IRB Frequently Asked Questions

Topics
General Information

Who can I contact for information or assistance with a proposed project which includes human participants?

The Office of Research & Grants Administration (ORGA) has made many informational resources available through the IRB section of the ORGA web site, including a link to the Office for Human Research Protections (OHRP) which has an extensive online library of regulations and guidance.

However, we realize that there are many areas in the regulations and guidance that can be difficult to interpret. We available to help you with questions and assist you in completing required paperwork.

We also are happy to present guest lectures or workshops on research protections & compliance to your classes.

Please contact: 

Sara Stevenson
compliance@orga.cofc.edu
 Research Protections and Compliance
Office of Research and Grants Administration
Campus Location: 407-F BellSouth (AT&T) Building
Phone: (843) 953-5885

What is the IRB?

The Institutional Review Board for the Protection of Subjects (familiarly known as the IRB) assures that all research with human participants conducted under the auspices of the College of Charleston addresses the three basic ethical principles of research set forth in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) and meets the requirements of the Common Rule (and subparts as applicable), the federal regulation (45CFR46) that governs human research.

Who serves on the IRB?

The IRB is an independent committee of the College of Charleston comprised of faculty members from a variety of disciplines and at least one representative from the community who has no affiliation with the College. The President of the College appoints voting members for three-year terms. The Research Protections & Compliance Coordinator, Office of Research and Grants Administration, serves as IRB Administrator and as an ex officio non-voting member of the IRB.

What authority does the IRB have?

The IRB may approve, require modifications in, or disapprove research activities involving human participants. Research that has been reviewed and approved by the IRB may be disapproved by officials of the institution for reasons not related to research ethics. However, those officials may not approve research if it has been disapproved by the IRB.

Research that has been reviewed and approved by the IRB is subject to continuing IRB review and must be reevaluated annually, or as otherwise determined by the IRB.

The IRB fulfills an additional institution-centered role, delegated by the Board of Trustees, of reviewing requests from researchers from other institutions and organizations to recruit study participants on the College of Charleston campus through official College channels. After consideration of risks to potential study participants and potential institutional liability, the IRB determines whether or not permission to recruit on campus should be granted to external researchers.

Isn't IRB review required only for federally funded projects?

No. College policy requires IRB review for all human participant research conducted at the College of Charleston.

I am not sure if my project requires IRB approval. What should I do?

Open the Human Research Review Application. Log on to the site using your Cougars Domain credentials (same as for email). The application begins with two questions which should help you determine if you need to complete and submit the form for review. The OHRP (Office for Human Research Protections of DHHS) also provides decision charts which may help you.

The most effective way to get an answer to your questions is to contact compliance@cofc.edu. There are many human participant-related nuances to research projects that are not immediately obvious and can affect whether or not the project requires IRB review.

I'm planning to use an existing data set. Are there any concerns since I won't be interacting directly with participants?

Pre-existing data may be in the form of existing data sets generated through research studies or data collected for purposes not originally intended as research. If data are publicly available or exist in a completely de-identified database, no IRB application is required as research using these data does not meet the definition of human participant research. Research with data sets which contain individually-identifiable information must be submitted for review.  See also IRB Guidance on Public Data Sets.

I am just evaluating my teaching methods or curriculum, do I need IRB approval?

Quality-improvement research that will be used solely for internal College purposes does not require IRB review unless there is a plan to disseminate the results beyond the College "walls" or the research data is being shared with an outside research entity.

What are my responsibilities in conducting research that involves human participants?

First and foremost, you are required to conduct research involving human participants in an ethical manner based on the principles of respect for persons, beneficence, and justice as described in the Belmont Report, and in accordance with the ethical guidelines of your profession. You should be familiar with and comply with College policies and procedures regarding the protection of human participants in research and be familiar with the federal regulations governing Human Participant Research.

You should ensure that you and all research staff working on the proposed project who will have direct and substantive involvement in proposing, performing, reviewing, or reporting the research (including students fulfilling these roles) complete approved training.

You must receive either exemption approval or formal IRB approval of your research protocol before interacting or intervening with the participants or collecting data about them.

You must report any unanticipated effects on participants, which become apparent during the course or as a result of experimentation and the actions taken as a result.

You must cooperate in the continuing review of your research, obtain prior approval before amending or altering the scope of the project or implementing changes in the approved consent form, and maintain documentation of consent forms and research progress reports for a minimum of three years after completion of the final report or longer if required by the sponsor or the institution.

