacy Rule generally requires subjects to give written Authorization before a covered entity may use or disclose patients’ PHI for research. A signed HIPAA Authorization represents an individual’s agreement to the use and disclosure of the individual’s PHI for the specified research purpose.

An authorization must contain several required elements and statements, including but not limited to a description of the PHI to be used and disclosed, the person authorized to make the use or disclosure, the  researcher may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed.

 

Section B- Questions related to Waiver of HIPAA Authorization and Alteration of HIPAA Authorization

  

The IRB may approve a HIPAA authorization process which does not include, or which alters some or all of the elements of a valid written authorization, or waives the requirement for written HIPAA authorization if the IRB finds and documents that the use of the subjects’ PHI meets the criteria for a waiver.

In granting an alteration or waiver of HIPAA authorization, the IRB must determine that the alteration or waiver, in whole or in part satisfies each of the following criteria:

  • The use or disclosure of PHI involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
  • an adequate plan to protect the identifiers from improper use and disclosure;
  • an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
  • adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted (i.e., under the HIPAA regulations).
  • The research could not practicably be conducted without the waiver or alteration; and
  • The research could not practicably be conducted without access to or use of the PHI.

 

  Question: What is the difference between a partial and complete Waiver of HIPAA Authorization?

 Answer: A waiver of HIPAA authorization is a determination that is made by the IRB.  An IRB can waive in full or in part the individual authorization required by the Privacy Rule to use and disclose PHI for research purposes.

Example of research study for which the IRB may grant a complete waiver of the Authorization:

  • A research study limited to a retrospective review of medical records (HIPAA Waiver for the entire study).

Example of research study for which the IRB may grant a partial waiver of the Authorization:

  • A research study collecting information during telephone screening (HIPAA Waiver for a portion of the study).

To request a waiver of HIPAA authorization the investigator must complete pages 1 and 2 of the HIPAA Request for Alteration or Waiver of Authorization.doc form and submit this document to the IRB for review and approval prior to using and/or disclosing PHI.

 

Question: Is it possible to get a HIPAA waiver to screen patient charts without having each patient first sign an Authorization form?

Answer: Yes. The Privacy Rule allows for certain activities regarding screening, recruiting or determining eligibility (e.g. chart reviews for determining eligibility) to occur without obtaining a HIPAA authorization.

The investigator must submit a HIPAA Request for Alteration or  Waiver of Authorization.doc . The waiver must be granted by the IRB before charts are screened.

 

Question: What is a HIPAA Alteration of the Required Elements and/or Statements?

Answer: A HIPAA Alteration of the Required Elements and/or Statements is a regulatory determination that is made by the IRB.  An IRB can approve to omit (waive), or change (alter) in part the individual authorization required by the Privacy Rule to use and disclose PHI for research purposes.

 

When investigators are planning to obtain an individual’s authorization to access their information, and they need to either remove (waive), or change (alter) some of the core elements or statements of an authorization, they must complete and submit Appendix A.  Appendix A is in the fourth page of the HIPAA Request for Alteration or Waiver of Authorization.doc form   The IRB must approve this request prior to the use and/or disclosure of PHI.

 

Example of an alteration of the authorization:

  • An authorization that requires to remove (waive) the element that describes each purpose of the requested use or disclosure because providing the purpose of the study would affect the results of the study.

 

Examples of studies withholding information about the study purpose and/or reason for procedures, in order to prevent biasing the results:

  • Subjects are asked to take a quiz for research but they are not told that the research question involves how background noise affects their ability to concentrate.
  •  To further understanding of how representations of same sex couples depicted in commercials influence consumer behavior, subjects are exposed to advertisements featuring gay couples and straight couples while their heart rate, facial muscle movement, and sweat responses are recorded. Subjects are informed that their reactions to the commercials are being studied, but not that the researchers are examining if the sexual orientation of characters in commercials influences them.

 To request to alter the HIPAA authorization, the investigator needs to submit a HIPAA Request for Alteration or Waiver of Authorization.doc  and Appendix A.

 

 Example of research study that requires waiving documentation/signature of the authorization:

  • Research on sensitive topics, such as domestic violence or illegal activities where the only link of a subject to the study is their signature on the authorization, and there is a risk of breach of confidentiality.

 To request a waiver of the participant’s signature on the HIPAA authorization, the investigator needs to submit a HIPAA Request for Alteration or Waiver of Authorization.doc  and Appendix A.

 

Section C- Questions Related to IRB Review and the Privacy Rule when Using Specimens for Research

 

Because the federal definition of human subjects research extends to people who are sources of biological specimens and identifiable private information, research with these materials often requires review and approval by the IRB. The level of IRB review  is based on the level of risk the study poses.

The risks of research with specimens potentially include one or both of the following:

  • The risk of harm from procedures used to obtain specimens, and/or
  • The risk associated with the loss of privacy and confidentiality due to personally identifiable information that may be associated with specimens.

Common questions involving research using human specimens are summarized below.

 

Question:  What type of IRB review is required for a research project using existing specimens? What HIPAA form do I need to submit?

  Answer: It depends on whether the existing specimens are identifiable. Existing specimens means the  specimens were collected for clinical purposes or for research studies other than the proposed research study.

If the existing specimens are not identifiable, and if the investigator will make no effort to re-identify the specimens, the specimens do not meet the definition of a human subject and IRB review would not be required.

On the other hand, if the specimens are identifiable, or efforts will be made to re-identify the samples, IRB review is required.

Research that only involves the use of existing identifiable specimens may qualify for exemption if one of the following is true:

  • the specimens are publicly available
  • Information is recorded in such a manner that the identity of the human subject cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects. In this case, the research may qualify for exempt status under Category 4.ii.

To address HIPAA submit a HIPAA Certification of De-Identification.doc

On the other hand, research involving previously collected specimens that have identifiers associated most likely qualifies for expedited review under category 5.  Use of specimen-associated identifiers must be restricted and privacy protection measures must be in place.

To address HIPAA submit HIPAA Request for Alteration or  Waiver of Authorization.doc

 

Question:  What type of IRB review is required for a research project using specimens that will be collected for research purposes by noninvasive means? What HIPAA form do I need to submit?

