Institute for Health Research
Institutional Review Board Rules and Guidelines
Adopted by the Trustees
July 1, 2018
The Institute for Health Research (IHR) is an exempt recognized NGO (non-governmental organization). The IHR Institutional Review Board (IHRIRB) has the responsibility to review, and the authority to approve or disapprove, all research activities that are referred to it, including the written Protocol for the research. Moreover, the IHRIRB retains the same responsibility to previously approved activities. IHRIRB has been established by Chartering Resolution of the Board of Trustees of the IHR.
The IHRIRB is established to protect the rights and welfare of human research subjects recruited to participate in holistic health research activities, including research regarding dietary supplements, medical foods, homeopathic remedies, traditional remedies and energetic or biofeedback modalities.
The IHRIRB reviews research proposals to assess the risks and benefits for the human subjects to be studied. Each proposal is reviewed using criteria described in IHRIRB Protection of Human Subjects. The research proposals are reviewed for safety, confidentiality (information about individuals is not released to anyone), degree of benefit, and the need for and quality of informed consent.
IHRIRB Protection of Human Subjects
The IHRIRB ensures that all research observes three principles of ethics: (1) respect for persons; (2) beneficence (to do no harm, and to maximize benefit); and, (3) justice. The IHRIRB looks closely at the negotiation between researcher and each potential volunteer, called the “informed consent process.”
The following table shows how those three ethical principles in research apply to individual volunteers.
|Ethical Principles||Individual Person|
|Respect for Person and Respect for Community||· People are autonomous; researchers must give them required information and obtain their fully informed consent
· The research does only what the person consents to. For instance, people are not identified in results without their explicit consent; they can refuse or withdraw their participation without pressure
· Special people have special concerns. For instance, IHRIRB should include members with expertise about such concerns.
|Beneficence||· Maximize benefits to individual volunteers. For instance, report their findings to them.
· Minimize risks to individuals. For instance, protect their privacy to avoid being stigmatized
|Justice||· People with less power should not be asked to undergo risky research that is of little benefit to them
· People with less power should be included in potentially beneficial research
IHRIRB Protocol Review Standards – Criteria for IRB approval of research
IHRIRB members are responsible for overseeing that:
- The proposed research design (Protocol) is scientifically sound and will not unnecessarily expose subjects to risk.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result.
- Risks to subjects are minimized.
- Subject selection is equitable.
- Informed consent is obtained from research subjects or their legally authorized representative(s).
- Additional protections are required for subjects likely to be vulnerable to coercion or undue influence.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data
The IHRIRB review standards table contains suggested questions that should be asked when considering if a research protocol meets regulatory requirements.
IHRIRB Review Standards Table
|Regulatory review requirement||Suggested questions for IHRIRB discussion|
|1. The proposed research design is scientifically sound & will not unnecessarily expose subjects to risk.||(a) Is the hypothesis clear? Is it clearly stated?
(b) Is the study design appropriate to prove the hypothesis?
(c) Will the research contribute to generalizable knowledge and is it worth exposing subjects to risk?
|2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result.||(a) What does the IHRIRB consider the level of risk to be?
(b) What does the PI consider the level of risk/discomfort/inconvenience to be?
(c) Is there prospect of direct benefit to subjects?
|3. Subject selection is equitable.||(a) Who is to be enrolled? Men? Women? Ethnic minorities? Children (rationale for inclusion/exclusion addressed)? Seriously-ill persons? Healthy volunteers?
(b) Are these subjects appropriate for the protocol?
|4. Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence.||(a) Are appropriate protections in place for vulnerable subjects, e.g., pregnant women, fetuses, socially- or economically-disadvantaged, decisionally-impaired?|
|5. Informed Consent is obtained from research subjects or their legally authorized representative(s).||(a) Does the informed consent document include the required elements?
(b) Is the consent document understandable to subjects?
(c) Who will obtain informed consent (PI, nurse, other?) & in what setting?
(d) If appropriate, is there a children’s assent?
(e) Is the IHRIRB requested to waive or alter any informed consent requirement?
|6. Subject safety is maximized.||(a) Does the research design minimize risks to subjects?
(b) Would use of a data & safety monitoring board or other research oversight process enhance subject safety?
|7. Subject privacy & confidentiality are maximized.||(a) Will personally-identifiable research data be protected to the extent possible from access or use?
(b) Are any special privacy & confidentiality issues properly addressed, e.g., use of genetic information?
