Policies and Procedures Governing Research with Human Participants

 Table of Contents  

 I.          Policies

 I.A.  Introduction

The Vice-Chancellors for Research at Southern University – Baton Rouge (SU-BR) and the Southern University Agricultural Research and Extension Center (SU Ag Center) are responsible for research on their campuses.  However, at the present time and within these policies and procedures, the Vice-Chancellor for Research at SU-BR (herein referred to as the “Vice-Chancellor for Research”) is the institutional official responsible for all research conducted by SU-BR and SU Ag Center faculty, staff, and students and external researchers who engage in research on the SU-BR and SU Ag Center campuses.  Under the auspices of the Vice-Chancellor for Research, it is the responsibility of the Institutional Research Oversight Committee (herein referred to as the “IROC”) to ensure that research is conducted within federal regulations, state statutes, institutional polices, and ethical principles and to address research misconduct.   The SU-BR Human Protection Administrator (herein referred to as the “Human Protection Administrator”) presently chairs the IROC and is the Research Integrity Officer, and IROC committee members include the chairpersons of SU-BR’s four research-risk committees:  Institutional Review Board for the Protection of Human Subjects (herein referred to as the “IRB”), Institutional Animal Care and Use Committee, Biohazards Safety Committee, and Recombinant DNA Committee.  Within the SU-BR and SU Ag Center research structures, the IRB has primary responsibility for ensuring that research involving human participants is reviewed and approved within federal regulations, state statutes, and institutional policies, and ethical principles.   

The IRB has been registered with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) (# 00002445), and SU-BR has federalwide assurance (FWA) (# 00002518).  Within its FWA agreement, SU-BR has assured that its and the Southern University and A&M College System Agricultural Research and Extension Center (herein referred to as the “SU Agricultural Center”) research with human participants, regardless of the source of support, shall be guided by the ethical principles in the Belmont Report (see Appendix A or http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm).  SU-BR has also agreed to apply the Common Rule and subparts B, C, and D of the Department of HSS and the Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects (45 CFR 46) to all of its human participants research (see Appendix B or http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ 45cfr45.htm).

As stated on the OHRP Web site (http://www.hhs.gov/ohrp/about/), the OHRP provides leadership and oversight on all matters related to the protection of human participants participating in research conducted or supported by the U.S. Department of Health and Human Services (DHHS). OHRP helps ensure that such research is carried out in accordance with the highest ethical standards and in an environment where all who are involved in the conduct or oversight of research with human participants understand their primary responsibility for protecting the rights, welfare, and well-being of participants. OHRP:

• establishes criteria for and approves assurances of compliance for the protection of human participants with institutions engaged in DHHS conducted or supported human participant research;
• provides clarification and guidance on involving humans in research;
• develops and implements educational programs and resource materials; and
• promotes the development of approaches to enhance human subject protections.

 Research projects involving human participants conducted under the auspices of SU-BR and the SU Agricultural Center by SU-BR faculty, staff, or students or by external investigators at either campus must receive approval before the research is initiated. The information in this policies and procedures manual is designed to provide principal investigators and research project personnel with the guidelines and process for obtaining initial approval (no more than one year- §46.109[e]) and approval for continuation (no more than one year - (§46.109[e]).  Those principal investigators who have questions about ethical practices and federal regulations relating to the use of human participants in research should obtain and read the Belmont Report and 45 CFR 46.  Reading these documents and DHHS OHRP guidance/educational materials and completing the online human participant training session will provide principal investigators with a better understanding of the reasons for review of research with human participants, the ethical principles that govern such research, and the statutory basis or enactment of these principles.  Where the purpose of the research involves the application of the Code of Federal Regulations of other regulatory agencies (e.g., U. S. Food and Drug Administration [FDA]), the IRB shall apply these regulations (e.g., CFR Title 21).  If principal investigators have questions about the requirement for completing training in the use of human participants, they should contact the Chairperson of the IRB. 

 It is the intention of the IRB to review and revise these policies and procedures yearly to ensure compliance with needed regulations and to provide guidelines to SU-BR, SU Agricultural Center, and external researchers.  Questions, comments, and suggestions regarding this manual or the IRB research project review and approval process should be sent to the Human Protection Administrator and Chairperson of the IROC:  Jimmy D. Lindsey, Ph.D. - (Office) 236 Blanks Hall; (Mailing Address) P. O. Box 11241, Southern University - Baton Rouge, Baton Rouge, LA 70813-1241; (Voice) 225-771-3950; (Facsimile) 225-771-5652; (E-mail) Jimmy_Lindsey@SUBR.Edu.

I.B.  Code of Research Ethics

     In 1971, the United States Department of Health, Education, and Welfare issued ethical guidelines that became federal regulations in 1974.  Four years later, in 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report, which identified three basic ethical principles that were used to develop the current Common Federal Policy for the Protection of Human Research now adopted by numerous federal departments and agencies.  These principles include: (a) Respect for Persons (Autonomy) – human participants have dignity and freedom and their consent to participate is required; (b) Beneficence  – investigators must maximize benefits and minimize risks and research-related risks must be reasonable with respect to expected benefits; and (c) Justice – the human participant recruitment and selection process is equitable and ensures fair treatment (see Appendix A). This present Federal policy, the Common Rule that was codified as the Common Federal Policy for the Protection of Human Subjects and published in 1991 in the Federal Register, is referred to as 45 CFR 46.  Title 45 CFR Part 46 regulations (see Appendix B) require and guide the actions of an IRB, and thus, the IRB is governed by 45 CFR 46 regulations and the principles set forth in the Belmont Report.

I.C. Responsibilities of the IRB

            The IRB is responsible for the review of all SU-BR and SU Agricultural Center research projects using human participants (§46.101; §46.103). The IRB will be comprised of the Chairperson and members appointed by the Vice-Chancellor for Research for two-year terms. The composition of the IRB will include representatives from faculty and members of the community (§46.107).  A student representative, with non-voting status, may also be appointed to the IRB. Nominations for IRB membership should be submitted to the Vice-Chancellor for Research who will then consult with the Human Protection Administrator and Chairperson of the IRB to assure that pertinent SU-BR and SU Agricultural Center units and the community are adequately represented in the makeup of the membership.

             Based on the Code of Federal Regulations (45 CFR 46), the Chairperson of the IRB shall determine if a research project submitted for review is exempt (§46.101), eligible for an expedited review (§46.110), or requires a full or convened review (§46.108[b]).  The Chairperson, on behalf of the IRB, can approve exempt research with or without revisions.  The Chairperson, in collaboration with individual IRB members or an ad hoc IRB committee can expedite research projects and approve these projects with or without revisions.  During the expedited review process, a third party, with knowledge about the protocol or with work experiences with the proposed participants, may also be asked to review the research and make recommendations (§46.107[f]).

 Approval of research projects necessitating a full review requires a quorum of the convened IRB, and minutes shall be taken at these meetings.  The scheduled meeting to review the proposed research must have a quorum, a majority vote is needed to approve or disapprove the research project, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).  If any IRB member has a potential conflict of interest with respect to the review of a research project (e.g., his or her research has been submitted for IRB approval), the member must declare this in advance of a review and not participate in voting on the research project (§46.107[e]).  However, and as is true for any principal investigator (applicant) submitting a research project for approval, an IRB member can provide requested information to the IRB in his or her role as a research investigator.   