Are there special requirements that must be met if my research involves participants from public schools?

Yes, if your research involves the inclusion of teachers, staff, or student participants from Charleston County School District, permission from CCSD must be granted and documented prior to submission of your protocol to the IRB. Procedures for conducting research in CCSD schools are available in the IRB section of the ORGA web site. Berkeley and Dorchester County School Districts do not have a similar requirement. However, whenever conducting research in K-12 schools, you must have written permission from the superintendent of schools (or equivalent) and school principal before recruiting teachers or students for your study.

College of Charleston Students as Participants (Subjects)

Can College of Charleston faculty members use students in their courses as participants (subjects) in their own research projects?

The IRB strongly discourages faculty from using students currently enrolled in their courses as subjects in their own research project unless there are sound reasons. A problem with student participation in research conducted by the students' instructor is the possibility that their agreement to participate will not be freely given - that they will feel subtly coerced, even if that is not your intention. Students may volunteer to participate out of a belief that doing so will place them in good favor with the instructor (i.e., that participating will result in receiving better grades, recommendations, or the like), or that failure to participate will negatively affect their relationship with the faculty generally (i.e., by seeming "uncooperative"). For this reason, the IRB pays special attention to the potential for coercion or undue influence and researchers should consider ways to reduce or eliminate the possibility of exploitation/coercion. In some cases, there is subtle coercion by association. For example, if an instructor supervises a student's independent research project and the student researcher wants to use students in the instructor's courses as subjects, the instructor should consider whether the independent study student has prior relationships with the students in the course (e.g., a junior or senior seeking subjects from a class with predominantly junior and senior majors in the same department).

There are ways to diminish the coercive aspect of student participation.

Instructors can have the data collected by an independent third party such as a colleague in their own or another department. They should do this in such a way that they would not know the identity of the students in the courses that participate: The instructor should not be present when the data are collected from the students in your courses and the third party should not be another student in the course.

Also, the instructors should make every effort to design the data collection so that they cannot easily access the students' names. Using an anonymous questionnaire without a signed consent form (oral consent) is the simplest method. However, If there is a need to match data from numerous sources or across time for individual students, you can use an identification number on a questionnaire that is matched to an identification number on their informed consent form. In all cases, the informed consent form should be turned in separately from the data collection instrument.

Can College of Charleston faculty members give extra credit to students in their courses for participating as subjects in their own or other colleagues' research?

A related concern is the potential for coercion in the use of extra credit as an incentive for an instructor's own students to participate in the instructor's or a colleague's research project. See also the related question above. Offering extra credit for participation in research is common, but not without problems. The justification most often offered for requiring student participation is educational benefit. Clearly, however, faculty-investigators may also need students in order to conduct their research, and giving course credit or extra credit is a means of obtaining sufficient participation rates. Again, the issue for the IRB is whether the arrangements for eliciting student participation are fair and noncoercive.

Instructors can minimize coercion by providing their students with other extra credit options that are comparable in terms of time, effort, and educational benefit. Quite often faculty offer short papers, special projects, book reports, and brief quizzes on additional readings as alternatives to participating in the instructor's research project. This raises the issue about the comparability of such alternatives with participating in research (e.g., that if they participate in studies, all they have to do is show up and spend the time, but if they choose to write a paper, it gets graded, and if they do extra readings, they have to be tested on them). One way to meet these concerns would be to give the alternatives of having students participate in the research, write a brief research paper, or attend a presentation by a campus speaker. The paper is not graded, and students who attend the speaker have only to show up to receive credit. Any extra credit, if provided, should not exceed 2% of the student's final grade.

Is a researcher who is not affiliated with the College of Charleston allowed to recruit our students as research participants?

Not without approval of the College IRB. Non-affiliated researchers must complete an External Request to Recruit Research Participants and have a contact person at the College of Charleston who is willing to assist as necessary. Further, the research must provide a benefit to the College student or community. A fee is charged for review of external requests. However, the fee may be waived if the researcher is a student or is not receiving external funds to conduct the research. All external requests are reviewed by the full IRB and may not be exempted or expedited.

College of Charleston Students as Researchers

Must research conducted by students be reviewed by the IRB?

