NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.
The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).
You may review the NIH posting regarding sIRB review by clicking here.
If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your question to firstname.lastname@example.org.
An Institutional Review Board (IRB) consists of persons federally designated and appointed by the Chief Research Officer to review and monitor research activities involving humans or private, identifiable information about humans. The purpose of the IRB is to protect the rights and welfare of individuals who are participating in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving humans. Once approved, the IRB is required by federal regulation to monitor the progress of the ongoing research, prospectively approve modifications, and, if necessary to protect participant(s), suspend a research project.
The office that supports the IRBs at ECU is called the Office of Research Integrity & Compliance. The ORIC offices are located at East Carolina University, 4N-70 Brody Medical Sciences Bldg., Mailstop 682, 600 Moye Boulevard, Greenville, NC 27834 and 2422 Old Cafeteria Complex, Main Campus. Mail delivery is to the Brody address only.
Both locations of the ORIC office are open from 8:00 am to 5:00 pm Monday-Friday.
Brody Location (Main Number) Telephone: 252-744-2914
Main Campus Location Number: 252-737-2958
Studies that qualify for exempt certification or expedited review may be addressed in four to five business days. However, given the workload of the reviewers, we ask that you allow 7-10 business days. Studies that require full board review are dependent upon when the next IRB meeting is being held and whether the agenda has been filled. This turnaround time does not include the time it may take a study to be reviewed and approved by Department Chairs and Ancillary Reviewers. Review and approval by these people is required before the study submission arrives in the IRB queue. The turnaround time described above also does NOT include the time that is required for submission, by the study team, of IRB requested modifications. IRB turnaround time is measured from the time the submission arrives in the IRB queue fully and properly prepared for review and approval to the date the IRB processes the approval.
The Behavioral & Social Science IRB meets every 1st & 3rd Wednesday of each month during Spring and Fall semesters with ad-hoc meetings convened as needed during the summer.
The Bio-medical IRB meets the 2nd & 4th Wednesday of each month.
Federal regulations mandate that an IRB have at least five members who come from varied backgrounds. The IRB may have as many members as necessary to perform a complete and adequate review of research activities. The IRB should have at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in nonscientific areas. The IRB should include at least one member not affiliated with the institution. No IRB may have a member participate in the IRB’s review of any project in which that member has a conflicting interest, except to provide information requested by the IRB.
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, assist in informing others about policy decisions or changes, or generalize findings beyond a single individual or an internal program (e.g., collaborations, publications or presentations.). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge", e.g., adding to a body of existing knowledge or creating a new body of knowledge, still falls under the definition of research. Research that is never published is still research. Participants in human research studies deserve protection whether or not the research is published.
Generalizable knowledge is not limited to quantitative studies designed to produce generalizations. Qualitative studies may also contribute to generalizable knowledge through the use of focus groups, case studies, ethnographies, interviews, or other means to identify general themes that others can choose to transfer to another situation
Examples of activities that typically are not generalizable include:
It is the scientist or scholar with primary responsibility for the design and conduct of a research project, including preparation of the proposal or research protocol.
In 1974 the National Research Act was signed into law. This law included the creation of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission was charged with developing guidelines that should be followed to assure that research involving humans met basic ethical principles. These principles of “Respect for Persons”, “Beneficence”, and “Justice” are the underlying principles of the regulations that now govern the use of humans in research. A full copy of the Belmont report, which lists the charge the Commission was given and the results of their efforts can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Respect for Persons is an ethical principal requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Beneficence is an ethical principle that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do no harm; and (2) protect from harm by maximizing anticipated benefits and minimizing possible risks of harm.
Justice is an ethical principle requiring fairness in the distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
An IRB protects the rights, safety, and welfare of human research participants by:
The IRB has the authority to:
For more information on the roles and responsibilities of the IRB, see §45 CFR 46.109.
