STATE UNIVERSITY OF NEW YORK
COLLEGE AT BROCKPORT

PROCEDURES MANUAL FOR
RESEARCH INVOLVING
HUMAN PARTICIPANTS

Approved by IRB Board 2/03
Minor revisions/updates made 8/06

SUNY College at Brockport Institutional Review Board Procedures

1. Statement of Principles

The following principles serve as the foundation for SUNY College at
Brockport's Institutional Review Board procedures described in this document.

It is the policy of SUNY College at Brockport to ensure that the rights and welfare of human research participants are adequately protected in research activities conducted under its auspices. In addition, federal and state laws and regulations require these protections. In order for the College to fulfill its responsibilities and to comply with the laws and regulations all human participants research conducted under College auspices (including class projects) must receive appropriate review and approval. In our Federal Assurance on file with the Office for Human Research Protections (OHRP), the College assures compliance with all requirements of Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) for all federally sponsored research and all other human participants research, regardless of source of funding (if any).

The College is guided by the ethical principles set forth in the Report of the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report).

Since the conduct of research with human beings may raise fundamental ethical and civil rights questions, no distinctions in the monitoring of research will be made between funded and unfunded research, or between research conducted by faculty, staff, students, other College personnel, or affiliated researchers.

2. Definitions

SUNY College at Brockport has adopted the definitions included in the Federal regulations for the protection of human participants in research (45 CFR 46.102).

A. Research means a systematic investigation (including research development, testing and evaluation) designed to contribute to general knowledge. Activities that meet this definition constitute "research" for purposes of these procedures, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

B. Human participant means a living individual about whom an investigator
(whether faculty, staff or student) conducting research obtains:
1) data through intervention or interaction with the individual, or
2) identifiable private information.

Intervention includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes communication about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e. the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order to obtain the information to constitute research involving human participants.

C. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant's participation in the procedure(s) involved in the research.

D. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

3. Institutional Review Board

A. Composition - the College has established its IRB in accordance with the requirements of 45 CFR 46.107.

The IRB shall consist of at least 5 members from diverse backgrounds to promote complete and adequate review of research activities commonly conducted at the College.
The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes and issues related to vulnerable populations, to promote respect for its advice and counsel safeguarding the rights and welfare of human participants.
The IRB will include qualified persons of both sexes so long as no selection is made on the basis of gender only.
The IRB will include at least one member whose primary concerns are in a non-scientific area and at least one member whose primary
concerns are in a scientific area.
The IRB will include at least one member who is not otherwise affiliated with the College and who is not part of the immediate family of a person who is affiliated with the College.
No IRB member may participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

B. IRB Appointment

The Provost and/or Dean of Graduate Studies and his/her designee (IRB Administrator) with input from the IRB Chair shall make appointments to the IRB for two year renewable terms that shall begin at the start of the College's academic year.
The Provost and/or Dean of Graduate Studies and his/her designee (IRB Administrator) shall appoint the Chair of the IRB on an annual basis.

C. IRB Membership Lists and Qualifications

The names, qualifications, and affiliations of the members of the IRB shall be on file with the U.S. Office for Human Research Protections (OHRP) in accordance with the requirements of the Federal Assurance Form, and at the office of the IRB Administrator.
All changes in IRB membership are reported to OHRP as appropriate.

D. Training of IRB Members

The IRB Chair, the IRB members, IRB Administrator, and Provost (whom
IRB reports to) will have successfully completed initial and continuing
education related to the protection of human participants before reviewing
human participant research protocols. Currently, training is provided
through giving each of those named above a copy of the comprehensive
IRB orientation written manual, and their completion of the CITI human
research participants online training modules.

E. Conflicts of Interest

In accordance with HHS regulations 45 CFR 46.107(e) no member of the IRB involved in any way with a protocol being reviewed by the IRB will be present in the room during the discussion of the protocol except to answer relevant questions posed by IRB members. This will be so noted in IRB meeting minutes.