The IHRIRB has the authority to approve, require modifications in, or disapprove the research Protocol and all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. If the IHRIRB determines that the research presents significant physical, social, or ethical risks to subjects, the IHRIRB may modify, suspend, or terminate approval research that has been associated with serious harm to subjects.
consist of a diversity of members including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes;
include at least one member with primary concerns in the scientific area and at least one with primary concerns in the non-scientific area;
and include one member otherwise unaffiliated with the .
The potential for conflicts of interest should be considered when selecting membership candidates.
IHRIRB members should complete a computer-based training (CBT) that provides more detailed information about their roles and responsibilities. The IHRIRB Chairperson must have successfully completed the NIH IRB on-line course:
On-line course for researchers:
Functions of the IHRIRB
The IHRIRB will:
conduct initial and continuing review of the research Protocol and the research, and report its findings and actions to the investigator and the institution (IHR);
determine which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IHRIRB review;
ensure prompt reporting to the IHRIRB of proposed changes in a research activity, and ensure that such changes in approved research, during the period for which IHRIRB approval has already been given, may not be initiated without IHRIRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.
ensure prompt reporting to the IHRIRB of any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IHRIRB; and any suspension or termination of IHRIRB approval.
Operations of the IHRIRB
Distribute complete study documentation to all members for review prior to the meeting
Vote to approve, require modifications in (to secure approval), or disapprove research activities based on compliance with IHRIRB policies
Communicate with investigators to convey the need for additional information, IHRIRB decisions, and criteria for appeals.
Provide to investigators or potential investigators information regarding what the research Protocol should contain, and in what order.
IHRIRB Record Requirements
Maintain current list of membership, qualifications, and contact information
Record minutes of meetings
Communications to and from the IHRIRB including annual renewal forms
Records of continuing review
IHRIRB Review Process
The Principal Investigator (PI) must submit a complete Protocol proposal for IHRIRB review. Once the IHRIRB receives the proposal, a letter will be sent to confirm receipt of the proposal. This letter will also inform the PI if any essential components of the Protocol proposal are missing.
The IHRIRB will review the Protocol proposal and initially respond regarding its general conformity to IHRIRB requirements. It is the PI’s responsibility, however, to submit the reviewed proposal to other IHRIRBs, such as a university, health maintenance organization (HMO), hospital, or other federal agency (e.g., CDC, NIH) IHRIRBs, as necessary.
The IHRIRB Chair will assign the Protocol proposal to a committee member who has the most experience and background in the area of study. This committee member will become the Primary Reviewer (PR). Using the detailed checklists herein, the PR will review the proposal.
The PR provides the Chair and IHRIRB committee members with a summary of his or her review. Each IHRIRB committee member receives a copy of the submitted proposal and the PR’s review two weeks prior to the next regularly scheduled IHRIRB meeting.
During the IHRIRB meeting, the committee has an opportunity to discuss the research proposal. The IHRIRB can vote to:
¨ Approve as is, or Approve with Recommendations
¨ Approve with Contingencies
A letter with the decision is mailed to the PI. If the Protocol is approved as is, or approved with recommendations, the work may begin once the IHRIRB receives final letters of approval from all IHRIRBs. If any changes are made to any part of the Protocol, the changes must first be approved by all the IHRIRB members.
If the proposal is approved with contingencies, the work may NOT begin until the PI has responded to the contingencies and has made appropriate changes to the proposal. The revised proposal must be submitted to the IHRIRB for its review. The IHRIRB members will review the PI’s responses at the next regularly scheduled meeting and vote to either approve, approve with further contingencies, defer, or disapprove.
If the proposal is deferred, the work may NOT begin until the PI has responded to IHRIRB requirements. Most deferrals are missing key requirements. The revised proposal must be submitted to the IHRIRB for its review. The IHRIRB members will review the PI’s responses at the next regularly scheduled meeting and vote to either approve, approve with contingencies, defer, or disapprove.
If the proposal is disapproved the work may not be conducted. Most disapprovals are missing essential requirements.
Once the IHRIRB approves a proposal, approvals will remain in effect for one year. At each anniversary of the initial approval, the PI must submit a research status report to the IHRIRB. The annual reviews are in effect for the duration of the project. Should any changes to the protocol occur between reviews by the IHRIRB, the PI should contact and notify the IHRIRB Chair as soon as possible, especially in reference to adverse effects.