Answer: Research that involves the collection of specimens for research purposes by noninvasive means may qualify for Expedited review- under Category 3.

Examples of these noninvasive collections of specimens are:

  1. Hair and nail clippings in a non-disfiguring manner
  2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
  3. Permanent teeth if routine patient care indicates a need for extraction
  4. Excreta and external secretions (including sweat)
  5. Un cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue
  6. Placenta removed at delivery
  7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
  8. Supra‑ and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
  9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
  10. Sputum collected after saline mist nebulization.

 

You will need to submit a HIPAA Authorization to Use and Disclose PHI for Research Purposes.doc

Question:  What type of IRB review is required for a research project using specimens collected for research purposes by invasive means? What HIPAA form do I need to submit?

Research that involves the collection of specimens for research purposes by invasive means/using procedures that pose greater than minimal risk to participants must undergo full committee review by the IRB.

Examples of these invasive collections of specimens are:

  • Collection of specimens through  a skin Biopsy
  • Collection of specimen through a bronchoscopy, amniocentesis or colonoscopy.

 

You will need to submit a HIPAA Authorization to Use and Disclose PHI for Research Purposes.doc

Question: My research study involves collecting sputum and lung aspirates from clinical procedures involving chronic smokers that are otherwise going to be thrown away.  The specimens will be provided by the pathology department without identifiers. The pathologist will not be involved in the research.  Do I have to get IRB review?  If so, what HIPAA form do I need to submit?

 Answer: You do not need to submit an application for IRB review nor you need to submit a HIPAA form. Your research is considered secondary research that is not human subjects research because: (a) the specimens were originally collected for clinical care and not specifically for the purpose of the investigator’s current research, (b) the specimens do not come with individually identifiable information, and (c) there is no interaction or intervention done specifically for the research.

  

Section D- Questions related to the Privacy Rule & Recruitment Activities

 

The IRB may approve a research proposal in which an investigator will obtain information for the purpose of screening, recruitment or determining the eligibility of prospective subjects without the prospective subject’s HIPAA authorization, however the following conditions must be met:

  • The investigator will obtain information related to screening, recruiting or determining eligibility through oral or written communication with the prospective subject.
  • The investigator will obtain identifiable information or identifiable biospecimens for screening, recruiting or determining eligibility by accessing records or stored identifiable biospecimens.
  • In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records /specimens will be reviewed.  The investigator may delegate the review to designated UConn Health research staff.

 

Question: At what point in recruitment may we gather information about a potential participant (e.g., if a potential participant calls our office after seeing a flyer, may we screen that person/ ask them about their history, or do we need the person to complete a written HIPAA Authorization prior to screening)?

Answer: If the IRB has approved your recruitment plan, including a partial waiver of Authorization to permit you to collect PHI for screening without written Authorization, you may take the person’s contact and screening information.  Investigators must also submit to the IRB a phone script using the Sample Phone Script for Screening Prior to Consent.doc . The IRB must approve the script prior to collecting information from potential participants over the phone.

The potential participant should know that in order to evaluate whether he or she is a candidate for the research, the researcher will need to share the caller’s information, and the caller may need to share information, with a limited number of others who staff the study.  If the person is deemed qualified for the study, then he/she will be asked to come in to sign an informed consent and a HIPAA Authorization. To protect the privacy of the potential participant all the information they provide will be kept only if he/she qualifies to proceed and decides to participate in the study.

 

Section E- Questions Related to HIPAA Identifiers and Coded Data/Specimens 

 

  Question: HIPAA specifies18 identifiers that must be removed to “de-identify” health information.  Is any one of these identifiers, all by itself, PHI?

 Answer: Not necessarily. PHI is information, including demographic information, which relates to (i) the individual’s past, present, or future physical or mental health or condition; (ii) the provision of health care to the individual; or (iii) the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual.  If the only identifier you have is a DOB and that DOB is not linked to any other health information and could not be sourced to a provider (e.g., UConn Health), the DOB alone would not be PHI.  However, if the DOB is coupled with other information, such as “a patient at UConn Health,” or “was one of 15 enrollees in a particular study,” this combination would be PHI.

 

 Question: What coded information or coded specimens means?

The Office of Human Research Protections (OHRP) has defined coded as:

  •  identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code);

and

  • a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

 

 OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research.

Examples of such additional activities include, but are not limited to:

(1) The study, interpretation, or analysis of the data resulting from the coded information or specimens; and

(2) Authorship of presentations or manuscripts related to the research.

   

Question: Is coded information identifiable?

 Answer: The Privacy Rule considers coded information to be de-identified if the 18 specific identifiers of the individual or of relatives, employers, or household members of the individual, listed below are coded and the person cannot reasonably be identified.

However, that code needs to be assigned by someone other than the investigator.  The code cannot be derived from any identifiable piece of information or combination of pieces of identifiable information.  The key to the code cannot be accessible to the investigator or research personnel using the de-identified data.

  • Names;
  • Address (including street address, city, county, zip code). The initial three digits of a zip code may be used if, according to the current publicly available data from the Bureau of Census: 1) the area formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and 2) the initial three digits of a zip code for a region containing 20,000 or fewer people is changed to 000;
  • All elements of dates (except year) for dates directly related to an individual (birth
  • date, admission date, discharge date, date of death), and all ages over 89 and all elements of dates (including year) indicative of such age, except that ages and  elements may be aggregated into a single category of age 90 or older;
  • Telephone numbers;
  • Fax numbers;
  • Electronic mail addresses;
  • Social Security numbers;
  • Medical record numbers;
  • Health plan beneficiary numbers;
  • Account numbers (bank, retirement, credit card, etc.);
  • Certificate/license numbers;
  • Vehicle identifiers and serial numbers, including license plate numbers;
  • Device identifiers and serial numbers;
  • Web Universal Resource Locators (URLs);
  • Internet Protocol (IP) address numbers;
  • Biometric identifiers, including finger and voice prints;
  • Full face photographic images and comparable images; and
  • Any other unique identifying number, characteristic or code.

