Institutional Review Board (IRB)
The Institutional Review Board
on the Use of Human Subjects in Research
The Institutional Review Board (IRB) is an Albright College committee tasked with the oversight of all research that involves human subjects.
|IRB Mission: To oversee and review all research projects that involve research with human subjects. It is important to note that the IRB reviews all projects, not just externally supported activities. These reviews include faculty/ student research and classroom activities as well. See IRB Policy for more details.|
Human Subject: (from 45 CFR 46, Section 102(f) )
|Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains…
Mandatory Training in Protection of Human Subjects
Albright College requires that all research personnel (faculty, staff and students) who have any role in research involving humans must complete training on the ethical guidelines and regulations regarding the protection of human research participants from research risks.
Please complete the training at the National Institute of Health (NIH) training website regarding human participant research ethics. Please anticipate that training may take 1-3 hours to complete. After completion, you will receive an electronic certificate with a certification number, which you can always retrieve in the future upon logon to the site. The NIH certification must be renewed every three years. Please note, if your research is exempt from IRB review only the Faculty Advisor is required to obtain the NIH certification.
NIH training: http://phrp.nihtraining.com/users/login.php
INSTITUTIONAL REVIEW BOARD
Policies and Procedures
“To protect the rights and welfare of human participants of research conducted by members of the Albright College community, including faculty, administrators, and students. This purpose shall be fulfilled by the review of proposals for such research by members of the IRB. IRB members will determine whether such research meets the standards for ethical conduct of research using human participants, as found in The Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects.”
- The IRB will consist of five faculty, administrative or staff members of Albright College and two faculty members who will serve as alternates.
- Members will serve indefinite terms, left to the discretion of the individual member.
- The Chair of the IRB shall appoint members.
- To the greatest extent possible, members of the IRB should represent divergent disciplines, community attitudes, and demographic backgrounds. The IRB shall include at least one member whose primary concerns and expertise are in scientific areas and at least one member whose primary concerns and expertise are in nonscientific areas.
- If a member of the IRB has an interest in a project under review, an alternate member of the IRB shall serve in that members place for review of that particular project.
- POLICIES AND PROCEDURES:
- Any person who is under the IRBs jurisdiction and wishes to conduct research using human participants (herein called a PI for principal investigator) must seek approval for such research from the IRB prior to the conduct of said research.
- PIs should begin the review process by submitting a completed Research Review Form, with all necessary materials and signatures, to the Chair of the IRB.
- The Chair of the IRB shall determine whether the form is complete. If necessary information or supplemental materials are not included; the form shall be returned to the PI for revision and completion.
- The Chair shall make a determination, based on the Research Review Form, whether the research falls under EXPEDITED or FULL review. Research projects eligible for EXPEDITED review are those which involve no more than minimal risk to the participants or are minor revisions of research previously approved by the IRB within the past three years. All other research is subject to FULL review by the IRB.
- Those projects designated as eligible for EXPEDITED review shall be reviewed by two members of the IRB (or an alternate in cases of conflict of interest). Other members of the IRB will be notified on a yearly basis of the approved projects to ensure that all members are informed of all research projects approved by the IRB.
- All members of the IRB shall review those research projects determined to be subject to FULL review of the IRB. A meeting of the IRB will be held to discuss these research projects and make a decision on whether to approve, disapprove or request modifications to these research projects.
- In order to approve research projects covered by this policy, the IRB shall determine that all of the following requirements are satisfied (for a full description, see section 46.111 of The Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects):
- Risks to participants are minimized.
- Risks to participants are reasonable in relation to anticipated benefits of the research project.
- Selection of participants is equitable, especially for vulnerable populations and for which there appears to be a clear benefit to the participants.
- Informed consent, when necessary, is sought from the participants or their legal representatives. The requirements for informed consent are listed in section 46.116 of The Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects.
- Provisions have been made to monitor and ensure the safety of the participants during the conduct of the research.
- Provisions have been made to protect the privacy of the participants and maintain the confidentiality of the data.
