IRB Application

The approval period of an nonexempt protocol is determined by the IRB but not more than one year

Renewal reminder notices are sent out 30 and 60 days in advance to the PI named on the protocol. However, these are courtesy reminders. It is ultimately the responsibility of the PI to ensure that the renewal is submitted prior to the renewal date.

All research activities must cease until approval is obtained. An incident report must be submitted to the IRB that explains the lapse in approval.

If all documents are sent along with the renewal, the review and approval process takes approximately 2 weeks.

No, a modification changes components of the currently approved protocol not the approval period

A modification is necessary whenever a PI deviates from the approved protocol. The modification approval process takes approximately 2 weeks.

No, the IRB must approve any changes prior to implementation

Yes. Any time a research staff member (research assistants, co-investigators, etc.) is added or removed, a modification needs to be sent.

Please note that it is the lead investigators responsibility to keep UNCG approved human subject’s research training and signed statements of confidentiality on file.

For each modification the IRB will make a determination if the change will require review by the full board review

If investigators wish to modify an ongoing IRB-approved research study, they must submit a request to the IRB and receive IRB approval before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to subjects (45 CFR 46.103(b)(4)). If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB.

Full text can be found at http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html

If investigators wish to modify an IRB approved consent form they must submit the request for modification to the IRB and receive IRB approval before starting to use the proposed modified consent form.

If investigators wish to modify their data collection method(s) in an ongoing IRB approved study they must submit the request for modification to the IRB and receive IRB approval before starting the use of the new data collection method(s). This is vitally important as changes in data collection method(s) can significantly affect the risk benefit ratio and in some cases require additional oversight.

If investigators wish to add additional personnel that were not initially noted in the initial protocol approval they will need to ensure that the individual(s) have completed the CITI training and submit a modification application.

If investigators wish to add additional personnel they will need to ensure that the individual(s) complete a statement of confidentiality and maintain this document in the research files and submit a modification application. The statement of confidentiality template can be found on the templates page.

If investigators wish to add a data collection site(s) to an ongoing IRB approved study they must submit the request for modification to the IRB and receive IRB approval before recruitment from the new site(s) is administered. A site approval letter from each new site needs to be submitted.

Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate

For studies qualifying for expedited/full committee review:

1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. a description of any reasonably foreseeable risks or discomforts to the participant;
3. a description of any benefits to the participant or to others which may reasonably be expected from the research;
4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
5. a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
6. for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. an explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights ; and
8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The federal regulations in addition to the state laws in which the research is conducted should be consulted. As a general matter, if an adult lacks capacity to consent, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementia whether temporary, progressive, or permanent only a legally authorized representative for that adult can give consent for participation in the research, unless the requirement to obtain informed consent is waived by the IRB in accordance with the federal regulations. Should the subject regain or develop the capacity to consent, then his or her consent must be obtained for any further research, as the consent of the legally authorized representative is no longer valid.

Full text can be found at http://answers.hhs.gov/ohrp/categories/1566

In most cases yes, the informed consent document has to be signed and dated.

The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent).

The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent.

In most cases some form of informed consent is required.

Waiver or alteration of the requirements for obtaining informed consent from adult subjects can occur. Of the three provisions only one apply to the type of research conducted at UNCG:
Research in general: an IRB may waive or alter the requirement of informed consent under the federal regulations, provided that the IRB finds and documents that all of the following four conditions are met:
1. the research involves no more than minimal risk to the subjects;
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. the research could not practicably (mere convenience to the investigator does not constitute practicability) be carried out without the waiver or alteration; and
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

For research involving children, see below in the Children section

Terms such as “passive” or “implied” consent are not referenced in the federal regulations. However, the federal government does reference altered or waived informed consent documents. These alteration or waivers include the requirement to document consent or parental permission has been waived.

The term “passive consent” is sometimes used in research with children to describe situations in which the investigator can assume that a parent is permitting a child to participate. For example, researchers collecting survey and behavioral data from children at school provide parents with information regarding the study by mail and ask the parent(s) to return a form if they do not want their child to participate. Sometimes this practice is referred to as an opt out procedure, which is not consistent with the regulatory requirement for seeking and obtaining parental permission. If the IRB determines that the conditions for waiver of parental permission can be met, then the IRB could waive the requirement for parental permission under 45 CFR 46.408(c) or 45 CFR 46.116(c) or (d). Even though not required by the regulations, an IRB may require that parents be given the opportunity to refuse permission even when the IRB has waived the regulatory requirement to obtain parental permission.

Full text can be found at http://answers.hhs.gov/ohrp/categories/1566

The IRB must determine, to the extent required by federal regulations on consent, that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent as well as the permission of the parents. In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.

Under the federal regulations the IRB may find that the permission of one parent is sufficient for research to be conducted. Where research is conducted at a higher risk with no direct benefit to the child, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with federal regulation on consent and the additional safeguards for research with children.

No, children give their assent to participate in research.

5-6  years old – verbal assent
7-17 years old – written assent

For the most part, yes, but the age and cognitive abilities of the kid may merit a waiver of some of the elements.

Yes, parental permission should be obtained prior to the child assent.

Only when the research is of high risk and/or there is not direct benefit to the child.

Yes, but the PI should provide adequate justification to the IRB.

Yes, but the PI should provide adequate justification to the IRB.