4. IRB Operational Details

In compliance with HHS regulations 45 CFR 46.103(b)(4) and (5), SUNY College at Brockport's IRB has adopted the following procedures.

A. IRB authority and responsibility

The IRB will review all research involving human participants. The IRB has
the responsibility and authority to review, approve, disapprove or require
changes in and monitor research activities involving human participants. No
IRB member or administrator involved in the conduct and/or supervision of a specific project shall participate in IRB review, except to provide information.

B. Levels of review

Research projects are reviewed at one of three levels depending upon the IRB's interpretation of the project's risk to human participants and on the federal guidelines that define the categories of review:

Category 1 - exempt review
Category 2 - expedited review
Category 3 - full review.

While the investigator makes the initial determination regarding the appropriate category of review, the IRB Chair and IRB Administrator will make the final level of determination. Any member of the IRB may request full review of any research submitted under expedited review,

C. Elements of Informed Consent and Review of Protocols

The review of human participants research is confined solely to procedures
affecting the rights and welfare of human participants. No evaluation is made of the scientific merit of the project unless participants are found to be "at risk," at which time the risk/benefit ratio of the project will be evaluated. Reviewof protocol focuses on issues of:

Risk/benefit ratio - a) risks to participants are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose participants to risk; b) 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 from the research. The IRB will examine study design or scientific merit only within the context of its risk/benefit analysis.
Equitable selection of participants and recruitment - selection criteria should consider all populations that might potentially benefit from the research, not just those readily available. The IRB will take into account the purposes of the research and setting in which the research will be conducted. The IRB ensures that the recruitment of participants is equitable and free of coercion.
Informed consent process - informed consent will be sought from each prospective participant or the participant's legally authorized representative and will be appropriately documented in accordance with 45 CFR 46.116 and 46.117 (Code of Federal Regulations). The reviewers will look for the process used to obtain informed consent not just the informed consent document. Reviewers must be convinced that all information regarding the study that would be relevant to participants' ability to make an informed decision to participate has been provided. A written signature is documentation of consent and is required for all Category 3 proposals. Proposals that fall into an exempt (Category 1) or expedited (Category 2) category do not require signed informed consent (unless they involve video or audio taping) but a written cover page with all the standard consent information needs to accompany the protocol for the IRB review. The elements of informed consent must include this information: a) identify the researcher and where they are from, b) include a description of the project, c) what is expected of participants, d) length of time required for participation, e) location of study, f) state that participation is "voluntary," g) indicate that the "subject can withdraw at any time without penalty," h) indicate that the "subject does not have to answer any question(s) they do not want to," i) payment if applicable and procedures, j) taping (if applicable) must include information about what will be done with the tapes for storage and disposal, j) include referrals (if applicable), k) include a risk/benefit statement - if there are no anticipated risks so indicate, l) that the study is confidential or anonymous and how the data will be disseminated, m) contact information for investigator and/or faculty advisor with phone number.
Privacy and confidentiality - the IRB will determine that adequate provisions have been taken to protect the privacy of participants and for ensuring confidentiality of participants and of study data as appropriate.
Special populations - when some or all of the participants are likely to be vulnerable to coercion or undue influence (such as minors, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons), additional safeguards must be included in the study to protect the rights and welfare of these participants.

D. Operational details by category of review

1. Procedures for all protocols - all protocols received in the IRB Office are assigned a number, logged into the IRB Log (by number, title, researcher(s) name and initial review category as indicated on the IRB cover page) by the IRB Administrator's Secretary and placed in a numbered folder with a standard form completed and placed in the right hand side of the folder. The IRB Chair is contacted to review proposals as they are received. They are reviewed by the IRB Chair within 1-4 working days of receipt. If the IRB Chair will be out-of-town for longer than a week during the academic year an alternate IRB Chair will be designated from among the IRB members.

