The IRB at Allegheny College is charged with reviewing and approving human participant research protocols. The oversight body for IRBs is the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/, under regulation 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).
Table of Contents
- Role of IRB at Allegheny College
- Carnegie Sub-board
- Human Participant Research
- Requirement for Completion of CITI Courses
- Levels of IRB Oversight
- HHS 45 CFR 46 Regulations
- Informed Consent Documentation
- Incomplete Disclosure and Deception Studies
- Vulnerable Populations
- Use of Demographic Questions
- Anonymity, Confidentiality, Privacy
- Guidance for Class Projects involving Human Participants
- Faculty Handbook (2014-2015) Description of Allegheny College IRB
- Abbreviated Version of the Exempt Categories
- Abbreviated Version of Expedited Categories
Role of the IRB at Allegheny College
First and foremost, the role of the IRB at Allegheny College is to ensure studies involving human participants are carried out in an ethical, beneficent, and just manner. The IRB views its role as part of the overall educational mission of a liberal arts college. While an IRB has existed at Allegheny College for decades, it was not until the mid-2000s that the AC IRB was officially registered with the OHRP and filed a Federalwide Assurance (FWA) with HHS, which was a necessary step to allow Allegheny College to submit grants containing human participant research to federal agencies. It was also at this time that Allegheny College contracted with Collaborative Institutional Training Institute (CITI) at the University of Miami to provide appropriate training for individuals who do human participant research. The final event that occurred at this time was the consolidation of a committee composed of an Administrative Review Board (ARB) and the Institutional Review Board (IRB). The ARB was composed of individuals from the faculty, administration, and students, and the IRB was composed of members from the faculty, the Counseling Center, students, and a member of the Meadville community. The role of the ARB was to review proposals for studies involving human participants not originating in academic departments. The role of the IRB under this format was to review proposals for research and class projects involving human participants arising from academic departments as well as projects from the Institutional Research office collecting new data or going beyond normal internal management use of information. When the two boards were consolidated and named the Institutional Review Board, the charge of the IRB was narrowed. While the IRB is no longer charged with reviewing applications for surveys or class projects that do not constitute research as defined by the OHRP, we encourage members of the community to seek advice as these types of projects are being developed to ensure they are done in a respectful and ethical manner.
Role of Carnegie Sub-board of the College IRB
Because of the number of senior projects and independent studies supervised by faculty in Psychology, a sub-board of the College IRB was established called the Carnegie sub-board. This sub-board reviews senior and independent projects involving human participant research supervised by faculty in Carnegie that fall under the categories of Exempt and Expedited. Senior or independent projects involving human participant research that fall under the category of Full, and any human participant research protocols developed by faculty in Carnegie must submit their applications to the College IRB not the Carnegie sub-board.
Human Participant Research
Research: The definition of Research as defined by the guidelines of the OHRP is: “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The AC IRB reads this conservatively and considers any study that involves human participants, where the information gathered is interpreted and disseminated, to fall under the charge of this committee. This conservative approach arises because there are no other committees on our campus, except for the Carnegie IRB, that vet the methods of data collection from human participants. Thus, if your study (this includes surveys) gathers information from humans, and the information will be interpreted or disseminated, a proposal should be filed with the AC IRB.
Human Participant: If the investigation involves data collected from humans, then this component of the definition of human participant research applies.
- Class projects involving human participants from the AC community, where the purpose of the project is to expose students to specific research methods, and where the data collected will not be disseminated beyond that specific class, do not need to file an IRB protocol. However, if the instructor of this course imagines he/she might have an interest in publishing or disseminating information from a class project it is important that a protocol is filed before data collection because IRB approval can not be granted retroactively. Please note that this exception does not extend to projects done for independent studies, senior projects, or summer research. See below for specific guidance for Class Projects, regardless of whether the information will be disseminated beyond the class or not.
- Certain types of oral history projects where information is gathered and reported without any interpretation, where interviews are conducted with adults who are not part of a vulnerable group, and where the questions being asked present no risk to the participants.