- The IRB will notify the PI in writing of the review decision. The IRB may approve, disapprove or require modifications to secure approval. The IRB shall include in its written notification a statement of the reasons for its decision. If the research project is not approved, the IRB shall give the PI an opportunity to respond in person or in writing to the IRBs decision.
- The IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRBs requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a written statement of the reasons for the IRBs actions and shall be reported promptly to the PI, the PIs supervisor if the PI is a student, and the appropriate Albright officials.
- Any research project not specifically covered by this policy should be referred to the Chair of the IRB to ensure that compliance standards are being met.
IRB Forms (Human Subjects)
Review Application Forms (HRRRF)
Expedited, Exempt, or Full Board Review
*Reference IRB Protocol Review Example Guide
Informed Consent Forms
**Confidential Research Information Sheet
**Anonymous Research Information Sheet
Sample “Web/Email” Consent Form (Updated) (recommended for use with email and SurveyMonkey for Confidential Research)
Sample “Web/Email” Cover Letter (Updated) (recommended for use when using SurveyMonkey for Anonymous Surveys)
Verbal/Oral Informed Consent
(Telephone interviews require the researcher to obtain verbal consent. The investigator should convey essentially the same information on the phone as on a consent form.)
Ages 17 & under
Additional Research Forms
|Adverse Event Form||IRB Adverse Event Form|
|Debriefing||Examples of Debriefing|
Checklists & Guides
Protocol Evaluation Form (used by IRB reviewers)
|Expedited/Exempt/Full Board||Human Research Review Example Guide|
FAQ’s of the IRB
- What is the Institutional Review Board (IRB) and why does it exist?
- Why does Albright have an IRB?
- What are the responsibilities of the IRB?
- What authority does the IRB have?
- What is the difference between Full Board review, Expedited review, and Exempt review?
- What determines whether a study is Exempt, Expedited, or goes to the Full Board?
- Do I need IRB approval before submitting a grant application?
- Do I need to submit an application for Exempt research?
- How long does the human subjects review process take?
- Must investigators obtain training in the protection of human subjects?
- What is the difference between anonymous and confidential research?
- What should I do when my research involves participants with limited English?
- What is a signed site letter of permission and how do I know if I need one?
- Where can I find more information about the IRB process?
- How complete do I have to be in describing my research project?
- Telephone Survey – What sort of review is needed? What sort of consent is required?
What is the Institutional Review Board (IRB) and why does it exist?
The institutional review board or IRB is an independent, administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution.
Why does Albright have an IRB?
As a recipient of federal funds for research, Albright is required to have an IRB that meets federal requirements to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.
As well, Albright is required to register with the Federal Office of Human Research Protections (OHRP) through a process called Federal Wide Assurance. In this Assurance, Albright is given the option to designate whether the College and the IRB will follow federal regulations for only federally funded research or for all research.
What are the responsibilites of the IRB?
In accordance with Title 45 of the Code of Federal Regulations, Part 46.111, in order to approve research, the IRB must determine that all of the following requirements are satisfied:
1. Risks to subjects are minimized.
(a) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(b) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished froms risks and research). The IRB should not consider 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 responsiblity.
3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vunerable populations, such as children, prisoners, pregnant women, elderly, mentally disabled persons and economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by Federal Regulations, Part 46.116.
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by Federal Regulations, Part 46.116.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, elderly, mentally disabled persons, and economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
It is the function of the IRB to: (1) determine and certify that all projects reviewed by the IRB conform to College policies and procedures and the regulations and policies set forth under the Common Rule regarding the health, welfare, safety, rights, and privledges of human subects; and (2) assist the investigator in complying with federal and state regulations.
What authority does the IRB have?
The IRB has the authority to suspend, place restrictions, or terminate the approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with unexpected adverse events. The IRB has the authority to observe or have a third party observe the consent process and the research if the IRB determines it to be indicated.