No, quality improvement (QI) activities do not need to be submitted to the UMCIRB. The federal regulations governing human research do not require review by the IRB of QI activities. The Office of Research Integrity & Compliance (ORIC) and the UMCIRB do not have jurisdiction over QI activities and there are no standard operating practices (SOP), formal or informal, that require review of QI activities by the UMCIRB or ORIC staff. It is our assumption that Department Administrators, faculty and staff at an academic institution understand the difference between QI activities and human research. If they do not there are tools on our website as well as on OHRP's website to help decipher the difference between the two.
Consultation with ORIC for assistance making the determination of QI -v- human research may be sought when an individual is unable to make the determination on their own because the line between the two is so uncertain. If consultation is sought, the Quality Activities Worksheet should be completed in its entirety before contacting ORIC. This worksheet can be found on this website. After review of the worksheet and discussion with the individual the ORIC staff member will indicate their determination at the bottom of the worksheet. There will be no letter of determination generated.
The following are links to tools for use in making the distinction between QI and human research:
(1) Is an Activity Human Subject Research Requiring IRB Review and Approval?
(2) Quality Improvement Activities FAQs - Office for Human Research Protections (OHRP)
Part 50 are the regulations for clinical research which were established in 1980 by the Food and Drug Administration. Part 56 are the regulations that govern the IRB in reviewing research activities that involve humans.
In 1991, the Federal Policy for the Protection of Human Subjects was adopted, covering research supported by many other federal agencies and departments. Revisions to the Common Rule were issued by DHHS in January 2017 and became effective January 21, 2019.
The Office of Human Research Protections (OHRP) was established within the U.S. Department of Health and Human Services. The OHRP provides leadership for all 17 Federal agencies that carry out research involving humans under the Common Rule regulations. The office focuses entirely on protection of human participants in research and supervision of Institutional Review Boards. OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct or support research involving human participants, and when the research institutions have included all research they conduct in their Assurances filed with OHRP, regardless of the funding source. The OHRP website is http://www.hhs.gov/ohrp/index.html.
According to DHHS regulations 45 CFR 46.103, every institution engaged in human research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). The FWA Signatory Official must be authorized to represent and commit the entire institution and all its components to a legally binding agreement. (See definition of engaged at http://www.hhs.gov/ohrp/policy/engage08.html
The OHRP has also developed an IRB registration system. Registration of an IRB/Independent Ethics Committee (IEC) with the OHRP is voluntary; however, IRB/IEC registration is required for any institution or facility that receives federal funding. IRB registration is also mandatory for research that involves Food and Drug Administration articles that fall within its purview. The registration process is coordinated through the OHRP.
Both the Biomedical and Behavioral & Social Sciences IRBs at ECU are registered with OHRP/FDA. The registration numbers for those Committees are:
The Food and Drug Administration has separate regulations and policies concerning IRB review as set forth in 21CFR 56.
The FDA has purview over regulations that must be followed when the research involves products such as drugs, devices, and biologics. This includes research and marketing permits for drugs, biological products, and medical devices for human use, etc. FDA is not concerned about whether the research is funded or what agency is funding it, if any. The regulations apply whenever the research involves the use of drugs, devices, or biologics, whether investigational in nature or approved.
See http://www.fda.gov/ and http://www.fda.gov/oc/gcp/guidance.html for information regarding good clinical practice for research studies involving human participants in FDA-regulated products.
Yes. FDA regulations require IRB review and approval of regulated clinical investigations involving human participants no matter where the investigation is to occur, e.g., physician’s office, hospital, health department, etc.
An individual is considered a human subject when he/she meets the following definition:
"… is a living individual about whom an investigator (whether professional or student) conducting research:
(1) Obtains information or bio-specimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or bio-specimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable bio-specimens."
Intervention includes both physical procedures by which information or bio-specimens are gathered (i.e. venipuncture) and manipulations of the subject or subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable bio-specimen is a bio-specimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the bio-specimen.
