- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect January 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after January 19, 2018 will be reviewed under the revised Common Rule. We are currently evaluating whether the changes will apply to studies existing prior to January 19, 2018.
- The definition of "human subject" has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private data are treated the same in the final rule.
- Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research.
- Overall, there are four new elements of informed consent; one new required element and three new optional (i.e."if applicable") elements. These new elements are generally related to the secondary use of data and samples and genomic research.
- The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
- Some minimal risk studies will no longer be required to undergo annual continuing review.
- Changes to the Common Rule mandate the use of a single IRB for multisite, cooperative studies. This requirement will be effective January 19, 2020.
- The revisions to the Common Rule go into effect January 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 01.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- For existing studies; ORIC is evaluating whether the changes will apply to these studies after the effective date.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
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, must include both men and women, and 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:
- oral histories that are designed solely to create a record of specific historical events*;
- service or course evaluations, unless they can be generalized to other individuals, departments, or institutions;
- services, courses, or concepts where it is not the intention to share the results beyond the ECU community;
- classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices;
- quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the ECU community.
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:
- Reviewing the full protocols for planned research studies to ensure that, in its judgment, the research meets the criteria found at 45 CFR 46.111.
- Confirming that the research plans do not expose participants to unreasonable risks.
- Conducting continuing review of approved research at intervals defined by the degree of risk of the research, but not less than once a year, to ensure that human participant protection remain in force.
- Considering unanticipated problems, interim findings, and any recent literature that may be relevant to the research.
- Assessing suspected or alleged noncompliance with approved procedures, complaints expressed by research participants, or violations of institutional policies.
The IRB has the authority to:
- Approve, disapprove, or terminate all research activities that fall within its local jurisdiction according to relevant Federal regulations and institutional policy.
- Require modifications in submissions, including previously approved research.
- Require that information, in addition to that specifically mentioned in §45 CFR 46.116, be given to participants when the IRB determines that this information would add to the protection of their rights and welfare.
- Require documentation of informed consent or allow waiver of documentation, in accordance with §45 CFR 46.117.
For more information on the roles and responsibilities of the IRB, see §45 CFR 46.109.
Important Regulations and Governing Agencies
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. The provisions are identical to DHHS Regulations (§45 CFR 46, Subpart A).
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
- ECU's FWA # is FWA00000658
- Vidant Medical Center's FWA # is FWA00000652
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:
- IRB00000705 East Carolina U IRB #1 (Biomedical)
- IRB00003781 East Carolina U IRB #2 (Behavioral/SS)
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.
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 research participant when he/she meets the following definition:
"… is a living individual about whom a researcher obtains either: (1) data through direct intervention or any type of interaction with the individual; or (2) identifiable private information about an individual. If information is obtained about a third party from a research participant, then these third parties may be considered research participants under certain circumstances."
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:
- individuals with questionable capacity to consent (cognitively impaired, traumatized, sedated, intoxicated, etc.),
- pregnant women, neonates, and fetuses,
- the terminally ill,
- individuals whose first language is not English
- individuals who are at risk of civil or criminal liability; and
- comatose patients.
- Subpart B of the Regulations addresses additional protections extended to research involving fetuses, pregnant women, and human in vitro fertilization.
- Subpart C pertains to protection of prisoners who are participants in human subject research.
- Subpart D addressed protections for children who participate in research. The regulations can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
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 six exempt categories as listed in §45 CFR 46.101(b):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to them.
- Any disclosure of the human participant’s responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
- The participants are elected or appointed public officials or candidates for public office.
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, i.e., records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified, directly or through identifiers linked to them.
- 5. Research and demonstration projects conducted by or subject to the approval of a Federal Department or agency heads and designed to study, evaluate, or otherwise examine public health benefit or service programs.
- 6. Taste and food-quality evaluation and consumer acceptance studies.
These exemptions do not apply to research involving prisoners. Further, the exemption in item 2 above does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed. Interviews, surveys, and interactive observations are not exempt, while educational tests and non-interactive observations are.
The first 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. If the research involves no greater than minimal risk, the study must be reviewed by an IRB but may be eligible for expedited review which is review of proposed research by the IRB Chair or a specified voting member, rather than by the entire IRB. If the risk to the subjects is greater than minimal, full IRB review is warranted.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) or
- Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week;
- from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
- hair and nail clippings in a nondisfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- 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;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
- sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
- physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
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))The wording of the Subpart C definition differs in several ways from the definition of “minimal risk” in 45 CFR Part 46, Subpart A which applies to human research as a general population. The differences are:
- Subpart C definition refers to “physical or psychological harm” rather than “harm or discomfort” as in subpart A.
