The Common Rule Federal Regulations (45 CFR Part 46) (updated 2018)

Suggestion: Complete the CITI Program training, which includes an orientation to these regulations, before reviewing the policies and guidance in this section.

Guidance & Educational Tools for Determining Level of Review & Developing Research Protocols

Obtaining Exempt Status for Certain Human Subjects Research Activities

Under certain circumstances, human research activities subject to the HRPP may be granted exempt status (45 CFR 46.104) . This means a study is considered to be research with human subjects but if it meets the criteria for one or more of the exemption categories the research is not subject to all of the regulatory requirements of 45 CFR 46. For some exemption categories the regulations require a "limited IRB review" and/or Privacy Board review of the initial application as part of the exemption determination. Investigators are not required to return to the IRB for approval of amendments to exempt studies, except where changes to the study take the project outside the scope of the original exemption.

Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.

Keuka College IRB require that requests for exemption be submitted via an IRB application, which includes specific questions to evaluate the protection of human subjects and to determine eligibility under each category of eligibility for exemption listed in the section below (1-8). It is the policy of the College that to be determined to be exempt, research must pose no more than minimal risk and the IRB does not determine that continuing review would enhance protection of research subjects.

The "Application for Exemption" form (available on this website) is configured to permit investigators to generate an application by demonstrating if and how their planned research qualifies for certain exemption categories based upon responses to questions; these applications must be submitted to the IRB for review and determination.

• Exemption applications requiring limited IRB review are evaluated via the expedited review process for assessment of provisions for subject privacy and confidentiality of data found at 45 CFR46.111(7) before an exemption determination is made.

If determined to qualify for exemption, the applicable exemption category or categories are documented IRB and a determination letter issued to the researcher. Both the application and letter of determination from the IRB remind researchers of the ethical obligation to ensure that participants are fully informed about the nature of a research project so that they can make an informed decision to participate.

Categories of Eligibility for Exempt Determination

Each of the federal exemption categories below may be applied to research subject to 45 CFR 46, Subpart B

• • • • (Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research) if the conditions of the exemption are met. (45 CFR 46.104(b)(1)) Exempt status is not granted for research subject to 45 CFR 46, Subpart C

      • (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), except where the research is intended for a broader subject population and only incidentally involves prisoners. (45 CFR 46.104(b)(2))

      • Exemptions 1, 4, 5, 6, 7, and 8 may be applied to research subject to 45 CFR 46, Subpart D

      • (Additional Protections for Children Involved in Research). 45 CFR 46.104(b)(3) indicates special limitations in the application of exempt status to research with children for exemption 2(i) and 2(ii). Exemptions 2(iii) and 3 cannot be applied to research with children. Those exemption categories with limitations for research involving children are also noted below.

      • FDA-regulated research may not be granted exempt status, except for Exemption 6 listed below.

      • Subject to the exceptions above, and consistent with IRB-specific SOPs, research may be granted exempt status if all proposed research activities involve procedures listed in one or more of the specific categories below. (See 45 CFR 46.104

Federal Exemption Categories (1-8)

• • 1. Research conducted in established or accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or [impact] 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.

    2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior (including visual or auditory recording), if at least one of the following criteria is met:

       • 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;

       • 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; or

       • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).

       • Application of this exemption category to research with children is limited to the use of educational tests or observation of public behavior where the investigator does not participate in the activities being observed. The exemption cannot be applied to projects involving surveys or interviews with children.

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

• • • 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;

    • 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; or

    • The information obtained is recorded by the investigator in such a manner that the identify of the human subjects can readily ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).

For the purpose of this provision, 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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subjects authorizes the deception through a prospective agreement to participate in research 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.

This category may not be applied to research with children.

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:

• • • • The identifiable private information or identifiable biospecimens are publicly available;

      • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the 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.

      • The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or

      • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (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, 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.

    • Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

    • Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision.

    • The research or demonstration project must be published on this list prior to commencing the research involving human subjects..

6. Taste and food quality evaluation and consumer acceptance studies:

• • • • if wholesome foods without additives are consumed; or

      • 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 Protections Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 45 CFR 46.111(a)(8).

8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

• • • • Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1) through (4), (a)(6), and (d);

      • Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;

      • An IRB conducts a limited IRB review and makes the determination required by 45 CFR 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section of 45 CFR 46.111; and

      • The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Elements of Informed Consent

The Office of Human Research Protections (OHRP) outlines the information (elements of informed consent) that must be conveyed to subjects as part of the informed consent document and process (45 CFR 46.116.

General Requirement - Key Information Section

Informed consent "must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or not might want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 45 CFR46.116(a)(5)(i)

Required Basic Elements

The informed consent document and informed consent document must contain at least the basic elements as listed below:

1. A statement that the study involves research

This includes explaining the purposes of the research and any procedures that the subject will undergo and specifying which procedures are experimental (e.g., a new drug, extra tests, non-standard methods of management such as randomizing the subject to a treatment or placebo arm). The statement must describe how much time the subject can expect to devote to the study (e.g., how long will study visits or research-related procedures take, what is the total expected length of participation after enrollment).​

2. A description of any reasonably foreseeable risks

This includes any reasonably foreseeable risks, discomforts, inconveniences, and harms associated with the research activities. These risks should not be understated nor glossed over. If additional risks are identified during the course of the research project, the IRB must be informed. In such cases, the IRB may require revisions to the consent process and document(s), and may require subjects previously consented to be re-contacted and informed about the new risks. The IRB must approve any protocol or consent revisions and any proposed communication to subjects about these revisions.