The IRB Chair after reviewing the proposal verifies the category of review based upon the IRB policies manual and approves the project as submitted, or requests changes be made prior to it being submitted to another IRB member for review (if expedited), or recommends it be sent to the full IRB board. The Chair makes written notes kept in each IRB folder as to his/her response. The file is then given to the IRB Administrator for appropriate follow-up depending on the Chair's response. (See specifics under each of the three categories below). The IRB Secretary emails revisions requested by reviewers to the project investigator (copy to faculty supervisor if a student investigator) requesting any revisions needed.

2. Exempt review - (Category 1)

A. To qualify for exempt review a research activity must present no
possible risks to subjects 18 years of age and older and be one of the following activities:

anonymous, mailed survey on innocuous topics
anonymous, non-interactive, non-participating observation of public behavior
secondary analysis of existing data.

The research is exempt from the requirements of informed consent but
the investigator is still responsible for protecting the rights, such as
privacy and welfare of the subjects.

B. Operational detail - if after review of a protocol the IRB Chair
determines that it does meet one of the three activities listed above he/she
will: a) approve the project as submitted; b) conditionally approve the
project pending revisions. The IRB Administrator or IRB Secretary will
contact the investigator by phone or email within 1-2 business days of
receiving the file from the IRB Chair informing the investigator (and their
faculty supervisor if a student) of the Chair's decision. If revisions are
needed they are submitted to the IRB Administrator in writing. Once the
required revisions have been made the investigator (and faculty supervisor
if a student) is told by the IRB Administrator or IRB Secretary by phone or email that they can begin the project immediately. All contact with
investigators and responses are recorded by the IRB Administrator or IRB
Secretary with the date in the project file. A written approval letter is sent
to the investigator (and the faculty supervisor if a student) by the IRB
Administrator's Secretary within 3 working days of the project's approval.
A copy is kept in the protocol file. If the project involves an anonymous
mailed survey the informational letter attached to the survey that includes
the required elements of informed consent is date stamped with the
approval date and sent with the approval letter. The researcher is instructed to use this version of the letter in their mailing. The approval letter also states that project approval will expire in one year from the date
of approval and that it is the responsibility of the researcher to notify
the IRB Administrator if the project will continue past that date,
if any modifications are made to the protocol or any adverse reactions
occur as a result of the research project.

3. Expedited Review (Category 2)

A. To qualify for expedited review a research activity must incur no more than minimal risk for participants or represent a minor change in previously approved research that involves no additional risks to research participants, in accordance with HHS regulations 45 CFR 46.100. Examples of research activities reviewed on an expedited basis include:

research on educational curricula or teaching methods involving normal educational practices
research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that participants cannot be identified
research on individual or group behavior of normal adults (18 years of age or older) where there is no psychological intervention or deception
interviews and interactive surveys on non-sensitive topics.
minor changes in previously approved research
continuations of approval for previously approved no-risk research with no more than minor changes in procedures.

B. Research activity involving an outside agency - (e.g. hospital,
public school, etc.), the investigator must secure written approval
on agency letterhead from an appropriate official within the agency
prior to conducting the research. This should be submitted with the
IRB protocol and given to the reviewer(s) with other materials. If it is
not provided when originally submitted, final approval will be delayed
until it is submitted to the IRB Administrator.

C. Operational detail - if after review of a protocol the IRB Chair
determines that it does meet one of the activities listed above he/she
will: 1) approve the project as submitted. In this case the entire protocol
including the signed cover sheet, responses to questions, informed consent
form(s), surveys, interview questions, agency letters of permission,
standardized tests, appendix materials, copy of certificate of completion of
required training (if this is not submitted with the protocol the IRB
Secretary verifies the successful completion of the required CITI
training modules prior to sending the materials to the reviewer) is sent
by mail to one other member of the IRB for review by the IRB
Administrator's Secretary. If the protocol involves minors then two IRB
members in addition to the Chair will review the proposal. Reviewers
are selected by the IRB Administrator based upon their expertise and
availability.