An IRB may waive the requirements for obtaining parental or guardian permission under any of the following four provisions:

The IRB makes and documents the required findings under the federal regulations for consent.
The IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and the following 2 additional criteria are also met:
1. an appropriate mechanism is in place to protect the children, and
2. the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition (45 CFR 46.408(c)). Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.

See the OHRP Informed Consent FAQ

Beginning on April 14, 2003, the Privacy Rule’s compliance date for most covered entities, IRBs gained authority to consider, and act upon, requests for a partial or complete waiver or alteration of the Privacy Rule’s Authorization requirement for uses and disclosures of PHI for research. Although HHS and FDA Protection of Human Subjects Regulations include protections to help ensure the privacy of subjects and the confidentiality of information, the Privacy Rule supplements these protections by requiring covered entities to implement specific measures to safeguard the privacy of PHI. If certain conditions are met, an IRB may grant a waiver or an alteration of the Authorization requirement for research uses or disclosures of PHI.

There are 3 conditions under which a CE can release PHI to a researcher:

Every subject has signed an authorization for the CE to release the PHI to the researcher. In most research cases, each subject must sign an authorization for the CE to release PHI to the researcher. Authorizations are separate from consent forms, and must contain specific information. Hospitals and other large CEs may require the researcher to use their standard agency authorization form. Researchers are advised to contact CEs and determine this before investing time in creating an authorization form specific to their research study.

An IRB has granted the researcher a waiver of authorization. An IRB can grant a waiver of authorization for release of PHI for a research study if it determines that obtaining a signed authorization from each subject is impractical, and that the researcher has taken sufficient safeguards to protect the data. A Request for Waiver of Authorization form is attached. However, researchers should be aware that CEs with their own IRBs might require that the waiver be granted by the agency IRB, rather than UNCG’s IRB. Researchers are advised to contact CEs and determine this before applying for a Waiver of Authorization from the UNCG IRB.

The researcher de-identifies the health information to HIPAA standards. De-identification to HIPAA standards requires removing considerable information, in addition to names. A list of data elements that must be removed is shown on page

Note: The burden for complying with HIPAA falls on the CE, so it is ultimately the responsibility of the CE to determine if the conditions that allow disclosure of PHI have been met. The UNCG IRB can help researchers throughout the process, but the CE will always be the one to make the final decision about whether PHI can be shared with a researcher.

Waiver of Authorization*: An IRB can grant waiver of authorization for a research study if it determines that (45 C.F.R. 164.512(i)):

The use or disclosure of protected health information (PHI) involves no more than a 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 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 by this HIPAA and approved by the IRB;

The research could not practicably be conducted without the waiver or alteration; and

The research could not practicably be conducted without access to and use of the PHI.

For more information:
IRB Factsheet
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule from the DHHS website

Psychology Clinic
Speech and Hearing Clinic
Speech and Hearing Program (Gateway North)
Student Health Services

The Privacy officer is responsible for providing information, receiving complaints and handling the administration of patients’ records rights such as access, amendment, and confidential communications.

The HIPAA Privacy officer at UNCG is: SaQuang Lam, Assistant Director of Student Health Services, Student Affairs s_lam@uncg.edu, 336-334-3085

The Security officer is responsible for the development and implementation of the policies and procedures required by the HIPAA Security Rule.

The HIPAA Security officer at UNCG is: Casey Forrest, University Chief Information Security Officer, Information Technology Services cjforrest@uncg.edu, 334-4374

The IRB requests one or both of the following when reviewing an IRB submission using PHI:

HIPAA authorization – written permission from the patients that allows use or disclosure of their protected health information for purposes other than treatment, payment or health care operations. This is usually obtained from the covered entity.

HIPAA Waiver of Authorization– Under limited circumstances, a waiver of the requirement for authorization for use or disclosure of private health information may be obtained from the IRB by the researcher. A waiver of authorization can be approved only if specific criteria have been met.

If other parties have access to, or may need to review, PHI pertaining to the covered entity’s patients, a covered entity (CE) may have to enter business associate agreements with a number of other parties with whom the covered entity has a business relationship. Business associates of the UNCG covered entities may be other UNCG units that perform work on behalf of the CE; and UNCG units may also serve as a business associate to a CE other than UNCG.

Contact the Office of the Provost. Their website can be found at: https://provost.uncg.edu/policies-procedures-forms/hipaa/.

When it is de-identified from the covered entity.

When it has been given to the participant by the doctor and that participant provided it to the researcher.

When it is given to the researcher through interviews or questionnaires from the participants as part of the study.

HIPAA Compliance policy
For more information on HIPAA policies at UNCG UNCG Office of the Provost
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule from the DHHS website 
NIH IRB Factsheet

No, however it is required that you have adequate plans to communicate with non-English speaking populations to ensure that the procedures are fully understood and that informed consent can be reliably obtained.

Yes, however, the PI must provide a plan to ensure that the participants understand what is going on in the research project

You should submit a plan to communicate information as appropriate to the population.
Typically all research related documents must be translated into the appropriate language.

Requirements within school districts can vary regarding conducting research. Some school systems may require an independent review of the research by a research review committee similar to an IRB, while others only need the superintendent or their designee to review and approve the research. Prior to IRB submission, the researcher should consult with the school district where the research will take place as to what their research policies are.

It is preferred that school district approval is obtained prior to IRB submission, however, if the school district requires UNCG IRB approval first, accommodations can be made.