3. A description of any benefits to the subject

Subjects must be provided with information about any benefits that may reasonably be expected from the research, either to them individually or to society at large. If there is no reasonable expectation of direct benefit, the subject must be informed. Payments for participation may never be listed as benefits of the research.

4. A disclosure of appropriate alternative treatment

To ensure subjects can make an informed choice about participation in the research, appropriate alternatives to participation that might be advantageous to subjects must be described, where applicable. For example, in a drug study, the medications being studied may be available outside the research study from a physician without the need to participate in the research. Investigators should be reasonably specific in describing the nature and type of available alternatives.

5. A statement describing the protections to privacy and confidentiality

Subjects must be told the extent, if any, to which individual privacy and confidentiality of research records that may identify them will be maintained, and who will have access to those records. For example, sponsors, funding agencies, regulatory agencies, and IRBs and other institutional officials may review research records. If a study involves the collection, use, or disclosure of protected health information, it will be regulated not only by the Common Rule but also by privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as well as special policies and standards required by the covered entity (e.g., health care provider, health plan, or clearinghouse) where the information originated.

6. For research involving more than minimal risk, a statement addressing research related injury

For research involving more than minimal risk, the consent process must provide an explanation as to whether any compensation or treatment will be provided to an injured subject (injury in this context refers both to physical injuries and to less tangible injuries, such as injury to reputation or legal rights). If so, the compensation and treatment should be described, or the subject should be told where to find additional information. In no event may the consent process or the documentation of consent include exculpatory language (e.g., requiring subjects to give up legal rights to which they otherwise would be entitled, such as the right to sue in case of an adverse response to a study intervention).

7. An explanation of whom to contact for questions or concerns

Subjects must be informed about whom to contact for answers to pertinent questions or concerns about the research or their rights as research subjects, as well as whom to contact in the event of a research-related injury, if injuries are foreseeable. Specifically, they should be told how to contact the researchers and whom they can contact if they cannot reach or do not want to speak with the researchers. They also should be told how to lodge a complaint (e.g., by contacting the acting IRB chairperson).

8. A statement that participation is voluntary

Subjects must be specifically informed that participation in a project is on a voluntary basis; that they may discontinue participation at any time; and that no penalty will be imposed, and no rights to which they would otherwise be entitled be waived as a result of refusal to participate in the research or later withdrawing from the research.

9. One of the following statements about the collection of identifiable private information or identifiable biospecimens, as applicable:

• • • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

    • A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements of Informed Consent

One or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent;

3. Any additional costs to the subject that may result from participation in the research;

4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;

6. The approximate number of subjects involved in the study;

7. A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;

8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Retention of Signed Consent

Signed consents must be retained for:

• • • At least three (3) years after completion of the research (seven (7) years if protected health information will be used or disclosed in connection with the study in accordance with HIPAA requirements); or

    • Longer if required by institutional policy or applicable sponsor agreements or regulations.

Investigators conducting research in health care settings are encouraged to retain original duplicates of informed consent documents in both the research record and the regular medical record to ensure compliance with the health care organization’s and research documentation requirements. Depending on the circumstances of the study, they may also be required to maintain documentation of HIPAA-compliant authorization.

Can the requirement for documenting Written Informed Consent ever be waived?

According to the Common Rule §46.117 (c) (1): An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:

(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;

(ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

Resources on Informed & Broad Consent from Citi Program

Final Rule Revisions on Informed Consent

Understanding Broad Consent

Basic Elements of Consent

Comprehensive Guide to Informed Consent (PDF Slide Presentation)

According to the Common Rule (effective 2018), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Conflict of Interest

"A conflict of interest involves the abuse -- actual, apparent, or potential -- of the trust that people have in professionals. The simplest working definition states: A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. An apparent conflict of interest is one in which a reasonable person would think that the professional's judgment is likely to be compromised. A potential conflict of interest involves a situation that may develop into an actual conflict of interest. It is important to note that a conflict of interest exists whether or not decisions are affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood" (Conflicts of Interest, 2004).

In their application for IRB review and approval, investigators involved in the conduct of research are required to disclose 1) if the investigators are receiving funding for the study, and 2) if there is risk for actual or perceived financial or other conflict of interest. In cases where the research is funded or there is conflict of interest, the investigator is expected to provide a statement for the institution and the IRB that describes their financial relationships with the sponsor of their research and/or the nature of the conflict of interest and how those conflicts will be managed over the course of the research project.

• Columbia University offers a free e-lesson to teach learners how to recognize specific types of conflicts of interest that involve the individual, the IRB member, and the institution, at https://ori.hhs.gov/education/products/columbia_wbt/rcr_conflicts/introduction/index.html

Investigators involved in the conduct of research supported by the National Institute of Health (NIH) or Public Health Service (PHS) are subject to additional training requirements on conflicts of interest.

• The NIH has developed an interactive training module designed for institutions and investigators involved in PHS or NIH-supported research that provides a downloadable/printable certificate upon successful completion of the course. Access the training module at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Student Records Are Protected

Federal law, the Family Education Rights and Privacy Act (FERPA), protects the privacy of student educational records which generally includes information maintained by Keuka College that identifies a student. Students should be aware of their rights under FERPA and faculty and staff should be aware of and follow their obligations under FERPA. The following resources are intended to help students, faculty, and staff understand FERPA and how to best protect the privacy of students in general.

Refer to:

Keuka College's FERPA policy on the college's website (external link)

Keuka College IRB's policy on research involving the use of Student Educational Records

If you have problems accessing content on this website, please first ensure you are logged in using your Keuka College email account. If you still have difficulties, please email the the Chair of IRB. at irb@keuka.edu.