All student-conducted research projects involving human participants that are intended to satisfy academic requirements for the Master's thesis, Bachelor's essay, or Independent Study are subject to IRB review. Other student-conducted human research projects that are expected to result in publication, poster, presentation outside the classroom, or public dissemination in some other form must also be reviewed. Additionally, some class projects or individual student projects done as part of a course intended to teach research methods are subject to IRB oversight.

Faculty-supervised class projects which do not involve minors, vulnerable populations, or greater than minimal risk, which are conducted solely for the purpose of developing research skills do not require IRB review unless there is an intention to disseminate the results beyond the classroom.

The IRB recommends inclusion of basic CITI training as a course requirement for research methods courses and other courses in which students may be involved in research with human participants. If students and faculty have completed the CITI training and this course work unexpectedly results in a project worthy of publication or presentation beyond the class, the IRB does not consider there to be barrier to dissemination (unless determined otherwise by the publication or presentation venue). A letter to this effect can be secured from the Research Protections & Compliance Coordinator if needed.

What kinds of class projects intended to teach research methods must be reviewed by the IRB?

Projects conducted outside the classroom and/or departmental research participant pool must be reviewed by the IRB if they involve minors (i.e., persons under the age of 18), a targeted population of adults whose ability to freely give informed consent may be compromised (i.e., persons who are socio-economically, educationally, or linguistically disadvantaged, cognitively impaired, elderly, terminally ill, or incarcerated), pregnant women and/or fetuses who may be put at risk of physical harm, a topic of a sensitive or personal nature, the examination or reporting of which may place the research participant at more than minimal risk, or any type of activity that places research participants at more than minimal risk.

In addition, IRB review is required if there is an intent to disseminate the result beyond the classroom, i.e. to create generalizable knowledge.

If a student assists on a College of Charleston faculty member's research project, is IRB review required for the student's part of the project?

No, providing the faculty member's research has been reviewed and approved by the IRB and the student is implementing part of the approved protocol. However, the student must complete the CITI training appropriate to the research project and be listed as a research associate under the personnel section of the IRB application. Students can be added to existing faculty research through the submission of a protocol modification.

If a student assists on a research project being conducted at another institution (for example, through an internship at MUSC), is College of Charleston IRB review required for the student's part of the project?

No, providing the research has been reviewed and approved by the other institution's IRB and the student is implementing part of the approved protocol. Note, however, that, if recruitment of study participants from College of Charleston is planned, permission must be given by the College of Charleston IRB to the external research mentor to recruit on our campus.

What are the responsibilities of the faculty sponsor in advising a student who engages in research involving human participants?

Recognizing that students are in a learning environment, the faculty sponsor has the primary responsibility of ensuring that the student understands and complies with the ethical principles of human research and federal regulations and College policy and procedures regarding the conduct of research involving human participants. The faculty sponsor should provide sufficient oversight to ensure that the research is conducted in accordance with the approved protocol and that any unanticipated problems are dealt with appropriately. Assistance in carrying out this role is available from the Research Protections & Compliance Coordinator and members of the IRB.

Effective Janaury 1, 2024, The faculty sponsor must serve as the PI of record for undergraduate student researchers and are responsible for assisting the student with developing the research methodology, the initial IRB submission, and all annual reporting requirements. 

Definitions

What is a HUMAN PARTICIPANT IN RESEARCH?

A human participant as defined in the federal regulations is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject. Anonymous surveys are included as interaction.

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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

How is RESEARCH defined in the context of IRB review?

Research is defined in the federal regulations as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

What are the ETHICAL PRINCIPLES outlined in the Belmont Report?

Respect for persons means that individuals must be treated as autonomous human beings and not used as a means to an end. We must allow people to choose for themselves, and provide extra protection to those with limited autonomy. The elements of autonomy are mental capacity (the ability to understand and process information) and voluntariness (the freedom from the control or influence of others). Rules derived from the respect for persons principle include the requirements for obtaining informed consent, for respecting the privacy of research participants, protecting the confidentiality of information about them, and providing protection for persons who are unable to consent for themselves.

The beneficence principle requires us to minimize harms and maximize benefits. Derived rules include requirements to use the best possible research design to maximize benefits and minimize harms, to ensure that the researcher is qualified to perform the procedures and handle the risks, and to prohibit the conduct of research that is without a favorable risk-benefit balance.

The principle of justice reminds us to treat people fairly and to design research so that its burdens and benefits are shared equitably. Derived rules include requirements to select subjects equitably and to avoid exploitation of vulnerable populations or populations of convenience.