- Certain types of ethnography where the individuals being observed are adults who are not part of vulnerable groups, where behavior being observed does not constitute illegal activity, and where the person who does the observation does not interact with those being observed.
- Collection of information for newspaper reporting is not considered to fall under the charge of the IRB.
- NOTE: It is assumed that if you, or students you are supervising, are carrying out the types of work described under the exceptions, correct training in the ethics of collecting information from human participants has been provided.
Requirement for Completion of CITI Courses
Regardless of the category of human participant research, individuals that develop protocols that involve human participants are required to complete the CITI course called Social and Behavioral Research (SBR). This includes research where a student is part of the team that develops the protocol. For individuals who did not play a role in developing the protocol, but are still members of the group carrying out this research (participating in administering surveys, analysis of de-identified data, for example), it is required that they complete the CITI Course called Students Conducting No More than Minimal Risk Research (SCMMR). In cases where a human participant study is conducted as a class project, where an IRB application is not required, we still strongly encourage the instructor to complete the SBR course and the students in the class complete the SCMRR course. You can access the CITI website here, and detailed instructions for registering for CITI and finding the appropriate course can be found here.
Levels of IRB Oversight of Human Participant Research
The levels of review described in the OHRP guidelines were developed based upon the perceived level of risk for a particular project. Unfortunately the names of the levels of review are not necessarily reflective of the most common usage of the words used for the categories.
HHS 45 CFR 46 Regulations
The main goals of these regulations are to assure that research with human participants follows the basic ethical principles of Respect for Persons, Beneficence, and Justice. To make sure these basic ethical principles are maintained, the HHS 45 CFR 46 regulations contain information about the composition of an IRB, the approval of a local IRB through a document called the Federalwide Assurance, and guidelines for developing Informed Consent documents. In addition, the regulations contain guidelines for human participant research that involves vulnerable subjects such as individuals under the age of 18, pregnant women, and prisoners.
- Human Participant Research Projects Exempt from Basic HHS Policy for Protection of Human Research Subjects. Protocols that fall into this category represent those that pose little or no risk to individuals who participate in them. In practice, Exempt protocols are reviewed by one member of the IRB. Once the protocol is approved, no further oversight by the IRB is required for these projects unless changes in the protocol or personnel occur. There are six categories defined in 45 CFR 46 as Exempt. However, Exempt DOES not mean that these projects do not require vetting through the IRB. The four categories most relevant to studies at Allegheny College are shown below. Exempt protocols do not require documented Informed Consent. However, it is suggested that participants be provided information about the research and a statement that participation is voluntary.
- Human Participant Research Projects Receiving an Expedited Review. Protocols that fall into this category represent projects that pose no more than minimal risk to participants of the study. In practice, Expedited protocols are reviewed by one member of the IRB. Unlike Exempt protocols, those listed as Expedited are required to be submitted for review every year. In addition, these projects must have documented Informed Consent by the participants. There are nine categories provided by the OHRP that define protocols that can be reviewed using the Expedited procedure. Those most relevant to studies at Allegheny are provided below in an abbreviated version.
- Human Participant Research Requiring a Full Review. Protocols in this category are considered to have more than a minimal risk (do not fall into either the Exempt or Expedited categories) and require that all members of the IRB review and approve the protocol. These protocols need to have documented Informed Consent by the participant and must be reviewed on a yearly basis.
Informed Consent Documentation
The role of the process of Informed Consent is to educate the participants about the purpose of your study, the risks involved to the participant in the study, the time required for participation, the methods involved, the benefits to the participant, whether new protocols are being used, the voluntary nature of participating, as well as how the confidentiality of the information from the research will be maintained. Documentation of Informed Consent is required for protocols that meet the conditions for an Expedited or Full Review by the IRB. The list of elements required by the OHRP can be found here. In addition the OHRP provides “Tips on Informed Consent.” In general, it is required that these take the form of a signed document. Exceptions can be made to the requirement for a signed form, and guidance for these types of cases can be found here. An important reminder here is that for research or studies defined as exempt, Informed Consent does not need to be documented.