D. Material sent to reviewer(s) includes - a standardized transmittal form
requesting return of the attached materials within seven business days of
the mailing of the proposal. Approval is requested by mail, fax or
electronically. Once written response is received from the reviewer(s)
(two reviewers if the protocol involves minors) it is reviewed by the IRB
Administrator. If a response is not received within 7 business days then
the IRB Administrator's Secretary will send a reminder notice by email
or voice mail requesting the reviewer's response. The response date of the
reviewer(s) is recorded on the form in the protocol folder. Their written
response is also included in the folder. The IRB Administrator's Secretary
will provide the folder with reviewers responses to the IRB Administrator
for action. Any changes required by the reviewer(s) are communicated
within 1-2 business days to the investigator by phone or email requesting
written response. When the IRB Administrator receives complete and
satisfactory revisions from the investigator she/he or the IRB Secretary at
the request of the IRB Administrator will contact the investigator (and their faculty supervisor if applicable) and inform them by phone or email within 2 business days that the project has been approved and they can begin research immediately using the approved consent form(s) and survey(s) and interview questions approved by the IRB. They are informed a formal letter will be coming in the mail. The IRB Administrator will then give the folder to her/his secretary and request that a date stamped copy of the final approved consent form requesting that the standard approval letter with a copy of the date stamped approved consent form be sent out to the investigator (and their faculty supervisor if applicable) within 3 business days. The date stamped is the day that the approved revisions have been received by the IRB Administrator. The protocol is approved for one year from that date.

Additionally, the memo notes that the investigator must immediately
contact the IRB Administrator if: a) there are any modifications needed; b)
a subject is injured; c) level of risk increases for participants.

2) If the IRB Chair conditionally approves the protocol pending revisions
then the IRB Administrator contacts by phone or email the investigator
within 1-2 working days after receiving the folder from the IRB Chair and
requests the required changes be submitted in writing. Upon receipt of the
revisions the steps listed above (if project is approved by Chair)
are followed.

3) If the IRB Chair concludes that this is a Category 3 protocol
and requires full IRB review the investigator (and faculty
supervisor if applicable) is contacted by phone or email by the IRB
Administrator or IRB Secretary within 1-2 business days of the IRB
Chair's review and asked to submit the paperwork for a full review and the
steps under a full review are then followed.

4. Full review (category 3)

A. All proposed research deemed by the IRB to present more than
minimal risk to human participants must be reviewed by the IRB
members.
B. Examples of research activities that must be reviewed by the full
IRB include:

research which might put subjects at risk
research involving deception
research involving psychological or physiological intervention
non-curricular, interactive research in schools
interviews or surveys on sensitive topics
research involving the use of "vulnerable populations" including pregnant woman, prisoners, mentally incompetent persons or minors that do not meet the criteria for an exempt or expedited review
research which for IRB review requires the expert opinion of an
occasional consultant
research to be conducted on the Internet
international research, including class projects conducted in another country. International research requires additional approval from an IRB (or similar body) in that country and a copy of the translation of the informed consent document and any survey or interview questions.

C. Operational details - after review of a Category 3 protocol submission (or determination by the IRB Chair, IRB Administrator or member of the IRB Board that a proposal should have full review) the investigator (and their faculty advisor if applicable) are asked which scheduled meeting of the IRB they can attend. All meetings will include a quorum of members as required by the IRB Policies. If the IRB Chair will be unavailable, then an alternate member of the IRB is designated as acting Chair for that meeting.
Student undergraduate class projects do not require a meeting of the full
IRB Board but can be reviewed by a meeting of three IRB Board members as per our policies. All research submitted by faculty/staff/ graduate students or undergraduate students conducting independent study or other research projects must go through the normal review process.

As soon as the meeting date is set the IRB Administrator's Secretary will mail to all IRB Board members (those who can attend and those who cannot) a copy of the entire protocol received including the signed cover page, responses to questions in IRB guidelines pertaining to a Category 3 review, survey instruments, interview questions, test forms, publicity, consent document(s), permission letters, copy of certificate of completion of required training in human subjects protection, copy of grant proposal (if externally funded research), appendix material, etc. Materials will be mailed or hand delivered to IRB members a minimum of 48 hours prior to the IRB meeting.