 

REFERENCES

 HIPAA Privacy Rule and Its Impacts on Research (nih.gov)

  • 2011-014.0.pdf– Health Insurance Portability and Accountability Act (HIPAA) in Research 

 

 

HSPP – April-May-June, 2023 –Newsletter

 

The Association for Accreditation of Human Research Protection Programs
UConn Health Human Subjects Protection Programs Preparation for Reaccreditation

The Association for Accreditation of Human Research Protection Programs (AAHRPP) is an independent, non-profit accrediting body that works to protect the rights and welfare of research participants and promotes high-quality research through an accreditation process.

AAHRPP’s accreditation standards meet or exceed U.S. federal regulatory requirements and the International Committee on Harmonisation –Good Clinical Practice (E6) guideline for protection, and are reasonable, attainable, and representative of current best practices.

UConn Health’s Human Subjects Protection Program (HSPP) achieved AAHRPP accreditation in 2006. As an accredited organization, our HSPP must periodically apply for re-accreditation every five years. This is a two-step process.

Step 1, consists of a self-evaluation of our program, followed by an AAHRPP review of our policies and procedures to ensure they meet regulatory and accreditation standards.

Step 2 is an onsite visit by AAHRP representatives to ensure that our policies and procedures are followed. Once our HSPP is scheduled for the reaccreditation visit an announcement will be sent to the research community.

To complete the reaccreditation step 1, the HSPP has revised multiple IRB policies to reflect our current practices, add required information and standards for accreditation.

In the tables below is a list of the IRB polices and forms that have been revised along with a short summary of the revisions.

If you have questions regarding those changes please send an email to either irb@uchc.edu or contact the Education Specialist at cagganello@uchc.edu , 860-679-8802.

2009-001.0.pdf – Reporting Unanticipated Problems to the Institutional Review Board: Edited section under “Self-Reporting” to clarify that the Principal investigators are to report to the IRB any noncompliance with the protocol or directives of the IRB that was within the control of the research team within 5 business days of becoming aware of the event.

2009-003.0.pdf – Imposing and Lifting Suspensions of IRB Approval or Imposing Terminations of IRB approval: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2009-005.0.pdf – Monitoring of IRB Approved Studies: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-006.1.pdf – Additional Protections – Pregnant Women, Fetuses or Neonates: Minor grammar changes.

2011-006.4.pdf – Additional Protections – Other Vulnerable Groups: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-006.5.pdf – Additional Protections – Fetal Tissue Transplants: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-007.0.pdf – Definitions Applied to Policies: Added definition of benign behavioral intervention. Edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).  Included revised common rule.

2011-008.1.pdf – Informed Consent – Process The general section was revised to request information about the informed consent methods and documentation and to alert the investigator that prospective IRB approval is required for any subsequent modifications made to the methods of obtaining consent or documentation of informed consent whether they are done by hard copy or electronically.

  • Changes to the process of obtaining consent by Phone / Fax to include that the individual obtaining consent must be approved by the IRB to consent and that such individual should have sufficient knowledge of the study to conduct the conversation and to answer any questions,; and the consent conversation should include an in-depth review of the consent document allowing sufficient time for questions to be asked and answered.
  • The process for obtaining consent via videoconference (e.g., WebEx, Zoom) was added with an explanation of how this process must be conducted.
  • A section about obtaining electronic documentation of consent was added with details of compliance expectations and acceptable methods and processes to obtain electronic signatures.
  • A section about electronic informed consent process when consent is not witnessed by study personnel was added to alert researchers that the investigator planning to use this method should discuss this plan with the IRB prior to submitting this method for approval to ensure this method is appropriate for the research (e.g., in compliance with applicable regulations).
  • Edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.0.pdf– Institutional Review Board – Membership: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.11.pdf – Institutional Review Board – Studies Conducted in Foreign Locations: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.14.pdf – Institutional Review Board – Human Subject Research Determinations: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-009.2.pdf – Institutional Review Board – Exemptions: Policy was edited to remove language related to pending adoption of the revised common rule and revisions to applicability of exemption 4(iii) at UConn Health.

2011-009.3.pdf – Institutional Review Board – Expedited Reviews : Policy was revised to include a complete list of the criteria for approval when conducting initial or continuing review for expedited submissions. In addition, when submissions are returned to the investigators with a status of “Approved Contingent,” the IRB reviewer can now add a deadline for the investigator to respond to the contingencies sent in a Response form.

2011-009.4.pdf – Institutional Review Board – Convened Meeting Operations: Policy was revised to add that when virtual IRB meetings are conducted the agenda item (inclusive of supporting documents) are shared on the screen in the videoconference.

2011-009.7.pdf – Institutional Review Board – Assignment of Status Codes: Policy was revised to clarify the IRB will assign the study status code “Closed by PI” to a study under oversight of an external IRB when the external IRB grants the request.  Under the status code title: “Inactive-Administratively Closed” the following was added: the IRB Administrator will assign this status code to exempt research after the anticipated completion date has passed.

2011-009.8.pdf – Institutional Review Board – Appeals Process: Policy was revised to indicate that when a principal investigator (PI) submits an initial appeal letter, it can be completed through a written correspondence (i.e., not limited to IRIS response).  Also, the letter sent by the IRB in response to the appeal made by the PI will contain a wet-ink or electronic signature of the IRB Chair.  In addition some edits were made to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-009.10.pdf – Institutional Review Board – More Frequent Review: Policy Appendix -A was revised to remove Panel 3 and CICATS.

2011-009.12.pdf – Institutional Review Board – Criteria for Approval: Policy was revised to clarify that students can be considered subjects who are likely to be vulnerable to coercion or undue influence.  In addition, policy revised to remove language indicating ‘if’ the revised common rule is implemented (see section describing limited IRB review).

2011-009.13.pdf – Institutional Review Board – Lapse in IRB Approval: Policy was revised to describe that investigator are notified either by email or iRIS correspondence about the need to submit a request for extension of the anticipated completion date or close the study.

2011-009.15.a.pdf – Institutional Review Board – Reliance on UConn Health as IRB of Record: Policy was revised to indicate SMART IRB template may be used to execute reliance agreements. The Office of Human Research Protection reliance agreement template was removed as it not preferred since it does not meet AAHRPP standards.