Investigators or research sponsors sometimes pay participants; the payment should be based on the time that the individual gives to taking part in the study. Payment based on effort or discomfort associated with participation is subjective and can differ greatly across individuals. Payment for time can be equitably divided should a participant be withdrawn or choose to drop out of the study. If you are conducting research and payment is offered to participants, you need to inform the IRB on how payment will be prorated and when payment will be provided (by visit, at the end of the study, etc.). Payment cannot be of such an amount that it creates coercion or undue influence.
It is federally required that participants who receive greater than $600 for participating in a research study must file an IRS Form 1099 as earned income. The informed consent document should include a statement to this effect as well as a description of the process about how the IRS Form 1099 will be generated.
Vulnerable research participants are persons who are relatively or absolutely incapable of protecting their own interests. The researcher and research team should be cognizant of the special problems of research involving vulnerable populations, justify the proposed involvement of these populations in the research, and include additional safeguards for their safety and welfare. These populations include:
If a research participant, while taking part in a study, becomes a prisoner, and the relevant research proposal was not reviewed and approved by the IRB without applying the additional regulations for protections for prisoners in research, the investigator must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now incarcerated prisoner-participant must be suspended immediately, unless doing so will put that individual at risk. Upon receipt of the investigator’s report that a previously enrolled research participant has become a prisoner, and if the investigator wishes to have the individual continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C (additional protections for prisoners in research). If the research is supported by federal funds, IRB approval is not sufficient to allow the study on that one prisoner to continue. The institution(s) engaged in the research involving the prisoner participant must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner participant must be withdrawn from the study.
OHRP allows one important exception to the requirement that all research interactions or interventions with, and obtaining identifiable private information about, the now incarcerated prisoner-participant must cease until the regulatory requirements for research involving prisoners are met. In special circumstances in which the investigator asserts that it is in the best interest of the participant to remain in the research study while incarcerated, the participant may continue in the research until the requirements of subpart C are satisfied.
The investigator must promptly notify the IRB of this occurrence, so that the IRB can re-review the study. Some regulations governing the use of prisoners may not apply to these circumstances and the staff in ORIC will keep the investigator informed of what, if any, additional actions must be taken.
Under Federal regulations, certain categories of activity are considered research but may be declared exempt from review by the IRB. However, at ECU, as at most institutions, this does require completing a brief application via the electronic submission system and submitting it to the UMCIRB for consideration. The PI cannot, because of potential conflicts of interest, make this determination; it must be made by the UMCIRB.
The following are the exempt categories as listed in §45 CFR 46.104(d):
Category #1. Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes,
(a) Most research on regular and special education instructional strategies, and
(b) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category #2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(a) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, e.g. coding numbers;
(b) Any disclosure of the human subjects' response outside the research would not reasonably place the individual at risk of criminal or civil liability or be damaging to the person's financial standing, employability, educational advancement or reputation; or
(c) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.
Category #3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(a) The information obtains is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(b) Any disclosure of the human subjects' response outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(c) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review.
If the research involves deceiving the subjects regarding the nature or purpose of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware or misled regarding the nature or purposes of the research.
Benign behavioral interventions are defined in the revised common rule as brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
Category #4. Secondary research for which consent is not required. Secondary research uses of identifiable private information or identifiable bio-specimens, if at least one of the following criteria is met:
(a) The identifiable private information or identifiable bio-specimens are publicly available;
(b) Information, which may include information about bio-specimens, is recorded by the investigator in such a manner that the identity of the human subjects 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;
(c) The research involves only information collection and analysis involving investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, sub-parts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45CFR164.512(b); or
(d) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Category #5. Research and demonstration projects that are conducted or supported by a Federal Department or agency or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public health benefit or service programs, including:
(a) Procedures for obtaining benefits or services under those programs;
(b) Possible changes in or alternatives to those programs or procedures; or
(c) Possible changes in methods or levels of payment for benefits or services under those programs.
Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangement, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department of agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
Category #6. Taste and food quality evaluation and consumer acceptance studies if:
(a) Wholesome foods without additives are consumed, or
(b) Food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U. S. Department of Agriculture (USDA).
