An Erskine Guide to the IRB and its Application Process

At Erskine College and Theological Seminary, the IRB serves a regulatory function that is essential to ensuring both ethical and legal standards regarding data and research at the institution as a whole. As a vital part of this Christian Community, it is essential that the process of maintaining the highest standards be clear to all individuals. To this end, the following Frequently Asked Questions have been assembled to help you. If you have questions that do not appear here, please feel free to e-mail the IRB Chairperson, Dr. Robert Elsner at elsner@erskine.edu or call him at (864) 379-6570.

Erskine College and Theological Seminary:

Christian Commitment and Excellence in Learning.

What is the IRB?

• The Institutional Review Board (IRB) is a committee established to review and approve any and all research involving humans, animals, or certain biological matter, including information about them derived from any sources.  The primary purpose of the IRB is to protect the rights and welfare of human participants in research, primarily through preventing difficulties and reconciling errors or breaches of trust.
• The IRB is empowered to review and approve all research within the institution for ethical standards, scholarship, and appropriateness at this institution.

What is research?

• Research is not only something done in a laboratory by people in white lab coats. Research is a systematic approach to a problem that is designed in advance and contributes to generalizable knowledge.  Research can take many forms and have many purposes. The IRB does NOT concern itself with classical library research done strictly with published materials.
• Research done as part of a course at the College or Seminary that is listed in the catalogue as a research methodology course is exempt from continuing review from the IRB review UNLESS publication of those data collected might be published. All course projects resulting in a research paper, however, ARE subject to review, albeit a special expedited process.
• All research in any form and for any purposes at Erskine College and Theological Seminary MUST comply with standard procedures for data collection, retention, and security.

What is a human subject (participant)?

• A human subject (participant) is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains

• (1) data through intervention or interaction with the individual, or
• (2) identifiable private information.” (45 CFR 46.102(f)).

• Erskine College and Theological Seminary actively encourages the term “Participant” always be used when discussing human beings, not the legal term of “Subject” in order to ensure the highest consideration is placed on the dignity of individuals willing to aid in the quest for knowledge.
• At times, research is performed on data from deceased individuals, and it is strongly recommended that these also be submitted to the IRB for review

What research has to be reviewed by the IRB?

• The IRB reviews and monitors human participants research conducted under the aegis of Erskine College and Theological Seminary. This includes any information controlled by FERPA or HIPPA

• The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.
• A federal law affecting all participants in the country’s health care system, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) was originally developed to improve the portability of coverage for people who lose or change employment, to promote administrative simplification through the use of electronic transactions, and to ensure the security and privacy of member information. It has been further enhanced to protect personal information in many forms and circumstances.

What is meant by “under the aegis of Erskine College and Theological Seminary?”

• Research that meets any of the following criteria is subject to review:

1. The research is sponsored by Erskine College and Theological Seminary.
2. The research is conducted or directed by any employee or trainee of the College or Seminary in connection with his or her Erskine College and Theological Seminary responsibilities.
3. The research involves access to any property or facility of Erskine College and Theological Seminary other than access to open spaces on the College or Seminary campus that are readily available to the public at large.
4. The research involves the use of non-public information in the custody of Erskine College and Theological Seminary to identify or contact human research subjects or prospective subjects.

 What about HIPAA?

• HIPAA stands for Health Insurance Portability and Accountability Act of 1996.
• HIPAA regulations are focused on privacy and security protections for individuals’ health care information: “protected health information” (PHI).
• Protected Health Information (PHI) includes individually identifiable health and health care payment information, including the demographic data that is a potential identifier of the individual, maintained in the records of health care providers.
• If a research study either uses or creates protected health information, documentation of the subject’s authorization to use such information is required.

Can HIPAA Authorization be waived?

• Yes, when strict confidentiality measures are in place.
• Yes, when the research could not practicably be conducted without the waiver or without access to the PHI.

What if I need to review medical records in order to identify subjects for recruitment?

• You may request a limited waiver of authorization for recruitment purposes as part of your application process. To do so, answer the following questions in your application:

• Will the information collected be limited only to that necessary to contact the subjects to ask if they are interested in participating in the study?
• How will confidentiality/privacy be protected prior to ascertaining desire to participate?
• When and how will you destroy the contact information if an individual declines participation?

What does it mean for data to be "de-identified"?