2011-009.15.b.pdf – Institutional Review Board – Reliance on External IRB: Trinity Health was added as an institution with which UCONN Health has an established collaborative agreement for minimal risk studies conducted by a student, fellow or resident. Also, policy now contains that when requesting reliance on an external IRB for a student/resident/fellow project, UCONN Health IRB may request the original approval letter to ensure the research is minimal risk.

2011-011.0.pdf – Research Personnel: Policy revised to include principal investigator (PI) responsibility to ensure the confidentiality and security of research records and data as described to the IRB in the submission materials, and to cooperate with all aspects of internal or external audits and inspections.

2011-012.0.pdf – Conflict of Interest – Research Personnel: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-012.1.pdf – Conflict of Interest – IRB Members: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-015.0.pdf – Recruitment and Payment:  Policy was revised to indicate that external researchers looking to advertise recruitment in UConn Health broadcast (e.g., Lifeline) messages do not need HSPP/IRB permission. Also revised to include procedure to use UConn Health as a recruitment site when UConn Health is not engaged.   Added edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

2011-016.0.pdf – Scientific Review: Policy was revised to include the Clinical Research Center and funding foundation as acceptable entities who may have conducted the scientific review of studies submitted for full board review.

2011-020.0.pdf – Humanitarian Use Device: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-022.0.pdf – Study Drug – General: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-022.2.pdf – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-023.0.pdf – Educational Requirements: Updated to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their) and minor punctuation and grammar changes.

2011-025.0.pdf – HSPP Evaluation / Institutional Support: Policy was revised to include minor updates to title of HSPP manager, and removing executive committee.

2014-034.0.pdf – Additional Requirements – Department of Education (Federal): Policy was revised to include that an email confirming with all of the information included in the FERPA verification form may be acceptable, provided the email is from the person at the school with the authority to grant the permission and sent from that individual’s institutional email address.  Added edits to reflect current guidance on diversity, equity and inclusion (change he/she to they, his/her to their).

Application Checklist for Initial Exempt Application  .doc: Exempt submission checklist Added the following requirements:  When submitting for Exempt determination under Exempt category 4.iii a confirmation that the data will remain protected under HIPAA for 4.iii is required.   If the protocol involves sharing data with indirect identifiers such as sharing a Limited Data Set with an external investigator the UConn Health investigators should provide confirmation they have in place a Data Use Agreement.    If the protocol involves sharing coded data the UConn Health investigators should provide confirmation they have a Don’t Ask /Don’t Tell agreement in place.

Application Checklist for Initial and Continuing Review Expedited .doc : Expedited submission checklist Added the following requirement:
When using electronic informed consent (eIC) (confirmation of part 11 compliance, hard copies of materials, access to eIC platform)
Application Checklist for Initial and Continuing Review Full Board.docx

Application Checklist for Initial and Continuing Review Full Board.docx : Added the following requirement : When using electronic informed consent (eIC) (confirmation of part 11 compliance, hard copies of materials, access to eIC platform).

Request for Exemption Form .doc: Request for Exemption Category 4.iii. was revised to be less restrictive but still ensure HIPAA protection for review as required under the exemption.

 

Guidance on Closure of Human Subject Research Studies

 

A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement. To do so, a closure form should be submitted to the IRB through the iRIS submission system for each non-exempt human research study (e.g., studies approved under Expedited review or Full Board review). The closure form should be submitted before the expiration of IRB approval, however, the PI can also submit a closure form after they have received a notice of lapse of approval.

If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.

A closure form allows the IRB to have a summary of the following information:
• the findings of the study
• the final enrollment data
• whether the study met the recruitment goals, and
• whether any of the following events occurred since the last approval (initial or continuing review):
o subject complaints
o unanticipated problems involving risk to subjects or others,
o unexpected profile of adverse events in terms of frequency and/or severity,
o non-compliance with or deviation from the approved protocol or procedures,
o audits, inspections or monitoring visits by internal or external personnel.
o any publications, presentations, trademarks, patents, etc. related to the study.

This guidance explains the circumstances in which a non-exempt human research study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.

Things to Consider before Closing Research Studies

• Investigators should honor wishes of the sponsor or funding source to keep the study open or to close the study. Some funding entities require IRB approval for the duration of the funding, even if human research activities are complete, or they may not allow the study to close without the sponsor’s permission. It is the PI’s responsibility to be aware of, and comply with, those requirements.

• Sponsors, contract research organizations (CROs), or coordinating center personnel may need to verify or monitor individually identifiable study data at a specific site where human subjects activities have been completed. The study team should verify whether these organizations require the studies to be open when conducting their monitoring visits. IRB approval must be maintained while these activities are occurring.

• Whenever possible, prior to closing a study, data should be permanently de-identified.

When to Close a Study

• For studies requiring continuing review (e.g., some Expedited studies and all full board studies ) a requests for closure should be submitted at the time the next continuation application is due or within 30 days after the completion of all study activity involving the use of private identifiable information or biospecimens, whichever comes first.

• Moreover, a closure form should be submitted to the IRB if the if the research study was not conducted or was canceled, or if each of the following conditions exist:
o The research is permanently closed to the enrollment of subjects
o The subjects have completed all research-related interventions
o The research is no longer active for long-term follow up of subjects
o Data has been de-identified.

• When a Principal Investigator terminates employment with UConn Health, the PI may submit a closure form to the IRB. Alternatively, the PI may submit a modification form requesting transfer of the study to another eligible Principal Investigator.
Retired investigators with Emeritus status at UConn Health may be permitted to keep the study open and continue as the PI with approval from the HSPP Director.

• When a student-led project is completed, the study should be closed with the IRB. This should occur prior to the student’s departure / graduation.

IRB Process of Expired studies, Lapsed Studies and Closure Forms

• Expired studies: If approval for continuation of non-exempt research is not sought, or a request to extend the expected completion date has not been received within a reasonable time frame (e.g., 30 days), IRB staff will administratively close the study and send a written notification to the Principal Investigator of the administrative closure. The research activity may not continue and a new application may be required to resume research activity.