At the completion of the project the PI is required to submit a final report to PIHRIRB. The PI must obtain and IHRIRB approval before any public presentation or publication of the data occurs.
Information the Investigator Provides IHRIRB
Overview: Procedures for IHRIRB Review
- Review IHRIRB research guidelines to ensure compliance..
- Review IHRIRB protocols to determine if you are eligible for exemption or expedited review.
- Submit proposal to IHRIRB
- Renew IHRIRB approvals annually.
- Submit annual progress reports.
- Obtain IHRIRB approval for all manuscripts that are to be submitted for publication
A research packet must contain the following items to be considered complete:
- A clear description of the research to be conducted.
- A copy of the consent form.
- Information on the consent process. See Appendix C for more information on informed consent
- If the Principal Investigator or Co-Investigator is faculty of a university or institution, a copy of the university or institution’s IHRIRB decision needs to be submitted.
- A copy of proposed procedures to maintain confidentiality and anonymity.
- If the proposal includes a survey or questionnaire, copies need to be submitted.
A complete application expedites the review process. Please submit the original protocol plus 10 copies to the IHRIRB.
See also Appendix A – Components of a Research Protocol Proposal
Appendix B – Detailed Research Protocol
Annual progress reports
Annual progress reports are usually done at one-year intervals from the date of initial review. The IHRIRB will send an annual renewal form to the Principal Investigator. An annual progress report is considered complete when the investigators provide the following:
- Specification as to whether or not there have been changes to the study protocol since the date of last review.
- Specification as to whether the research project has been completed since the date of last review.
- Total number of subjects enrolled.
- Total number of subjects withdrawing from the project.
- Total number of subjects withdrawing within the past 12 months of the project.
- Identification of all instances of complications or unexpected results of study activity.
- Documentation of internal review of results to date.
A complete progress report expedites the review process. If you have any questions, please do not hesitate to contact any individual in the contact lists.
A manuscript review packet must contain the following items to be considered complete:
- If an author is an employee of , the manuscript must include the standard disclaimer: “The opinions expressed in this paper are those of the author and do not necessarily reflect the views of .”
- A copy of the IHRIRB approval letter.
- The name of the Journal the article will appear in.
- Anticipated date for submission of publication.
- A copy of the manuscript including authors, title, abstract, article, and references.
Expedited review procedures
Expedited review procedures may be judged appropriate for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
Research that may be reviewed by the IHRIRB through an expedited review procedure includes:
1) some or all of the research found by the reviewer to involve no more than minimal risk,
2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be carried out by the IHRIRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IHRIRB. In reviewing the research, the reviewers may exercise all of the authorities of the IHRIRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure.
In the case of an expedited review procedure, all members shall be advised of research proposals which have been approved under this procedure.
Components of a Research Protocol Proposal
The IHRIRB’s assessment of your research proposal involves a series of steps: (1) identifying the risks associated with the research, as distinguished from the risks the participants would experience even if not participating in the research; (2) determining that risks will be minimized; (3) identifying the probable benefits to be derived from the research; (4) determining that risks are reasonable in relation to the benefits to the participants, if any, and the importance of the knowledge to be gained; (5) ensuring that potential participants will be provided with an accurate and fair description of the risks or discomforts of the anticipated benefits; and (6) determining the intervals of periodic review.
To ensure that the IHRIRB completes their review in a timely manner, your proposal must include the following information, as applicable:
¨ Cover letter with a list of all investigators and a contact person and telephone number
¨ Detailed protocol of study design, sampling, analyses, timelines, evaluation, and community involvement
¨ Informed consent and assent forms
¨ Other attachments, such as a copy of scripts or survey that will be used, materials that will be distributed, etc.
If your proposal is missing any required items, review of your proposal will be delayed.
Detailed Research Protocol
Your research Protocol should discuss in detail how you plan to carry out the research, how you will analyze the data that you collect, and what you plan to do with the results. The following are points that you should address in your protocol.
Introduction and Background
¨ Provide relevant research background and explain why this activity is necessary or important.
¨ Describe the potential impact of the proposed research.
¨ Provide a complete description of the study design, sequence, and timing of all study procedures that will be performed. Provide this information for pilot, screening, intervention, and follow-up phases. Include all materials that will be used in the procedure, such as surveys, scripts, questionnaires, etc. Attach flow sheets if they will help the reader understand the procedures.
¨ Describe how study procedures differ from standard care or procedures (e.g., medical, psychological, educational, etc.).
