MinerAlert
MinerAlert
When the IRB makes any of the following determinations, the decision will be reported within 30 days to applicable regulatory and sponsoring agencies, as required by the institution’s FWA:
IRB determinations of reportable events will be reported to the appropriate regulatory agency or agencies, if applicable under the University’s FWA and/or FDA regulations. Reports of unanticipated problems involving risks to subjects and others, incidents of serious and/or continuing noncompliance, and suspensions and terminations of research activities should be sent to the following entities within 30 days of the IRB’s determination:
Reports should contain the following information:
Surveys have been one of the most used data collection tools in social sciences. What was once done using paper-based surveys is now being accomplished using the Internet and, due to the relative ease of Internet distribution, results in a large increase in the number of surveys people are asked to complete. Some researchers feel that over-surveying has led to survey fatigue and a wide-spread decrease in survey response rates. Therefore, to ease the potential for survey fatigue and to assure a good response rate for the survey, consideration should be given to:
Regardless of how surveys are distributed, the IRB must review the proposed research, including the surveys, evaluate subject recruitment methods, the informed consent process and document, data collection and storage methods, risks of participation, and other features of the research to assure adequate subject protections. Therefore, the appropriate IRB forms must be completed and submitted. Research involving the use of surveys is usually minimal risk and can be reviewed by an expedited process or deemed exempt from IRB review, unless the survey questions are sensitive, potentially provoking psychological distress.
As stated previously, there is always a requirement to obtain informed consent from research subjects. Researchers must discuss the study purpose, procedures, potential risks and benefits, the voluntary nature of participation, researcher contact information if subjects have questions, and the other required elements of informed consent. However, the regulations allow the IRB to approve a waiver or alteration of the consent process in which some of the required elements may be omitted and/or the method of obtaining and documenting consent altered.
Approval is usually granted for an informed consent process that includes a consent document in the form of a cover letter that is at the beginning of the survey. It is recommended that researchers use the Study Information Sheet or compile required aspects of informed consent in paragraph form when creating a consent form for survey research. In this consent cover letter, subjects are informed about the study and told that they can opt out of the research simply by not continuing to the survey questions, and they may withdraw at any time by exiting the survey. The requirement for obtaining written documentation of consent (a signature) is waived as subjects' agreement to participate is signified by completing the survey.
Researchers who conduct online research should add the following information to their recruitment message:
Internet communication is widely used and provides access to an enormous amount of information to “Internet communities.” Access to these communities and the information associated with them raises several ethical questions and challenges for researchers and IRB.
In their research proposals, University researchers should, at a minimum describe:
Proposals for Internet research may meet criteria for exemption from IRB review. However, other issues may dictate a higher, more stringent level of review such as:
The following is the IRB policy concerning research involving the study of medical records or other forms of protected health information (PHI). The policy is not intended to supersede any current medical records guidelines or other policies concerning PHI.
The Health Insurance Portability and Accountability Act (HIPAA), also known as “The Privacy Rule,” set standards and regulations to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability, and/or their privacy. HIPAA allows researchers to access and use PHI when necessary to conduct research. Not all research is subject to HIPAA regulations; HIPAA only affects research that uses, creates, or discloses PHI.
PHI is any information in the medical record or designated record set that can be used to identify an individual that was created, used, or disclosed while providing a healthcare service such as treatment or diagnosis.
HIPAA defines 18 specific identifiers that create PHI when linked to health information:
HIPAA regulations allow researchers to obtain approval to access and use PHI when necessary to conduct research.
PHI can be used or disclosed for research purposes if it has been de-identified and impossible to link back to a specific participant. 45 CFR 164.514(e) provides more details for de-identified PHI.
Research use or disclosure of identifiable PHI with authorization of the research subject is permitted providing that use or disclosure is for only the PHI that was originally authorized. To use or disclose additional information, the PI must obtain authorization or request a waiver of the requirements to obtain authorization.
To use or disclose identifiable PHI without authorization of the research subject, the PI must accomplish one of the following:
The IRB must review requests for waiver of the requirement for obtaining authorization for use and disclosure of PHI. If a waiver is approved, the IRB must notify the investigator in writing of its determination. PIs must maintain in their files the letter from the IRB which, in addition to the other required information listed below, identifies the IRB and the date on which the waiver or alteration of the requirements to obtain authorization was approved by the IRB. The letter should also include a statement that the IRB has determined that the waiver or alteration satisfies the following criteria:
Genetic Materials are defined as human tissue samples (saliva, blood, serum, tumor, etc.) on which genetic-related research, such as identification and location of specific genes, study of gene products, inherited human traits, or identification and analysis of DNA mutations, may be performed. Research involving genetic materials require approval from the Institution Biosafety Committee prior to beginning the research.
For research in which samples (blood, tissue, saliva, etc.) will be prospectively acquired without identification, the following issues must be presented in the consent form and discussed with the research subjects:
As for research acquiring anonymous samples, research utilizing samples collected with identifiers must be clearly presented in the consent form and discussed with research subjects. The following issues should be considered and discussed as appropriate:
This section does not apply to principal investigators (PI) who collect biological fluids or other types of human tissue for analysis as a part of a specific research project. A human tissue or data repository is a collection of tissue samples or data with the intent of establishing a relatively large collection of data or tissue that will be accessed by other investigators who may or may not be located at the University.