• Lapsed studies: If approval of the study has lapsed due to lack of a response to contingencies or a request for continuing approval or to extend the completion date has not been received the study may administratively be closed. The IRB will send a written notification to the PI. Prior to closure the IRB will issue a final request for response by email to the PI and study contacts and the PI will be given a reasonable period within which to respond (e.g. one or two weeks).

• Closure forms: When a closure form is submitted, the IRB will review any new information provided in the closure form and determine whether any additional action is required on the part of the IRB or the investigator. Upon review of the closure form, the status of the study is changed in the iRIS system (e.g., “Closed by PI”) and an outcome letter is issued confirming the closure.

Principal Investigator Responsibilities with Closed Studies

The principal investigator (PI) continues to have responsibilities for a study even when IRB oversight of a study is no longer required. These responsibilities include:

• Verifying all research activities have been completed. The PI should ensure that all research-related activities, interventions or interactions with human subjects or individually identifiable data have been completed at the site(s) approved under the Principal Investigator’s IRB application at the time a closure form is submitted to the IRB or at the time of approval expiration, whichever occurs first.

If after a study is closed, the PI wishes to engage in an activity such that the criteria for closure listed above would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.

• Record Retention Research data from the completed study should be stored and protected in the manner approved by the IRB and consented to by the research participant so as to maintain the privacy and confidentiality of the participants.

Per HSPP Policy 2011-024.0.pdf – File Requirements & Record Retention Requirements , investigators must maintain research records for three years beyond the completion/termination of the study. Investigators should be aware that other laws and requirements (e.g., funding agency) may require a longer record retention period. Per the HIPAA regulation, investigators are to retain documents relating to uses and disclosures, authorization forms for 6 years from the date of creation or the date when it last was in effect, whichever is later.

Investigator should be familiar with the record retention format described in the UConn Health HSPP Policy 2015-024.1.pdf – Record Retention Format .

Investigators should ensure that any specific regulatory and/or sponsor requirements are met for record retention or submission of reports.

• Confidentiality and Data Security. If the PI is maintaining identifiable private data or specimens, the protections described in the IRB application and to subjects must be maintained for the time frame described. The PI must continue to honor any commitments made to participants as part of the approved research (e.g., providing information about study results; payment for research participation).

• HIPAA authorization. The PI may have obtained HIPAA authorization from subjects to access their medical records, with an expiration date that is far in the future. If the PI still has permission to access medical records at the time they want to close the study that permission expires upon study closure.

 

 

U.S. Department of Health and Human Services Food and Drug Administration
Common Inspection findings from 2017-2022

 

The Food and Drug Administration (FDA) has released their Bioresearch Monitoring (BIMO) Fiscal Year 2022 Metrics. Below is a partial description of the common inspection findings from 2017-2022. The full report can be found here: https://www.fda.gov/media/165853/download

Common Sponsor-Investigator Inspectional Observations:
• Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57; accountability for the investigational product; Investigator Statement (FDA 1572); Financial disclosures.
• Failure to select qualified investigators and/or monitors, ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.
• Failure to submit an Investigational New Drug (IND) application.
• Inadequate subject protection; informed consent issues.
• Failure to notify FDA of termination of investigator.

Common Sponsor/CRO Inspectional Observations:
• Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.
• Failure to meet the abbreviated requirements for investigational device exemptions (IDEs).
• Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57; accountability for the investigational product; Investigator Statement (Form FDA 1572); Financial disclosures.
• Failure to submit an Investigational New Drug (IND) application; IND safety report.
• Failure to submit current list of all participating investigators to FDA at six-month interval after FDA approval of the study.

Common Clinical Investigator Inspectional Observations:
• Failure to comply with Form FDA 1572 requirements, protocol compliance
• Failure to follow the investigational plan; protocol deviations
• Inadequate and/or inaccurate case history records; inadequate study records
• Inadequate accountability and/or control of the investigational product
• Safety reporting; failure to report and/or record adverse events
• Inadequate subject protection; informed consent issues

 

Difference Between De-Identified Data Sets and Limited Data Sets
&
Limited Data Sets and Data Use Agreements

 

Under the Health Insurance Portability and Accountability Act (HIPAA) de-identified data is data from which all 18 HIPAA identifiers that could be used to identify an individual or the individual’s relatives, employers, or household members have been removed.

Unlike a de-identified data set, a limited data set is still considered Protected Health Information (PHI). As defined by HIPAA, limited data sets (LDS) are data sets stripped of certain direct identifiers that are specified in the Privacy Rule. They are not de-identified information under the Privacy Rule.

A limited data set is protected health information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual: (1) names; (2) postal address information, other than town or city, State, and zip code; (3) telephone numbers; (4) fax numbers; (5) e-mail addresses; (6) social security numbers; (7) medical record numbers; (8) health plan beneficiary numbers; (9) account numbers; (10) certificate/license plate numbers; (11) vehicle identifiers and serial numbers; (12) device identifiers and serial numbers; (13) web URLs; (14) Internet Protocol (IP) address numbers; (15) biometric identifiers, including fingerprints and voiceprints; and (16) full-face photographic images and any comparable images.

Distinct from de-identified data, a limited data set contains protected health information that is associated with indirect identifiers as defined in the HIPAA privacy rule. Protected health information in limited data sets may include the following indirect identifiers: town, city, state and zip code, and dates directly related to an individual, including birth date, admission date, discharge date and date of death.

The table below describe in detail the HIPAA identifiers that must not be present in a de-identified data set or in a limited data set.

 

 

DATA ELEMENT DE-IDENTIFIED DATA SET  LIMITED DATA SET
Names. Remove Remove
Postal address information. Remove Remove
Town, city, state and zip code. Remove Can retain city, town, state or full zip code.
All elements of dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. Remove Remain
Telephone numbers, fax numbers; e-mail addresses, web URL addresses, IP addresses. Remove Remove
Social security number, medical record number, health plan beneficiary number, any account number, certificate or license number. Remove Remove
Vehicle identifiers and serial numbers, including license plate numbers, Device identifiers and serial numbers. Remove Remove
Full-face photographic images and any comparable images, Biometric identifiers, including fingerprints and voiceprints. Remove Remove
Any other unique identifying number, characteristic or code. Remove Remove

 

Limited Data Sets and Data Use Agreements

If indirect identifiers must be kept within a limited data set (LDS) in order to perform a research study and the information is to be disclosed outside of UConn Health, the principal investigator must enter into a Data Use Agreement (DUA) with the data recipient. A DUA may also be utilized when UConn Health is the  recipient of a LDS. Only after the agreement has been executed can the limited data set be used/disclosed.