What is meant by MINIMAL RISK?

Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life by the general population (not the target population) or during performance of routine physical or psychological examinations or tests. The concept of risk goes beyond physical risk and includes risks to the participant's dignity and self-respect as well as psychological, emotional, or behavioral.

What is INFORMED CONSENT?

Informed consent is an ongoing educational process to ensure participants' understanding of the research and their willingness to participate. It begins with non-coercive identification and recruitment of participants, involves full disclosure about the study and any potential conflict of interest that the researcher may have, and gives ample opportunity for participants to ask questions and reflect on information before deciding whether or not to enroll in the study. Informed consent involves using language that is understandable to participants and use of proxies for individuals whose ability to give consent is compromised.

What does PRIVACY mean in the context of human research?

Privacy refers to an individual's right to control access to him/herself and to his/her personal information. Behavior or information is considered private if it occurs in a context in which an individual can reasonably assume that no observation or recording is taking place or can reasonably expect will not be made public (for example, a medical, educational, or employment record). Participants' expectations form the basis of making distinctions between public and private behavior. It is reasonable to consider behavior in a shopping mall public and behavior in the home private, but individuals may have expectations of privacy in very public spaces. For instance, members of an on-line support group may consider it an invasion of privacy if their public communications are the subject of research. Research participants must always be given the right to choose what they will reveal, when, and under what circumstances.

What are some of the privacy concerns with participant identification and recruitment?

Certain methods of participant identification can constitute violations of privacy. Consider a recruitment technique known as 'snowball sampling' in which the researcher asks a participant to provide names of other individuals who have characteristics or experiences of interest to the researcher. If the topic is innocuous, such as in an oral history project about the history of an event, the likelihood of invasion of privacy is minimal. But in other circumstances, such as a study of cancer survivors, the individuals contacted by the researcher may consider the researcher's knowledge of them an invasion of privacy. Approaching a potential participant in a public setting could be considered an invasion of privacy if it places him/her in an unsafe situation (for example, approaching a gang member for a case study in the presence of other gang members). Participants' privacy may also be violated if they are approached in a way that is not confidential, such as through a company e-mail system, particularly when the study deals with a topic of a sensitive nature.

Are there any privacy issues when observing individuals for research purposes?

Regardless of how innocuous the research topic, observational studies that collect information that an individual might choose not to reveal or that disregard the individual's right to control information about him/herself raises ethical concerns. In designing an observational study, the researcher should ask him/herself several questions. Will private identifiable information be collected about an individual without his/her knowledge (e.g., covert observation recorded on videotape) in a situation in which he/she could reasonably expect privacy? If so, is it likely that reasonable people would be offended by such an intrusion? Would the information gathered place the individual at risk of harm if disclosed? Do the benefits of the study justify possible invasion of privacy of individuals in the study? What, if anything, should those individuals be told later? Can the research be redesigned to avoid the intrusion?

Is privacy a concern only for those individuals directly participating in my research?

No. If you plan to solicit private information about third parties (individuals other than those persons directly participating in the research), you must consider whether or not this activity would constitute an invasion of their privacy. For instance, asking children about their parents' alcohol use could be considered invasion of the parents' privacy; instead, the researcher should solicit this information directly from the parents.

What does CONFIDENTIALITY mean in the context of human research?

Confidentiality refers to agreements made with research participants, through the consent process, about if and how information provided by the participants will be protected. Many social and behavioral science studies are about innocuous topics, do not collect participants' names, do not audio- or videotape participants, and result in data sets which contain no identifiers. Once this is explained to participants and the data are collected, confidentiality can be assured without additional confidentiality procedures. However, If data are individually identifiable, if the research topic is sensitive, if subjects will be taped, or if the researcher plans to use the data for purposes other than those of the original study, the researcher must put into place more complex procedures for ensuring confidentiality and communicate these procedures to the participant.

The researcher should consider:

  • The real need for identifiers and the possibility of destroying any identifiers after data collection to make the data anonymous
  • Who will have access to the study data, both now and in the future?
  • How data will be reported (in aggregate? using pseudonyms? using real names?)
  • What will be done with any audio- or videotapes during or after the research (will they be destroyed? shown at conferences or meetings? used for training students? saved for research use as yet unknown?)
  • How data will be protected from inadvertent disclosure or unauthorized access (authorized staff only? computer passwords? locked file cabinets?)