D. IRB meeting - the members of the IRB meet 30 minutes prior to the
investigator joining the group. The IRB Chair (or designee)
calls the meeting to order and requests comments from the IRB
members regarding pros/cons of materials received based upon
the IRB procedures for items to be reviewed and included in consent
forms and review process detailed on pages 4-5. Notes are made by the
IRB Chair and this is the basis for the discussion with the investigator.

E. IRB minutes - the IRB Administrator (or designee) takes minutes at
the IRB meetings as stipulated by OHRP regulations at 45 CFR
46.115(a)(2). The minutes document:

a) separate deliberations, actions, and votes for each protocol
undergoing initial or continuing review by the convened IRB;
b) the vote on all IRB actions including the number of members voting
for, against, and abstaining. If a member is unable to attend the meeting
but shares comments in advance with the IRB Chair or IRB
Administrator these are shared with the IRB by the IRB Chair and noted
in the minutes. In accordance with HHS regulations at 45 CFR
46.108(b) initial and continuing reviews of research are conducted by
the IRB at meetings at which a majority of members are present,
including at least one member whose primary concerns are in
nonscientific areas for Category 3 reviews. Approval of the research
is by a majority vote of the quorum. Should the quorum be reduced
during a meeting (e.g. loss of quorum due to departure of a member)
the IRB will not take any further actions or votes unless the quorum
can be restored. Minutes are distributed as per the process in these
procedures detailed under the section of Notification to IRB Members.

F. IRB action - one of three determinations is made by the IRB at a
meeting:

Approval without questions, concerns or requests for modifications.
Approved pending modifications. The reasons for requested changes are shared with the investigator (and their faculty supervisor if applicable) at the meeting. The research activity may not be undertaken until each of the IRB's concerns are addressed and submitted to the IRB Administrator for review and approval. The IRB members determine at the meeting if the modifications are serious enough to warrant their review in addition to the IRB Administrator's prior to final approval. The decision is recorded in the meeting minutes.
Disapproved. While this action is very rarely taken, the IRB may disapprove a proposed activity with serious and substantive problems and/or that fails to meet College, Federal or State guidelines for the protection of human participants.

G. Approval period - the IRB has the option (although rarely if ever
used) of approving a project for less than one year and requiring
the investigator to provide required status report within a specified
period of time. This would be so noted in the IRB meeting minutes
and in the approval letter sent to the investigator.

When the IRB Administrator receives complete and satisfactory revisions from the investigator she/he will ask the IRB Secretary to will contact the investigator (and their faculty supervisor if applicable) by phone or email within 2 business days that the project has been approved and they can begin research immediately using the approved consent form, surveys, and interview questions approved by the IRB. They are informed that a formal letter will be coming in the mail. The IRB Secretary will then send a date stamped copy of the final approved consent form and survey and/or interview questions (if appropriate) to be sent to the investigator (and their faculty supervisor if a student) within 3 business days. The date stamped is the day that the IRB met to review the protocol. The protocol is approved for one year from the date of the IRB meeting unless the IRB has mandated a shorter period of time at their meeting. Additionally, the approval letter states that the investigator must contact the IRB Administrator immediately if:

a) there are any modifications needed to the project; b) a subject is
b) injured or complaints are made;
c) the level of risk increases for participants.

H. IRB Consultants - if it is determined that consultants or experts
will be required to advise the IRB in the review of a protocol
(ex. international research) the research protocol will also be
distributed to the consultant or expert prior to the meeting of the IRB.
The IRB Chair or Administrator will decide if this is necessary before
the meeting. If IRB member(s) desire additional expertise as part of
their review then a consultant may be contacted after the initial meeting
and the consultant's response will be provided to the full IRB by email
or written mail after the meeting. At the meeting the IRB will decide if
they need to meet again to consider this information or if this can be
addressed by mail.