The U.S. Department of Health & Human Services (HHS), Office of Human Research Protections (OHRP) requires operation of data and tissue repositories be overseen by an IRB. The IRB must review, approve the procedures and conditions under which data and/or tissue specimens are collected, stored, and shared, and ensure that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. As part of its oversight responsibility, the IRB must review and approve a tissue and/or data collection protocol, or section of a protocol, and an informed consent document relating to the collection of the tissue specimens and/or data. For specific OHRP guidance refer to http://www.hhs.gov/ohrp/policy/reposit.html.
Collection of data or tissue for storage in a repository must be reviewed and approved by the IRB. The IRB is familiar with the circumstances of the local research setting and must weigh considerations like local professional and community standards, institutional policies and resources, and the needs of differing subject populations.
An IRB application must be submitted and, along with the standard requirements, address:
Written documentation of informed consent (consent form) should be obtained from each donor subject. An informed consent document/addendum specific to the repository should be used in addition to any other consent forms, or the information may be included in a consent form that describes the entire research project.
Including among the basic elements of informed consent, there should be a clear description of:
Informed consent information describing the nature and purposes of the research should be as specific as possible. Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing, and the consent form should also include a section for the participant to choose whether to allow the specimen to be used in genetic research.
Informed consent documents may not include any exculpatory language through which subjects are made to waive or appear to waive any legal rights.
The informed consent document should also contain an acknowledgement that collector-investigators and the repository are prohibited from providing recipient investigators with access to the identities of donor-subjects or to information through which the identities of donor-subjects could be readily ascertained.
A written submittal agreement for tissue collectors should require written informed consent of the donor-subjects utilizing an informed consent document approved by the local IRB. It should also contain an acknowledgment that collectors are prohibited from providing recipient-investigators with access to the identities of donor-subjects or information through which the identities of donor-subjects may readily be ascertained.
Investigators are encouraged to obtain a written usage agreement from recipient investigators that states the following:
Recipient acknowledges that the conditions for use of this research material are governed by the IRB overseeing the repository in accordance with HHS regulations at 45 CFR 46. The recipient agrees to comply fully with all such conditions and to report promptly to the repository any proposed changes in the research project and any unanticipated problems involving risks to donor-subjects or others. Recipient remains subject to applicable State or local laws or regulations and institutional policies that provide additional protection for human subjects.
For federally funded projects, it is highly recommended that a Certificate of Confidentiality be obtained to protect the confidentiality of repository specimens and data.
The research material may be only utilized in accordance with the conditions stipulated by the IRB overseeing the repository. Any additional use of this material requires prior review and approval by the IRB overseeing the repository, and where appropriate, by an IRB at the recipient site.
Recipient investigators may never be given information that would allow identification/re-identification of specimens of data to a specific donor.
A covered entity’s use or disclosure of PHI to create a research database or repository, and the use or disclosure of the PHI from the database or repository for a future research purpose are each considered as a separate research activity under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.
In general, the Privacy Rule requires authorization for each activity unless an IRB waives or alters the authorization requirement. A single authorization can cover uses and disclosures for multiple activities of a specific research study, including the collection and storage of data and/or tissue specimens. However, a compound authorization is not allowed where the provision of research-related treatment, payment, or eligibility for benefits is conditioned on only one of the authorizations and not the other. For example, if an investigator conducts a clinical trial that also involves collection of tissues and data (PHI) for storage in a central repository for future research use, the actual future research use would require the investigator to obtain a separate authorization for use and disclosure of PHI or a waiver of the requirement for IRB authorization.
For research involving human subjects, federal regulations require that, when appropriate, research plans make adequate provisions for monitoring data to ensure the safety of research participants. The regulations do not specify when or how this monitoring should be accomplished. For each study, researchers and the IRB must determine the type and level of monitoring required to assure subject safety and well-being.
Minimal Risk Studies: Much of the research conducted at the University pertains to social and behavioral sciences and is generally considered to be not greater than minimal risk. Thus, many research studies may not be required to establish a Data and Safety Monitoring Plan (DSMP). However, sponsors or the IRB may require DSMPs regardless of risk. In all research, regardless of whether formal data and safety monitoring plan are required, investigators are responsible for providing ongoing oversight to protect the safety and welfare of study participants.
Greater Than Minimal Risk: All human subject research involving the use of investigational drugs, biologics, or devices require a DSMP. For other types of interventional human subject research involving greater than minimal risk, a DSMP should be strongly considered and may be required by the IRB.
The methods and amount of monitoring required are somewhat dictated by the type and magnitude of risk involved, the population to be studied, and the complexity of the research, and can range from monitoring by the researcher or a group of researchers to the establishment of a Data and Safety Monitoring Board (DSMB).
Investigators should ensure that the following issues are addressed in the plan:
Initial Review: For research requiring a DSMP, the IRB will review the submitted DSMP to assure adequacy for protection of subjects from risks to the extent possible.