¨ If any deception or withholding of complete information is required, explain why this is necessary and attach a debriefing statement.
¨ Describe where the study will take place
¨ A letter of approval and cooperation from each participating site is needed. For example, if the study will be conducted in the local school system, an approval letter from the School Board and Superintendent are necessary.
¨ Explain how the nature of the research requires or justifies using the participant population.
¨ Provide the approximate number and ages for the control and experimental groups.
¨ Describe the gender and minority representation of the participant population.
¨ Describe the criteria for selection for each participant group.
¨ Describe the exclusion criteria exclusion for each participant group.
¨ Describe the source for participants and attach letters of cooperation from agencies, institutions, or others involved in the recruitment.
¨ Explain who will approach the participants and how the participants will be approached. Explain what steps you will take to avoid coercion and protect privacy. Submit advertisements, flyers, contact letters, and phone contact protocols.
¨ Explain if participants will receive payments, services without charge, or extra course credit.
¨ Explain if participants will be charged for any study procedures.
Risks and Benefits
¨ Describe the nature and amount of risk of injury, stress, discomfort, invasion of privacy, and other side effects from all study procedures, drugs, and devices. Describe the amount of risk the community may be subjected to.
¨ Describe how due care will be used to minimize risks and maximize benefits.
¨ Describe the provisions for a continuing reassessment of the balance between risks and benefits.
¨ Describe the data and safety monitoring committee, if any.
¨ Describe the expected benefits for individual participants, the community, and society.
¨ Describe how adverse effects will be handled.
¨ Discuss if facilities and equipment are adequate to handle possible adverse effects.
¨ Explain who will be financially responsible for treatment of physical injuries resulting from study procedures (e.g., study sponsor, subject, organization compensation plan, etc.).
Confidentiality of Research Data
¨ Explain if data will be anonymous (no possible link to identifiers).
¨ Explain if identifiable data will be coded and if the key to the code will be kept separate from the data.
¨ Explain if any other agency or individual will have access to identifiable data.
¨ Explain how data will be protected (e.g., computer with restricted access, locked file, etc.).
Consent Forms and Assent Forms
¨ If the consent form is written, submit copies of all consent and assent forms for each participant group. If an oral consent or assent script will be used, submit written scripts for each group.
¨ If you will not use a consent form or script, submit written justification of waiver of consent.
Drugs, Substances, and Devices
¨ List all non-investigational drugs or other substances that will be used during the research. Include the name, source, dose, and method of administration.
¨ List all investigational drugs or substances to be used in the study. Include the name, source, dose, method of administration, IND number, and phase of testing. (INDs must be registered with the appropriate institutional pharmacy.) Provide a concise summary of drug information prepared by the investigator, including available toxicity data, reports of animal studies, description of studies done in humans, and drug protocol.
¨ List all investigational devices to be used. Provide the name, source, description of purpose, method, and Food and Drug Administration IDE number. If no IDE is available, explain why the device qualifies as a non-significant risk. Attach a copy of the protocol, descriptions of studies in humans and animals, and drawings or photographs of the device.
¨ Describe how materials with potential radiation risk will be used (e.g., X-rays and radioisotopes).
¨ If you will use materials with potential radiation risk, describe the status of annual review by the Radiation Safety Committee. If the annual review has been approved, attach a copy of the approval.
¨ Describe the medical, academic, or other personal records that will be used.
¨ Describe the type of audio-visual recordings, tape recordings, or photographs that will be made.
¨ Explain if the Scientific Instrument Division will test all instruments. If not, describe the safety testing procedures.
Informed consent is one of the primary ethical requirements underpinning research with human participants; it reflects the basic principle of respect for people. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or discrete moment of time. Informed consent ensures that prospective participants will understand the nature of the research and can knowledgably and voluntarily decide whether or not to participate. This protects both the participant, whose autonomy is respected, and the investigator, who otherwise faces legal hazards.
The Nuremburg Code, developed by the International Military Tribunal that tried Nazi physicians for the “experiments” they performed on unconsenting inmates of concentration camps, was the first widely recognized document to deal explicitly with the issue of informed consent and experimentation on human participants. The first principle of the code states:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
All subsequent codes and regulations, insofar as they pertain to competent, adult participants, follow these principles closely.
Federal regulations require that certain information must be provided to each participant:
¨ A statement that the study involves research, an explanation of the purposes of the research and the expected duration of participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
¨ A description of any reasonably foreseeable risks or discomforts to the participants.