It is the responsibility of the Chairperson of the IRB to retain, file, update, and monitor all documentation that will include, at a minimum: (a) IRB membership, members’ expertise/competencies, school/unit represented, dates for appointments and renewals, and so forth; (b) minutes of IRB meetings, including the attendance and voting record on research projects reviewed and policy issues discussed; (c) research projects reviewed and the decision on each; (d) research projects in the queue for approval; and (e) appeals in the queue and those concluded with documentation of the decisions (§46.115).  The Chairperson shall also establish a database of pertinent information, including but not limited, to the following: (a) the dates of reviews and decisions; (b) the dates that investigators must submit reports; (c) the dates that the IRB must convene to re-review approved research projects that required a full review; and (d), a computation of types of research reviewed, categories of researchers, and other data required on the IRB forms (§46.115).  

Although this policies and procedures manual outlines the appeal process for principal investigators who do not agree with the decision of the IRB and SU-BR and the SU Agricultural Center have due process procedures, in accordance with SU-BR’s FWA terms of agreement (http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm), all human participant research to which the FWA applies, except for research exempted or waived in accordance within the Code of Federal Regulations (46:101[b] or 46:101[i]), will be reviewed, prospectively approved, and subject to continuing review at least annually by the IRB.  The IRB has authority to approve, require modifications in, or disapprove the covered human participant research (§46.109).  For research approved by the IRB, further appropriate review and approval by any department or agency conducting or supporting the research or by officials of the institution holding the FWA may be required.  Also, under federal regulations (46:113), the IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements, has been associated with unexpected serious harm to human participants, or present other problems or concerns (e.g., violation of Louisiana statutes, SU-BR and SU Agricultural Center policies, or ethical principles).  A research project may also be suspended if there are problems or concerns with conflict(s) of interest, the practices of the principal investigator or research project personnel, or the credibility of functionality of the research site.  In emergency cases, the Chairperson of the IRB, alone or in collaboration with others (e.g., the Human Protection Administrator, individual IRB members, an ad hoc IRB committee, a third party), can suspend or terminate research when there is unexpected serious harm to participants. If the Chairperson of the IRB is not available, the Human Protection Administrator, the Chairperson of the IROC, or the Vice-Chancellor of Research can suspend or terminate a research project or research privileges.  

I.D.  Compliance for SU-BR, SU Agricultural Center, and External Investigators           

Research projects conducted by SU-BR and SU Agricultural Center faculty, staff, and students and external principal investigators or research project personnel conducting research on either campus that involve human participants and have as their purpose contributing to the generalizable knowledge base must receive approval from the IRB before the research is initiated. SU-BR and SU Agricultural Center faculty, staff, and students serving as key personnel in a research project where the principal investigator is at another university or agency must comply with the requirements of these policies. Further, research involving human participants conducted by SU-BR, SU Agricultural Center, or external investigators that is sponsored by SU-BR or the SU Agricultural Center, uses either campuses’ property or facilities, or uses either campuses’ non-public information to contact or identify prospective participants must also receive approval.   

SU-BR and SU Agricultural Center faculty, staff, and student inquiries that are internal to the campuses (e.g., SU-BR student class projects, journalistic interviews, faculty or peer surveys, etc.), clinical practices (e.g., SU-BR nursing, speech/language pathology), and evaluative projects (e.g., personnel, student, or program evaluation) are not considered research projects if the purpose of the inquiry is to generate data that will not be (a) generalized, (b) added to the existing literature or knowledge base, or (c) used to develop presentations or publications for external audiences.  Also, the systematic investigation of publicly available archival records is not considered as research with human participants.  

For course-based or related inquiries, the SU-BR professor of record or SU Agricultural unit administrator is to serve as the "Principal Investigator" and ensure the impartial selection and ethical treatment of human participants.   For school- or unit-based inquiries, the school/unit's administrator or designee shall serve as the "principal investigator" and ensure the impartial selection and ethical treatment of human participants.             

I.E.  Criteria for Evaluation  

            The IRB shall determine that all of the following requirements are satisfied to approve research involving human participants (§46.111):

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

(2) Risks to [participants] are reasonable in relation to anticipated benefits, if any, to [participants], and 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 [participants] would receive even if not participating in the research). The IRB 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 [participants] 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 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 [participant] or the [participant’s] legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of [participants].

(7) When appropriate, there are adequate provisions to protect the privacy of [participants] and to maintain the confidentiality of data.

(b) When some or all of the [participants] 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 [participants].

Ethical Principles

During the research project proposal review process, the IRB shall be concerned with a number of ethical principles pertaining to the protection of human participants, including benefits vs. risks, informed consent, privacy and confidentiality, and population and sample selection, research design, interventions, instrumentation, and data collection and analyses.  The use of vulnerable populations (e.g., research involving minors/children, pregnant women and fetuses, prisoners, individuals with specific disabilities, and individuals who are economically or educationally disadvantaged) and proposals for selected funding agencies (e.g., National Institutes of Health [NIH]) will also create specific, regulation-directed evaluative considerations.  

            Benefit(s) vs. risk(s) acknowledges that a degree of risk accompanies most research, but that risks must be reasonable in relation to the potential benefits (e.g., one minimal risk is the loss of confidentiality).  Therefore, this principle requires that the principal investigator maximizes benefits and minimizes risks associated with human participants.  In evaluating this criterion, the IRB shall particularly focus on any potential risk due to research-related physical, psychological, social, or economical threats.  Essentially, the decision to identify a research project as exempt, qualifying for an expedited review, or requiring a full or convened review is based upon the potential magnitude or degree of risk in relation to expected benefits as presented by the research and the participants involved.  For example, exempt research generally involves human participants in non-compromised situations where the degree of potential risk is low or practically nonexistent.  Research qualifying for an expedited review should present no more than a minimal risk and pertain to only certain procedures.  Strictly adhering to the principles of informed consent and privacy and confidentiality is the major safeguard in minimizing the risks in most social science research. Regarding benefits, the principal investigator must understand and be able to articulate the potential benefits or significance of the research, particularly with vulnerable populations (i.e., research with human participants cannot be conducted simply for the sake of research).    

            Informed consent (regarding applicable research) requires that human participants freely agree to participate, and within this agreement, they understand the extent and elements of their involvement.  It also necessitates documentation of that consent, unless a wavier is granted by the IRB.  Participants should understand the general intent of the research (as reasonably as possible), the benefits and risks resulting from their involvement, and the conditions for their withdrawal or their termination without penalty.  The basic and additional elements of consent the principal investigator should address in a Research Permission Form or Consent to Participate Form are listed below.  The specific procedures the principal investigator shall use to ensure comprehension and obtain informed consent from vulnerable populations must be described (e.g., minors/children, pregnant women, individuals with specific disabilities, and persons who are economically or educationally disadvantaged).   

The basic elements of consent include:  

·        State Purpose of the Research Study and Procedures

·        Describe Possible Risks or Discomforts.