In cases where a survey will be administered electronically for research requiring Expedited or Full Review, it is important to be aware that this complicates the issue of obtaining documented Informed Consent. Advice for these types of situations can be gathered from information provided by the Research and Engagement office at UMass Amherst, and for individuals using the platform SurveyMonkey for administering their surveys, there are specific guidelines here.
For studies with individuals who are younger than 18 years of age, designated as children, Informed Consent can not be obtained from the participants, but rather, a parental or guardian signature is required on the Informed Consent document. In some cases, if the child is old enough to understand an explanation of the research presented in an age-appropriate way, it is also advised that the child be allowed to provide assent for willingness to participate.
Incomplete Disclosure and Deception Studies
In certain cases studies are done in which certain information is withheld from participants (Incomplete Disclosure) or participants are provided a false scenario about what is being investigated (Deception). An excellent explanation of this can be read in the linked document from UCLA. If you are considering using either Incomplete Disclosure or Deception, it is important to carefully justify the reason for doing so in your protocol. Because participants of these studies are not provided all of the information in the Informed Consent document, it is required that debriefing of the participants occurs after they complete the study. It is possible to request that certain components of the debriefing also be withheld, however this must be appropriately justified in the protocol of the study as well. Again, information provided by UCLA provides guidance. For protocols that are reviewed as Exempt, and for those reviewed as Expedited or Full that do not use Incomplete Disclosure or Deception, the federal guidelines do not mandate that a debriefing must be done. However, many protocols do provide additional information for the participants after they complete the study, and it is polite to provide information about how participants could obtain information about the outcomes of the study.
The OHRP provides specific guidance for individuals who are members of vulnerable populations. The OHRP has specific guidelines for studies involving pregnant women, fetuses, neonates, children, and prisoners. The type of human participant research being conducted determines the mechanisms by which these individuals should be protected. Even though the OHRP provides specific guidance for the groups identified above, this does not mean that these represent the only vulnerable populations that need to be considered. The CDC has an excellent page that provides additional guidance for determining whether your research involves a vulnerable or at risk population. In general, if your research involves investigating only a vulnerable or at risk population, your protocol must provide a justification of why this population, as opposed to the entire population, should be studied. Also, care must be taken when studies involve children or adults who are cognitively impaired, since in many cases, research involving those who do not have the ability to fully understand the implications of the research, must have a designee that can provide informed consent for the individuals, and, it is also appropriate, to obtain verbal assent or refusal from the cognitively impaired population. In the case of pregnant women, there are certain cases where they are not considered a vulnerable group. If, for example, you are interested in doing a survey of all adult females in the community, and that includes pregnant females, this might constitute a study exempt from 45 CFR 46 regulations. However, if the research targets pregnant women, those studies generally move to the category of expedited or full.
Use of Demographic Information in Surveys (Thanks to Beck Dawson for Assistance on this Section)
Collecting demographic information from participants of a study is a common practice. Doing so allows the researcher(s) to assess differences between genders, age groups, and socio-economic status, among other factors. When adding questions about demographic characteristics to a survey, questionnaire, or other data collection instrument, the researcher(s) must carefully consider the following:
- How will the demographic information be used? Is it necessary to collect such information in order to answer the primary research question under study?
- Are the questions about demographics written in a way that will provide you – the researcher – with valid and reliable data?
- Could collecting the demographic information threaten the anonymity of the participants of the study?
Collecting demographic data from participants has become a common practice; however, it should only be collected if the goals of the research project include looking at demographic differences among the participants. There is no need to collect demographic information unless it is needed to answer the research question or will be used for statistical analyses to control for confounding variables. Demographic questions should be written to consider the specific population of your investigation.
Take, for example, a community where 85% of the population is Caucasian, 10% of the population is black, and the remaining 5% is composed of a variety of ethnicities, Hispanic, Asian, or Native American. If you include all races in your demographic questions, there will be very few individuals participating who are not Caucasian or black, and, thus, for the other categories it would be difficult to say their responses are true representation of the entire group. In addition, because of the limited number of individuals in some categories, there is some likelihood that you will compromise the anonymity of these participants. Thus, in this case, the race questions should be limited to the following responses: Caucasian, black, or other. The other category protects the anonymity of participants who make up the racial minorities in town.