If I'm not collecting participant names, addresses, or social security numbers, are there any concerns about confidentiality?

Possibly. It is sometimes possible to identify subjects indirectly based on combinations of demographic data. For example, Hispanic female soccer players at the College of Charleston will likely be limited in number. African American sales managers over 40 with MBAs employed by a mid-size company for at least five years are probably identifiable. Using individual-level data when reporting research results could violate these participants' expectations of privacy and agreements about confidentiality and could be damaging if the study concerns sensitive topics such as the use of steroids or employee assessments of their managers.

What does EXEMPTION really mean?

In the context of human participant research, exemption means that while the project meets the federal definitions of human subject and research, the risks posed to the participants are extremely low. Therefore the research does not require the level of scrutiny and paperwork.  The request for exemption by checking the appropriate category when submitting the IRB application.  Determination is made by the Exemption Reviewer who may request further information before approving the exemption, or may advise the  investigator that the application musst be submitted for IRB review .

Research determined to be exempt must still adhere to the ethical principles of the Belmont Report and meet the basic requirements for informed consent.

Training For Researchers

Is any special training in human participant research required before I can begin doing research involving human participants?

Yes. The College of Charleston IRB requires completion of online CITI Program training. You must complete training before you can submit your application. Training must be updated every five years, or when a protocol is submitted which requires additional training modules beyond those originally completed. Additional modules are required when the previous training has been only in the area of exemption and the new project requires expedited or full IRB review. If your research project involves children, vulnerable participants, international research, research on the internet, and/or research in the biomedical sciences, you will be required to complete training modules on those topics.

Do research project staff or students who are assisting me in my work require any special training in human participant research?

Yes. All research staff, including student assistants, who will have direct and substantive involvement in proposing, performing, reviewing, or reporting the research must complete CITI Program training.

The IRB Application Process

How do I apply for approval of my research?

Access the IRB eForms (Forms) from the IRB section of the ORGA web site and complete the Human Research Review Application. This application is designed to lead you through all of the requirements for your project, including whether it will be reviewed for exemption or require IRB review by expedited reviewers or the full Board.

How will my application be reviewed and how long will it take before I receive notification?

This depends on the type of review required. Administrative review for exemption takes about 5 days, expedited review takes about two weeks, and full Board review requires that the project be discussed at a convened meeting. The meeting schedule is posted in the IRB section of the ORGA web site. With all types of review, you will receive notification either of approval or of requested clarifications or revisions within a few days of the determination.

What will the IRB look for when reviewing my application?

During its review, the IRB looks to see that the researcher has taken steps to assure that risks to participants are minimized, risks are reasonable in relation to anticipated benefits, selection of participants is equitable, adequate preparation is taken to protect privacy of participants and confidentiality of information about them, and adequate provisions are made for ongoing monitoring of participants' welfare.

When may I begin my research project?

You will receive an e-mail notice with an attached approval letter. If there is an informed consent document, you will also receive a copy with the IRB approval noted on it which you may duplicate for use. You must use the officially approved consent document.

You may not begin any interaction or intervention with the participants before receiving this official notification. If you begin work with the participants before receiving notification, the IRB will not retroactively grant approval or exemption. You will be in non-compliance, and you will be required to destroy data collected before approval has been granted.

Is there any way I can begin interacting or intervening with the participants or collecting data about them before the IRB completes its review?

No. You must wait until you receive formal notification via e-mail that your protocol has been formally approved. A hardcopy letter will follow the e-mail. If you begin work with the participants before receiving formal approval, the IRB will not retroactively give you approval. You will be in non-compliance, and you will be subject to sanctions.

Types of Review

What kinds of projects can be reviewed administratively for EXEMPTION?

The federal regulations establish six exemption criteria. Most College of Charleston exempt research falls under categories 1, 2, 3, or 4.

Category 1. Evaluation/Comparison of Instructional Strategies, Techniques or Curricula

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 most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2. Educational tests, Surveys, Interviews or Observations

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:

(i) 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; or

(ii) Any disclosure of the human subjects’ responses 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.

Note:  This category may include anonymous surveys which deal with sensitive aspects of the research participants' own behavior such as illegal conduct, drug use, sexual behavior or use of alcohol if participants are advised in the consent form of the sensitive nature of the research and information about contact persons if the participant becomes distressed are included in the consent form and the questionnaire.