·        Describe Possible Benefits to Participants or Others.

·        Disclose Available Alternative Courses of Treatment.

·        Describe Available Medical Treatment for Adverse Experiences (Greater than Minimal Risk).

·        Describe the Extent of Confidentiality.

·        Delineate Whom to Contact about the Research.

·        State the Following: Participation is Voluntary; Refusal to Participate Involves No Penalty or Loss of Benefits to which the Participants are Otherwise Entitled; Participants May Discontinue Participation Without Penalty or Loss of Benefits to which the Participants are Otherwise Entitled.

 Additional elements of consent include  

·        State the Procedure May Involve Currently Unforeseeable Risks to the Participants, or Fetuses if the Participants Become Pregnant.

·        Describe Anticipated Circumstances Under Which Participation may be Terminated by the Investigator without Regard to the Participants' Consent.

·        Disclose Additional Cost to Participants as a Result of Participation.

·        Describe Circumstances of a Decision to Withdraw from the Study and Procedures for Orderly Termination.

·        State that Significant New Findings that May Relate to Participants' Willingness to Continue Participation will be Disclosed to the Participants.

·        State the Possible Number of Participants Involved in the Study.  

            The IRB shall focus on the privacy and confidentiality mandate that the principal investigator assures that the data collected cannot be linked to the research participants, unless explicit consent is obtained. This may require that participants are unknown by identifiers to the principal investigator or research project personnel; identifiers are replaced by a coding system that makes it impossible to trace the reported data back to any participant. In general, questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures for experimental and non-experimental research must be carefully constructed to limit personal identifiers to those essential to the purpose(s) of the research.  Again, and where possible, participant data should be coded to remove all personal identifying information and data that have the potential to reveal participants’ identities should be stored in locked or protected files that are accessible only to the principal investigator and authorized research project personnel.  If data are to be collected using "non-research project persons" or "drop boxes," the specific procedures for ensuring privacy and confidentiality with these data collection systems are to be described in detail.  If the research protocol requires audio or video taping of human participants, participants’ informed consent must be secured before the taping.  The principal investigators must also indicate how consent for the use of these tapes for internal or external presentations will be obtained (i.e., a waiver of the normal confidentiality of research data).  Investigators must also describe how greater care will be used for the treatment of more sensitive research data (e.g., information that could put the participants at risk of criminal or civil liability or be damaging to the participants' employability or financial standing).  

Population and sample selection require the use of a method that results in a fair and equitable selection of human participants for research purposes (e.g., identifying the population, conducting a power analysis to determine sample size, and randomly selecting the sample).  Selection of human participants should take into consideration the purpose(s) of the investigation, the setting(s) where the research will be conducted, the use of sound methodological principles and procedures and interventions, and the population from which participants will be recruited (e.g., individuals who are vulnerable cannot be involved in research for convenience or because they can be easily manipulated).  The IRB shall also focus on how the principal investigator (a) selects the population and sample, (b) protects and ensures the voluntary participation of participants where there is an investigator- participant relationship (e.g., professor - student), (c) describes how needed permission(s) will be obtained from other appropriate entities or individuals prior to initiating research (e.g., IRB at another university), and (d) addresses human participants training criteria or the inclusion of specific groups (e.g., women and minorities) where appropriate to the purpose(s) of the study and the research methodology (e.g., National Institutes of Health [NIH] guidelines - see training notice below).   As required by 45 CFR 46:304(b), the IRB shall augment its membership when it reviews proposals involving prisoners (e.g., appoint a prisoner or a prisoner representative with the appropriate background and experiences).  For research involving other vulnerable populations (e.g., children, individuals with cognitive impairments, pregnant women, the elderly, individuals who are economically or educationally disadvantaged), the IRB may add to its membership individuals who are knowledgeable about the protocol or have work experiences with these proposed participants (§46.107[f]).  

            Next, the IRB shall focus on the methodology the principal investigator will use to conduct the research, including research design, statistical analyses (e.g., meeting assumptions), instrumentation (e.g., valid and reliable measures), and appropriate interventions.  The methodology to be used must be based on sound principles and procedures (a) to maximize the generalizability of findings and (b) ensure that human participants are not denied the best-known social science intervention or clinical treatment available (i.e., participants must be provided the standard of care available).  For example, the principal investigator is not only to describe the methodology in detail but also should provide authoritative support that procedures are methodologically sound or empirically based.  Also, if a social science intervention or clinical trial is being conducted and the efficacy of a certain procedure or drug has already been established, participants cannot be offered less than that of standard intervention or care.  And, the principal investigator must avoid any procedures that result in unnecessary physical, psychological, social, or financial harm and terminate an experiment when its continuation could lead to death or irreparable harm.   

The IRB requires that the principal investigator and appropriate research project personnel submit documentation (NIH certificate of completion) of requisite knowledge base or training in the use of human participants. This training can be accessed on the Web site of the NIH Office of Human Subjects Research (http://ohsr.od.nih.gov/).  While this training module was developed for NIH staff, other institutions seeking to meet training requirements in this area can use it.   

Research with Pregnant Women, Fetuses, and Neonates  

Under 45 CFR 46, pregnant women are a vulnerable population (§ 46:107), and fetuses and neonates have statutory protections.  The IRB shall review and approve research involving pregnant women, fetuses, and neonates following Part A regulations and specific DHHS safeguards in Part B (§ 46:201 - § 46:207).  Depending on the purpose of the research, the specific participants, and the nature of the risk(s), the IRB may include in its membership individuals who are knowledgeable about the protocol or have work experiences with the proposed participants (§46.107[f]).  

Research with Children  

Under 45 CFR 46, children are a vulnerable population (§ 46:107).  The IRB shall review and approve research involving children following Part A regulations and specific safeguards in Part C (§ 46:401 – § 46:409). By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.  Depending on the purpose of the research, the specific children participants (e.g., characteristics, wards, and the nature of the risk(s), the IRB may include in its membership individuals who are knowledgeable about the protocol or have work experiences with the proposed participants (§46.107[f]) (e.g., wards).  If children are to participate in a research project, parents or guardians must give consent and children must assent.

Research with Prisoners  

Under 45 CFR 46, prisoners are a vulnerable population (§ 46:107). The IRB shall approve research involving prisoners following Part A regulations and specific safeguards in Part C (§ 46:301 – § 46:306). By regulatory definition, a "prisoner" means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing (§ 46:303[c]).  When reviewing research involving prisoners, the IRB shall include in its membership a prisoner or prisoner’s representative to serve as an advocate for the proposed participants.  

If SU-BR and SU Agricultural Center faculty, staff, or students intend to conduct DHHS-supported research involving prisoners as participants, SU-BR must certify to the Secretary (through OHRP) that the IRB has made the seven findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible categories of research under 45 CFR 46.306(a)(2).  SU-BR must send OHRP a certification letter, to that effect, which should include the name and address of the institution and specific identification of the research protocol, including the relevant grant number.  