¨ A description of any benefits to the participant or to others which may reasonably be expected from the research.
¨ A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
¨ A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
¨ For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
¨ An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant.
¨ A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
The regulations further provide that the following additional information be provided to participants, where appropriate:
¨ A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
¨ Anticipated circumstances under which the participant’s participation may be terminated by the investigator without the participant’s consent.
¨ Any additional costs to the participant that may result from participation in the research.
¨ The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant. If your study offers compensation for participation, specify the effects of termination of participation on that compensation. (The compensation should be prorated to reflect the duration of participation rather than an “all or nothing” so that it appears fair and non-coercive).
¨ A statement that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue.
¨ The approximate number of participants involved in the study.
Investigators may seek consent only under circumstances that provide the prospective participant or his or her representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the participant or representative. The consent process may not involve the use of exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence.
In your research protocol, you will need to explain the process of administering consent. The protocol should address the following questions:
¨ Is consent obtained in a reasonably quiet, unhurried setting?
¨ Is there a knowledgeable person present who can answer questions in a clear manner, using layman terms?
¨ Will this knowledgeable individual assess the participant’s comprehension?
¨ Have you considered the availability of translators for those who may only speak their native language? Similarly, if you may be including participant who are illiterate, deaf, blind, etc., have you accommodated their needs?
¨ Do you plan to provide a copy of the consent form to each participant ?
¨ If children (under age 18) are involved in your study, do you have a parental consent form? If the study involves minimal risk, then consent of one parent is adequate; if it involves more than minimal risk, then you must obtain permission of both parents.
¨ If the child is old enough to make at least some decisions themselves (usually at least 5 or 6 years of age, but this is specific to their culture), have you set up a form and process for their assent?
¨ Who will explain the research to the potential participants? Should someone in addition to or other than the investigator be present?
¨ Should participants be reeducated and their consent required periodically?
¨ If a waiver of some or all of the consent requirements is requested, does the importance of the research justify such a waiver? Is more than minimal risk involved? Can the research design be modified to eliminate the need for deception or incomplete disclosure? Will participants be given more information after completing their participation? Would the information to be withheld be something prospective participants might reasonably want to know in making their decision about participation?
In addition to a detailed discussion of the components of the consent and assent forms and the administration process, you will need to include labeled copies of each form specifying its type (e.g., parental consent, child assent, regular consent), participant (e.g., community focus group members, adult vaccine recipients), and situation where it will be used (e.g., for pretest of screening instrument, administration of provider questionnaire, etc.)
Sample Informed Consent
INFORMED CONSENT AND RELEASE
Informed Consent and Release
- The undersigned understands that the Researcher and any organization through which the Researcher conducts research evaluations only, acts for religious, charitable, scientific research and educational purposes. The organization(s) and Researcher(s) do not diagnose, prescribe for, or treat disease conditions; nor do they claim to prevent, mitigate or cure disease conditions.
Persons who suspect medical conditions are advised to seek an appropriate health care professional. Our research may support wellness and healing, and may support treatment, but is not a treatment of disease by itself. It is no substitute for a licensed physician’s diagnosis and treatment. If the undersigned has been diagnosed by a licensed physician, the undersigned will disclose this information to the Researcher. Clinical trial, clinical study or experimental subjects may receive a placebo only and not any therapy or treatment being researched..
- The undersigned does hereby give Informed Consent for research to be performed.
- The organization and Researcher(s) do not make any representations, promises or guarantees. The recommendations and modalities used are not intended to, and will not, prevent, mitigate, treat or cure any disease condition, including, but not limited to, cancer and immune deficiency diseases.
- The undersigned does hereby accept full responsibility for the use of these procedures and advice, releasing, indemnifying and holding the organization and Researcher(s) harmless from all claims arising from participation in these procedures. The undersigned acknowledges that the Researcher(s) does not diagnose, treat or claim to prevent, mitigate or cure human disease. The undersigned agrees that the undersigned will not bring a complaint or lawsuit against the organization or Researcher(s) for any reason, including, but not limited to, the grounds that these recommendations and modalities are experimental, or are not approved, accepted or acknowledged to be effective.
- The undersigned does hereby give the organization and Researcher(s) permission to use the information gathered during these procedures, with personal identification removed (anonymous data), for research and educational purposes.
Dated: _______________________, 20___.
Research Practitioner Signature Client Signature
Consent form Copyright 2018 Ralph Fucetola JD