**The exempt categories above are applicable to Sub-part D, which provides for additional protections of children involved as participants in research except for categories #2 and #3. Exempt category #2(a) and (b) may apply to research in children involving educational tests of the observation of public behavior when the investigator(s) do not participate in the activities being observed. Exempt category #2(c) does not apply to research involving children.
***The exempt categories above are not applicable to human research activities involving prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
The criterion to be eligible for Expedited Review is that the study cannot be greater than minimal risk. IRBs must evaluate research studies in terms of the risk the research poses to human participants. The IRB should also review the informed consent process according to the level of risk posed. Expedited review is review of proposed research by the IRB Chair or his/her designee rather than by the full committee. Research involving no greater than minimal risk, minor changes in previously approved research (amendments), and research for which limited IRB review is a condition of exemption may all receive expedited review. If the risk to the subjects is greater than minimal, full IRB review is warranted.
Minimal risk (defined in §45 CFR 46.102) is defined such that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please note that there are special circumstances which are taken into consideration with research involving prisoners as research subjects.
For research involving prisoners, additional regulations must be applied. These additional regulations at §45 CFR 46, Subpart C, define “minimal risk” as follows:
“Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons” (§45 CFR 46.303(d))
When full board review is necessary, the research proposal is presented and discussed at a meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those voting members present.
The investigator will receive electronic notification documenting the committee’s findings typically within 48 hours.
In order to approve research, the IRB must ensure that the following requirements are satisfied:
It is an analysis of the potential risks to participants considered against the potential benefits to the individual or to the research objectives of the study.
At ECU we have an electronic IRB submission, review and tracking system. It is through the use of this electronic system that you will create and submit new studies, amendments to existing studies, continuing reviews and reportable events.
Any changes to the protocol, consent form or research process must have UMCIRB approval before they may be implemented. Requests for changes (amendments) to approved studies must be promptly submitted via the electronic submission system at any time during the approved period. There are special circumstances in which immediate changes must be made to protect research subjects against immediate risks.
It is a process that involves conveying accurate and relevant information about the study and its purpose; disclosing known risks, benefits, alternatives, and procedures; answering questions; and enabling the potential participant to make an informed decision about whether to participate. Informed consent represents the basic principle of “Respect for Persons” in which the autonomy of an individual (i.e., the individual’s right to determine what will happen to him/her) is respected. There are federal guidelines that govern the consent process as well as consent documents to be used in human research.
* Please be reminded that informed consent is a communication process that continues during the entire study.
In order for consent to be valid, it should be based on the following critical elements:
The document should include all of the elements required by the federal guidelines governing human research, as well as any other information prospective participants might need to make an informed decision about participation. Consent documents should be written in nontechnical language that can be understood by the proposed participant population consistent with their educational level, familiarity with research, and cultural views.
The consent document must make clear that participation in research is voluntary, and it should not include any language waiving or appearing to waive participants’ rights.
We provide consent templates for your use. We have incorporated the required elements as well as additional elements into the templates along with instructions on how to complete the document for use for your study. You may find these templates on the UMCIRB website on the “Forms, Documents & Templates” page or in the electronic submission system.
The UMCIRB consent templates should be used for all studies where informed consent will be required and there is no sponsor informed consent template(s). If the study team has been provided with an informed consent template by a study sponsor which contains the essential elements of informed consent and, if necessary, the additional elements of informed consent and FDA required ClinicalTrials.gov language they may use that template for their study consent document. HOWEVER, you must insert certain institutionally required language into the consent document in order for the IRB to approve the document for use. The required language that must be inserted into the sponsor's template is contained in a document titled "Information Sheet for the Use of a Sponsor's Informed Consent Document Template." This document can be found on the UMCIRB website on the "Forms, Docs & Templates" page or in the electronic submission system.
Advertisements, fliers, or brochures prepared to recruit and inform potential participants about a study are considered part of the informed consent process and, as such, also require review and approval by the IRB.
1. A statement that the study involves
research, an explanation of the purposes of the research and 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 reasonable
foreseeable risks or discomforts to the subject.