Under its authority at 45 CFR 46.115(b), the OHRP requires SU-BR to also submit to OHRP a copy of the research proposal so OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one. The term “research proposal” includes:  the IRB-approved protocol; any relevant DHHS grant application or proposal; any IRB application forms required by the IRB; and any other information requested or required by the IRB to be considered during initial IRB review.  OHRP also encourages the institution to include the following information in its prisoner research certification letter, to facilitate processing: OHRP Assurance #,  RB # for Designated IRB, Date(s) of IRB Meeting(s) in which protocol was considered, including a brief chronology that encompasses: Date of initial IRB review, Date of Subpart C review, and epidemiological waivers.  

Research with Individuals with Cognitive Impairments  

Under 45 CFR 46, individuals with a cognitive impairment are a vulnerable population (§ 46:107). The IRB shall approve research involving individuals with cognitive impairments following Part A regulations and additional DHHS safeguards to protect the rights and welfare of these participants. According to the Institutional Review Board Guidebook Section D Cognitively Impaired Persons (http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g5), an individual with either a psychiatric disorder (e.g., psychosis, neurosis, personality, or behavior disorders), an organic impairment (e.g., dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.  Depending on the purpose of the research, the specific participants, and the nature of the risk(s), the IRB may include in its membership individuals who are knowledgeable about the protocol or have work experiences with the proposed participants (§46.107[f]).  One of the major ethical concerns in reviewing research involving individuals with cognitive impairments will be informed consent (i.e., their capacity to understand the information presented and their ability to make a reasoned decision about participation).  

Research with the Elderly/Aged  

The IRB shall approve research involving the elderly following Part A regulations and additional DHHS safeguards to protect the rights and welfare of these participants. There are no specific regulations governing research with elderly participants, aside from the regulatory requirement that the IRB provides additional protections for specially vulnerable persons (§ 46:111). According to the Institutional Review Board Guidebook Section H Elderly/Aged Persons (http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g9), it is generally agreed, however, that the elderly are, as a group, heterogeneous and not usually in need of special protections, except in two circumstances: cognitive impairment and institutionalization. Under those conditions, the same considerations are applicable as with any other, nonelderly participant in the same circumstances.  

Also, there is no age at which prospective participants should become ineligible to participate in research. Most older people are neither cognitively impaired nor live in institutional settings. Although there are difficulties in recruiting and obtaining the consent of the elderly to participate in research (e.g., older persons tend to avoid research that interrupts their daily routine, is uncomfortable or inconvenient, or is not designed to provide direct benefits to them; they may be more difficult and more costly, may have hearing or vision problems, and therefore, require more time to have the study explained to them; they also drop out of studies at a higher rate than do younger participants), the inclusion of older persons in the research enterprise is important.

The IRB shall ensure that the elderly are not excluded or treated specially; that older participants are protected and are not the object of disdain, stereotyping, or paternalism; and that older persons share in the benefits and burdens of research.  The IRB will treat cognitive impairment in elderly participants as it treats cognitive impairment in any prospective participant.  Depending on the purpose of the research, the specific participants, and the nature of the risk(s), the IRB will include in its membership individuals who are knowledgeable about the protocol or have work experiences with the elderly (§46.107[f]). 

The use of age as the criterion of ability to consent, and therefore participate in research, is not valid.  

Research with Individuals who are Economically and Educationally Disadvantaged  

The IRB shall approve research involving individuals who are economically or educationally disabled following Part A regulations and additional DHHS safeguards to protect the rights and welfare of these participants. There are no specific regulations governing research with individuals who are economically or educationally disabled, aside from the regulatory requirement that the IRB provides additional protections for specially vulnerable persons (§ 46:111).  To the extent that prospective research populations are also economically or educationally disadvantaged, the IRB shall safeguard their rights and welfare by making sure that any possible coercion or undue influence is eliminated (e.g., compensation that is not commensurate with the risk, discomfort, or inconvenience involved, or recruiting in institutional settings where voluntary participation might be compromised).  

The IRB shall also safeguard the consent process (and, indeed, the entire research relationship) to ensure open and free communication between the principal investigator and research project personnel and the prospective participants. Consent documents must be written in language easily understandable to participants; the possibility of illiteracy should be accounted for, as should the need for communicating in foreign languages. The informed consent documents should be available in English and other languages as appropriate to the research population(s). Foreign language consent documents should be developed using quality control procedures, such as translation from English to the other language and then back to English, to ensure that the information is correctly conveyed. The role of cultural norms of participants should also be addressed [§ 46:111(b)]. Depending on the purpose of the research, the specific participants, and the nature of the risks(s), the IRB may include in its membership individuals who are knowledgeable about the protocol or have work experiences with the proposed participants (§46.107[f]).  

            Finally, the principle of ethical responsibility for researchers also requires that the principal investigator and research project personnel think through and establish a plan, in writing, for monitoring the research project to assure that the risk(s) of physical, psychological, social, and economical harm remain minimized, and the benefits for the participants are maximized.  The principal investigator must also conduct the research following the approved protocol (or obtain IRB approval for protocol changes), report adverse events and actions taken, conduct research-related activities using ethical principles and sound methodological and clinical practices, and suspend or terminate the research when there is the potential for or serious harm occurred to human participants.  

II.         Processes and Procedures for Initial and Continuation Approval  

II.A. Application for Initial Approval of a Research Project  

            The principal investigator (applicant) of a research project involving human participants must complete the IRB Application for Initial Review Form (see Appendix C), submit a proposal describing the research project (see paragraph below), and attach required documentation, including the consent form(s) for adults or parents and assent form(s) for children (see Appendix D for templates for sample consent form for adult, assent form for children, and parental/ guardian consent form); copies of the instruments to be used; and NIH human participants training tutorial certificate for himself or herself, co-investigators, and appropriate research project personnel.  If the research is sponsored by an agency, organization, or institution, the principal investigator (applicant) must submit a copy of the grant application and approved changes.  The research described in the protocol submitted to the IRB and in the grant application must be similar.  The IRB initial application form provides the name of the principal investigator and other researcher(s) and status(es), title of the research, funding source, population and research design to be used and related information (e.g., nature of and consideration for a vulnerable population), procedures, and elements of informed consent among other items (e.g., waiver request).  This form will also require specific signatures (e.g., principal investigator, major professor/advisor, or professor of record). 

The proposal should include a title page, abstract, and sections that state the purpose of and a rationale for the research, the research questions and hypotheses, the methodology to be employed, significance or benefits of the study for participants or others, and the plan for protecting human participants.  In the methodology section, the principal investigator (applicant) shall indicate the population and size (N); sample and size (N), power analysis used to determine sample size, and procedure used to select sample (e.g., simple random selection); research design and analyses (e.g., independent and dependent variables, statistics and assumptions); instruments (describe sections and items; provide validity and reliability data); and general procedures (e.g., participant selection technique, protocols and procedures to be used).   The principal investigator (applicant) must also indicate in the proposal: (a) if the population or sample will be identified to the principal investigator or research project personnel by some recognizable descriptor such as name or social security number, and if so, how the privacy and confidentiality of the population or sample will be protected; (b) what impartial provisions will be used in selecting participants from vulnerable and other populations; (c) how consent will be obtained (e.g., basic and additional elements applied) and how the research will be explained to the participants so as to assure that they are “informed” as to the purpose of the research; (d) waiver requests and rationales for such waivers (e.g., basic or additional elements of consent, internal or external use of audio or video tapings); and (e) HIPAA  Privacy statement, if applicable.  Additionally, the proposal must identify the investigator’s plan for monitoring the research project to assure that risks remain minimal and benefits maximized.  