Category 3. Benign Behavioral Interventions (NEW Exemption Category)

Benign behavioral interventions are 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.

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(i) 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; or

(ii) Any disclosure of the human subjects’ responses 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.

Note: If the research involves deceiving the subjects regarding the nature or purposes 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 of or misled regarding the nature or purposes of the research.

Category 4. Secondary Research for which Consent is Not Required.

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include biospecimens, 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;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is for the purposes of ‘‘health care operations’’ or ‘‘research’’ or for ‘‘public health activities and purposes’’ (as defined in the federal regulations; or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch 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 federal regulations.

Category 5. Research and Demonstration Protocols Conducted or Supported by a Federal Department or Agency

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 (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or 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 arrangements, cooperative agreements, or grants.

Category 6. Taste, Food Quality Evaluation, and Consumer Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies:

(i) If wholesome foods without additives are consumed, or

(ii) If a 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 FDA or approved by the EPA or the USDA Food Safety and Inspection Service.

Are research projects that appear to meet the exemption criteria always exempted?

No, there are exceptions to the rule. Research involving children cannot be exempted for survey and interview procedures or for observation of public behavior except when the investigator does not participate in the activities being observed. Restrictions may also apply to prisoners, pregnant women, fetuses, or human in vitro fertilization. Finally, research that poses more than minimal risk to participants cannot be exempted.

What kinds of projects qualify for EXPEDITED REVIEW?

The College of Charleston IRB utilizes the seven categories of research that qualify for expedited review outlined in the OHRP Guidance document. These apply only to minimal risk research and does not include research meet any of the exemption categories). Most College of Charleston research falls under categories 4, 5, 6, and 7.

  1. Clinical studies of drugs and medical devices (only when certain conditions are met).
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture (subject to certain age, health status, body weight, sample volume, and sampling frequency limitations).
  3. Collection of biological specimens for research purposes by noninvasive means (subject to certain conditions of collection).
  4. Collection of data through non-invasive procedures, such as application of physical sensors to the surface of the body, weighing, testing sensory acuity, and moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. 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.

What is FULL IRB REVIEW?

Full IRB review takes place at a meeting of the IRB where a quorum of the members are present. Research which has greater than minimal risk to the participants must always be reviewed by the Full IRB. Full IRB review may also be requested by the researcher submitting an IRB application or by any member of the IRB. External requests for recruitment of participants at the College must be reviewed by the full IRB.

Informed Consent

What constitutes INFORMED CONSENT?

Securing potential participants' agreement to participate in research is more than asking them to read and sign a consent form. Instead, it is an ongoing educational process to ensure participants' understanding of the research and their continued willingness to participate throughout the duration of the research project. Informed consent involves full disclosure about the study and any potential conflict of interest that the researcher may have and gives ample opportunity for participants to ask questions and reflect on information before deciding whether or not to enroll in the study. Informed consent involves using language that is understandable to participants and use of proxies for individuals whose ability to give consent is compromised. Usually, the participant's consent to participate is documented in writing. Usually the participant's consent to participate is documented in writing.

Is informed consent always required and must it always be documented in writing?

No. In certain cases, the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, including the written documentation of consent. These include cases where the research a) involves evaluation of a public benefit or service program or b) when the research presents no more than minimal risk, the waiver or alteration will not adversely affect the rights and welfare of the participants, the research could not practicably be carried out without the waiver or alteration, and, when appropriate, the participant is provided with pertinent information after participation. The researcher must specifically request a waiver of informed consent or specific elements or a waiver of written documentation of consent in the Human Research Review Application and must fully justify the request.

What should the written informed consent form look like?

If the IRB requires written informed consent, the researcher must follow one of the model consent formats that are available on the ORGA IRB web page. Informed consent includes the following required elements:

  • Identification and affiliation of the researcher.
  • A statement that the study involves research.
  • An explanation of the purpose of the research.
  • The expected duration of participant's involvement in the study.
  • A description of study procedures, especially identification of experimental procedures, if any.
  • A description of reasonably foreseeable risks or discomforts to participant, both those that are minimal and those that may be more than minimal A description of any benefits which may reasonably be expected for the participant or for society.
  • Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
  • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
  • An explanation of any costs associated with participation.
  • For research involving more than minimal risk, an explanation of any medical treatments available if injury occurs, what treatments consist of, and where to obtain further information.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue his/her participation at any time without penalty or loss of benefits to which he/she is otherwise entitled.
  • The names of contact persons to ask questions about the research, to ask questions about research participants' rights, and to report research-related injuries or other adverse events.

