IV. The authority of the HSCL

Scope of authority: What types of studies must be reviewed

This Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:

1. The research is sponsored by this institution, or
2. The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
3. The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
4. The research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.
5. The research is carried out by an organization which has a FederalWide Assurance (FWA) and which has indicated HSCL as their IRB of record.

The term "research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.

Precedent and practice have established the principle that certain kinds of activities that might be called "human subjects research" do not require review for the protection of human subjects. The following kinds of activities do not require such review:

1. accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
2. research using only historical documents; and
3. research using only archaeological materials or other historical or pre-historical artifacts. Pilot studies, pre-tests, and other "preliminary" investigations are considered research, and must be reviewed unless they fall into one of the excluded categories listed above.

Classroom activities may include instructing students in research methodologies and techniques. If the sole purpose of the activity is to teach students research techniques or methodology and not to develop or contribute to generalizable knowledge, it is not considered to be research. However, if students will practice research methodologies on human beings, they should be instructed in the ethical conduct of such activities and should be advised to obtain informed consent from their practice subjects.

Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution, likewise, are not considered research activities. However, if the data collected are generalizeable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. Sometimes, data from a quality improvement or quality assurance activity become of interest to the external community after they have been analyzed. In these cases, the research use of the data collected for another purpose must be reviewed.

The same distinction may apply to routine observation activities. For example, what begins as an observation of classroom activity may evolve into a research project that goes beyond the classroom. Researchers are obligated to submit the research activity for review as soon as the research activity changes. For example, a research activity involving analysis of teaching methods or classroom management for review may prompt the researcher to look for academic achievement or discipline problems outside the classroom. So, what was initially a research project that was exempt from full board review because the research was conducted within a regular or special education setting becomes a research activity that must receive review and approval by the full board. Due to differing interpretation of the Exempt category (46.101 (b)) on the part of federal agencies and confusion that use of the term has caused researchers, this IRB uses only Expedited and Full Board Review. Projects that would have been included as Exempt are now given Expedited review.

Research requiring review

HSCL must review all research with human participants. There are two broad categories of studies requiring review: those that require full board review and those that qualify for expedited review. Under expedited review there are two categories: Exempt and Expedited review. Research projects that meet the criteria for Exempt or Expedited review are not exempt from any review at all, but must receive expedited review by a HSCL member or members appointed by the Chair. At the University of Kansas that person is the HSCL Coordinator and the Associate Coordinator.

No risk research

Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from full board review and must be reviewed by the HSCL Coordinator, who makes the determination as to the level of review needed. Each of the categories is quoted from Title 45, Code of Federal Regulations, Part 46.101 (b), and is followed by an explanatory paragraph. Research with certain populations, such as children, pregnant women, prisoners, and persons with impaired cognitive ability may require full board review, depending upon the nature of the research.

45 CFR 46.101 (b) (1). 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 on the comparison among instructional techniques, curricula, or classroom management methods.

The purpose of this category is to exempt research on educational practices, in an educational setting. This category does not extend to research conducted in a school setting but not related to the instruction in that institution. For example, an evaluation of two methods of fourth grade classroom instruction in a local school district would qualify as exempt research. A sociometric survey of children's preferences for playmates in the same school, involving the same children, would not qualify as exempt research. As the example indicates, research on minor students can be exempt if it is educational research in the sense intended here.

45 CFR 46.101 (b) (2).Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

1. information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and
2. any disclosure of the subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

45 CFR 46.101 (b) (3). Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:

1. the human subjects are elected or appointed public officials or candidates for public office; or
2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

45 CFR 46.101 (b) (4). Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

"Existing," means that the data have been collected and are available in their complete form (i.e., no other data collection will take place) at the time the researcher develops a proposal for their use. Use of data not already available in such a manner must be considered under some other rubric. State and federal laws preclude the use of certain kinds of existing data (including health care information, records of drug and alcohol treatment, and records of psychiatric care) from use by researchers without human subjects review, regardless of whether they are "existing" or recorded by the investigator in such a way that subjects cannot be identified..