To approve research in which the IRB considers whether the provisions for monitoring data to ensure the safety of research participants are appropriate, the IRB must determine that the research plan makes adequate provisions for monitoring the data. In the review, the IRB might consider provisions such as:
Continuing Review: Researchers with DSMPs should submit information indicating that monitoring occurred as described in the research protocols. If a DSMP was not initially required, researchers should submit a summary of unanticipated problems along with any new information or literature that may be relevant to the research.
Cooperative activities are those in which the University faculty, students or staff, obtain access to human subjects involved through one or more cooperating institutions, or when PIs from cooperating institutions obtain access to human subjects at the University. Activities involving investigators from one or more institutions who may exchange, or pool similar data obtained from human subjects who participate in independently sponsored projects are not cooperative activities.
When a PI plans to conduct research at a site external to the University (not owned or operated by the University), the PI is responsible for ensuring that the external site is willing to engage in the collaboration.
If the external site is engaged in the conduct of the research, the PI will provide the following information as part of the IRB submission:
If UTEP is the lead or coordinating institution, the PI should note in the initial IRB application that UTEP is the lead or coordinating institution of a multi-site study. The PI should also provide the following information:
When the UTEP PI is the lead investigator of a multi-site study, the PI must submit information to the IRB regarding the communication process between sites and the management of information obtained during the study such as unanticipated problems, interim results, and protocol modifications. The IRB will evaluate the management plan as it relates to the adequacy of the protection of subjects.
The University may permit reliance on an external IRB. The UTEP IRB may also agree to serve as the reviewing IRB for multi-site projects in which University faculty, staff or students are engaged. All instances of such reliance for non-exempt research will be documented in a reliance agreement that describes the responsibilities of the reviewing and the relying IRB. Such agreements will be signed by the Vice President for Research & Innovation or designee.
Examples of situations in which UTEP may agree to rely on an external IRB include, but are not limited to:
Reliance agreements and/or local context documents, at a minimum, must document responsibilities such as regulatory application, initial/continuing review, vulnerable population approvals, COI review, unanticipated problem reporting, and record maintenance. Reliance agreements are signed by the Institutional Official or designee.
Unaffiliated researchers who are interested in conducting research involving UTEP, its students, faculty, or staff must request permission from the UTEP IRB. Permission is not required if the research involves a broader subject population that only incidentally includes UTEP students, faculty, or staff. Documentation must be provided from the researcher’s home IRB. A UTEP faculty or staff member sponsor is required if the researcher wishes to collect data on the UTEP campus.
The IRB Chair or his/her designee will review the request from the external researcher to determine if UTEP’s IRB will accept the IRB approval of the researcher’s home institution. The IRB reserves the right to request that the protocol go to the UTEP IRB for review and approval, should the Chair decide that the nature of the study requires the independent scrutiny of the UTEP IRB to protect its students and employees.
All applicable Clinical Trials and all NIH funded clinical trials must be registered by the responsible party, typically the sponsor, on ClinicalTrials.gov within 21 days of enrolling the first study participant. Registration must include descriptive information, recruitment information, location, and contact information.
Applicable clinical trials include:
Small feasibility trials and larger clinical trials of prototype devices with a primary measure of feasibility rather than health outcomes and trials using only de-identified human specimens are not Applicable Clinical Trials.
Members of the International Committee of Medical Journal Editors (ICMJE) will consider the results of clinical research for publication only if the trial has been registered prior to enrollment of the first subject.
Summary results must be published within 1 year of the completion date of the clinical trial (date of final data collection for the primary outcome measure). Results data must include participant flow, demographic and baseline characteristics, primary and secondary outcomes, statistical test results, adverse event information, and the full protocol/statistical analysis plan.
For each clinical trial supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects has to be posted by the PI on a publicly available Federal website established as a repository for such forms. The form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
Noncompliance can result in an inability to publish in certain journals. ICMJE journals require verification of registration and results reporting before accepting manuscripts for publication. Federal penalties include civil or criminal judicial actions, civil monetary fines of up to $10,000 per day, and potential impacts on future grant funding selection decisions.
The data collected on the participant, to the point of withdrawal, must remain part of the study database and may not be removed. The informed consent document cannot give the participant the option of having data removed.
When a participant is withdrawing, the investigator may ask whether the participant wishes to provide continued follow-up and further data collection after their withdrawal from the interventional portion of the study. Consent must be obtained and approved by the IRB. If consent is not given, the researcher must not access confidential records, but may consult public records (e.g., survival status) and review prior data.
Situations may arise when a physician finds it is in the best interest of a patient in a life-threatening situation to administer an investigational product prior to receiving IRB approval. Such a use is deemed an emergency use.
In accordance with FDA regulations, the IRB may allow for emergency use if the situation meets the definition under 21 CFR 56.102(d) and is reported to the IRB within 5 working days of actual use. Criteria include:
Informed consent is expected unless both the PI and an independent non-participating physician certify in writing that life-threatening circumstances prevent consent and no alternative approved therapy exists. Certification must be submitted to the IRB within 5 working days after the use.