When the protocol is approved, the investigator will receive a copy of his/her approved consent form with the IRB. This approved form is to be used for making copies to be distributed to potential participants.

How do I handle informed consent if my study participants are minors?

In the State of South Carolina, minors are those persons under the age of 18. Parental (or guardian) permission is required before children may participate in research. If the child is too young to agree or refuse to participate in the research, parent/guardian permission alone is sufficient.

If the child is old enough (at least 7 years old) to agree or refuse to participate, you need to secure parent/guardian permission and either verbal or written assent of the child. Even very young children have some capacity to give assent verbally or through their actions. Children age 14 or older may indicate assent by signing the parent/guardian permission form if they are capable of understanding it. Note that the IRB requires a copy of the script or form that will be used when securing the child's assent. Information for children must be age-appropriate. Samples of parental (guardian) permission and child assent forms are available on the IRB web page.

Making Changes to an Approved Protocol

What should I do if I want to make changes to an exempt protocol?

Even though your project was approved as exempt, you will still need to submit an Addendum requesting a Protocol Modification prior to instituting your change. If the Research Protections & Compliance Coordinator agrees that the study continues to meet exemption criteria, you will be informed, and you may then implement the changes.

If the proposed changes are such that exemption criteria no longer apply, you must stop the research and submit a new application before implementing the changes.

What should I do if I need to make changes to my IRB-approved protocol?

Any proposed changes in the protocol must be reviewed and approved by the IRB prior to implementation. You need to submit an Addendum requesting a Protocol Modification. Modification requests for protocols that originally received expedited review are expedited. Likewise, requests for modifications for protocols that originally received convened review but were determined to be of minimal risk are also expedited, provided the proposed modification does not increase the level of risk to participants. Protocol modifications with greater than minimal risk are reviewed by the full IRB at a convened meeting.

You will be officially informed of approval of the modification request, at which time you may begin implementing the modified procedures.

Reporting Unanticipated Problems with the Research

What should I do if I experience unanticipated problems with my research that impacts the participants?

If you experience any unanticipated problems or adverse events involving risk or injury to research participants, you must report them, this includes any event that is related or possibly related to the research but was not expected based upon available data or experience. This includes any adverse event that has greater severity or frequency than originally anticipated. An Adverse Event Report Addendum should be completed and submitted to ORGA as soon as possible, and in no case later than two working days after the adverse event occurs. ORGA will notify IRB members, administrators, and sponsoring agencies as necessary and will assist you in developing the best course of action.

Continuing Review of Research

How long is my protocol approval effective?

The protocol approval is usually effective for one year. Two months before the anniversary date of the original approval, you will be reminded to either submit a continuing review request or a final report. If you wish your approval to be continued, you must submit your request in sufficient time for IRB review and approval to take place before the original expiration date. Continuation approvals are normally for an additional twelve months.

My protocol received exemption approval. Does it require further review?

Exempt protocols do not require yearly continuing review. Remember, however, that changes must be requested using an eForm Addendum and must be approved prior to instituting them.

What happens if I fail to request continuation in sufficient time?

If the IRB does not have sufficient time to review and act on your continuation request and your current approval expires, you must stop all interaction or intervention and all data collection and analysis, unless doing so would cause an adverse event. You will be notified in writing that human participant activity must cease. You will not be permitted to resume these activities until you have completed the proper paperwork and the IRB has given you official approval to continue.

How long should I keep my protocol in active status?

Protocol approvals must be current if you are still enrolling participants, interacting or intervening with them, collecting data about them, or analyzing the data. It is not unusual for researchers to keep protocols active for many years.

Final Report

I'm finished with my project, including data analysis. Do I need to do anything more?

Yes. You need to submit a Final Report Addendum, so that the project can be officially closed out.

Suppose I file a final report and then decide at some later date that I want to use the data for additional analysis related to my original research project or for some other purpose.

If your data contains no identifiable information, then you do not need to submit anything to the IRB. However, if there is anything in your data that may potentially identify an individual participant, you will need to submit a new application to the IRB. Research using pre-existing data usually qualifies for either exempt or expedited review.

Updated 12/20/2017