The IRB jurisdiction extends to all research (funded and not funded) involving human subjects conducted at Albright College, as well as research conducted elsewhere by Albright faculty, staff, and students.
The IRB makes its independent determination whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected.
Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may NOT approve research if iit has been disapproved by the IRB.
If the IRB chair, member, or staff person feels that the IRB has been unduly influenced by any party, corrective action will be taken to prevent additional occurences.
– The review criteria are the same.
– Both types of review are documented communication process between investigators and reviewers.
– Expediting reviewers and the full IRB can request modifications to submissions and can approve protocols, continuing reviews, and amendements to approved protocols.
– Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter reivew periods may be required.
A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB.
Exempt research does not have to be reviwed by the IRB at all. Instead, the determination of exempt is made by the chair of the IRB and the only review of the study is by the IRB chair.
What determines whether a study is Exempt, Expedited, or goes to the Full Board?
Research may be eligible for exemption from the federal regulations if all the activities associated with the research fall into one or more of six categories. Of the six categories, three are frequently used by social and behavioral scientists. They are:
1. Some research conducted in established or commonly accepted educational settings, involving normal educational practices.
2. Some research involving educational tests (cognitive, diagnostic, aptitude acheivement), survey procedures, interview procedures, or observation of public behavior. (NOTE: This category does not apply to research involving children.)
3. Some research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data are publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.
While these studies do not require review in accordance with the federal regulations, some procedure is necessary to make the determination that they are eligible for exemption. Institutional procedures vary, but the common element is that the institution, not the investigator must make the determination.
To be eligible for Expedited review research must meet two criteria:
1. Post no more than minimal risk to subjects.
“No more than 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.”
2. All of the activities associated with the research fall into one or more of the expedited categories specified in the regulations.
Eligible activities are similar to those for Exempt research (some suveys, interviews, and data analysis) with the addition of some minor or non-invasive medical procedures, such as blood pressure readings, weight measurements, MRI use in research and blood draws.
Studies sent to the Full Board for review typically involve potentially vulnerable populations and/or studies that involve sensitive topics including, but not limited to, illegal behaviors, drug use, alcohol use, or other dangerous behaviors and trauma.
In addition, Albright requires all human subject research involving External Funding to be reviewed by the Full Board at a convened meeting.
Do I need IRB approval before submitting a grant application?
No – if you do not have a fully developed human subjects’ protocol, you can still apply for a grant. However, sponsoring agencies and Albright require that in order to proceed with the research, the investigator MUST obtain full board IRB approval prior to enrolling human subject participants in the study.
Do I need to submit an application for Exempt research?
Yes – the Albright human subjects’ policy requires the chair of the IRB to make the initial determination that a protocol is exempt or nonexempt. Albright faculty, staff, and students may not conduct exempt research until they receive exempt notification from the IRB.
How long does the human subjects review process take?
If your research is found to be exempt and informed consent revisions are not required, you should receive an exempt notification email within 3 business days after your completed application is received. If your research is found to be non-exempt and qualifies for an expedited review, your research will be reviewed within two weeks of receiving your complete application. If your research is found to be non-exempt and does not qualify for an expedited review, your research will be reviewed by the full board.
Must investigators obtain training in the protection of human subjects?
The HHS regulations for the protection of human subjects (45 CFR part 46) do not require investigators to obtain training in the protection of human subjects in research. However, an institution holding an OHRP-approved Federal Wide Assurance (FWA) is responsible for ensuring that its investigators conducting HHS-conducted or supported human subjects research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects.
Therefore, as stated in the Terms of the FWA, OHRP strongly recommends that institutions and their designated IRBs establish training and oversight mechanisms (appropriate to the nature and volume of their research) to ensure that investigators maintain continuing knowledge of, and comply with, the following:
– Relevant ethical principles
– Relevant federal regulations
– Written IRB procedures
– OHRP guidance
– Other applicable guidance
– State and local laws; and
– Institutional policies for the protection of human subjects
Furthermore, OHRP recommends that investigators complete appropriate institutional educational training before conducting research on human subjects.