I. Research activity involving an outside agency - (e.g. hospital,
public school, etc.), the investigator must secure written approval
on agency letterhead from an appropriate official within the agency
prior to conducting the research. This should be submitted with the
IRB protocol and given to the reviewer(s) with other materials. If it is
not provided when originally submitted, final approval will be delayed
until it is submitted to the IRB Administrator.

5. Continuing Review

A. Operational details - at the beginning of each month the IRB
Administrator's Secretary refers to the IRB log and sends out a standardized two-page memo to all investigators who had their projects approved 11 months ago. The memo (see appendix) reminds the investigator that their project was approved for 12 months and that if they wish to continue they must seek approval for an additional 12 months by submitting the information detailed in the memo to the IRB Administrator immediately.

B. Continuing review process - the information to be submitted to the
IRB Administrator by an investigator seeking continuation of any protocol includes: a) number of subjects involved in the previous year; b) a description if applicable of any adverse events or unanticipated problems involving risks to subjects or others; withdrawal of subjects from the research, or complaints about the research during the previous year; c) a summary of any recent literature, findings or new information about any risks associated with the research; d) a copy of the current informed consent document; e) a general summary of research findings from the previous year; f) detailed explanation of any changes requested for the next year in procedures, recruitment, number and type of participants, etc.

The IRB Administrator's Secretary puts the information for a continuing
review into the original folder for this investigator and contacts the IRB
Chair to review the information. This will be done within 4 business days of receiving the information (during the academic year). The IRB Chair then determines if the project category has changed since it was previously approved. (Projects can only have two continuing reviews - after the third year it must go through the entire IRB approval process).
a) If it fits the activities for an expedited proposal and no substantial changes or problems have occurred then it is sent by the IRB Administrator to one other member of the IRB for expedited review following the same process as detailed on previous pages for expedited review. If minors are involved it is sent to two reviewers in addition to the Chair's review. The IRB Administrator's Secretary will send the reviewers the new information received from the investigator for the continuing review and the original protocol that was approved.
b) If the protocol originally required a full Category 3 review then the same process will be followed as listed for a Category 3 review in the previous section. If there are only minor or no changes to the project the IRB Chair may elect to have the review conducted by mail without a formal meeting. In this case the proposal is mailed to every member of the IRB Board within 2 days of the Chair's decision, by the IRB Administrator's Secretary. Unanimous approval must be received in writing from each Board member for it to be approved. Responses are requested in one week. If unanimous approval is not received from each member of the IRB than a full Board meeting is called by the IRB Chair within 10 business days of receiving the continuing review request.

C. IRB meeting minutes - will document as separate deliberations all actions and votes regarding continuing reviews that require full review.

D. Protocol approval - When the IRB Administrator receives complete
and satisfactory revisions from the investigator or the IRB immediately
approves the continuing review they will ask the IRB Secretary to
contact the investigator (and their faculty supervisor if applicable) and
inform them by phone or email within 2 business days that the project
has been approved and they can begin research immediately using the
approved consent form. The IRB Secretary will then send a date
stamped copy of the final approved consent form, survey and/or
interview questions (if appropriate) and standard approval letter to the investigator (and their faculty supervisor if applicable) within 3 business days. The protocol is approved for one year unless the IRB mandates a shorter period of time. The approval date is the date that all revisions were received and approved if an expedited (Category 2) review, and the date of the IRBmeeting if a full (Category 3) review. Additionally, the approval letter states that the investigator must immediately contact the IRB
Administrator if: a) there are any modifications needed; b) a subject is injured or a complaint made; c) the level of risk increases for participants.

E. Verification from other sources that no material changes have
occurred - if the IRB has received complaints from participants in
research projects or the investigator reports any adverse events the IRB
will seek external verification of the actual process being followed by
the investigator in conducting the research. The IRB Chair and/or IRB
Administrator will themselves with at least one other IRB member
discuss the projects procedures with the investigator, a select group of
participants, and other relevant people. This will be accomplished
within 14 business days upon receiving the request for the continuation
of the protocol. The IRB Administrator will provide the report to the
IRB Board at least 48 hours prior to the IRB meeting to discuss the
issue. The IRB will use this information in their deliberations regarding
approval of the application and impose any modifications or changes
they deem appropriate depending upon the case.