45 CFR 46.101 (b) (5). Research and demonstration projects which are conducted by or subject to the approval of the department or agency heads, and which are designed to study, evaluate or otherwise examine:

1. Public benefit or service programs;
2. Procedures for obtaining benefits or services under those programs,
3. possible changes in or alternatives to those programs or procedures; or
4. possible changes in methods or levels of payment for benefits or services under those programs.

The "department or agency heads" referred to here are federal, not state, local, or university. This category of exempt research refers to activities sponsored by federal agencies to evaluate their own benefit or service programs.

45 CFR 46.101 (b) (6). Taste and food quality evaluation and consumer acceptance studies,

1. if wholesome foods without additives are consumed or
2. if a food is consumed that contains a food ingredient at or below the level of and for a use 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.

The following categories of research are not exempt, and always require review by the HSCL board: 1) research involving prisoners; 2) research on minor children unless the research qualifies as educational research in the sense of 46.101 (b) (1), above, or where the research does not involve direct interaction with the child, and 3) research using non-public records.

Minimal risk research

Some research that presents no more than minimal risk to participants must still be considered through full board review if the participants are minors, cognitively impaired, or institutionalized. Occasionally a research project initially requires full board review because the procedures are new to the board and the board must satisfy itself that the research presents no more than minimal risk.

Research projects that meet the criteria for Expedited review must fall under a set of descriptions found in a list of categories published by the Office for Human Research Protections, effective as of November 9, 1998. Even if the research activities fall under one of the categories for Expedited review the research procedures must present no more than minimal risk to participants. The expedited category list appears below.

An expedited review procedure consists of a review of research involving human subjects by the HSCL chairperson or by one or more experienced reviewers designated by the chairperson from among members of the HSCL in accordance with the requirements set forth in 45 CFR 46.110.

Research activities involving "no more than minimal risk" and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed using an expedited procedure by a subcommittee of a human subjects review committee: Each of the categories is quoted from the federal regulations at 45 CFR 46, and followed by an explanatory paragraph. Much behavioral research that does not qualify for exemption may be reviewed as minimal risk using the expedited procedure. This category is designed to accommodate research activities that pose no more than minimal risk to subjects and that are not eligible for exemption.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
1. Research on drugs for which an investigational new drug application (21 CFR Part 312) 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.)
2. Research on medical devices for which
1. an investigational device exemption application (21 CFR Part 812) is not required; or
2. 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:
1. 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
2. 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:

1. hair and nail clippings in a non-disfiguring manner;
2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
3. permanent teeth if routine patient care indicates a need for extraction;
4. excreta and external secretions (including sweat);
5. 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;
6. placenta removed at delivery;
7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
8. 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;
1. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
9. 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:

1. 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;
2. weighing or testing sensory acuity;
3. magnetic resonance imaging;
4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
5. 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 nonresearch 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.)
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. (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.)
8. Continuing review of research previously approved by the convened HSCL as follows:
1. Where
1. the research is permanently closed to the enrollment of new subjects;
2. all subjects have completed all research-related interventions; and
3. the research remains active only for long-term follow-up of subjects; or
2. Where no subjects have been enrolled and no additional risks have been identified; or
3. Where the remaining research activities are limited to data analysis.
Researchers who wish to have their applications for continuing review of projects previously reviewed by the full Human Subjects Review Committee will have to demonstrate that the above conditions have been met.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the HSCL has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

This category applies to situations in which the full Human Subjects Review Committee conducts a continuing review of a study and determines that the continuing activity poses only minimal risks.

Research requiring full committee review

All research conducted by faculty, staff, or students that is not eligible for exempt or expedited review must be reviewed by the full HSCL. The HSCL has the authority to disapprove, modify or approve studies based upon consideration of human subjects protection aspects.