In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health’s (NIH) requirement for the training of key personnel in NIH-sponsored or conducted human subjects research.
What is the difference between anonymous and confidential research?
A response is anonymous if NOBODY but the respondent knows who it came from. For example, a survey questionnaire which is returned without any identifiers at all is anonymous. In contrast, a confidential situation is one in which someone KNOWS the identity of the respondent but that information is protected by some measure(s). For example, if you promise to remove the name from a survey questionnaire and to substitute code numbers, you are protecting confidentiality; but, as long as YOU saw the name you cannot claim it is anonymous. It is important to remember that names are not the only identifiers. If you have only one senior citizen in your class, for example, then a questionnaire passed out to the class which asked for age would not be anonymous. There must be no identifiers for the data to qualify as anonymous; data cannot be made anonymous by stripping identifiers (since whoever stripped the identifiers had an opportunity to know the identities).
What should I do when my research involves participants with limited English?
If you are planning to study a group of human subjects with limited English skills it is your job as the researcher to be responsible for ensuring the participants truly comprehend the purpose of the study, and what will be required for their participation. If the research subject’s native language is not English, please provide assurance in your protocol (not the consent form) that they will only interview subjects with good English speaking/reading/writing skills. Otherwise, the consent form must be translated. Please remember, consent forms must be written at an eighth grade reading level as well as the research subject’s native language.
What is a signed site letter of permission and how do I know if I need one?
A “signed” site letter of permission is required for conducting research at a site other than Albright. Researchers must receive written permission from the site coordinator of the business, institution, or agency they wish to conduct research at. If researchers want to send completely anonymous surveys to an organization and have provided self-addressed stamp envelopes advance permission will not be required.
Please also note, if the research is being conducted at an agency where only the senior member of the staff will be interviewed, then a signed site letter of permission is not necessary. In that case, the person being interviewed would only need to sign a consent form. If your research is being conducted at another Educational institution it will require approval from the IRB of Albright as from the IRB at the institution where the study was peformed.
For help filling out your human research review request form, please reference our IRB Protocol Template.
How complete do I have to be in describing my research project?
You need to describe the project in enough detail that reviewers can understand just what is to be done. It is best to describe the process step-by-step, so you don’t leave something out and/or the reviewer does not confuse one step with another. Remember, the reviewers may not be familiar with the jargon of your field of research. Explain things in terms that an educated layperson can readily understand. If you are in doubt as to whether to include an element in the description, PUT IT IN. Better redundancy and over description than gaps in your account.
Telephone Survey – What sort of review is needed? What sort of consent is required?
It is obviously very difficult to obtain a signed consent form in a telephone exchange. (In these days of ubiquitous fax machines, it not IMPOSSIBLE to do this; but it would be complicated and awkward.) Generally, verbal consent is adequate. However, it must still involve ALL the elements of fully informed consent. In order to verify this, the IRB must review a script of just what will be said to each potential subject to obtain their consent. The IRB must also review the script for the telephone survey, as well as a description of the process of identifying potential subjects and measures to protect the confidentiality of participants.
IRB TRAINING CERTIFICATION:
All Faculty Sponsors, IRB members, and Responsible Researchers are to certify that they are familiar with the ethical guidelines and regulations regarding the protection of human research participants from research risks by having completed, within the last three years, the National Institutes of Health (NIH) training regarding human participant research ethics. Please anticipate that training may take 1-3 hours to complete. After completion, you will receive an electronic certificate with a certification number, which you can record on the Human Research Review Request Form and always retrieve in the future upon logon to the site. Note: If your certification date exceeds 3 years beyond the date of your IRB submission, you are required to re-take the training and gain new certification. The training can be found at the following link.
NIH training: http://phrp.nihtraining.com/users/login.php
Note: Private Investigators whose studies are classified as exempt are not required to complete NIH training however their Faculy Advisors will need to provide their certification credentials on the Human Research Review Request Form.