Questions about demographics also need to be written in a way so that participants can give valid and reliable (aka truthful) responses. For example, in Meadville, where a large percentage of the population works hourly jobs, asking individuals to estimate their household annual income may be complicated. Individuals who are salaried, on the other hand, will likely provide a valid and reliable response to a question about annual household income. In some cases, to avoid introducing sampling bias into your study, and ensure that you are collecting valid and reliable data, it is suggested that education be used as a proxy measure for income. Ask participants what is the highest level of education they have achieved (some high school; high school diploma; some college; college graduate; post-college degree).
It is possible for a study with too many and too specific demographic questions to describe a single member of the community; making him/her known or not an anonymous participant. For example, if gender, age, race, neighborhood of home, and education level are all required questions on a survey, it might become impossible to hide the identity of a well-educated Asian female aged 40-50 living in the North End of Meadville because there is likely only one individual in Meadville with all of those characteristics.
Demographic questions should only be specific enough to meet the goals of the study. Collecting too much and too specific information about the participants can both decrease the validity of your research because there are too few individuals in that category, and cause harm to the participants if their identify is revealed through the release of specific demographic information.
Anonymity, Confidentiality, Privacy
These terms are often confused. However, for purposes of Human Participant studies there are specific definitions for these terms. This description from Office of Research Regulatory Affairs at Rutgers University is helpful for understanding the distinctions of these terms.
Guidance for Class Projects Involving Human Participants
Many faculty at Allegheny College have their students engage in some form of human participant research as part of the structure of their class. Many times the projects for the course have been determined by the instructor and have been used previously; in other cases students have more of a role to play in the development of the specific project. If the faculty member has an interest in disseminating the outcome of these studies beyond the members of the class, the study then becomes research according to our interpretation of the OHRP definition, and thus, a proposal must be submitted to the IRB. In this case, the faculty member needs to complete the CITI course titled Social and Behavioral Research. We also encourage that students in the class complete the CITI course titled: Students conducting no more than minimal risk research.
In cases where the faculty member has no interest in disseminating the information beyond the members of the course, there is no requirement for submission of an application to the IRB. However, as is the case of those protocols reviewed by the IRB, it is expected that instructors who assign Class Projects involving human participants provide proper training for the students in the class, and, the study abides by the ethical principles of the specific discipline.
Regardless of whether an application to the IRB is required for the class project,recommendations are given below for carrying out these projects in an ethical way.
For the purposes of class projects, it his highly recommended the study protocol poses no or minimal risk to the participants.
In cases where class projects recruit participants that are not members of the course, it is highly recommended that recruitment occurs on the Allegheny College campus and only individuals 18 years or older participate. If you are interested in recruiting participants beyond the Allegheny College campus, it is highly recommended that you begin the process of designing the study by contacting Dave Roncolato (Director of Civic Engagement). We strongly discourage class projects that recruit individuals from vulnerable populations (children, prisoners, nursing home residents, patients, cognitively impaired individuals etc.). In the OHRP guidelines, these individuals are provided specific consideration, and in many cases, these types of studies require informed consent.
If class projects will recruit participants who are members of a formal group or organization on campus (athletic groups, ASG, sororities, fraternities, student groups, individuals using the Counseling Center or Winslow Health Center), we request that you obtain a signed signed letter from the coach or advisor of the group, indicating that the class has permission to use these individuals as participants in their research. For class projects that constitute research, these letters are required in the application submitted to the IRB.
We encourage consideration of whether an Informed Consent document (which requires obtaining signatures from participants) is necessary or desirable. Even in cases where a signed Informed Consent document is not required, we encourage project leaders to ensure that participants receive information about the study either verbally or in writing.
These guidelines are for class projects where individuals are participants in the study. For example, if a class project is designed to give a presentation to a group, this is not considered a human participant study.