3. A description of any benefits to the
subject or to others that may reasonably be expected from the research.
4. A disclosure of appropriate
alternative procedures or courses of treatment, if any, which might be
advantageous to the subject.
5. A statement describing the extent,
if any, to which confidentiality of records identifying the subject will be
maintained. The possibility that the Food and Drug Administration may inspect
the records should be noted.
6. For research involving more than
minimal risk, an explanation as to whether there is any compensation for
injury, 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 subject’s
rights, and who to contact in the event of a research related injury to the
8. A statement that participation is
voluntary, that refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and that the subject may
discontinue participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled.
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable bio-specimens:
(i) A statement that identifiers might be removed from the identifiable private information or identifiable bio-specimens and that, after such removal, the information or bio-specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subjects or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject's information or bio-specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Six additional elements:
1. A statement that the particular
treatment or procedures may involve risks to the participant (or the embryo or
fetus if the woman is or may become pregnant), which are currently
2. Anticipated circumstances under
which the subject’s participation may be terminated by the investigators
without regard to the subject’s consent.
3. Any additional costs to the subject
that may result from participation in the research.
4. The consequences of a subject’s
decision to withdraw from the research and procedures for orderly termination
of participation by the subject.
5. A statement that significant new
findings developed during the course of the research which may relate to the
subject’s willingness to continue participation will be provided to the
6. The approximate number of subjects
involved in the study.
7. A statement that the subject's bio-specimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
9. For research involving bio-specimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
If it is anticipated that a consent form will be needed for those who may speak a foreign language then the consent form should be translated into the language that the participant understands. The UMCIRB requires that all non-English consents be submitted for review and approval. If this is not included in the original submission, and the study team encounters a potential participant who does not speak English, you will need to submit an amendment to the study to include a “Short Form”, i.e. a modified version of the informed consent. The Short Form should be used on only one occasion. If, after this initial encounter, you encounter other participants who do not speak English then an amendment to the study will need to be submitted which includes a translated version of the entire consent document for use.
Assent is an agreement by an individual not considered fully autonomous and therefore unable to give valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Whether assent is documented or even carried out depends upon the maturity of the individual being asked to take part in the research and the setting in which the research is being implemented. Often it is appropriate to waive documentation or even the entire assent process.
An individual or judicial or other body authorized under applicable law to consent to take part in research, on behalf of a prospective participant. The LAR is asked to consider what he/she believes would be the decision of the person for whom consent is being sought. An LAR will be asked to sign a consent document and that signature will represent what he/she believes is what the person would want to do. In North Carolina, an LAR is often next of kin, but can also be a significant other, a court-appointed guardian, or even a person’s social worker (in extreme cases). When trying to decide who can act as an LAR, it is usually the same person who can sign permission for medical care.
It is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile or other electronic means and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile or other electronic means.
Principal Investigators are ultimately responsible for the informed consent process. However, it may be someone other than the PI who obtains and documents the informed consent of participants or their legally authorized representatives. This person will need to be named in the application to the IRB so that there is sufficient evidence that the person obtaining and documenting informed consent is appropriate and has had appropriate training in human research protections. There are situations under which the IRB can approve a waiver of informed consent, or a waiver of documentation of informed consent., respectively (45 CFR 46.116, 45 CFR 46.117). Investigators must give a copy of the informed consent document to each research participant or LAR, and keep the signed original or a copy of it for their records (45 CFR 46.117(a); 45 CFR 46.115(b)).
FDA does not require a third person to witness the consent documentation unless there is insufficient time to allow the participant or representative sufficient time to read and discuss the consent document before it is signed. see 21 CFR 50.27(b).
Illiterate persons who understand English may have the consent read to them and “make their mark,” if appropriate under applicable state law. There are federal requirements that state there must be a signature of someone who has witnessed the consent process as well as the signature of the person conducting the consent process. This is specifically important if a “short form” is used. Investigators should be cautious when enrolling individuals who may not truly understand what they have agreed to do.