1. HSCL shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including proposed changes in previously approved human subject research.
2. HSCL shall require that information given to subjects as part of informed consent is in accordance with '46.116. HSCL may require that information, in addition to that specifically mentioned in '46.116, be given to the subjects when in HSCL's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
3. HSCL shall require documentation of informed consent or may waive documentation in accordance with '46.117.
4. HSCL 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 HSCL approval of the research activity. If the HSCL 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. HSCL shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

Procedure

HSCL communicates to the researchers in writing, via email, fax, or surface mail (campus or U.S. Mail) about the status of their application, whether it has been sent for full board review, has received expedited review and approval, or has received expedited review but that there are issues to be addressed prior to approval. Applications sent for full board review are initially sent to three primary reviewers at least one of whom has expertise in the area being reviewed.

HSCL avoids assigning only board members with expertise in a particular area to review applications for research in their area because it is important to obtain the perspective of someone who does not possess expertise with the topic just as it is important to have reviewers with experience and expertise in the proposed area of research.

The letter sent to researchers list the researcher's name and address, the project title, and the HSCL project number that has been assigned to the application. The letter informs the applicant not to begin research, to respond in a point-by-point fashion to the issues raised, including in the response any documents that have had to be revised. For applications that have received HSCL board review and have been designated as Not Approved or Disapproved, the Coordinator or Faculty Chair presents the researcher's response to the board. Sometimes, researchers ask or are invited to speak with the board if their application will be discussed at the convened meeting.

For Expedited reviewed projects and projects to which the HSCL gave a Contingent designation, the Coordinator may read the response and decide if the researcher has adequately addressed the issues raised, including the submission of documents that required revision.

Criteria for HSCL approval of research

In order to approve research covered by this policy the HSCL 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 the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HSCL 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). The HSCL should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the HSCL should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the 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.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Lotteries or Drawings

Offering the chance of winning a prize for participation constitutes gambling, according to Kansas Statute. Three elements that make an activity illegal under the Kansas statutes when all three are present are: chance, consideration, and prize. Therefore, to make a drawing legal, eliminate one of those elements, such as "consideration" by allowing anyone to submit his name on a ticket or form for a drawing for a prize without his having to complete the survey or questionnaire, because otherwise, you have the act of completing the survey being the "consideration" that allows only those who participate in the study and do the survey to have a chance for the prize. Your other option is to eliminate the reference to the drawing in your information statement.

Internet Research

If investigators wish to use the Internet or electronic mail to conduct surveys or email interviews some extra precautions are necessary. Researchers should know and comply with web site rules for chat rooms and other sites and be sensitive to the expectations of privacy and support that some chat rooms and web sites imply.

Because respondents' electronic addresses are typically provided when they return such surveys by e mail or respond to email questions, PIs should devise a plan for stripping such information to maintain the confidentiality and anonymity of respondents' names. The investigator should therefore inform subjects that, while effort will be made to protect subjects privacy, security and confidentiality of participants' responses cannot be guaranteed because it is possible that, through intent or accident, someone other than the intended recipient may see the subject's response.

Genetics Research

There are currently no specific sections of 45 CFR 46 that deal with genetics research, however, the same confidentiality and privacy rules apply to genetics research as other human subjects research. Participants in genetics research projects are to be told who is gathering the data, by what method, with whom it will be shared, what confidentiality protections will be in place, and for how long the data will be kept. In some cases, particularly minority populations or communities with small populations, confidentiality may be difficult to guarantee and so extra precautions should be taken to protect their data. Some studies that may include genetics components include growth- and maturity-related variations in body size and function and its impact on the health of children and adolescents; physical activity, adiposity, and atherosclerotic risk factors during growth and maturation, pediatric obesity, and the genesis of the metabolic syndrome in children and adolescents. Other studies at KU where DNA plays a role are population migration and language studies, and diabetes studies. Researchers should be aware of subject's rights when a subject decides to withdraw from a study. The federal regulations (45 CFR 46.116 (a) (8) clearly require that subjects be free to withdraw from participation without penalty or loss of benefits to which they are otherwise entitled.