A student whose research project will be used to add to the knowledge base by being published or presented at a conference (e.g., capstone project, clinical paper, thesis, dissertation) is to submit his or her prospectus/proposal.  If the research project is a thesis or dissertation, the prospectus/proposal must have been approved by the student’s thesis or dissertation committee prior to submission to the IRB.  

II.B. Consent and Assent Forms  

Participants in most research projects will sign a consent form for adults (§46.107[f]) and parents/guardians (§46.405107[c])) or assent form for children (§46.405[c]) – also see §46.117; therefore, the application for IRB review should include this document (see Appendix D). The form(s) should provide the general and specific information human participants need to make an "informed decision" to participate in the study.  It should include the basic and additional elements of consent listed above, where appropriate.  The consent form must be legible, well written, and appropriate for the reading or comprehension level of the participants.  If there is reason to believe that the participants are illiterate or do not read English, the consent form must be read to those participants or written in an appropriate foreign language, with that documentation noted on the form.   

The assent form for children must be legible, well written, and appropriate for the reading or comprehension level of the participants.  If there is reason to believe that child participants are illiterate or English is their second language, the assent form must be read to the children, with that documentation noted on the form.  

If the participants are from vulnerable populations (e.g., have sensory or language barriers, economic or educational disadvantages), the principal investigator (applicant) must describe how the consent form was developed.  This description could include readability, translating English to a foreign language and translating the foreign language back to English, the use of an interpreter, or another means of communication to assure that the participants are able to give informed consent.   If the participants are children under the age of 18, a parent or guardian must sign the consent form.  The principal investigator (applicant) should also have the minors/children sign an assent form.   

The requirement of informed written consent may be waived or altered (§46.117) if the research could not practically be carried out without the waiver or alteration or in cases when the principal risk (in using signed consent) is a breach of confidentiality.   Again, the principal investigator (applicant) should provide in the proposal/protocol reasons for not addressing the basic or additional consent elements or requesting a waiver of consent and the informed consent action to be taken.  

II.C.     Review Process for Initial Approval  

            The principal investigator (applicant) must submit three paper copies and one copy on diskette of the required IRB review documents (e.g., IRB Application for Initial Review Form, proposal/protocol, consent form, assent form, NIH training certificate, grant application) to the Chairperson of the IRB by the first of the month for consideration that month, unless a full review is required.    Within a maximum of 15 working days, the Chairperson of the IRB shall make the decision if the research project is exempt (§46.100), eligible for an expedited review (§46.110), or requires a full or convened review of the IRB (§46.108) (see VI. Definitions and Appendix B  - exempt and non-exempt research).  If needed, the Chairperson of the IRB can consult with individual IRB members, an ad hoc IRB committee, the Human Protection Administrator, or a third party (individuals who are knowledgeable about the protocol or have work experiences with the proposed participants - §46.107[f]) to make a decision at any point during the review process.  The IRB can also request that a third party attend meetings during the review process. However, outside persons are not eligible to vote to approve or disapprove a research project (§46.107[f]).  

            If the Chairperson of the IRB deems the research project to be exempt, the Chairperson shall inform the principal investigator (applicant) of the decision (e.g., approved, approved with revisions, or disapproved and reason) within five (5) working days of the decision. If the Chairperson of the IRB deems the research as warranting an expedited review, the chairperson shall obtain the recommendations of at least one IRB member, an ad hoc IRB committee of two members, or a third party and forward the decision (approved, approved with revisions) to the principal investigator (applicant) within 15 working days.  An expedited review cannot be used to disapprove research; this decision shall be made by the full board (§46.109[a]).  If the Chairperson of the IRB deems the research as not eligible for exempt or expedited status, the Chairperson shall convene the IRB for a full review, but may assign individual IRB members, an ad hoc IRB committee, or a third party (§46.107[f]) to review the proposed research and provide recommendations to the full board.  The scheduled meeting to review the proposed research must have a quorum, a majority vote is needed to approve or disapprove the research project, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).  The principal investigator (applicant), research project personnel, and individuals from the research site may be invited to the scheduled meeting to present the research and answer questions.  

If the principal investigator (applicant) is also applying for funding to support a research project that uses human participants, they can opt to submit the required IRB forms and documentation and seek pending approval from the Chairperson of the IRB prior to the grant submission or follow the routine protocol as specified by these policies.  Pending approval may be granted in cases that the research project is dependent upon the securing of funding.  However, the principal investigator (applicant) should keep in mind that requirements for review differ from one funding agency to the next (i.e., some funding agencies require that the IRB process be completed prior to grant submission) and that “pending” does not authorize the principal investigator (applicant) or research project personnel to initiate the research.   

A research project will not be approved if: (a) it violates IRB requirements, state statutes, SU-BR and SU Agricultural Center policies, or ethical principles; (b) there is the potential for serious harm to participants (adverse events); (c) it lacks sound methodological or clinical procedures; (d) there are concerns about the qualifications of the principal investigator (applicant) or research project personnel.  If it is a student research project, the qualifications of the major/professor or professor of record will be considered; and (e) there are concerns about the credibility or functionality of the research site.   

When a research project is approved, the Chairperson of the IRB shall complete and sign the Initial Approval Form for Exempt (or NonExempt) Research and obtain the signatures of the Chairperson of the IROC and Vice-Chancellor for Research, notification of the institution (§46.109[d]).  The principal investigator shall be given a copy of the approval form, and thus, notified that the research has been approved (§46.109[d]).   

If the research project is not approved, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator and the Human Protection Administrator of the decision to disapprove the initial research and the reason for the decision (§46.109[d]). The Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC and the Vice-Chancellor for Research of the decision and reason for the decision.  The principal investigators can appeal the IRB’s decision (see II.H. Appeals Process for Disapproved Research) or submit a new research project proposal for initial review.   

11.D.  Research Project Timeline and Summary/Annual Report for Initial Research  

Research projects that receive initial approval by the IRB are approved for specific time intervals not to exceed one year (§46.109[e]).   The time interval will depend upon (a) the purpose of the research, (b) the nature of the risk(s), and (c) the vulnerability of the participants.  Research with human participants cannot continue beyond the time period approved by the IRB.  

If a research project with initial approval is completed one month prior to the anniversary of the approval, the principal investigator shall submit to the Chairperson of the IRB a Summary/Annual Report Form (see Appendix E).  If the approved initial research is ongoing one month prior to the anniversary of the approval, the principal investigator must submit to the Chairperson of the IRB at the beginning of that month a Summary/Annual Report Form (see Appendix E), an Application for Continuation Form (see Appendix F), and documentation for any changes to the initially approved research project.  