• A deidentified data set may not include any direct identifiers of the individual or of the individual’s relatives, employers, or household members. The following are examples, not an exhaustive list:

• Names
• Geographic subdivisions smaller than a state
• Zip codes
• All elements of dates except year directly related to an individual, including birth or death or dates of health care services or health care claims
• Telephone numbers
• Fax numbers
• Electronic mail addresses
• Social security numbers
• Medical record numbers
• Health plan beneficiary identifiers
• Account numbers
• Certificate/license numbers
• Vehicle identifiers and serial numbers, including license plate numbers
• Device identifiers and serial numbers
• Web universal resource locators (URL)
• Internet protocol (IP) address numbers
• Biometric identifiers, including finger and voice prints
• Full face photographic images
• Any other number, characteristic or code that could be used by the researcher to identify the individual
• Note: Although a de-identified data set cannot contain a birth date, it may contain the individual’s age expressed in years, months, days, or hours, as appropriate, except for individuals who are aged 90 years or more. For persons aged 90 years and above, the age in a de-identified data set can only be stated as being within the category of age 90 or above.
• If an individual is within a specific population, then other normally non-identifying factors become identifiers. For example in a small town, a woman who wears a size 46 dress might be identified by that information, this is not deidentified.

What kinds of IRB review are there?

• There are three levels of IRB Review, including

1. Full Board;
2. Expedited; and
3. Determining if exempt from continuing review.

• These levels are determined by the nature of the protocol, level of potential risk to human participants, and the participant population. The determination of level of review applicable to a particular study is made by the IRB. Regardless of the kind of review, all applications use the same submission form.

• Convened IRB review (Full Board)

o       Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk. The IRB meets at least monthly when any proposals are submitted. Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study.

• Expedited IRB review

• Only research involving no more than minimal risk to subjects may be considered for expedited review. An expedited review is conducted by an individual reviewer or a few reviewers, rather than going to the full board.
• The Erskine College and Theological Seminary IRB may use an expedited review procedure to review some or all of the research found by the reviewers to involve no more than minimal risk or minor changes in previously approved research during the period (of one year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.
• The IRB Chairperson keeps all IRB members advised of research proposals that have been approved by expedited review by providing members with the title, PI and a brief summary of each expedited protocol. The minutes of IRB Meetings include documentation that this information was provided. For each expedited study review, the IRB files must contain documentation showing the specific permissible categories justifying the expedited review, the review and action taken by the IRB Chair or designated reviewer and any findings required under 45 CFR 46 or 21 CFR 50 or 56

• Federal guidelines provide categories for expedited review. These categories are listed below, but practical examples include:

• blood sampling in minimal amounts
• review of records collected for non-research purposes (such as chart reviews, student assessments, etc.)
• survey research

• Types of research eligible for expedited review

·        Category 1 Research on drugs for which an investigational new drug application (21 CFR 312) is not required or research on medical devices for which a) an investigational device exemption application (21 CFR 812) is not required or b) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

·        Category 2 Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, nonpregnant adults, who weigh at least 110 pounds. For these subjects, amounts drawn may not exceed 550 ml in an 8-week period and no more than 2 times per week; or (b) 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/kg in an 8-week period and collection may not occur more frequently than 2 times per week.

·        Category 3 Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at the time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

·        Category 4 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: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

·        Category 5 Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

·        Category 6 Collection of data from voice, video, digital, or image recordings made for research purposes.

·        Category 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.

·        Category 8 Continuing review of research previously approved by the convened IRB (a) where the research is permanently closed to the enrollment of new subjects, and all subjects have completed all research- related interventions, and the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis and report writing.

·        Category 9 Continuing review of research, not conducted under an investigational new drug application or an investigational device exemption where Category 2 through Category 7 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

What research is exempt from continuing IRB review?

• All research that is planned at Erskine College and Theological Seminary is subject to the IRB application process. Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB. An exemption is granted by the IRB upon review of the application. No individual has the right or authority to assume that their research is exempt, and all MUST be submitted to the IRB.
• Since this constitutes a review, albeit minimal, protocols that are deemed exempt at Erskine College and Theological Seminary are effectively “exempt from continuing review.”

