Human Subjects Research

Kutztown University Policy EC-013

1. Purpose

   This policy is established for the purpose of protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Kutztown University; and in order to comply with Title 45 Code of Federal Regulations, Part 46, Protection of Human Research Subjects. 

2. Scope

   This policy applies to all research projects, conducted by students, staff and faculty, which involve human subjects. 

3. Key words and phrases:

   • Research - a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research: 

     1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.  (However, if collecting data from multiple oral histories and the research in generalizing data to a group, it may be considered research.)

     2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

     3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

     4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

   • Human Subject - a living individual about whom an investigator (whether professional or student) conducting research: 
        (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 
        (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 

     • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., 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. 

     • 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 that has been provided for specific purposes by an individual and that the  individual can reasonably expect will not be made public (e.g., a medical record). 

     • Identifiable private information is private information for which the identity of the  subject is or may readily be ascertained by the investigator or associated with the  information. 

     • Identifiable biospecimen is a biospecimen for which the identity of the subject is or may  readily be ascertained by the investigator or associated with the biospecimen. 

   • Institutional Review Board (IRB) - generic term used to designate the local institutional review committee which is required under the regulations to review research involving human subjects. At local institutions, these committees are given various names, such as committee on human subjects, or the human investigations committee. 

   • IRB approval - the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. 

   • Certification - the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. 

   • Clinical trial - a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 

   • Code of Federal Regulations (CFR) - a compendium of rules issued by Federal agencies. 

   • Legally authorized representative - an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research. 

   • Minimal risk - 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. 

   • Public health authority - an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. 

   • Competence - a legal term, used to denote capacity to act on one's own behalf, the ability to understand information presented to appreciate the consequences of acting (or not acting) on that information, and to make a choice. 

   • Confidentiality - pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission. 

   • Informed Consent - a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure. 

   • Principal Investigator (investigator) - the scientist or scholar with primary responsibility for the design and conduct of a research project. 

   • Privacy - control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally or intellectually) with others. 

   • Written, or in writing - refers to writing on a tangible medium (e.g., paper) or in an electronic format. 

4. Policy & Procedure(s)
   

   Kutztown University’s policy is that no research done under its jurisdiction expose persons who participate as subjects or respondents to unreasonable risks to their health, general well-being, or privacy.  

   The IRB reviews research, conducted by students, staff and faculty, or outside individuals and organizations, which involve human subjects. This document defines the makeup of the IRB and its functions. The approval of the IRB is a requirement for research projects involving human subjects. 

   • Composition of IRB

     1. The IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. 

     2. IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. 

     3. IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

     4. IRB may not have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. 

     5. IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. 

     6. Faculty IRB committee members shall be appointed by the Committee on Committees. The Provost will appoint one administrator and a person not affiliated with the university. 

   • Review of Research 

     1. The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption.   

     2. The IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. 

     3. The IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117. 

     4. The IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. 

     5. The IRB shall conduct continuing review of research requiring review by the IRB at intervals appropriate to the degree of risk, not less than once per year, unless an IRB determines otherwise that continuing review of research is not required.  

   • Criteria for Approval of Research 

     1. In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied: 

        1. Risks to subjects are minimized: (1) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (2) whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes. 

        2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and in relation to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). 

        3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. 

        4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.  

        5. Informed consent will be appropriately documented or appropriately waived. 

        6. When appropriate, the research plan makes adequate provision for monitoring data collected to ensure the safety of subjects. 

        7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 

        8. For purposes of conducting the limited IRB review, the IRB need not make the determinations above, and shall make the following determinations: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained; (ii) Broad consent is appropriately documented or waiver of documentation is appropriate; and (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 

        9. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. 

   • Suspension or Termination of Research

     1. Unanticipated problems involving risk to subjects or others must be reported immediately to the IRB and may lead to suspension or termination of research. 

     2. Serious or continuing noncompliance with federal regulations or the requirements or determinations of the IRB may lead to suspension or termination of research. 

     3. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head supporting the research, and any other necessary parties. 

   • Types of Review 
     

     The role of the University's IRB is to ensure compliance with University policy as well as with applicable federal regulations for funded research as detailed in the CFR, (45 CFR Part 46), and any other federal regulations currently in force or which may be introduced in the future.  

     There are three general categories of review.

     1. Exempted Review. The Chair of the IRB determines whether a particular research project is exempt. As necessary, the Chair will consult with members of the IRB when making a decision on exemption requests. If exempt, the investigator will be so notified by the Chair. 
        
        Any revisions/changes to the  research protocol affecting human subjects may affect the original determination of exemption and therefore must be submitted for review and subsequent determination.   
        
        

        The following categories are considered eligible for Exempted Review:

        1. 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. 

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

        3. (i) 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: (A) 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; (B) 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 (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

           (ii) 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.

           (iii) 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.
           
           
        4. Research 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 information about 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 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
           
           

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

        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. 

        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. 

        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: 

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

           (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117; 
           
           (iii) An IRB conducts a limited IRB review and makes the determination required by §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; and  
           
           (iv) 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. 
           

     2. Expedited Review. Research activities involving no more than minimal risk and for minor changes in approved research may be eligible for Expedited Review.
        