II.E. Review Process for Continuation Approval  

If the approved initial or continuation research is ongoing one month prior to the anniversary of the approval, the principal investigator must complete and submit to the Chairperson of the IRB the necessary documentation (e.g., Summary/Annual Report Form, Application for Continuation Form, research project or protocol changes, research sponsor approval for changes) to request a review for continuation.  The Chairperson of the IRB shall determine the type of review for continuation approval, expedited or convened (full board), based on (a) the purpose of the research project, (b) the nature of the risk(s) and benefit(s), (c) the vulnerability of human participants, (d) completed research project procedures, and (e) procedures to be conducted.  If the Chairperson of the IRB deems the research as warranting an expedited review, the chairperson shall obtain the recommendations of at least one IRB member, an ad hoc IRB committee of two members, or a third party and forward the decision (approved, approved with revisions) to the principal investigator (applicant) within five working days of the decision.  An expedited procedure cannot be used to disapprove continuation research; this is the responsibility of the full board (§46.109[a]).  If the Chairperson of the IRB deems the research as warranting a convened review, the Chairperson of the IRB may assign individual IRB members, an ad hoc IRB committee, or a third party (§46.107[f]) to review the proposed continuation research and provide recommendations to the full board.  The IRB may invite the principal investigator and others involved with the research to attend the meeting to present the research and answer questions, but it is not obligated to extend this invitation (§46.109[d]).  However, the IRB may consider new information (not submitted with the application) when reviewing the research. The scheduled meeting to review the research must have a quorum, a majority vote is needed to approve or disapprove continuation, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving the continuation; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).   

The Chairperson of the IRB shall complete and sign the Approval Form for NonExempt Research (Continuation) and obtain the signatures of the Chairperson of the IROC and Vice-Chancellor for Research, notification of the institution (§46.109[d]).  The principal investigator shall be given a copy of the approval form, and thus, notified that the research has been approved for continuation (§46.109[d]).  If the research project is not approved for continuation, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator and the Human Protection Administrator the decision not to approve continuation and the reason for the decision (§46.109[d]).  The Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC and the Vice-Chancellor for Research of the decision and the reason for the decision.  The principal investigator can appeal the IRB’s decision (see II.H. Appeals Process for Disapproved Initial and Continuation Research) or submit a new research project proposal for initial approval.  

II.F. Research Project Timeline, Summary/Annual Report, and Application for Continuation Research  

The IRB shall grant approval for research projects to continue for specific time intervals not to exceed one year (§46.109[e]).   The time interval will depend upon (a) the purpose of the research, (b) the nature of the risk(s), (c) and the vulnerability of the participants.  Continuation research with human participants cannot continue beyond the time period approved by the IRB.  

If the research project approved for continuation is completed one month prior to the anniversary of the continuation approval, the principal investigator shall submit to the Chairperson of the IRB a summary/annual report form (see Appendix E).  If the approved continuation research project is ongoing one month prior to the anniversary of the continuation approval, the principal investigator must submit to the Chairperson of the IRB at the beginning of that month a Summary/Annual Report Form (see Appendix E), an Application for Continuation Form (see Appendix F), and other documentation needed to review the research project for continuation (e.g., changes in the research project personnel or protocol).  

II.G. IRB Decisions and Actions  

The IRB shall review and has the authority to approve, tentatively approve pending receipt of additional information, or disapprove research projects (§46.109[a]) according to the following:  

Approved:  The protocol is approved as submitted.  

Pending:  A protocol is considered pending when the problems identified in the protocol are not serious and generally fall into two categories:  (a) the principal investigator (applicant) needs to clarify an aspect of the research or provide additional information or (b) minor changes need to be made to the protocol or in the consent or assent document.  In these cases, approval can be given after the principal investigator (applicant) rewrites the protocol and/or informed consent and/or submits to the Chairperson of the IRB a written response to the questions and concerns.  The Chairperson can then poll IRB members to receive final approval, as appropriate, or can approve the changes as submitted.  The research cannot be initiated before the pending problems are resolved.  

Disapproved:  The IRB shall disapprove the proposed research if: (a) it violates IRB requirements, state statutes, SU-BR and SU Agricultural Center policies, or ethical principles; (b) there is the potential for serious harm to participants (adverse events); (c) it lacks sound methodological or clinical procedures; (d) there are concerns about the qualifications of the principal investigator (applicant) or research project personnel.  If it is a student research project, the qualifications of the major/professor or professor of record will be considered; and (e) there are concerns about the credibility or functionality of the research site.  In the event disapproval is foreseen, the IRB may invite the principal investigator and others concerned with the research to attend the meeting to discuss the protocol, research project personnel, and other issues; it is not obligated to extend this invitation (§46.109[d]).  The scheduled meeting to review the research must have a quorum, a majority vote is needed to disapprove the research, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving the continuation; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).  

II.H. Appeals Process for Disapproved Research           

If the IRB disapproves initial or continuation research and the principal investigator disagrees with the decision, the principal investigator can appeal the decision using the following process:  

First, within 30 days of the notification of the IRB decision, the principal investigator (applicant), in writing, may submit an appeal to the Chairperson of the IRB requesting that the IRB reconsider its disapproval decision and approve the research.  The written appeal must be based on the following reasons:  (a) new information is available that was not available during the decision-making process; (b) there are concerns that policies and procedures were not followed; or (c) the decision to disapprove exceeds the severity of the identified violations of IRB policies or problems found with the research.  No other grounds shall be considered.  The principal investigator (applicant) is to attach to the written appeal a copy of all documents sent to the IRB (original and modified), documents received for the IRB, and new information to be considered.   

The Chairperson of the IRB may appoint individual IRB members, an ad hoc IRB committee, or a third party to review the appeal and make recommendations to the full board.  At the next IRB meeting, the IRB shall consider the appeal and vote to approve the research or to sustain the disapproval.  The IRB may request that the principal investigator and others involved with the research attend the meeting, but it is not obligated to do so (§46.109[d]).  However, the IRB may review new information submitted after the appeal was received.  There must be a quorum at the meeting, a majority vote is needed to approve or disapprove the appeal, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for approving the research or sustaining the disapproval; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).  

If the appeal is approved, the Chairperson of the IRB shall complete and sign the Approval Form for NonExempt Research (Initial or Continuation) and obtain the signatures of the Chairperson of the IROC and Vice-Chancellor for Research   (notification of the institution - §46.109[d]).  The principal investigator shall be given a copy of the approval form, and thus, notified that the research has been approved initially or continuation (§46.109[d]).  If the appeal is disapproved, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator (applicant) and the Human Protection Administrator of the decision not to approve the research and the reason for the decision (§46.109[d]).  The Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC and the Vice-Chancellor for Research of the IRB’s decision and the reason for the decision (§46.109[d]).  

Second, within 30 days of the notification that the IRB did not approve the appeal, the principal investigator, in writing, may submit an appeal to the Vice-Chancellor for Research requesting that the IRB again reconsider the approval of the research.  The written appeal at this level must also be based on the following reasons:  (a) new information is available that was not available during the decision-making process; (b) there are concerns that policies and procedures were not followed; or (c) the decision to disapprove exceeds the severity of the identified violations of IRB requirements or problems found with the research.  No other grounds shall be considered.  The principal investigator (applicant) is to attach to the written appeal a copy of all documents sent to the IRB (original and modified), documents received from the IRB, and new information that the Vice-Chancellor for Research may consider.  