What the regulations do not address, however, is how to treat data or tissue samples obtained from subjects who subsequently withdraw from the study. A similar question was addressed by the California Supreme Court in the Moore case [John Moore v. The Regents of the University of California (1990)]. While Moore constitutes binding legal authority only in California and has not, as of this writing, been adopted in other jurisdictions, the court's findings may be helpful for exploring possible approaches to handling the treatment of data and tissue samples when a subject withdraws from a genetic study.

In Moore, the California Supreme Court held that cell lines established from a donated sample are not the property of the person who donated the sample. Extrapolating to the broader context of genetic research generally, the underlying principle would be that withdrawal releases the subject from providing further information or tissue samples, and perhaps requires the removal of the subject's identity from all research records, but does not require the investigator to eliminate the resulting data from the study or to destroy the cell line.

In pedigree studies, for example, investigators may respond to a request to withdraw by removing all information about that person and his or her spouse and children from the pedigree, but it is not clear that removal of the information is required by the human subjects regulations or any other legal principle.

The Human Subjects Committee will deal with such questions on a case-by-case basis.

Review by Institution

Research covered by this policy that has been approved by HSCL may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by HSCL.

Authority to require progress reports from the investigators and oversee the conduct of the study

For approved research, HSCL will determine which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was a previous HSCL review and approval. (46.109)

HSCL's continuing review of research is conducted through a Status Report Form in which the investigator must provide information regarding project status, withdrawals and complaints, summary of findings, adverse events, risks and benefits, and a copy of the investigator's current consent form.

A board member may propose that continuing review be done at more frequent intervals than once per year, or the board as a whole may do so. Once a decision has been reached, the PI is informed in writing about the reporting requirements.

Authority to suspend or terminate approval of a study

HSCL has authority to suspend or terminate approval of research that is not being conducted in accordance with the HSCL's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination or approval shall include a statement of the reasons for the HSCL's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Department or Agency head.

Flow path for HSCL's Processing of Complaints and Allegations Against PIs

1. Complaint/Allegation is received by HSCL coordinator.
1. Receipt of the complaint is noted to the HSCL chair, the Vice Provost for Research and Graduate Studies, and the Director of Research Integrity.
2. Acknowledgement of receipt of complaint is sent to complainant, with an indication that the matter has been taken under inquiry.
2. The complaint is checked against the existence of any approved HSCL protocol.
1. If no approved protocol exists, the complaint is forwarded to the Director of Sponsored Programs as a possible instance of noncompliance. The PI, faculty supervisor (if any), and the chair of the department from which the project originated are advised by the HSCL coordinator of this noncompliance, and the Director of Sponsored Programs shall make formal allegations of academic misconduct (in the case of a student) or scholarly/scientific misconduct (in the case of a faculty member) to the appropriate administrator.
2. If an approved protocol exists, proceed to step III below.
3. The complaint is checked against the existing HSCL protocol.
1. If the procedures carried out by the PI were not approved by HSCL, or if there is a violation of the approved protocol, then the complaint is forwarded to the Director of Sponsored Programs as an instance of noncompliance. The PI, faculty supervisor (if any), and the chair of the department from which the project originated are advised by the HSCL coordinator of this noncompliance, and the Vice Provost shall make formal allegations of academic misconduct (in the case of a student) or scholarly/scientific misconduct (in the case of a faculty member) to the appropriate administrator.
2. If there is no obvious violation of the approved protocol, proceed to step IV.
4. By definition, in reaching this step it should have been determined that the project had been approved by HSCL, and that there is no obvious violation of the approved protocol.

The HSCL coordinator sends a copy of the complaint to the PI, faculty advisor (if any), and chair of the department from which the project originated. The PI and faculty supervisor (if any), are directed to respond to the charges in writing within 5 days.

Authority to place restrictions on a study

HSCL will review, and have the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research. For approved research, HSCL will determine which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was a previous HSCL review and approval.

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Questions? Please contact:
David Hann
785-864-7429 | dhann@ku.edu
Coordinator | Human Subjects Committee of Lawrence (HSCL)

— or —

Mary Denning
785-864-7385 | mdenning@ku.edu
Associate Coordinator |Human Subjects Committee of Lawrence (HSCL)