6. Expedited Review of Minor Changes

If modifications to a project fit the category of an expedited review
(Category 2) described previously than the same actions taken for a
review of an expedited process will be utilized. However, if the changes
are substantial and the proposal was originally reviewed as a full
(Category 3) review than the same process for a category 3 review will
be utilized.

7. IRB Review of Projects More Than Annually

Approvals of protocols are generally for one year. In rare circumstances, at an IRB meeting the Board may mandatea shorter approval period is warranted if they feel that the level of risk to participants warrants a shorter approval period. The specific dates of reporting to the IRB will be decided on a case-by-case basis and will be so noted in the minutes of the IRB meeting and the approval letter sent to investigators.

8. IRB Review in Emergency Situations

No biomedical research is conducted at our institution. However, if
a participant in a research study should experience injury or self-harm
during a research project approved by the IRB the IRB Administrator
will call an emergency meeting of the IRB with the project investigator
to address actions to be taken in accordance with the procedures
listed in #9.

9. Reporting to the IRB and Other Agencies

A. The IRB approval letter (and continuing review reminder) sent to
investigators clearly states that any changes in the procedures, consent forms, survey/interview questions, publicity, etc. or any adverse events must be reported immediately to the IRB Administrator. Once the IRB Administrator receives this information she/he will contact the IRB Chair and depending upon the changes or situation and the initial level of review an appropriate course of action will be taken following all of the procedures for the appropriate level of review.

B. Reporting to external agencies including OHRP or any external
funding source of: a) any unanticipated problems involving risks to subjects or others; b) any serious or continuing noncompliance with 45 CFR Part 46; c) or any suspension or termination of IRB approval will be made by the IRB Administrator to the IRB Chair, IRB members, and Provost at SUNY College at Brockport, investigator (and faculty supervisor if applicable), department Chair and School Dean. If the project does have external funding in addition to those individuals previously cited the Research Foundation Operations Manager, the appropriate contact person at OHRP, and the funding agency will also be informed in writing within 2 business days of the reporting of the incident. Appropriate action/investigation will be carried out immediately by the IRB Administrator and IRB Chair to determine the next course of action. All research on this project will cease immediately until resolution of the issue has occurred. The full IRB Board will be provided with all relevant documentation and meet at an emergency meeting with the investigator and any other relevant persons to determine the most appropriate course of action. Their response will be shared in writing with all of the individuals noted above.

10. Retention of IRB Records

The IRB Administrator's Secretary maintains IRB files in the Office of
Academic Affairs by year and numbered sequentially of all protocols
received. Specific information with the number, title, investigator's
name, level of review, and approval date is kept in separate IRB logs
(notebooks) by year.

HHS regulations at 45 CFR 46.115(b) require that IRB records be
retained for at least 3 years after completion of the research. State law
requires they be retained for 6 years - this is our practice. Information
more than 4 years old is boxed, labeled and sent to the College's library
for storage. All records are easily accessible for inspection and copying
by authorized representatives of OHRP and other relevant agencies.

11. Notification to IRB Members

A. IRB minutes - within 3 business days of an IRB meeting the minutes are prepared by the IRB Administrator and emailed to IRB members and d to the investigator (and their faculty supervisor if applicable). Any changes to the minutes are made immediately upon being brought to the attention of the IRB Administrator and revisions disseminated.

B. Notice to IRB of exempt and expedited actions - at the beginning of
each month during the academic year (September - May) a report is
prepared by the IRB Secretary (based upon the IRB log) listing with
number, title, and investigator (and faculty advisor if applicable) a list of
all exempt and expedited proposals approved in the previous month(s) for
their information.

1/03 approved by IRB Board
Minor updates made 8/06 by IRB Administrator