 The Vice-Chancellor for Research shall render a decision on the appeal within 30 working days or assign the task of reviewing the case to the IROC, the Office of Research and Strategic Initiatives Advisory Committee, or a third party.    If the appeal is approved (i.e., the IRB is to again reconsider the approval of the research), the Vice-Chancellor for Research shall communicate this approval of the appeal and the rationale for the approval to the Human Protection Administrator, the Chairperson of the IROC, and the principal investigator (applicant).  The Human Protection Administrator shall communicate the Vice-Chancellor for Research’s decision to the Chairperson of the IRB.  If the Vice-Chancellor for Research denies the appeal, the same lines of communication would be used, and the IRB’s decision is final.  

Upon receipt of the Vice-Chancellor for Research’s approval of the appeal and the rationale for the approval, the IRB shall again follow procedures and use lines of communication similar to those in the first step of the appeals process (see above). This is the last level in the appeals process, and the IRB’s decision is final (§46.109[a]).  

If it is the decision of the IRB not to approve the research project and the research is sponsored by a federal department or agency, the Human Protection Administrator shall notify the sponsor that the research was not approved by the IRB. If the research project was sponsored by another agency, institution, or organization, it is the principal investigator’s responsibility to notify the sponsor that the IRB did not approve the research.  

II.I. Changes in Protocols for Approved Research  

Changes in nonexempt research (e.g., protocol, methodological or clinical procedures, consent or assent process, research site) require IRB review and approval prior to the initiation of the planned changes (§46.103[b][4][iii]).  The only exception is when it is necessary to eliminate apparent immediate hazards to participants and the IRB should be immediately informed of this necessity. A change in instruments or protocols for approved exempt research that has the potential to negatively alter the risk of harm to human participants must be reviewed by the IRB prior to the initiation of the planned change.  For example, changes that can potentially result in a risk to the confidentiality and privacy or informed consent of the human participants must be re-submitted to the IRB for review and approval.  This approval is required because such changes may cause a research project to no longer be exempt from IRB review.   

II.J. Adverse Events during Approved Research  

An adverse event is defined as “an undesirable and unintended, although possibly expected, result of therapy or other intervention. A physical, psychological, or social injury to a participant in a research study” (see http://www.tdh.state.tx.us/ irb/Define.htm).  A definition for adverse event can also be found in IV. Definitions. The principal investigator, within 24 hours and in writing, must notify the Chairperson of the IRB of any event that presents an immediate risk to the health, informed consent, or privacy/confidentiality of the human participants in a research project.  The notification must declare the adverse event, the risk, the action taken to address the adverse event, and plans for addressing the risk(s) in the future.  If an emergency (i.e., an adverse event occurred that was harmful to the participants), the principal investigator should take immediate action and then inform the Chairperson of the IRB as to the actions taken.   

The Chairperson of the IRB shall review the adverse event, action taken, plan to address this adverse event in the future, protocol, consent or assent form, and other research-related documentation (e.g., drug/device brochure), if applicable, and report the event to the full board for recommended action.  The principal investigator or others involved in the research may be invited to attend the meeting to discuss the adverse event, action(s) taken, and plan to ensure that the adverse event does not occur in the future.  The IRB action can be as follows:  (a) no action needed, (b) revision of protocol or informed consent or assent process,  (c) approve plan to address the adverse event and have principal investigator inform currently enrolled participants of changes, and (d) stop a protocol until more information is available.  Changes made to the informed consent process or the protocol must be submitted to the IRB for prospective approval.   

II.K. HIPAA Privacy Rule for Approved Research  

The privacy provisions of the federal law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses (http://www.hhs.gov/ocr/hipaa/bkgrnd.html). The full text of the Privacy rule and DHHS' educational materials on the Rule can be found on the Office for Civil Rights (OCR) HIPAA Privacy Web site (http://www.hhs.gov/ocr/hipaa). DHHS educational materials on the Privacy Rule for the research community can be found on the OCR HIPAA Privacy Web site (http://privacyruleandresearch.nih.gov/).  

Organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).  The principal investigator should be aware of the Privacy Rule because it establishes the conditions under which covered entities can use or disclose PHI for many purposes, including research.  The Privacy Rule specifies that a covered entity may neither use nor disclose PHI for research purposes unless the patient has provided, in advance, his or her written authorization for such use or disclosure.  This authorization may be combined with the informed consent document.  Six essential elements apply to any authorization:  (a) a description of the information to be used (e.g., age, height, blood pressure, IQ score, diagnosis, depression rating, number of treatments, etc); (b) who will use or disclose it; (c) to whom it will be disclosed; (d) the purpose for which it will be disclosed; (e) an expiration date which may indicated as “end of study;” and (f) a patient’s dated signature.  

II.L. Ethics/Conflict of Interest for Researchers  

A conflict of interest arises when the principal investigator or research project personnel are or may be in a position to put their own interest before the best interests of research participants.  The IRB must be informed of potential conflicts of interests.  The principal investigator submitting a research project for initial or continuation approval must disclose all interests (e.g., financial, copyright, patent) that may be perceived as a conflict with the best interest of the participants in order for the research to be considered for approval.  If the IRB determines that a conflict exists that could influence the research or jeopardize the well-being of the participants, the IRB may require additional information about the conflict or may require that the conflict be resolved before the research is approved.  In addition, the IRB may require that additional information be given to the participants “when in the IRB’s judgment the information would meaningfully add to protection of rights and welfare of participants” (45 CFR 46.109[b]; 21 CFR 56.109[b]).   

Concerns have grown that financial conflicts of interest in research, derived from financial relationships and the financial interests they create, may affect the rights and welfare of human participants in research.  Financial interests are not prohibited, and not all financial interests cause conflicts of interest or affect the rights and welfare of human participants.  DHHS recognizes the complexity of the relationships between government, academia, industry, and others, and recognizes that these relationships often legitimately include financial relationships.  However, to the extent financial interests may affect the rights and welfare of human participants in research, the IRB, SU-BR and the SU Agricultural Research Center, and the principal investigator and research project personnel need to consider what actions regarding financial interests may be necessary to protect human participants (DHHS Financial Guidance Document, January, 2001; also see http://www.hhs.gov/ohrp/special/conflict.html).   

Furthermore, the IRB is also responsible for ensuring that members who review research have no conflicting interest (§46.107[e]). An IRB member with research under initial or continuing review shall have the same rights and opportunities this policies and procedures manual affords other principal investigators (applicants).  However, the IRB member must declare in advance of the review the conflict of interest and not participate in voting on the research project.  

II.M. Research Project Verification or Audit

The Chairperson of the IRB, alone or in collaboration with others (e.g., individual IRB members, an ad hoc IRB committee, a third party, the Human Protection Administrator) can determine which approved research projects require verification from sources other than the principal investigator to ensure that no significant changes have occurred since the previous IRB review (§46.103[b][4][ii]). This required verification can also be approved by the IRB during the review of research projects or at subsequent meetings.  The verification process could involve conducting audits (or inquiries) to collect information and having individual IRB members, an ad hoc IR committee, or a third party observe the informed consent procedures and conduct of the research.  