Faculty Handbook (2014-2015) Description of Allegheny College IRB
3.10 Institutional Review Board
The principal function of the Institutional Review Board is to safeguard the rights and welfare of participants taking part in research activities either originated by members of the College community or conducted at the College by others. Since the College IRB is registered with the Office of Human Research Protection (OHRP) of the U.S. Department of Health and Human Services (DHHS), policies and procedures of the IRB are consistent with OHRP standards, specifically the Code of Federal Regulations
(CFR) Title 45, Part 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
- The specific responsibilities of the IRB are:
- To conduct both initial and continuing review of all human research conducted by any member of the College community either on or off campus as well as any research conducted at the College by outside groups or organizations to determine if such research is (a) exempt from review, or (b) subject to either expedited or full review;
- To address any questions as to whether a specific activity constitutes research under relevant OHRP definitions (“research …a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.” CFR Title 46, Part 46, §46.102);
- To conduct required reviews of research projects, including classroom projects, that meet the OHRP definition of research;
- To review alleged violations of participants’ rights in human research as identified in relevant governmental regulations, the Belmont Report, or established professional codes when such review is requested; if, in the judgment of the IRB, a violation has occurred, it will be reported, in the case of faculty, administrators, or staff, to the Provost and, in the case of students, to the Academic Integrity Board;
- To implement current state and federal regulations regarding the protection of human participants in research projects;
- To establish and publish the procedures that will govern IRB decision making at the College;
- To establish sub-boards of the IRB authorized to determine exemption from review or to conduct expedited review; all reviews requiring full board review must be conducted by the IRB.
- Projects to be reviewed by the IRB include research activities:
- Conducted by a member of the College community or research conducted at the College by persons who are not members of the College community;
- To be submitted for funding to outside agencies, if required by that agency;
- For which any member of the college community requests a review;
- Involving human participants while a faculty member is at another institution or collaborating with colleagues from another institution, unless that faculty member has obtained the approval of an IRB at the other institution (Note: approval from another institution must be sent to the College IRB);
- Involving the sharing of data or tissue from a previously approved project.
- Used for institutional research that collects new data or goes beyond the normal internal management uses of information analysis, or when questions arise in institutional research concerning compliance with protection of human participant guidelines.
- The specific responsibilities of the IRB are:
- Procedures for obtaining IRB approval of projects.
- Approval must be secured in writing before any recruitment of participants may begin. The specific procedures for the submission of proposals, including deadlines, answers to frequently asked questions, and required forms are available on the IRB web site.
- Researchers may request an exemption from review, an expedited review, or a full board review from the IRB. Decisions of the IRB are sent to key participants (i.e., student, faculty advisor, administrator, etc.) in writing. No project may begin until written permission is received.
- Full board review requires that a quorum of the members of the IRB are present, including at least one nonscientist, and that accurate records of decisions and votes are maintained. Email and proxy votes are not permitted for full board reviews.
- Projects will normally be reviewed during the regularly scheduled meetings of the IRB. Special meetings may be called by the Chairperson as needed. All actions of the IRB require a majority vote of the membership of the IRB. Members of authorized sub-boards will not be considered as part of the membership of the IRB when conducting full IRB reviews.
- The IRB makes every effort to work with researchers to ensure that all research is in compliance with relevant governmental and disciplinary ethical standards. In the event that permission to conduct a project is denied, that decision is final. The College administration may, at its discretion, refuse to allow an approved project to proceed, but it cannot give permission to permit a project which has been denied by the IRB.
- Record Keeping
- The IRB has overall responsibility for maintaining records required by the OHRP for both the IRB and any authorized sub-boards. These records include, but are not limited to:
- An annual list of members;
- Information on the names of researchers, titles of projects, dates proposals are received, and IRB decisions.
- Copies of all proposals and required forms along with copies of any associated correspondence.
- Copies of the minutes of all IRB meetings, including the names of those present and a record of all votes taken.
- Signed informed consent forms which must be retained in a secure location for three years.