This DUA is required under the HIPAA Privacy Rule. This agreement establishes the ways in which the information in the limited data set may be used, the purpose for which it was disclosed, and identifies who is permitted to use or receive the information.

Moreover, the DUA stipulates that the recipient will use appropriate safeguards to maintain the confidentiality and protect the data from further disclosures.

Since the data use agreements establish institutional obligations and bind the institution to the terms of the agreement, investigators are not authorized to execute research DUAs. UConn Health DUAs for research related activities are processed through the Office of Sponsored Programs Sponsored Program Services (SPS) or the Office of Clinical and Translational Research (OCTR). The specific contacts in these offices are listed below:

• If the DUA is related to a Clinical Trial contact: Donald Deyo, Contract Specialist (deyo@uchc.edu), or the OCTR main inbox (octrclinicaltrial@uchc.edu).

• If the DUA is unrelated to a Clinical Trial contact: Jennifer Pomales pomales@uchc.edu

The table below describes whether IRB review approval is required for a de-identified data set or for a limited data set, and when a Data Use Agreement is required.

 

DE-IDENTIFIED DATA SET   LIMITED DATA SET
IRB Review/Approval  IRB and Investigator can determine the project /research is Not Human Subject research.
May be used in any manner, not regulated under HIPAA.
If the data is not readily identifiable, IRB can determine Not Human Subject Research.
IRB does not require HIPAA Authorization or Waiver.
Data Use Agreement Not required. Required.

UConn Health DUAs for research related activities are processed through the Office of Sponsored Programs Sponsored Program Services (SPS) or the Office of Clinical and Translational Research (OCTR).

 

OHRP’s Common Rule Webinar

Join the introduction-level, webinar titled “Unlocking the Mysteries of the §46.111 Criteria for IRB Approval of Research.”

This presentation will explain the criteria for IRB approval of research and include case studies and interactive quizzes to demonstrate the way the criteria can be applied.
Date: Tuesday, July 11, 2023, 12:00 PM EDT
Spots are limited. Registration is required to attend and receive a certificate of attendance.

Register for this webinar at: https://www.zoomgov.com/webinar/register/WN_9RbRyAwjQY2N_kRxFPbT-w

New NSF Responsible Conduct of Research Requirement— Effective 7/31/23

UConn Health is committed to maintaining the highest ethical standards in the performance, reporting, reviewing and proposing of research and scholarly activity. In support of this commitment and to fulfill funder requirements, UConn Health offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices.

A recent National Science Foundation (NSF) requirement expansion includes RCR training for faculty and other senior personnel, and will require that the training address mentor training and mentorship. These new requirements apply to NSF proposals submitted on or after July 31, 2023.

A list of RCR trainings at UConn Health that fulfill NSF RCR requirements can be found on our UConn Health RCR webpage. Be on the lookout for additions to the RCR offerings in the coming months!

ClinicalTrials.gov Modernization Efforts

Let your voice be heard! ClinicalTrials.gov is getting a facelift and the National Library of Medicine wants your feedback.

 

The National Library of Medicine (NLM) is holding a virtual public meeting to discuss the ongoing modernization efforts for ClinicalTrials.gov on April 25th, 2023, from 12:30-3:00 p.m. They will provide a detailed look at the current beta websites–– both the public-facing ClinicalTrials.gov site as well as the entry system site for researchers, known as the Protocol Registration and Results System or PRS. They will provide progress updates and ask for feedback from stakeholders. For the meeting agenda and a link to register, visit the NLM website.

For questions regarding ClinicalTrials.gov at UConn and UConn Health, please contact local PRS Administrator, Ellen Ciesielski

NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan)

The Office of the Vice President for Research would like to share some information with researchers who may be affected.

The National Institutes of Health (NIH) is hosting a virtual, public listening session next Wednesday, April 12, 2023, from 1:00 – 3:00 pm for feedback on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan). The virtual listening session will be viewable through NIH Videocast. Further information about the listening session, including the agenda and how to sign up to make oral comments, can be found on the event page of the Office of Science Policy (OSP) website. The slots for oral comments will be provided in the order they are received until all slots have been filled, and must be received by April 10, 2023.

Written Request for Information (RFI) responses on the NIH Public Access Plan will continue to be accepted until April 24, 2023.

For questions, you can contact OSP at SciencePolicy@od.nih.gov.

 

 

HSPP- October-November- December,2022 – Newsletter

FDA Warning Letter Regarding the Failure to Submit INDs for the Conduct of Clinical Investigations 

with an Investigational Product that met the Definition of a Combined Product.

 

Inspections of clinical trials are conducted as a part of the U.S. Food and Drug Administration (FDA)’s Bioresearch Monitoring Program.  These inspections are designed to evaluate the conduct of research and to help ensure that the rights,   safety, and welfare of human subjects have been protected.  Below you will find a short summary of a warning letter issued because of the failure to submit an investigational new drug application.

 

Warning Letter to Dr. David M. Lubeck/Arbor Centers for EyeCare

 On November 18, 2022, the FDA issued a warning letter to Dr. David M. Lubeck/Arbor Centers for EyeCare.  The FDA officials inspected Dr. Lubeck study and concluded that the investigator did not adhere to the FDA regulations governing the conduct of clinical investigations and the protection of human subjects. Specifically, the investigator failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with investigational new drugs that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].

The FDA argued that the investigational product used in combination with another drug comprised  both a drug and a device components and was therefore a combination product within the meaning of section 503(g) of the FD&C Act (21 U.S.C. 353(g)).