II.N. Suspension or Termination of Approved and Not Approved Research

Within the Federal Code of Federal Regulations (§ 46.113), the IRB has the 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 (adverse events).  A research project or research privileges can also be suspended or terminated if there are:  (a) violations of regulatory agency regulations (e.g., FDA), state statutes, SU-BR and SU Agricultural Center policies, or ethical principles; (b) deviation in the conflict of interest disclosure or conflict of interest is not reported; (c) the principal investigator or research project personnel are not engaging in sound or empirically based research practices; and (d) there are concerns regarding the credibility or functionality of the research site.  Depending on the violation of IRB requirements (also other regulations, statutes, and principles), adverse events, or problems and concerns, the Chairperson of the IRB, alone or in collaboration with others (e.g., individual IRB members, an ad hoc IRB committee, a third party, the Human Protection Administrator), can suspend a research project at any time during an inquiry or investigation to assure the protection of human participants.  The principal investigator can also suspend or terminate a research project or research privileges.  

A research project is suspended when a temporary hold is placed on the research.  A research project is terminated when IRB approval is withdrawn or stops research that has not been approved.  Research projects that are suspended or terminated cannot (a) recruit or enroll new participants, (b) conduct interventions, or (c) engage in data collection or analyses.  With a request from the principal investigator and supporting evidence, the IRB may approve for the principal investigator to conduct follow-up activities and analyze data collected, if they are in the best interests of the human participants.    

When a complaint is submitted to the IRB or the IRB has information that a research project is not in compliance with IRB policies or other problems or concerns exist (see above), the Chairperson of the IRB shall notify the principal investigator of the allegation, non-compliance, or problem and undertake (or appoint an ad hoc IRB Committee or a third party to undertake) an inquiry or investigation that has as its purpose:  (a) dismissal of the complaint; (b) identification of minor or inadvertent non-compliance or problems that are not putting the human participants at risk and make recommendations.  For example, the principal investigator would be notified of the violation or problem and directed to submit a report that delineates the minor or inadvertent non-compliance or problem, describes the corrective or other actions to be taken to ensure compliance or eliminate the problem, and state the date the actions will be completed.  Also, if it is found that the principal investigator has not obtained IRB approval to conduct the research, the principal investigator and immediate supervisor (e.g., dean, major professor/advisor) would be notified of this violation of IRB policies and directed to terminate the research and complete the IRB procedures to have the research project reviewed; or (c) identify major violations of IRB requirements or other problems and prepare a report that describes the violations, adverse events, or problems and outlines evidence supporting the findings.  The report may also recommend that the research project be suspended or terminated.  The inquiry or investigation could involve reviewing documents, interviewing individuals knowledgeable about or involved in the research, or conducting an internal audit.   

At the next scheduled meeting of the IRB, the investigative report for suspension or termination will be presented, and the findings are to be discussed.  The IRB can request that the principal investigator and others involved with the research attend the meeting, but it is not obligated to extend this invitation (§46.109[e]).  However, the IRB may review new information submitted after the investigation or the writing of the report.  There must be a quorum at the meeting, a majority vote is needed to suspend or terminate the research, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for approving the research or sustaining the disapproval; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).       

If it is the decision of the IRB to suspend a research project, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator, the principal investigator’s supervisor (e.g., dean, major professor/advisor, professor of record), and the Human Protection Administrator of the suspension of the research project and the reason for the decision. If the non-compliance to IRB requirements, adverse events, or other problem(s) resulted in serious risk to the human participants, the Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC, the Vice-Chancellor for Research, the ORHP, related regulatory agencies, and the sponsor of the research of the suspension.  Upon receipt of the notification of suspension, the principal investigator must notify the participants of the suspension and stop all research activities.  With the approval of the IRB, the principal investigator can continue follow-up and data analysis activities if they are in the best interests of the participants.  

If the violation of IRB requirements or problem is minor or had minimal or no impact on the well-being of the human participants (e.g., violation of the research project’s approved timeframe), the same lines of communication described above will be used for notification of the suspension; however, this type of suspension does not have to be reported to the OHRP, other regulatory agencies, and the sponsor of the research when (a) the principal investigator ensures compliance or the problem is eliminated, and (b) the IRB votes to reinstate the research project.  Within 10 working days of notification of the suspension, the principal investigator is to take steps to move the research project to compliance (e.g., submit an application for continuation) or eliminate the problem and submit a report to the IRB describing the actions taken and a plan to ensure that the non-compliance or problem does not occur in the future.  The IRB at its next meeting shall review the report and vote whether or not to reinstate the research project.  There must be a quorum at the meeting, a majority vote is needed to reinstate the research project or sustain the suspension, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for approving the research or sustaining the disapproval; and a written summary of the discussion of controverted issues and their resolution (§46.115[a][1]).  

If the research project is reinstated, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator, the principal investigator’s supervisor (e.g., dean, major professor/advisor, professor of record), and the Human Protection Administrator of the reinstatement.  The Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC and the Vice-Chancellor for Research of the reinstatement.  

If it is the decision of the IRB to terminate a research project, the Chairperson of the IRB, within five working days and in writing, shall notify the principal investigator, the principal investigator’s supervisor (e.g., dean, major professor/advisor), and the Human Protection Administrator of the decision and the reason for the decision.  The Human Protection Administrator, within five working days and in writing, shall notify the Chairperson of the IROC, the Vice-Chancellor for Research, the OHRP, related regulatory agencies, and the sponsor of the research of the termination.  Upon receipt of the notification of termination, the principal investigator must notify the participants of the termination and stop all research activities.  With the approval of the IRB, the principal investigator can continue follow-up and data analysis activities if they are in the best interests of the participants.  

II.O. Appeals Process for Suspended or Terminated Research  

If the IRB suspends or terminates a research project and the principal investigator disagrees with the decision, the principal investigator can appeal the decision using the following process:  

First, within five days of the notification of the IRB’s decision, the principal investigator, in writing, may submit an appeal to the Chairperson of the IRB requesting that the IRB reconsider its decision to suspend or terminate the research and reinstate the research. The written appeal must be based on the following reasons:  (a) new information is available that was not available during the decision-making process; (b) there are concerns that policies and procedures were not followed; or (c) the decision to disapprove exceeds the severity of the identified violations, adverse events, or problems found with the research.  No other grounds shall be considered.  The principal investigator is to attach to the written appeal a copy of all documents sent to the IRB (original and modified), documents received for the IRB, and new information to be considered.   

The Chairperson of the IRB may appoint individual IRB members, an ad hoc IRB committee, or a third party to review the appeal and to make a recommendation.  At the its next meeting, the IRB shall consider the appeal and vote whether to reinstate the research or sustain the suspension or termination.  The IRB may request that the principal investigator and others involved with the research attend the meeting, but it is not obligated to extend this invitation so (§46.113).  However, the IRB may review new information submitted after the appeal was received.  There must be a quorum at the meeting, a majority vote is needed to reinstate the research project or sustain the suspension or termination, and minutes shall reflect IRB members present; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for a