- Subpart C definition compares the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life, or in “routine medical, dental, or psychological examinations,” rather than in daily life or “routine physical or psychological examinations or tests” as in subpart A.
- Prisoner regulations define “healthy persons” as the comparison group against which the risks of the research should be measured, rather than leaving the comparison group unspecified, as in subpart A. OHRP interprets the term “healthy persons” in this definition as referring to healthy persons who are not prisoners.
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:
- Risks to participants are minimized by using procedures consistent with sound research design that do not unnecessarily expose participants to risk.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those that may result from the research, as distinguished from those participants would receive even if not participating.
- Selection of participants is equitable. The IRB should consider the purposes of the research and the setting in which the research will be conducted and be particularly mindful of the special problems of research involving vulnerable populations. Participants should share equally in foreseeable benefits and risks.
- Informed consent is sought, and will be obtained, from each prospective participant or the participant’s legally authorized representative in accordance with, and to the extent required by 45 CFR 46.116.
- Informed consent is appropriately documented in accordance with, and to the extent required by 45 CFR 46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
- Additionally, when some or all of the participants are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, or persons) additional safeguards are included in the study to protect the rights and welfare of these participants.
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.
Documentation Submission Requirements
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 participant must be COMPETENT to begin the informed consent process. If the participant is not competent because of age, illness, incapacity, or any other reason, special protections apply or the participant may not be included in the research.
- The research team must DISCLOSE all relevant information to the potential participant. The information must be sufficient to allow the potential participant to decide whether to participate. It is generally accepted that the potential participant must be given the following information: the purpose of the study; nature of the procedure; reasonable alternatives to the proposed intervention; and risks, benefits, and uncertainties of each possible intervention.
- The participant must COMPREHEND the information. The research team must evaluate the potential participant’s ability to understand the proposed intervention in the study.
- The participant must AGREE to the proposed intervention in the research study.
- The participant’s agreement must be VOLUNTARY and free from coercion.
- Participants must be informed that even after they have made a voluntary agreement to participate in the study, they may WITHDRAW such agreement at any time without penalty.
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 ORIC website on the “Forms, Documents & Templates” page or in the electronic submission system.
The ORIC 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 eight (8) essential elements of informed consent and, if necessary, the six (6) 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 ORIC 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.
Eight essential elements:
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 subject.
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.
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 unforeseeable.
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 subject.
6. The approximate number of subjects involved in the study.
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.
Unanticipated Problems Involving Risks to Participants or Others
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.
- Unexpected event: not previously identified in nature, severity, or degree of incidence in the investigational plan, protocol, or study application (including any supplementary plan or application); any adverse experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended (based on 21 CFR 312.32(a))
- Any breaches in confidentiality that would place the participant or others at risk.
- Any change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
- Any change to the protocol that was taken without prior IRB approval to eliminate apparent immediate hazard to a research participant.
- Incarceration of a participant when enrolled on a study not approved under Subpart C provisions.
- Related or possibly related to participation in research: there is at least a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research. UMCIRB extends this definition to a minimum of 30 days post-administration of the test article or intervention
- Increased risk of harm: suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
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 eight 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. 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. The maximum period of time for which the IRB can grant any approval is one year. Therefore, 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.
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(b)), 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 is being terminated or closed. For studies that received review and approval by full IRB review or expedited review the study closure should be reported to the IRB via the electronic submission system using the “Create New Continuing Review” function. When you initiate the electronic Continuing Review process you will be prompted to let the IRB know if this is a “Continuing Review or “Final Report”. You will select Final Report in order to close out the study. 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 in the electronic submission system study workspace.
Researchers are required to maintain, for a minimum of three years, all of the following:
- Any submissions to the IRB (captured in electronic submission system)
- All correspondence to and from the IRB (which should also be in the electronic submission system); and
- All signed informed consent documents.
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.
IRB Training Modules
East Carolina University is located under the heading “All Others” and can be found by clicking on the drop down arrow.
Log on to the CITI website and print out another copy. If you are unsuccessful at printing another copy, you may contact the ORIC office.