Furthermore, the FDA underlined that because the primary mode of action of the investigational combination product was attributable to the product and because the product met the definition of a drug under section 201(g) of the FD&C Act, an IND was required for any clinical investigation of the investigational combination product used in such Protocol.

Among other important issues noted in this investigation was that the investigator did not wait the 30 days to enroll subjects in the study.  An IND does not go into effect upon FDA’s receipt of the IND submission. Rather an IND generally goes into effect 30 days after FDA receives the application, or on earlier notification by FDA that the clinical investigation in the IND may begin (21 CFR 312.40(b)). The FDA emphasized that FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation that must be conducted under an IND in accordance with 21 CFR 312.40.

For more details about the inspection of this study and the findings of the FDA please review the Warning Letter to Dr. Davd M. Lubeck.

Developing a Mobile Health App?

Updated FTC-HHS online tool helps developers understand which federal laws apply

 

 

The Federal Trade Commission (FTC) in conjunction with the Department of Health & Human Services (HHS) Office for Civil Rights (OCR), the HHS Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA) have updated the Mobile Health App Interactive Tool. This tool is designed to help developers of health-related mobile apps understand what federal laws and regulations might apply to them.   The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance tool will point the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the 21st Century Cures Act and ONC Information Blocking Regulations.

 

Developers and others seeking more information about how the HIPAA Rules might apply to their health apps should visit OCR’s HIPAA and Health Apps page, which contains information on how HIPAA applies to a range of example health app scenarios and offers key questions to consider in determining when HIPAA’s regulations cover a particular health app.

 

IRB Forms – Update

The following forms were updated in the IRB website:

  1. Sample Cover Letter for a Survey Study.docx (09/02/2022)
  2. Application Checklist for Initial and Continuing Review Full Board.docx (09/02/2022 – New Contact Information for Institutional Biosafety Committee )
  3. Application Checklist – Single Patient Expanded Access .docx(9/22/2022)
  4. Request for Exemption Form .doc(09/30/2022)
  5. Guidance for Completing Continuation Form.docx (10/12/2022)
  6. Guidance for Preparing a Chart Review Study .docx(10/12/2022)
  7. HIPAA Authorization to Use and Disclose – Spanish.doc (11/7/2022)

 

The following forms were added to the IRB website:

 

 

The following educational resources were added to the IRB website:

 

National Institute of Health (NIH) Policy for Data Management and Sharing

Investigators Resources

 

 

The National Institute of Health (NIH) has posted a one-page handout “The Who, What, Where and When of the NIH Data Management and Sharing (DMS) Policy” summarizing the most important information for investigators regarding the NIH Policy for Data Management and Sharing.  Click on the image to go to their website and explore the info/links in the handout.

 

The University of Pennsylvania has shared the following resources on its website to aid investigators to comply with the National Institute of Health (NIH) Policy for Data Management and Sharing

 

NIH’s checklist that walks researchers through the elements of a DMSP

NIH is constantly updating its FAQ page on the DMSP. Check back for your questions.

Includes NIH webinar recordings and registration information for upcoming presentations.

Provides points to consider and sample language for informed consent documents of research studies which plan to store and share data and/ or biospecimens for future use.

Penn Libraries uses DMPTool to assist with writing data management plans. DMPTool is a resource researchers can use to draft data management plans. The new NIH DMSP template is available in the tool. We can provide comments on your DMSP if you need assistance. See our contact information on this page.

The National Institute of Mental Health (NIMH) has developed four example DMSPs that are consistent with NIMH and NIH requirements.

NIH institutes and centers may have other data sharing requirements in addition to the NIH DMS Policy. Make sure to read your applicable policy carefully.

A comprehensive listing of all NIH activity codes that generally require applicants to submit a Data Management & Sharing Plan

Provides an overview of ICPSR’s NIH funded archives and recommendations for designating ICPSR for your data to meet the requirements of the NIH DMSP.

Created by librarians and other research support professionals, this working group has created a variety of resources that researchers can use to prepare for the NIH DMS Policy implementation. Resources include glossaries, a DMSP checklist for researchers, and an example DMSP for the 2023 expectations.

Recent article on the NIH DMSP policy that covers 10 key recommendations for creating a DMSP that is both maximally compliant and effective.

Research Data & Digital Scholarship Data Sharing Services

NIH Repositories

 

Cornell University has excellent resources and tools on its website to aid investigators to comply with the National Institute of Health (NIH) Policy for Data Management and Sharing.

 

In addition, the NIH National Library of Medicine has posted the following resources:

 

 

 

Office of Human Research Protection (OHRP) Luminaries Lectures Series

Educational Resources for Investigators

 

The Office of Human Research Protection  Luminaries Lectures Series features videos by esteemed individuals with thought-provoking insights on diverse aspects of human research protections.

Some of the recently added videos are listed below.  These videos are covering the challenges of research during public health emergencies and research studying usual care practices, as well as thoughts from representatives in the research community on how to promote diversity and engagement in research participation:

  • “The Covid Drug Wars” – What We Learned from the Front Lines
  • “Unusual Practices Masquerading as Usual Care”
  • “Vulnerability, Justice, Equity, and Engagement: A Conversation About Public Health and Human Subjects Research”

Click here and start watching!

 

Changes in the HSPP/IRB

  

Administrative Manager and Deputy Director of HSPP: Julia Blair has been named Administrative Manager of the HSPP, after filling the role on an interim basis since June following Deb Gibb’s retirement.  She can be reached at jblair@uchc.edu and (860) 679-7555.

 

HSPP- July, August, September, 2022 – Newsletter

HSPP- July, August, September, 2022 – Newsletter

Revision to Exemption Category 4 (iii)

To ensure the protection of identifiable private information (IPI) at UConn Health in compliance with The Privacy Rule, the HSPP will limit use of the exemption 45 CFR 46.104(d)(4)(iii):
Secondary research uses of identifiable private information, [when] the research involves only information collection and analysis involving the investigator’s use of identifiable health information (not biospecimens) when that use is regulated under [HIPAA].
Exemption 4(iii) applies to secondary research ‘use’ of the IPI which is protected under HIPAA, however the release, transfer or provision of access to a non-covered entity / third party would constitute a ‘disclosure’ where the IPI is no longer protected and the exemption would not apply.
Effective October 1, 2022, to ensure compliance with HIPAA and the Common Rule (45 CFR 46), the UConn Health HSPP will restrict the use of exempt category 4(iii) to studies where the Principal Investigator is UConn Health faculty (whose home/primary institution is UConn Health) and the data is not shared outside UConn Health or with non-UConn Health personnel.
New applications to the IRB seeking approval for secondary research use of identifiable private information which do not qualify for exemption under category 4 should request expedited review by the IRB. More information on exempt and expedited submissions can be found on the HSPP website or by contacting the HSPP Education Specialist, Mayra Cagganello at x8802 or cagganello@uchc.edu.