Changes to a study (protocol amendments) must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the participants. (21 CFR 56.108(a) (4)). Participants who are presently enrolled and actively taking part in the study should be informed of the change if it might relate to their willingness to continue in the study (21 CFR 50.25(b) (5)). FDA does not require re-consenting of participants that have completed their active participation in the study, or of those who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled individuals.
However, if the change to the study is being initiated because of identified risks that do not show up during active intervention, then all participants should be notified so that they might be aware that this previously unknown risk has now been seen.
Federal regulations 21 CFR 50.25(a) (7) require three contacts to be provided to participants. There needs to be contact information for the person best suited to answer questions about the research. This is generally the Principal Investigator. There should be a contact listed for questions about the research participant’s rights, and at ECU that is the Director of the Office of Research Integrity & Compliance. Finally there needs to be contact information for reporting research-related injury. This can be the Principal Investigator or the person with whom the participant interacts most frequently in the research, such as a research coordinator, research nurse, or co-investigator. It is also important that the person named as the contact for reporting research-related injury be someone that can be reached through a direct line, a call service, or beeper at any time. Participants experiencing unanticipated problems as a result of taking part in a research project should not have to leave voice messages or wait a weekend to get a response from someone knowledgeable about the research.
Studies conducted with an investigational agent or device (IND or IDE) are subject to the requirements of both the regulations set forth by the Department of Health & Human Services as well as the Food and Drug Administration regulations. 21 CFR part 312 (clinical investigations) as well as 45 CFR 46, Subpart A (Research involving human subjects). The FDA and OHRP have provided guidance documents that define unanticipated problems involving risks to participants or others. The researcher and team are responsible for reporting, to the IRB, study sponsor , NIH, and FDA (according to 21CFR312.32), any unanticipated problems involving risks to participants or others if they are unexpected; related or possibly related to participation in research; and increase the risk of harm. Safety problems must be identified and reported to the IRB in a manner outlined in the approved protocol.
Federal regulations make no distinction between the issues the IRB must consider during initial review and those they must consider at the time of continuing review. The criteria for initial approval and continuing approval are exactly the same. However, at the time of continuing review, the IRB must also consider whether there has been identified any changes to the risk/benefit ratio. For research that is considered greater than minimal risk and for FDA-regulated research, continuing review will be conducted at intervals appropriate to the degree of risk, no less than once a year. The length of time between continuing reviews is dependent upon many factors such as whether this research is novel in humans, whether it involves an extremely risky procedure, the experience of the research team in conducting the procedures etc. It is important that the researcher remains cognizant of the expiration date for his/her IRB approval and submit a continuing review report which allows sufficient time for the IRB review to occur and the PI to address any concerns the IRB may raise. Continuing review of a study is submitted via the electronic IRB system.
There are exceptions to the requirement for continuing review. Unless the IRB determines otherwise, continuing review of non-FDA-regulated research is not required in the following circumstances:
The IRB reserves the right to require continuing review for other research for which it provides review, approval and oversight.
If IRB approval of a specific study expires before continuing review and approval occur, investigators must stop all research activities related to that study (45 CFR 46.103(a)), except where they judge that it is in the best interests of those already enrolled to continue to participate. When investigators make this judgment, they must promptly notify the IRB. When the IRB reviews the investigator’s decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects. Investigators may resume the human participant research activity once continuing review and approval by the IRB has occurred.
Yes, it is the investigator’s responsibility to notify the IRB that the research study has been completed or terminated for some reason and is being closed. For non-exempt studies that received full or expedited IRB review and approval the study closure should be reported to the IRB via the electronic submission system using the “Create Final Report” function. For studies that were certified exempt study closure should be noted by clicking the button titled “Study Completed” located on the left side of the screen of the study work space.
Researchers are required to maintain, for a minimum of three years, all of the following:
If the research involves the generation, collection or use of protected health information about the participants, the researchers must also maintain the HIPAA authorizations (or documentation of waivers or alterations) and research data for a minimum of six (6) years after the end date of the study.
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