- Sub-boards authorized by the IRB are obligated to provide the chair of the IRB with:
- An annual list of members;
- A list of titles of all projects reviewed by the committee, together with the decision reached on each and all required documentation at least once per year;
- The names of the researchers and advisors as well as the date of receipt and approval.
- The IRB will provide reports as required by either the College or state and federal regulations.
- The IRB has overall responsibility for maintaining records required by the OHRP for both the IRB and any authorized sub-boards. These records include, but are not limited to:
- Membership, Membership Selection, Terms of Office, and Chairperson Selection
- The membership of the IRB, excluding sub-boards, will be composed of the following:
- A minimum of five persons, at least three of whom are Allegheny College faculty, who have successfully completed a College approved IRB ethics certification program;
- Among the members, at least one must have a scientific background, at least one must have a nonscientific background, and at least one should have no affiliation with the College, including being a family member of a member of the College community;
- IRB members should serve staggered three year terms; members may be re-appointed at the conclusion of their term;
- The IRB may, at its discretion, appoint consultants to the IRB to address specific concerns requiring specialized knowledge;
- The Provost will appoint a Human Protections Administrator who is an ex-officio member of the committee.
- The chairperson will be one of the faculty members elected by the IRB.
- The membership of the IRB, excluding sub-boards, will be composed of the following:
Abbreviated versions of the exempt categories—link to full list is given below
- Research conducted in educational settings that involves normal education practices: “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” is the only category of research where participation of individuals under 18 (children) are exempt from the 45 CFR 46 guidelines. This only applies for individuals under the age of 18 if there is no interaction between the researcher and the children, and, where no additional surveys or assessment, beyond what is normally administered, is completed by the children.
For the categories below, when research involves individuals under the age of 18 OR members of vulnerable populations (pregnant women, prisoners, mentally challenged individuals, economically or educationally disadvantaged individuals and groups) the proposed research is not exempt.
- Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior EXCEPT when information is recorded in such a way that human subjects CAN be identified AND disclosure of the responses outside of 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.
- Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior of elected or appointed public officials or candidates for public office are exempted from the guidelines of item 2—that is—for research involving these individuals, participants can be identified and questions of a sensitive nature can be asked.
- Research involving the collection or study of existing information in public databases OR if information is from a database where no identifiers are linked to the subjects.
Abbreviated version of expedited categories—link to full list is given below
- New studies of drugs already on the market where risks to participating individuals is minimal. Note: if using already marketed drugs, it is important that individuals who propose a project such as this address the risks associated with use of the marketed drug, and that the study is novel and the protocol clearly explains the anticipated beneficial information that will be provided by this study.
- Collection of blood samples by finger stick 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. Note: It is important if you will be collecting blood samples through finger prick that it be done using an instrument that does not expose the researchers or participants to blood.
- Prospective collection of biological specimens for research purposes by noninvasive means. At Allegheny College the most likely types of biological specimens that would be collected are (a) saliva collected without stimulation or stimulated by chewing gumbase or wax, or applying dilute citric acid to the tongue; (b) dental plaque and calculus collected in a manner consistent with routine prophylactic techniques; (c) mucosal cells collected by buccal swab or mouth washing.
- 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. At Allegheny College examples of studies of this nature include (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) testing sensory acuity; (c) weighing; (d) using electrocardiography or electroencephalography; (e) 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 non-research 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.)
- Continuing review of research previously approved by the convened IRB as follows when no new subjects are enrolled, all data collection is completed, and remaining research activities are limited to data analysis.
- Continuing review of research where categories two (2) through eight (8) above 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.
Additional Websites that Contain Helpful Information
Categories Exempt from 45 CFR 46 Regulations
Expedited Review Categories—Complete-from-OHRP website
How to Decide Expedited VS Exempt Studies
HSS/OHRP Decision Charts
HSS/OHRP Informed Consent Checklist – Basic and Additional Elements
UCLA Information about the distinction between Incomplete Disclosure and Deception
UW information about focus groups
Anonymity, Confidentiality, Privacy Definition from Rutgers