 

National Institute of Health (NIH) Policy for Data Management and Sharing

The National Institute of Health (NIH) Data Management and Sharing policy was published on October 29, 2020, and will go into effect on January 25, 2023. The two year delay in implementation was planned to give time to institutions to learn and prepare for enactment of the policy.

This policy applies to all research funded (in whole, or in part) or conducted by NIH that results in generation of scientific data. The goal of this NIH Data Management and Sharing policy is to benefit everyone, namely investigators, funding agencies, the scientific community, and, most importantly, the public. Data sharing provides more effective use of NIH resources by avoiding unnecessary duplication of data collection. It also conserves research funds to support more investigators. As stated in this policy “data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, re-use hard-to-generate data, and explore new frontiers of discovery.”

The NIH DMS Policy requires researchers to submit a plan to preserve, to share the data and to show compliance with said plan.

The NIH has made available multiple educational materials to inform and educate researchers about this policy at sharing.nih.gov. Below please find the links to the webinars

Webinar I: Understanding the New NIH Data Management and Sharing Policy –
o Resource Slide Deck
o Webinar Recording

Webinar II: Diving Deeper into the New NIH Data Management and Sharing Policy
o Resource Slide Deck

To access the frequently asked questions regarding this policy please click on 2023 Data Management & Sharing Policy

Uconn Health – Research Participant Feedback Form
Now available in Redcap

The Human Subjects Protection Program (HSPP) is responsible for ensuring that studies are conducted in compliance with internal policies, federal regulations and ethical standards. When research participants complete and submit a Research Participant Feedback Form, the HSPP is able to learn about the study volunteer experiences.

Participants can access the Research Participant Feedback form in two ways:
1) Download the form from the IRB website at http://research.uchc.edu/rcs/hspp/volunteers/. Forms must be completed and emailed or faxed following the instructions on the form.
2) *NEW* Research participants may submit this form electronically by accessing the REDCap form at https://redcap.link/UConnHealth-Feedback-Research from a computer or mobile device.

The IRB and HSPP encourage the research community to help research volunteers to complete this form.

IRB Forms – Update

The following updates have been made to IRB forms:

Added new contact information to the following forms:
Application Checklist for Initial and Continuing Review Full Board.docx (09/02/2022 – New Contact Information for Institutional Biosafety Committee)
• IRB Website : Related Departments and Committees-
Institutional Biosafety Committee (IBC): Investigators must obtain approval from the IBC prior to seeking local IRB approval for research studies that deal with recombinant DNA. Investigators may contact Vijayasmitha Rayadurg in the Office of Research Safety for additional information.

Added new template language to the following form:
Sample Cover Letter for a Survey Study.docx (09/02/2022)

Changes to the Requests for Exemption form to limit Exempt Category 4 (iii) to researchers and activities internal to UConn Health.

Request for Exemption Form .doc (09/30/2022)

 

Continuing Review Guidance

Considerations for When the IRB Evaluates the Progress of a Research Study

According to Robert J. Amdur & Elizabeth A. Bankert. IRB Management and Function. 2nd Edition., Jones & Bartlett, 2006, “Continuing review is a monitoring mechanism that assures that continuing safeguards are in place to protect the rights and welfares of research participants.”

When a Protocol/study is submitted for renewal or continuing review the investigator is to report the study progress and findings. When conducting the continuing review, OHRP recommends that IRBs evaluate the following issues to determine whether the study’s approval should be renewed:

Consistent with the IRB-approved Protocol
The IRB should confirm that the information provided by the investigator at the time of continuing review is consistent with the research protocol previously approved by the IRB.

Total Subject Enrollment
Evaluating information about the number of subjects enrolled in the research at the time of continuing review may allow the IRB to ascertain whether enrollment is consistent with the planned number of subjects described in the IRB-approved protocol. Has accrual progressed as planned? If not, will this affect the ability of the researchers to complete the study?

A marked difference between the actual and expected rates of enrollment may indicate a problem with the research project that requires further evaluation, including whether the research project is likely to provide sufficient data to answer the scientific question(s) being posed.

Subject Withdrawals
Subjects may discontinue their participation in research at any point for various reasons (e.g., serious adverse events, conflicts with the investigators, transportation problems, etc.).
The IRB’s continuing review procedures in general should provide for review of:
• The number of subjects who discontinued their participation; and
• A summary of the reasons for the withdrawals, if known.
IRB review of this information may shed light on problems related to the conduct of the research.

To provide an accurate account of the enrollment data, UCONN Health IRB recommends that prior to completing a Continuation form in the iRIS submission system, the Principal Investigator should have the enrollment information for the study available. If this is not the first request for continuation (e.g. study has been open form more than one year), the enrollment data should build off of the previously submitted request for continuation. Investigators should use the enrollment data in the previously approved continuation form as a starting point. The Enrollment Guidance.docx should be reviewed to provide an accurate account of enrollment numbers, screen failures or withdrawals.

Office of Human Research Protection (OHRP) – Resources
Luminaries Lecture Series

OHRP continues to add new videos to help the research community learn about multiple topics.
Click here to view the latest videos of distinguished speakers from OHRP’s Research Community Forum co-sponsored with Northwell Health this past May.
New additions include:
• The COVID Drug Wars That Pitted Doctor vs. Doctor
• Improving Health Equity in Clinical Research
• Vulnerability, Justice, Equity, and Engagement, A Conversation Public Health and Human Subjects Research
• Unusual Practices Masquerading as Usual Care