Exemption

• Certain types of research may be exempted from continuing review. However, because the involved investigators and all research at the College or Seminary may be put at considerable risk if a study is inappropriately excluded from IRB review, exemptions must be confirmed by the chair of the IRB or a designee upon review of applications for exemption. Since this constitutes a review, protocols that are deemed exempt at Erskine are effectively “exempt from continuing review.”
• An investigator may not initiate research involving human participants that the investigator believes is exempt until the investigator has received formal written concurrence of this exempt determination from the IRB. Changes to exempted studies must be reviewed by the IRB just as amendments to studies receiving expedited or convened IRB review. In some instances, changes to an exempted study may render it no longer exempt.

Categories for exemption from continuing review

• While human participants (subjects) research involving prisoners or protected populations (children, elderly, pregnant women, etc.) is never exempt from IRB review, research activities involving other human subjects may be exempted from IRB review if the only involvement of human subjects fits within one or more of the following categories (as listed in 45 CFR 46.101(b)):

• Category 1 (Most administrative and classroom-based research at Erskine will fall into this category, but not all) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or
• Category 2 Research not involving children that is limited to the use of educational tests, survey procedures, interview procedures or observations of public behavior unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. This exemption does not apply to research involving children except for research involving observations of public behavior when the investigator does not participate in the activities being observed, or interact directly with the children. All other exemptions apply to research involving children. [45 CFR 46 101(b)(2) as modified by Subpart D 45 CFR 46.401 (b)]; or
• Category 3 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 Category 2 of this section, if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter; or
• Category 4 Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; or
• Category 5 Research and demonstration projects conducted by or subject to approval of a federal agency and designed to study, evaluate or otherwise examine some aspect of (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; or
• Category 6 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

·        If information comes to the attention of the IRB suggesting that there are factors increasing the sensitivity and/or potential risk to human subjects in research that otherwise would appear to qualify for exemption under the criteria listed above, the IRB may, in its own sole judgment, deem the protocol to be subject to expedited or convened IRB review.

What about student research or class projects?

• Some student work is clearly research and requires IRB approval but other student class activities present a challenge to know if they fall under IRB governance. It is always best to enquire by e-mail to the IRB Chair, Dr. Elsner at elsner@erskine.edu.

How do I apply?

• Submit an Application for IRB Approval of Human Participants Research (see Forms). Instructions accompany the application.

What is the required ethics education?

• Human Subjects Protection Education is required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at Erskine College and Theological Seminary that involves human participants. You are welcome at any time to visit the citiprogram.org website and take any and all training provided there, including refresher courses.  

Do I have to get consent from study participants?

• YES! Under almost all circumstances, they will sign a document containing all the elements of informed consent.
• The informed consent process gives potential participants a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate, and reminds them that they can STOP PARTICIPATION AT ANY TIME. With no penalty whatsoever. This includes loss of payment for participation. Once a form is signed, they must get any benefits, even if they refuse to participate any further and no data is collected.  
• The consent form should provide readily understandable information in an amount appropriate to the level of risk in participating.
• Some or all of the elements of consent, including signatures, may be waived under certain circumstances, but this must be in writing from the IRB. If you do not have such a letter from the IRB, you are considered legally negligent and subject to sever legal penalties.

Does Erskine have a consent form template?

• Yes, Erskine College and Theological Seminary uses common consent form templates. See the Forms page.
• If consent is being asked for participation of minors, then the Assent form must be used to get permission of parents AND the assent of the child.

How do I obtain consent from Non-English speaking participants?

• Researchers should take great care when obtaining informed consent from individuals who do not speak English or whose understanding of the language is limited.
• Researchers should be fluent in the participants’ languages or interpreters should be available during the consent process and throughout the participants’ participation as needed.
• Consent forms should be prepared in the language understandable to potential participants.
• The most careful consideration needs to be exercised when obtaining informed consent from individuals who do not speak, or have limited use of English.
• When performing research using non-English speaking participants, the use of short form consent documents should only be used when unexpected circumstances arise and there is not sufficient time to prepare a full consent form translation. The short form may not be used as a convenient way to circumvent translation of the full consent form.
• While the use of non-English speaking participants presents a unique set of challenges for the researcher, care must be taken not to exclude non-English speaking subjects from research that may have potential benefits.

Translation and informed consent

• Attention should be paid to both oral interpretation and written translation in the informed consent process.
• Oral interpretation

• Oral interpretation should be performed by a qualified individual who is not a family member of the prospective subject. The individual performing the interpretation should be available for ongoing communication between subjects and investigators.