        Protocols will be reviewed by the Chair and/or one or more experienced committee members. The reviewer(s) may refer it for full committee review.
        
        

        The categories of research eligible for Expedited Review are: 

        1. Clinical studies of drugs and medical devices only when condition (i) or (ii) is met. 

           (i) Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) 

           (ii) Research on medical devices for which an investigational device exemption application is not required; or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. 

        2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 

           (i) 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; or 

           (ii) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week. 

        3. Prospective collection of biological specimens for research purposes by noninvasive means. 

           Examples: (i) hair and nail clippings in a non-disfiguring manner; (ii) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (iii) permanent teeth if routine patient care indicates a need for extraction; (iv) excreta and external secretions (including sweat); (v) 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; (vi) placenta removed at delivery; (vii) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (vii) 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; (ix) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (x) sputum collected after saline mist nebulization. 

        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: (i) 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; (ii) weighing or testing sensory acuity; (iii) magnetic resonance imaging; (iv) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (v) 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 (such as medical treatment or diagnosis). 

        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. 

        8. Continuing review of research previously approved by the convened IRB as follows: where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis. 

     3. Full Committee Review. Any research not covered by the conditions of Exempted Review or Expedited Review will be referred to the IRB for full review. 

   • Record Retention

     Records relating to the approved research (e.g., consent forms) under 45 CFR 46 must be retained by the investigator for at least (3) three years after completion of the research. An investigator who leaves the university prior to the end of the 3-year retention period must notify the IRB, specifying the new location of the records. If records are maintained by a student or research assistant, the records must be turned over to the faculty member after the research has been conducted. 

   • Reporting and Continuing Review

     1. Investigators must ensure prompt reporting to the IRB of proposed changes in a research activity and ensure that such changes in approved research, during the period for which IRB approval has already been given, will not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subjects.  This reporting is required for all approved research, whether the determination was exempt, expedited or full.  Note that changes to the research may affect the original determination and, therefore, must be submitted for review and subsequent determination.   

     2. Investigators must ensure prompt reporting to the IRB of any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with federal regulations or determinations of the IRB. 

     3. Investigators report progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB.  IRB conducts continuing review of ongoing research at intervals appropriate to the degree of risk and will indicate requirements in the approval letter.   

   • Informed Consent and Assent

     In most research activities, the investigator must obtain informed consent from each subject or the subject's legally authorized representative (e.g., parent, guardian or legal representative).  An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. In situations where full disclosure of the purpose of the research is not possible because it could bias the outcome, the investigator has the responsibility to debrief subjects concerning the purpose of the research.

     • 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 might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 

     • Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. 

     • No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
       

       Basic elements of informed consent: 
       

       1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental; 

       2. A description of any reasonably foreseeable risks or discomforts to the subject; 

       3. A description of any benefits to the subject or to others that may reasonably be expected from the research; 

       4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 

       5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 

       6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 

       7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; 

       8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and 

       9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: 

          1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such 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 

          2. 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.

       10. 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). 

     • General waiver or alteration of consent:  
       
       

       An IRB may waive the requirement to obtain informed consent for research and may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent. An investigator must complete the appropriate form and submit it to the IRB for approval, if they wish to alter consent, waive the requirement to obtain consent or waive the requirement for a signed consent.

       • In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

         1. The research involves no more than minimal risk to the subjects; 

         2. The research could not practicably be carried out without the requested waiver or alteration; 

         3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; 

         4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and 

         5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

       • The informed consent form may be either of the following:

         1. A written informed consent form that meets the requirements set forth above. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.

         2. A short form written informed consent form stating that the elements of informed consent set forth above have been presented orally to the subject or the subject's legally authorized representative, and that the key information was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form.

       • 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:

         1. 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;

         2. 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

         3. 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.

       • 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.  

         Requirements for permission by parents or guardians and for assent by children: 

         1. The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived. 

         2. The IRB shall determine, in accordance with and to the extent that consent is required, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research that not involving greater than minimal risk or research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. Where research involves greater than minimal risk and no direct benefit (but likely to yield generalizable knowledge about a subjects disorder or condition);  and research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 

         3. In addition to the provisions for waiver contained in above, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

       • There are additional protections for pregnant women, human fetuses and neonates involved in research, additional protections pertaining to biomedical and behavioral research involving prisoners as subjects, and additional protections for children involved as subjects in research.  These additional protections can be reviewed in Title 45 Code of Federal Regulations, Part 46, Subparts B, C & D.   

5. Effective Date
   
   1993

6. Endorsed By
   

   
   University Senate – 1993 
   University Senate – October 7, 2019 

7. Approved By
   

   University President – 1993 
   University President – October 22, 2019 

8. Last Revised

   October, 2008 
   February, 2011
   July, 2019 

9. Last Review
   
   

   August, 2011 
   August, 2012
   August, 2013 
   August, 2014 
   August, 2015 
   August, 2016 
   August, 2017 
   August, 2018 
   July, 2019
   August, 2020 
   June 2026 (renamed from ACA-040)

Further information regarding the protection of human subjects can be found in the Code of Federal Regulations, 45 CFR 46.